Athough most artificial joints resemble the shape and structure of the joint they're designed to replace, one new prosthesis the reverse shoulder takes a different approach, reversing the position of the normal ball-and-socket design. The purpose of this anatomical flip-flop is to give you a shoulder that is stable enough to let you raise your arm, even if your rotator cuff is torn beyond repair, according to Cleveland Clinic's Arthritis Advisor.
"When we replace a shoulder joint, it's normally with a traditional, anatomically shaped design," says Joseph P. Iannotti, M.D., Ph.D., chairman of the department of orthopaedic surgery at Cleveland Clinic. "But this design only makes sense if the tears in your rotator cuff are repairable."
A working rotator cuff is the key to normal shoulder function since it's this group of four tendons encircling the shoulder that keeps the joint stable, holding the head of the humerous firmly against the curve of the scapula (glenoid cavity). Only when this head is stable can it act as an effective fulcrum, allowing the pull of your rotator cuff and deltoid muscles to raise your arm.
Loss of function
"As you age, it's not uncommon to develop a large tear in your rotator cuff," says Dr. Iannotti. "We often see tears in people in their 60s and 70s that may have been there for months or even years."
At some point, when a tear develops, the rotator cuff is unable to hold the humeral head within the socket, allowing it to slip out of place, hindering shoulder function. "Such tears can lead to pseudo or functional paralysis," says Dr. Iannotti. "Though your nerves are fully functional, you can no longer raise your arm to shoulder level."
If the tear is repairable, the shoulder muscles not too atrophied, and the shoulder has severe arthritis, your surgeon will likely recommend a traditional shoulder prosthesis whose design mimics the natural position of the humeral head (ball) and scapular depression (socket). This anatomic design is an effective solution as long as your repaired rotator cuff can provide adequate stability to the new joint.
"Some 20 to 30 percent of patients with significant rotator cuff tears and arthritis still have enough residual function to raise their arms to shoulder level before surgery, and are still good candidates for an anatomic prosthesis," says Dr. Iannotti.
Reverse-shoulder prerequisites However, if your tears are irreparable, the pain from arthritis is significant and, most importantly, you are unable to lift your arm to 90 degrees, then you may be a candidate for a reverse-shoulder procedure. Though the reverse shoulder prosthesis (made by DePuy, Tornier, Encore, and Zimmer) has been used clinically in Europe for more than two decades, it only received approval from the U.S. Food and Drug Administration in November 2004.
"Though I mostly recommend reverse shoulders for those over age 70, it can also make sense for younger patients who have a previous shoulder implant that has failed," says Dr. Iannotti, who has performed more than 120 of the procedures.
Candidates for a reverse shoulder must meet two other criteria good deltoid muscle function and a healthy glenoid bone. The importance of these is best explained by looking at the design of the reverse shoulder prosthesis.
Stable by design
As the name implies, the reverse shoulder flip-flops the normal position of the shoulder's ball and socket, putting a metal (titanium) stem topped with a plastic cup where the head of your humerus was and, on the other side, putting a metal plate and partial sphere (glenosphere) where the depression (glenoid cavity) on your scapula was. According to design engineers, this reversal changes the center of rotation within the joint, making the new head of the prosthesis inherently stable, regardless of the health of your rotator cuff.
With this design, good glenoid bone quality is a must because the bone must hold the screws which anchor the plate that holds the metal glenosphere. A functioning deltoid muscle is important since the new prosthesis depends upon this muscle for its arm-lifting power.
"As long as you have about 75 percent deltoid function, you'll be eligible for a reverse shoulder," says Dr. Iannotti.
Measured expectations
The range of motion you regain with a reverse shoulder will depend, in part, on how much function remains in your rotator cuff. "At a minimum, even with a little or no cuff function, you should be able to raise your arm to shoulder level," says Dr. Iannotti. "And those who retain at least partial function, especially in the posterior rotator cuff tendons, will often obtain 120 to 140 degrees of shoulder elevation."
Of course, getting to that point means a serious commitment to rehabilitation. The rehab program with a reverse shoulder is similar to that with an anatomic shoulder design, but it often can begin a bit sooner, since the shoulder's more innately stable design is less dependent on the health and healing of surrounding tissues.
Imperfect solution
Though a reverse shoulder can be a big help to certain people, it's far from an ideal solution. "The nature of the design puts a higher than normal load on the screws that are anchored into the glenoid process and, with repeated stress, can become loose and cause premature failure," explains Dr. Iannotti, who still views the reverse shoulder as a last-resort salvage solution in very selected patients.
"The reverse shoulder remains a complex procedure, for which there is not enough data to know long-term greater than 10-year results," says Dr. Iannotti. "What we do know is that, for a select group, it may be the best hope for more normal shoulder function."
Are You a Candidate?
If you experience or have one or more of the following, you may be eligible for a reverse shoulder procedure:
-- Severe shoulder arthritis with ongoing pain
-- Inability to raise extended arm to shoulder height
-- Irreperable large or massive rotator cuff tears
-- Healthy bone stock in scapula clavicle (glenoid cavity)
-- Functioning deltoid muscle
-- At least 65 years old, but younger if you've experienced failure of a previous shoulder replacement
Belvoir Media Group, LLC.
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суббота, 21 мая 2011 г.
пятница, 20 мая 2011 г.
Using Statins To Potentially Treat Rheumatoid Arthritis
Study finds statins have beneficial effect on rheumatoid arthritis cells in vitro
Statins, a class of drugs widely used to treat high cholesterol, have also recently been studied for their potential role in inflammation and other cell processes, including immune response. They have also been shown to induce apoptosis (cell death) in normal cells and tumor cells. Rheumatoid arthritis (RA) causes proliferation of synovial tissue, which lines the joints, but little is known about the effect of statins on this type of tissue. A study published in the February 2006 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis) examined whether statins are able to induce apoptosis in synovial cells of patients with RA and found that they have potential as a novel way of treating the disease.
The activation and proliferation of synovial cells, which is thought to play a key role in RA, may be exacerbated when apoptosis of synovial cells is either insufficient or resistant to treatment. In the first study to demonstrate whether statins can induce apoptosis in synovial cells of RA patients, researchers led by Takao Nagashima of Jichi Medical School, Tochigi, Japan measured the effect in vitro of two statins, fluvastatin (a fat-soluble statin) and pravastatin (a water-soluble statin) on human synovial cells from patients with RA and osteoarthropathy. "In the present study, we demonstrated that fluvastatin induced apoptosis in synoviocytes from patients with RA, but not in those from patients with osteoarthropathy, suggesting that the apoptotic effect of fluvastatin is a mechanism for suppression of inflammatory arthritis such as RA by statins," the authors state.
They were also able to determine the pathway by which apoptosis occurred: the inhibition of protein geranygeranylation (a process involving the metabolism of certain proteins that is essential for proper cell function, including the survival of vascular smooth muscle cells) was shown to be necessary for apoptosis to occur in these cells. Specifically, the pathway involves inhibition of the geranylgeranylated protein RhoA/RhoA kinase, which has already been shown to be involved in apoptosis.
The researchers point out that the in vitro concentrations they used of the statins were much higher than amounts that would normally be prescribed to patients. Although they note that it is possible that in the human body relatively low, but sustained, blood levels of statins would exert an effect similar to that seen in vitro with higher concentrations and short incubation times, they acknowledge that the therapeutic effect of fluvastatins in patients remains to be determined.
The authors conclude: 'The induction of apoptosis in RA synovial cells by fluvastatin and the biologic antiatherosclerotic properties of the statins suggest that they may turn out to be ideal therapeutic agents in RA. Based on these results, we propose that the statins warrant clinical trials as potential modifiers of RA."
Article: "Apoptosis of Rheumatoid Synovial Cells by Statins Through the Blocking of Protein Geranlgeranylation," Takao Nagashima, Hitoaki Okazaki, Kazuo Yudoh, Hiroaki Matsuno, Seiji Minota, Arthritis & Rheumatism, February 2006; 54:2; pp. 579-586.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc./
Statins, a class of drugs widely used to treat high cholesterol, have also recently been studied for their potential role in inflammation and other cell processes, including immune response. They have also been shown to induce apoptosis (cell death) in normal cells and tumor cells. Rheumatoid arthritis (RA) causes proliferation of synovial tissue, which lines the joints, but little is known about the effect of statins on this type of tissue. A study published in the February 2006 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis) examined whether statins are able to induce apoptosis in synovial cells of patients with RA and found that they have potential as a novel way of treating the disease.
The activation and proliferation of synovial cells, which is thought to play a key role in RA, may be exacerbated when apoptosis of synovial cells is either insufficient or resistant to treatment. In the first study to demonstrate whether statins can induce apoptosis in synovial cells of RA patients, researchers led by Takao Nagashima of Jichi Medical School, Tochigi, Japan measured the effect in vitro of two statins, fluvastatin (a fat-soluble statin) and pravastatin (a water-soluble statin) on human synovial cells from patients with RA and osteoarthropathy. "In the present study, we demonstrated that fluvastatin induced apoptosis in synoviocytes from patients with RA, but not in those from patients with osteoarthropathy, suggesting that the apoptotic effect of fluvastatin is a mechanism for suppression of inflammatory arthritis such as RA by statins," the authors state.
They were also able to determine the pathway by which apoptosis occurred: the inhibition of protein geranygeranylation (a process involving the metabolism of certain proteins that is essential for proper cell function, including the survival of vascular smooth muscle cells) was shown to be necessary for apoptosis to occur in these cells. Specifically, the pathway involves inhibition of the geranylgeranylated protein RhoA/RhoA kinase, which has already been shown to be involved in apoptosis.
The researchers point out that the in vitro concentrations they used of the statins were much higher than amounts that would normally be prescribed to patients. Although they note that it is possible that in the human body relatively low, but sustained, blood levels of statins would exert an effect similar to that seen in vitro with higher concentrations and short incubation times, they acknowledge that the therapeutic effect of fluvastatins in patients remains to be determined.
The authors conclude: 'The induction of apoptosis in RA synovial cells by fluvastatin and the biologic antiatherosclerotic properties of the statins suggest that they may turn out to be ideal therapeutic agents in RA. Based on these results, we propose that the statins warrant clinical trials as potential modifiers of RA."
Article: "Apoptosis of Rheumatoid Synovial Cells by Statins Through the Blocking of Protein Geranlgeranylation," Takao Nagashima, Hitoaki Okazaki, Kazuo Yudoh, Hiroaki Matsuno, Seiji Minota, Arthritis & Rheumatism, February 2006; 54:2; pp. 579-586.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc./
четверг, 19 мая 2011 г.
CEL-SCI Study Shows CEL-2000 Vaccine Blocks Progression Of Rheumatoid Arthritis
CEL-SCI Corporation (NYSE CVM) and their scientific collaborators announced that the Company's CEL-2000 vaccine demonstrated that it is able to block the progression of rheumatoid arthritis (RA) in a mouse model. The results were published in the scientific peer-reviewed Journal of International Immunopharmacology (online edition) in an article titled "CEL-2000: A Therapeutic Vaccine for Rheumatoid Arthritis Arrests Disease Development and Alters Serum Cytokine / Chemokine Patterns in the Bovine Collagen Type II Induced Arthritis in the DBA Mouse Model" with lead author Dr. Daniel Zimmerman. The study was co-authored by scientists from CEL-SCI, Washington Biotech, Northeastern Ohio Universities Colleges of Medicine and Pharmacy (NEOUCOMP) and Boulder BioPath.
CEL-2000, administered after disease (RA) symptoms had started, prevented, in a statistically significant manner, the further development of arthritic conditions, including joint swelling and deformation, bone and cartilage changes and was accompanied by serum cytokine alterations over the CEL-2000 treatment period with comparable or better activity than the well accepted etanercept (Enbrel®) therapy. The mode of action is very consistent with the findings of induction of IL-12 followed by interferon gamma and an inhibition of TNF-alpha and IL-17 production. TNF-alpha and IL-17 are both key cytokines for induction of the pathology seen in rheumatoid arthritis and TNF-alpha is the target of many current RA therapies such as Enbrel, Remicaid, and Humaria. The protection effect mediated by CEL-2000 treatment against RA was also demonstrated histologically with significant reductions in: 1) inflammation, 2) cartilage destruction, 3) bone resorption, and 4) pannus membrane formation in the synovial space compared to untreated controls.
Geert Kersten, Chief Executive Officer of CEL-SCI said, "These experimental results were achieved through a reduction of the inflammatory response that is known to attack the patients' joints. The mode of action of CEL-2000 in RA appears to be similar to our new investigational therapy for H1N1 hospitalized patients, as it attempts to avoid the excess TNF-alpha and other pro-inflammatory cytokines. We feel that this new data is encouraging both for this rheumatoid arthritis vaccine as well as in support of our H1N1 treatment currently under development."
In these studies, mice were injected with collagen to induce the autoimmune (RA) disease. Therapy with Enbrel or CEL-2000 was initiated after disease (RA) symptoms have been established and treatment continued for 28 days after the initiation of a significant, uniform, and measurable level of arthritic disease in groups of mice. CEL-2000 was administered only twice, however Enbrel had to be administered every other day for the 28 day study period (as indicated for Enbrel use). The extent of disease, as measured by deformation of foot joints (Arthritic Index (AI) score), of untreated animals and any improvements resulting from CEL-2000 and Enbrel treated animal were then compared. In another study, CEL-2000 was administered 5 times over a 70 day period and the animals were monitored for a total study period of 90 days. In each case, CEL-2000 treatment proved effective in blocking progression of disease (RA) with statistically significant reduction in AI score compared to controls. The CEL-2000 treatment was deemed safe and well tolerated without any reported adverse effects related to treatment.
The CEL-2000 treatment appeared to change the course of the immune response in the diseased (RA) animals, limiting the development of the destructive action of Th17 and tumor necrosis factor alpha (TNF-alpha). Analysis of serum levels of 21 cytokines/chemokines after 10 days of CEL-2000 treatment indicated reductions in the characteristic cytokine markers of rheumatoid arthritis, TNF-alpha and IL-17, as well as IL-6, and MCP-1. A number of cytokine changes were also seen with Enbrel treatment, but to a lesser degree than that seen with CEL-2000 treatment.
CEL-2000 may also offer a number of potential advantages over existing rheumatoid arthritis treatments, such as Enbrel. Data collected in the animal studies conducted with CEL-2000 demonstrated that CEL-2000 is an effective treatment against rheumatoid arthritis even with administration of many fewer treatments than for example Enbrel. CEL-2000 is also potentially a more disease-type specific therapy, should be significantly less expensive to manufacture, and finally, CEL-2000 could also be useful for patients who are not able to take or who may be unresponsive to other existing anti-arthritis therapies.
This research featured the multidisciplinary team of collaborators bringing to the project expertise of several different animal models of arthritis (Washington Biotech), long time association with modern molecular therapies and evaluation for RA (Bolder Biopath), experience with other LEAPS immunogens, and experience and expertise studying cytokines and with mechanistic studies of the LEAPS technology (NEOUCOMP), and peptide technologies (21st Century Biochemicals) to complement the expertise of the CEL-SCI researchers.
Rheumatoid arthritis treatments comprise an approximately $13 billion market. Enbrel, a leading rheumatoid arthritis treatment sold by Amgen and Wyeth, reported US sales in 2007 of about $3.2 billion. Enbrel is a soluble recombinant protein of a human TNF-alpha receptor linked to human IgG Fc. In some cases, human or humanized monoclonal antibodies specific against TNF-alpha have also been used for therapy in rheumatoid arthritis. These therapies remove or inactivate TNF-alpha, a natural human cytokine required in many immune functions for normal defenses.
CEL-SCI's rheumatoid arthritis vaccine CEL-2000 was discovered as part of work with the Company's ongoing research and development activities with its L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. Any disease for which an antigenic sequence has been identified, such as infectious, parasitic, malignant or autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S. technology.
The concept behind the L.E.A.P.S. technology is to directly mimic cell-cell interactions and activate immune cells with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to a immune-cell binding ligand (ICBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S. construct and ICBL used, CEL-SCI is able to direct the outcome of the immune response towards the development of T-cell function with primarily effector T-cell functions (T Lymphocyte; helper/effector T lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]). Therefore, it would appear that the L.E.A.P.S. construct represents a chimeric peptide with bi-functional behavior.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2009. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Source: CEL-SCI Corporation
View drug information on Enbrel.
CEL-2000, administered after disease (RA) symptoms had started, prevented, in a statistically significant manner, the further development of arthritic conditions, including joint swelling and deformation, bone and cartilage changes and was accompanied by serum cytokine alterations over the CEL-2000 treatment period with comparable or better activity than the well accepted etanercept (Enbrel®) therapy. The mode of action is very consistent with the findings of induction of IL-12 followed by interferon gamma and an inhibition of TNF-alpha and IL-17 production. TNF-alpha and IL-17 are both key cytokines for induction of the pathology seen in rheumatoid arthritis and TNF-alpha is the target of many current RA therapies such as Enbrel, Remicaid, and Humaria. The protection effect mediated by CEL-2000 treatment against RA was also demonstrated histologically with significant reductions in: 1) inflammation, 2) cartilage destruction, 3) bone resorption, and 4) pannus membrane formation in the synovial space compared to untreated controls.
Geert Kersten, Chief Executive Officer of CEL-SCI said, "These experimental results were achieved through a reduction of the inflammatory response that is known to attack the patients' joints. The mode of action of CEL-2000 in RA appears to be similar to our new investigational therapy for H1N1 hospitalized patients, as it attempts to avoid the excess TNF-alpha and other pro-inflammatory cytokines. We feel that this new data is encouraging both for this rheumatoid arthritis vaccine as well as in support of our H1N1 treatment currently under development."
In these studies, mice were injected with collagen to induce the autoimmune (RA) disease. Therapy with Enbrel or CEL-2000 was initiated after disease (RA) symptoms have been established and treatment continued for 28 days after the initiation of a significant, uniform, and measurable level of arthritic disease in groups of mice. CEL-2000 was administered only twice, however Enbrel had to be administered every other day for the 28 day study period (as indicated for Enbrel use). The extent of disease, as measured by deformation of foot joints (Arthritic Index (AI) score), of untreated animals and any improvements resulting from CEL-2000 and Enbrel treated animal were then compared. In another study, CEL-2000 was administered 5 times over a 70 day period and the animals were monitored for a total study period of 90 days. In each case, CEL-2000 treatment proved effective in blocking progression of disease (RA) with statistically significant reduction in AI score compared to controls. The CEL-2000 treatment was deemed safe and well tolerated without any reported adverse effects related to treatment.
The CEL-2000 treatment appeared to change the course of the immune response in the diseased (RA) animals, limiting the development of the destructive action of Th17 and tumor necrosis factor alpha (TNF-alpha). Analysis of serum levels of 21 cytokines/chemokines after 10 days of CEL-2000 treatment indicated reductions in the characteristic cytokine markers of rheumatoid arthritis, TNF-alpha and IL-17, as well as IL-6, and MCP-1. A number of cytokine changes were also seen with Enbrel treatment, but to a lesser degree than that seen with CEL-2000 treatment.
CEL-2000 may also offer a number of potential advantages over existing rheumatoid arthritis treatments, such as Enbrel. Data collected in the animal studies conducted with CEL-2000 demonstrated that CEL-2000 is an effective treatment against rheumatoid arthritis even with administration of many fewer treatments than for example Enbrel. CEL-2000 is also potentially a more disease-type specific therapy, should be significantly less expensive to manufacture, and finally, CEL-2000 could also be useful for patients who are not able to take or who may be unresponsive to other existing anti-arthritis therapies.
This research featured the multidisciplinary team of collaborators bringing to the project expertise of several different animal models of arthritis (Washington Biotech), long time association with modern molecular therapies and evaluation for RA (Bolder Biopath), experience with other LEAPS immunogens, and experience and expertise studying cytokines and with mechanistic studies of the LEAPS technology (NEOUCOMP), and peptide technologies (21st Century Biochemicals) to complement the expertise of the CEL-SCI researchers.
Rheumatoid arthritis treatments comprise an approximately $13 billion market. Enbrel, a leading rheumatoid arthritis treatment sold by Amgen and Wyeth, reported US sales in 2007 of about $3.2 billion. Enbrel is a soluble recombinant protein of a human TNF-alpha receptor linked to human IgG Fc. In some cases, human or humanized monoclonal antibodies specific against TNF-alpha have also been used for therapy in rheumatoid arthritis. These therapies remove or inactivate TNF-alpha, a natural human cytokine required in many immune functions for normal defenses.
CEL-SCI's rheumatoid arthritis vaccine CEL-2000 was discovered as part of work with the Company's ongoing research and development activities with its L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. Any disease for which an antigenic sequence has been identified, such as infectious, parasitic, malignant or autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S. technology.
The concept behind the L.E.A.P.S. technology is to directly mimic cell-cell interactions and activate immune cells with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to a immune-cell binding ligand (ICBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S. construct and ICBL used, CEL-SCI is able to direct the outcome of the immune response towards the development of T-cell function with primarily effector T-cell functions (T Lymphocyte; helper/effector T lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]). Therefore, it would appear that the L.E.A.P.S. construct represents a chimeric peptide with bi-functional behavior.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2009. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Source: CEL-SCI Corporation
View drug information on Enbrel.
среда, 18 мая 2011 г.
MabThera for moderate-severe rheumatoid arthritis, good study results
Roche together with development partners Genentech and Biogen Idec announced today that a Phase IIb clinical study of
MabThera/Rituxan (rituximab) met its primary endpoint of a greater proportion of MabThera-treated patients achieving an
American College of Rheumatology (ACR) 20 response at week 24, compared to placebo, in patients who were also treated with
methotrexate (MTX). In this study, patients with moderate-to-severe rheumatoid arthritis (RA) who received two infusions of
MabThera over a two-week period in combination with a stable dose of MTX experienced improved symptoms compared to patients
who received placebo and MTX. The benefit in the MabThera/Rituxan treated patients was present regardless of whether
additional corticosteroids were administered.
"The preliminary data from this latest study in rheumatoid arthritis confirms MabThera as a promising alternative to current
therapies available to patients with RA and are consistent with earlier data showing efficacy and safety of MabThera. As we
continue to explore and evaluate MabThera as a potential treatment for RA, we look forward to the results of ongoing analyses
which will be presented next year", commented Dr. Eduard Holdener, Head of Global Pharma Development, Roche.
This Phase IIb study, DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of
Rituximab in RA), was designed to evaluate the efficacy and safety of varying doses of MabThera/Rituxan in combination
with methotrexate in patients with active RA who currently have an inadequate response to methotrexate. The influence of a
short initial course of corticosteroids was also evaluated.
All regimens in the study were generally well tolerated. The reported rate of serious adverse events was not significantly
different than seen in previous studies of MabThera/Rituxan in RA. MabThera/Rituxan is also being studied in an additional
ongoing trial, REFLEX (Randomised Evaluation oF Long-term Efficacy rituXimab in RA)
in patients who have an inadequate response to anti-TNF alpha (tumour necrosis factor) therapies.
MabThera/Rituxan is a therapeutic antibody that selectively depletes B cells, which may play a key role in the inflammatory
cascade of RA. B cells are an important element in the immune system, helping the body to fight off infection. However in
autoimmune diseases like RA, the immune system acts abnormally leading to an attack on normal healthy tissue such as the
joints.
By depleting B cells, which are believed to be involved in maintaining the attack on healthy tissue, MabThera/Rituxan is
thought to break the cycle of rheumatoid arthritis disease. MabThera/Rituxan is already proven effective in RA following a
single course of therapy1,2.
There is a large unmet clinical need for RA treatments. Only around 50 percent of patients respond to and maintain treatment
with DMARD (disease modifying anti-rheumatic drugs) therapy long term. Data from existing clinical trials indicates that
MabThera/Rituxan is safe and well-tolerated in people with RA.
About the Study
DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of R in RA) is a
Phase IIb study evaluating the efficacy and safety of varying doses of MabThera/Rituxan and corticosteroids in combination
with a fixed dose of methotrexate in patients who have failed at least one disease-modifying anti-rheumatic drug (DMARD) and
are inadequately responding to methotrexate. A total of 465 patients from the United States, Canada, Europe, and Australia
were randomised in this multi-centre, randomised, double-blind, placebo-controlled study. DANCER included three different
dosages of MabThera/Rituxan (placebo; 2x500mg; 2x1000mg) and corticosteroid (placebo; i.v. 200mg; and i.v. 200mg + p.o.
570mg).
About MabThera/Rituxan
Unlike current RA treatments, MabThera/Rituxan is a therapeutic monoclonal antibody that selectively targets B cells, which
are believed to play a key role in the inflammatory cascade of the disease. By doing so, MabThera/Rituxan aims to break the
inflammatory cascade of RA - a series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion
that is characteristic of the disease in which B cells are thought to play a key role. MabThera/Rituxan has been used for
over 7 years for the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL) with over 380,000 patients
treated to date.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining
in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately
leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement
limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the eyes, lungs or blood
vessels may be involved. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than
50% of patients can continue to work or function normally on a day to day basis. RA is one of the most common forms of
autoimmune disease and affects more than 6 million people worldwide, up to 2 million of whom are in Europe.
ACR improvements
The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the
American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms
and measures of their disease. For example, a 20 or 50 percent level of reduction (the percentage of reduction of RA
symptoms) is represented as ACR20, ACR50. ACR 20 indicates a 20 percent improvement in the number of swollen and tender
joints, as well as a 20 percent improvement in three of five categories: patient assessment, physician assessment, pain
scale, Health Assessment Questionnaire, and acute phase reactant (erythrocyte sedimentation rate or c-reactive protein) ACR50
response is exceptional for existing treatments and represents a significant improvement in a patient's condition. A 'Major
Clinical Response' is defined as a continuous ACR 70 maintained for at least 6 months.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-intensive healthcare groups. Its core
businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention,
diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality
of life. Roche is number one in the global diagnostics market, the leading supplier of medicines for cancer and
transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in
prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai.
About Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or
are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the
United States and licenses several additional products to other companies. The company has headquarters in South San
Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional
information about the company, please visit gene.
About Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology. As a global leader in the development, manufacturing,
and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare.
For product labelling, press releases and additional information about the company, please visit biogenidec.
All trademarks used or mentioned in this release are legally protected.
References:
1. Edwards J et al. Efficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritis. New England
Journal of Medicine 2004;350:2572-81
2. Emery P et al. Efficacy and safety of rituximab at 2 years following a single treatment in patients with active arthritis.
Oral presentation ACR 2004.
MabThera/Rituxan (rituximab) met its primary endpoint of a greater proportion of MabThera-treated patients achieving an
American College of Rheumatology (ACR) 20 response at week 24, compared to placebo, in patients who were also treated with
methotrexate (MTX). In this study, patients with moderate-to-severe rheumatoid arthritis (RA) who received two infusions of
MabThera over a two-week period in combination with a stable dose of MTX experienced improved symptoms compared to patients
who received placebo and MTX. The benefit in the MabThera/Rituxan treated patients was present regardless of whether
additional corticosteroids were administered.
"The preliminary data from this latest study in rheumatoid arthritis confirms MabThera as a promising alternative to current
therapies available to patients with RA and are consistent with earlier data showing efficacy and safety of MabThera. As we
continue to explore and evaluate MabThera as a potential treatment for RA, we look forward to the results of ongoing analyses
which will be presented next year", commented Dr. Eduard Holdener, Head of Global Pharma Development, Roche.
This Phase IIb study, DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of
Rituximab in RA), was designed to evaluate the efficacy and safety of varying doses of MabThera/Rituxan in combination
with methotrexate in patients with active RA who currently have an inadequate response to methotrexate. The influence of a
short initial course of corticosteroids was also evaluated.
All regimens in the study were generally well tolerated. The reported rate of serious adverse events was not significantly
different than seen in previous studies of MabThera/Rituxan in RA. MabThera/Rituxan is also being studied in an additional
ongoing trial, REFLEX (Randomised Evaluation oF Long-term Efficacy rituXimab in RA)
in patients who have an inadequate response to anti-TNF alpha (tumour necrosis factor) therapies.
MabThera/Rituxan is a therapeutic antibody that selectively depletes B cells, which may play a key role in the inflammatory
cascade of RA. B cells are an important element in the immune system, helping the body to fight off infection. However in
autoimmune diseases like RA, the immune system acts abnormally leading to an attack on normal healthy tissue such as the
joints.
By depleting B cells, which are believed to be involved in maintaining the attack on healthy tissue, MabThera/Rituxan is
thought to break the cycle of rheumatoid arthritis disease. MabThera/Rituxan is already proven effective in RA following a
single course of therapy1,2.
There is a large unmet clinical need for RA treatments. Only around 50 percent of patients respond to and maintain treatment
with DMARD (disease modifying anti-rheumatic drugs) therapy long term. Data from existing clinical trials indicates that
MabThera/Rituxan is safe and well-tolerated in people with RA.
About the Study
DANCER (Dose-Ranging Assessment iNternational Clinical Evaluation of R in RA) is a
Phase IIb study evaluating the efficacy and safety of varying doses of MabThera/Rituxan and corticosteroids in combination
with a fixed dose of methotrexate in patients who have failed at least one disease-modifying anti-rheumatic drug (DMARD) and
are inadequately responding to methotrexate. A total of 465 patients from the United States, Canada, Europe, and Australia
were randomised in this multi-centre, randomised, double-blind, placebo-controlled study. DANCER included three different
dosages of MabThera/Rituxan (placebo; 2x500mg; 2x1000mg) and corticosteroid (placebo; i.v. 200mg; and i.v. 200mg + p.o.
570mg).
About MabThera/Rituxan
Unlike current RA treatments, MabThera/Rituxan is a therapeutic monoclonal antibody that selectively targets B cells, which
are believed to play a key role in the inflammatory cascade of the disease. By doing so, MabThera/Rituxan aims to break the
inflammatory cascade of RA - a series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion
that is characteristic of the disease in which B cells are thought to play a key role. MabThera/Rituxan has been used for
over 7 years for the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL) with over 380,000 patients
treated to date.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining
in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately
leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement
limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the eyes, lungs or blood
vessels may be involved. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than
50% of patients can continue to work or function normally on a day to day basis. RA is one of the most common forms of
autoimmune disease and affects more than 6 million people worldwide, up to 2 million of whom are in Europe.
ACR improvements
The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the
American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms
and measures of their disease. For example, a 20 or 50 percent level of reduction (the percentage of reduction of RA
symptoms) is represented as ACR20, ACR50. ACR 20 indicates a 20 percent improvement in the number of swollen and tender
joints, as well as a 20 percent improvement in three of five categories: patient assessment, physician assessment, pain
scale, Health Assessment Questionnaire, and acute phase reactant (erythrocyte sedimentation rate or c-reactive protein) ACR50
response is exceptional for existing treatments and represents a significant improvement in a patient's condition. A 'Major
Clinical Response' is defined as a continuous ACR 70 maintained for at least 6 months.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-intensive healthcare groups. Its core
businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention,
diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality
of life. Roche is number one in the global diagnostics market, the leading supplier of medicines for cancer and
transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in
prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai.
About Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or
are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the
United States and licenses several additional products to other companies. The company has headquarters in South San
Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional
information about the company, please visit gene.
About Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology. As a global leader in the development, manufacturing,
and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare.
For product labelling, press releases and additional information about the company, please visit biogenidec.
All trademarks used or mentioned in this release are legally protected.
References:
1. Edwards J et al. Efficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritis. New England
Journal of Medicine 2004;350:2572-81
2. Emery P et al. Efficacy and safety of rituximab at 2 years following a single treatment in patients with active arthritis.
Oral presentation ACR 2004.
вторник, 17 мая 2011 г.
Access To Psychological Support And Self-Management Courses Could Ease The Emotional Burden Of Arthritis/Rheumatism, Survey Says
An online survey for World Arthritis Day (WAD), completed by over 3,600* respondents revealed that access to psychological support and self-management courses could help people with arthritis/rheumatism cope more effectively with their condition and achieve better quality of life. Healthcare professionals, people with rheumatic disease and their carers, who responded to the survey, highlight the importance of integrating psychological support into the standard treatment regime.
The survey, a project run by the European League Against Rheumatism (EULAR) Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), was completed by people with arthritis/rheumatism, their carers and health professionals from over 50 countries across the world.
Ninety seven percent of people with rheumatism/arthritis and carers indicated that this condition affects them/people they care for emotionally and 5% of them said it may lead to depression. Despite of the scale of the problem only 35% of the survey respondents said they raise the emotional impact of their arthritis/rheumatism with their doctor.
Clinical data demonstrates that the quality of life of these people can be enhanced by introducing special coping strategies1. The majority of people with arthritis/rheumatism who responded to the survey saw the need for professional support: 85% emphasised that psychological support (psychotherapy, sessions with psychologists, treatments) should be included in the overall care and over a half of them would like to have access to self-management courses.
Similarly, health professionals are increasingly aware of the psychological impact of arthritis/rheumatism: 71% said they bring this problem up during a consultation, 33% said they refer their patients to the specialist treatment (e.g. psychotherapy) and 22% suggest a self-management course, if one exists in the given country.
"The main message coming out of the World Arthritis Day survey is the real need for a holistic approach in treating people with arthritis and rheumatism, ensuring the treatment paradigm covers all aspects of these conditions and not just the physical symptoms. This is clearly voiced by both patients and physicians and needs to be recognized and addressed within the structure of national healthcare systems" - said president of EULAR Executive Committee, Prof. Ferdinand C. Breedveld.
"Our survey clearly demonstrates that both people with arthritis/rheumatism and healthcare professionals recognize the importance of addressing psychological aspects of this condition. Yet, in many countries support is not available or limited. - said Sandra Canadelo, Chairperson of the Standing Committee of People with Arthritis/Rheumatism in Europe (EULAR) - This year, on World Arthritis Day, we hope that our call for better access to different forms of psychological support for people with arthritis/rheumatism will be heard by health policy makers on a national and international level."
The findings from the Think Positive survey correspond with the available clinical evidence. This evidence demonstrates that arthritis/rheumatism can have a debilitating effect on people's lives by restricting physical, psychological and social function. A half to two thirds of people with arthritis/rheumatism report lost social relationships, disrupted leisure activities and limitations in employment because of psychological problems2. In many cases some types of arthritis/rheumatism can be associated with depression and anxiety3.
Results from the Think Positive survey are reflected in the individual stories of people with arthritis/rheumatism who share personal experiences of coping with their conditions emotionally and finding the best way to a keep positive frame of mind. Their testimonials are available on WAD website worldarthritisday/
About the WAD survey
The World Arthritis Day survey is a project run by EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE). Every year the survey looks at different aspects of arthritis/rheumatism and generates useful statistics to support a call for better standards of treatment and care for people with arthritis/rheumatism. The "Think Positive" theme acknowledges the emotional impact of this condition and the need for better psychological support being offered to people with rheumatism/arthritis.
About self-management courses
Self-management courses are run by people with arthritis/rheumatism who have been especially trained to teach techniques which help people get greater control over their disease, increase their confidence and improve their quality of life. These sessions create forums during which people feel comfortable to share their experiences and learn from each other. They enhance dialog and relationship building with other people affected by arthritis/rheumatism.
About EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE)
The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations. EULAR endeavours to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic diseases.
The national organisations of people with arthritis/rheumatism across Europe work together via the EULAR Standing Committee of PARE. The EULAR Standing Committee of PARE brings together representatives of arthritis and other musculoskeletal user groups around Europe to work towards improving the quality of life for the more than 100 million people in Europe living with these conditions. The committee's vision is of people with arthritis and other musculoskeletal conditions in Europe being empowered to lead full and independent lives.
More information is available on the website worldarthritisday/ and eular/
References:
1 Covic T et al, The impact of passive coping on rheumatoid, Rheumatology 2000; 39: 1027 1030
2 Ryan S, The Psychological and Social Implications of Rheumatoid Arthritis, available at NHS library: library.nhs.uk/musculoskeletal/viewresource.aspx?resid=5218 accessed on 22.08.08
3 Abdel-Nasser et al, Depression and depressive symptoms in rheumatoid arthritis patients: an analysis of their occurrence and determinants, Rheumatology, Volume 37, Number 4, April 1998 , pp. 391-397(7)
Acknowledgement
The WAD 'Think Positive' survey is supported by an educational grant from Pfizer
Source: Birte Gl??esing
Ruder Finn Public Relations
The survey, a project run by the European League Against Rheumatism (EULAR) Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), was completed by people with arthritis/rheumatism, their carers and health professionals from over 50 countries across the world.
Ninety seven percent of people with rheumatism/arthritis and carers indicated that this condition affects them/people they care for emotionally and 5% of them said it may lead to depression. Despite of the scale of the problem only 35% of the survey respondents said they raise the emotional impact of their arthritis/rheumatism with their doctor.
Clinical data demonstrates that the quality of life of these people can be enhanced by introducing special coping strategies1. The majority of people with arthritis/rheumatism who responded to the survey saw the need for professional support: 85% emphasised that psychological support (psychotherapy, sessions with psychologists, treatments) should be included in the overall care and over a half of them would like to have access to self-management courses.
Similarly, health professionals are increasingly aware of the psychological impact of arthritis/rheumatism: 71% said they bring this problem up during a consultation, 33% said they refer their patients to the specialist treatment (e.g. psychotherapy) and 22% suggest a self-management course, if one exists in the given country.
"The main message coming out of the World Arthritis Day survey is the real need for a holistic approach in treating people with arthritis and rheumatism, ensuring the treatment paradigm covers all aspects of these conditions and not just the physical symptoms. This is clearly voiced by both patients and physicians and needs to be recognized and addressed within the structure of national healthcare systems" - said president of EULAR Executive Committee, Prof. Ferdinand C. Breedveld.
"Our survey clearly demonstrates that both people with arthritis/rheumatism and healthcare professionals recognize the importance of addressing psychological aspects of this condition. Yet, in many countries support is not available or limited. - said Sandra Canadelo, Chairperson of the Standing Committee of People with Arthritis/Rheumatism in Europe (EULAR) - This year, on World Arthritis Day, we hope that our call for better access to different forms of psychological support for people with arthritis/rheumatism will be heard by health policy makers on a national and international level."
The findings from the Think Positive survey correspond with the available clinical evidence. This evidence demonstrates that arthritis/rheumatism can have a debilitating effect on people's lives by restricting physical, psychological and social function. A half to two thirds of people with arthritis/rheumatism report lost social relationships, disrupted leisure activities and limitations in employment because of psychological problems2. In many cases some types of arthritis/rheumatism can be associated with depression and anxiety3.
Results from the Think Positive survey are reflected in the individual stories of people with arthritis/rheumatism who share personal experiences of coping with their conditions emotionally and finding the best way to a keep positive frame of mind. Their testimonials are available on WAD website worldarthritisday/
About the WAD survey
The World Arthritis Day survey is a project run by EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE). Every year the survey looks at different aspects of arthritis/rheumatism and generates useful statistics to support a call for better standards of treatment and care for people with arthritis/rheumatism. The "Think Positive" theme acknowledges the emotional impact of this condition and the need for better psychological support being offered to people with rheumatism/arthritis.
About self-management courses
Self-management courses are run by people with arthritis/rheumatism who have been especially trained to teach techniques which help people get greater control over their disease, increase their confidence and improve their quality of life. These sessions create forums during which people feel comfortable to share their experiences and learn from each other. They enhance dialog and relationship building with other people affected by arthritis/rheumatism.
About EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE)
The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations. EULAR endeavours to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic diseases.
The national organisations of people with arthritis/rheumatism across Europe work together via the EULAR Standing Committee of PARE. The EULAR Standing Committee of PARE brings together representatives of arthritis and other musculoskeletal user groups around Europe to work towards improving the quality of life for the more than 100 million people in Europe living with these conditions. The committee's vision is of people with arthritis and other musculoskeletal conditions in Europe being empowered to lead full and independent lives.
More information is available on the website worldarthritisday/ and eular/
References:
1 Covic T et al, The impact of passive coping on rheumatoid, Rheumatology 2000; 39: 1027 1030
2 Ryan S, The Psychological and Social Implications of Rheumatoid Arthritis, available at NHS library: library.nhs.uk/musculoskeletal/viewresource.aspx?resid=5218 accessed on 22.08.08
3 Abdel-Nasser et al, Depression and depressive symptoms in rheumatoid arthritis patients: an analysis of their occurrence and determinants, Rheumatology, Volume 37, Number 4, April 1998 , pp. 391-397(7)
Acknowledgement
The WAD 'Think Positive' survey is supported by an educational grant from Pfizer
Source: Birte Gl??esing
Ruder Finn Public Relations
понедельник, 16 мая 2011 г.
Expanded Indications, Novel Targets Driving Activity In Autoimmune Disease Therapeutics
Already a major
therapeutic disease sector accounting for drug sales in excess of $18
billion worldwide, the incidence of autoimmune disease in developed
countries is increasing. The impact of autoimmunity on patient
quality-of-life is well known, but it has only been in the last ten
years with the introduction of biological drugs capable of modulating
the immune cascade that effective therapies for this most intractable
family of diseases have become available. The result has been a drug
sector that has grown rapidly to include more than a half-dozen
products with annual sales exceeding $1 billion.
The past few years have been marked by expanded indications, creating
new treatment options for caregivers and their patients. But in spite
of these recent successes -- and in part because of them -- work to
identify and develop new therapeutic candidates has intensified.
As with virtually any drug with significant efficacy, side effects
remain a major issue. Much of the current wave of development
activity is focused on the search for new classes of autoimmune drugs
that achieve a therapeutic benefit with minimal side effects. These
approaches include drug candidates that target specific immune
response processes, such as inhibiting the action of adhesion
molecules or interfering with the migration of activated immune cells
from lymph nodes.
Arthritis, because of its market size and economic importance, is
often the therapeutic target for pipeline therapies in this sector,
while less prevalent disease segments benefit almost exclusively
through secondary or expanded indications. The outlook for the
psoriasis segment is closely linked to the commercial market for
arthritis treatment, due to the significant prevalence of psoriasis
patients to suffer from psoriatic arthritis.
The Greystone research study 'Autoimmune Disease Therapeutics'
analyzes approved and development-stage therapeutic drugs for six
major autoimmune disease segments, and includes forecasts, analysis,
descriptions and evaluations of current and probable future market
developments, technology issues, and business factors.
More information is available
here.
About Greystone
Greystone Associates is a medical and healthcare technology
consulting firm providing services in strategic planning, venture
development, product commercialization, and technology and market
assessment.
Greystone Associates
therapeutic disease sector accounting for drug sales in excess of $18
billion worldwide, the incidence of autoimmune disease in developed
countries is increasing. The impact of autoimmunity on patient
quality-of-life is well known, but it has only been in the last ten
years with the introduction of biological drugs capable of modulating
the immune cascade that effective therapies for this most intractable
family of diseases have become available. The result has been a drug
sector that has grown rapidly to include more than a half-dozen
products with annual sales exceeding $1 billion.
The past few years have been marked by expanded indications, creating
new treatment options for caregivers and their patients. But in spite
of these recent successes -- and in part because of them -- work to
identify and develop new therapeutic candidates has intensified.
As with virtually any drug with significant efficacy, side effects
remain a major issue. Much of the current wave of development
activity is focused on the search for new classes of autoimmune drugs
that achieve a therapeutic benefit with minimal side effects. These
approaches include drug candidates that target specific immune
response processes, such as inhibiting the action of adhesion
molecules or interfering with the migration of activated immune cells
from lymph nodes.
Arthritis, because of its market size and economic importance, is
often the therapeutic target for pipeline therapies in this sector,
while less prevalent disease segments benefit almost exclusively
through secondary or expanded indications. The outlook for the
psoriasis segment is closely linked to the commercial market for
arthritis treatment, due to the significant prevalence of psoriasis
patients to suffer from psoriatic arthritis.
The Greystone research study 'Autoimmune Disease Therapeutics'
analyzes approved and development-stage therapeutic drugs for six
major autoimmune disease segments, and includes forecasts, analysis,
descriptions and evaluations of current and probable future market
developments, technology issues, and business factors.
More information is available
here.
About Greystone
Greystone Associates is a medical and healthcare technology
consulting firm providing services in strategic planning, venture
development, product commercialization, and technology and market
assessment.
Greystone Associates
воскресенье, 15 мая 2011 г.
Cost Shifting May Make Arthritis Medications Too Expensive For Medicare Beneficiaries
Biologic disease-modifying antirheumatic drugs (DMARDs) such as adalimumab, etanercept and infliximab are effective at reducing symptoms and slowing progression of rheumatoid arthritis (RA). These drugs act more quickly, require less laboratory monitoring, and are better tolerated than nonbiologic DMARDs, but they are also up to 100 times more expensive. Insurance plans differ greatly in their coverage of and cost sharing for biologic DMARDs, sometimes shifting a large portion of the cost of patients. A new study examined the cost-sharing structures for biologic DMARDs in Part D plans and the resulting cost burden to patients. The study was published in the June issue of Arthritis Care & Research.
In 2003, Congress created the Medicare Replacement Drug Demonstration (MRDD) to provide temporary drug insurance until the start of Medicare Part D in 2006. The MRDD, which ran September 2004 - December 2005, targeted low-income vulnerable Medicare patients with select conditions, including RA, who did not have comprehensive drug insurance coverage. This program had similar cost-sharing arrangements to Medicare Part D and evaluations showed that it reduced financial barriers and improved health outcomes. However, unlike the MRDD, Part D plans could place high-cost items such as biologic DMARDs in a specialty tier, where they are subject to higher patient cost sharing. There is concern that specialty tiering imposes a heavy financial burden on RA patients.
Led by Jennifer M. Polinski of Brigham and Women's Hospital in Boston, researchers followed almost 15,000 vulnerable, low-income patients who were enrolled in the MRDD as they transitioned into Part D in 2006. They grouped patients into one of three drug coverage options: enrollment in a Part D plan further stratified by a Medicare Advantage or stand-alone plan, other creditable coverage or unknown coverage. They examined the benefit design of each plan, as well as potential differences in beneficiaries' annual out-of-pocket costs for biologic DMARDs under three coverage scenarios.
They found that 81 percent of poor and disabled Medicare beneficiaries with RA who participated in the MRDD program had enrolled in Part D plans by July 2006. Compared with stand-alone Part D plans, Medicare Advantage plans offered lower deductibles, lower premiums, and were more likely to require copayments (which are fixed), rather than coinsurance (typically a percentage paid by the insured person pays after an insurance deductible has been exceeded). They also placed significantly fewer restrictions on biologic DMARD reimbursement. "In spite of the greater generosity and lesser restrictions of Medicare Advantage plans, the most sick and most financially needy patients enrolled in these plans less often than they did in stand-alone plans," the authors note.
Most patients enrolled in plans that placed biologic DMARDs on high-cost specialty tiers and used coinsurance proportions as high as 75 percent. The specialty tier was created to ensure that beneficiaries receiving high-cost biologic agents were not discriminated against in terms of cost sharing, but there is concern about the financial impact of this structure, especially the widespread use of high coinsurance. The study found that Part D plans that require coinsurance instead of copayments shift the financial burden of these high-cost medications from the plan to the patient and to Medicare. In plans where cost sharing is high (e.g. plans with high coinsurance), patients may delay or not even begin therapy due to the high cost; in plans with cost sharing that is steep but manageable (e.g. plans with high copayments) patients may begin therapy but then discontinue it when faced with paying the full cost of the medication out of pocket. "Neither scenario is optimal for patients who may benefit from biologic DMARDs," the authors point out.
Specialty tier and coinsurance resulted in estimated annual expenditures for patients that exceeded $4,000 despite drug insurance coverage and more Part D plans have adopted specialty tiering over time. In 2006, 60 percent of the national stand-alone plans used this system but by 2008, 87 percent were using it. Similarly, between 2006 and 2008 the number of plans charging 33 percent coinsurance increased more than five-fold. "Patients assume up to 28 percent and Medicare assumes more than 58 percent of the costs of biologic DMARDs in our scenarios, yet neither is in a position to sustain such financial burden," the authors conclude. "As more biologic DMARDs are approved and used for RA and more plans use the specialty tier system, both beneficiaries and Medicare face costs they may be increasingly unable to afford."
Article: "Impact of Medicare Part D on Access to and Cost Sharing for Specialty Biologic Medications for Beneficiaries with Rheumatoid Arthritis," Jennifer M. Polinski, Penny E. Mohr, Lorraine Johnson, Arthritis & Rheumatism (Arthritis Care & Research), June 2009.
Source:
Sean Wagner
Wiley-Blackwell
In 2003, Congress created the Medicare Replacement Drug Demonstration (MRDD) to provide temporary drug insurance until the start of Medicare Part D in 2006. The MRDD, which ran September 2004 - December 2005, targeted low-income vulnerable Medicare patients with select conditions, including RA, who did not have comprehensive drug insurance coverage. This program had similar cost-sharing arrangements to Medicare Part D and evaluations showed that it reduced financial barriers and improved health outcomes. However, unlike the MRDD, Part D plans could place high-cost items such as biologic DMARDs in a specialty tier, where they are subject to higher patient cost sharing. There is concern that specialty tiering imposes a heavy financial burden on RA patients.
Led by Jennifer M. Polinski of Brigham and Women's Hospital in Boston, researchers followed almost 15,000 vulnerable, low-income patients who were enrolled in the MRDD as they transitioned into Part D in 2006. They grouped patients into one of three drug coverage options: enrollment in a Part D plan further stratified by a Medicare Advantage or stand-alone plan, other creditable coverage or unknown coverage. They examined the benefit design of each plan, as well as potential differences in beneficiaries' annual out-of-pocket costs for biologic DMARDs under three coverage scenarios.
They found that 81 percent of poor and disabled Medicare beneficiaries with RA who participated in the MRDD program had enrolled in Part D plans by July 2006. Compared with stand-alone Part D plans, Medicare Advantage plans offered lower deductibles, lower premiums, and were more likely to require copayments (which are fixed), rather than coinsurance (typically a percentage paid by the insured person pays after an insurance deductible has been exceeded). They also placed significantly fewer restrictions on biologic DMARD reimbursement. "In spite of the greater generosity and lesser restrictions of Medicare Advantage plans, the most sick and most financially needy patients enrolled in these plans less often than they did in stand-alone plans," the authors note.
Most patients enrolled in plans that placed biologic DMARDs on high-cost specialty tiers and used coinsurance proportions as high as 75 percent. The specialty tier was created to ensure that beneficiaries receiving high-cost biologic agents were not discriminated against in terms of cost sharing, but there is concern about the financial impact of this structure, especially the widespread use of high coinsurance. The study found that Part D plans that require coinsurance instead of copayments shift the financial burden of these high-cost medications from the plan to the patient and to Medicare. In plans where cost sharing is high (e.g. plans with high coinsurance), patients may delay or not even begin therapy due to the high cost; in plans with cost sharing that is steep but manageable (e.g. plans with high copayments) patients may begin therapy but then discontinue it when faced with paying the full cost of the medication out of pocket. "Neither scenario is optimal for patients who may benefit from biologic DMARDs," the authors point out.
Specialty tier and coinsurance resulted in estimated annual expenditures for patients that exceeded $4,000 despite drug insurance coverage and more Part D plans have adopted specialty tiering over time. In 2006, 60 percent of the national stand-alone plans used this system but by 2008, 87 percent were using it. Similarly, between 2006 and 2008 the number of plans charging 33 percent coinsurance increased more than five-fold. "Patients assume up to 28 percent and Medicare assumes more than 58 percent of the costs of biologic DMARDs in our scenarios, yet neither is in a position to sustain such financial burden," the authors conclude. "As more biologic DMARDs are approved and used for RA and more plans use the specialty tier system, both beneficiaries and Medicare face costs they may be increasingly unable to afford."
Article: "Impact of Medicare Part D on Access to and Cost Sharing for Specialty Biologic Medications for Beneficiaries with Rheumatoid Arthritis," Jennifer M. Polinski, Penny E. Mohr, Lorraine Johnson, Arthritis & Rheumatism (Arthritis Care & Research), June 2009.
Source:
Sean Wagner
Wiley-Blackwell
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