The investigational compound tocilizumab (ActemraTM) significantly reduces disease activity in patients with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate, researchers announced at the European League Against Rheumatism (EULAR) 2007.
Josef Smolen, MD, chairman of the rheumatology department at the Medical University of Vienna, reported findings in 623 patients who had been randomized to receive tocilizumab 8 mg/kg, tocilizumab 4 mg/kg, or placebo, administered by intravenous infusion every four weeks. Tocilizumab is a novel monoclonal antibody targeting interleukin (IL)-6 signaling.
All patients enrolled in the study had moderate to severe active RA despite long- term metrotrexate treatment.
Participants in the trial continued to receive concomitant oral or parenteral methotrexate at their pre-study dose of 10 to 25 mg weekly throughout the trial and stopped all other disease-modifying anti-rheumatic drugs upon entry into the study.
The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at 24 weeks.
Results of the phase III tOcilizumab Pivotal Trial in methotrexate Inadequate respONders (OPTION) trial showed that 58.5% of patients in the 8 mg/kg group and 47.9% in the 4 mg/kg group achieved ACR20 responses at week 24 compared with 26.5% in the placebo group.
Also, 22% who received tocilizumab 8 mg/kg achieved ACR70, and 43.9% achieved ACR50. Only 2% of the placebo cohort achieved ACR70, and 10.8% achieved ACR50.
The analysis also showed a decrease in the Disease Activity Score in 28 joints (DAS28) starting the second week. At 24 weeks, the mean DAS28 score was reduced by 3.43 in the 8 mg/kg tocilizumab group, 2.63 in the 4 mg/kg tocilizumab group, and 1.55 in the placebo group.
Both doses of tocilizumab were generally well tolerated, and there was a similar rate of adverse events in the three study groups. The incidence of infections was slightly higher than with placebo but no incidence of tuberculosis was observed.
"Overall, the results show that tocilizumab in combination with methotrexate provides rapid and significant improvements in the signs and symptoms of RA," Dr. Smolen said.
He added that the high efficacy of Il-6 receptor inhibition with tocilizumab confirms the critical role of Il-6 in the pathophysiology of RA.
By Jill Stein
Jillstein03cs
суббота, 25 июня 2011 г.
пятница, 24 июня 2011 г.
Double Trouble For Rheumatoid Arthritis Patients: PLC-gamma-2 Regulates Osteoclastogenesis And B Cell Differentiation
Rheumatoid arthritis (RA) is best known as a chronic inflammatory disease caused by the immune system inappropriately attacking the joints. However, the autoimmune response also leads to the recruitment and/or differentiation of cells known as osteoclasts -- which are cells that degrade and resorb bone. Current treatments for patients with RA target either the joint-specific immune response or the osteoclast-mediated bone erosion.
Now, in a study appearing online on October 19 in advance of publication in the November print issue of the Journal of Clinical Investigation, researchers from Washington University have shown that the protein PLC-gamma-2, which was already known to regulate the differentiation of B cells (one of the immune cells crucial to the autoimmune response seen in RA), is required for normal osteoclast development and function in mice. Roberta Faccio and colleagues therefore suggest that targeting PLC-gamma-2 might lead to control of both the immune-mediated joint destruction and osteoclast-mediated bone erosion seen in RA.
TITLE: PLC-gamma-2 regulates osteoclastogenesis via its interaction with ITAM proteins and GAB2
AUTHOR CONTACT:
Roberta Faccio
Washington University School of Medicine, St. Louis, Missouri, USA.
Contact: Karen Honey
Journal of Clinical Investigation
Now, in a study appearing online on October 19 in advance of publication in the November print issue of the Journal of Clinical Investigation, researchers from Washington University have shown that the protein PLC-gamma-2, which was already known to regulate the differentiation of B cells (one of the immune cells crucial to the autoimmune response seen in RA), is required for normal osteoclast development and function in mice. Roberta Faccio and colleagues therefore suggest that targeting PLC-gamma-2 might lead to control of both the immune-mediated joint destruction and osteoclast-mediated bone erosion seen in RA.
TITLE: PLC-gamma-2 regulates osteoclastogenesis via its interaction with ITAM proteins and GAB2
AUTHOR CONTACT:
Roberta Faccio
Washington University School of Medicine, St. Louis, Missouri, USA.
Contact: Karen Honey
Journal of Clinical Investigation
четверг, 23 июня 2011 г.
Vioxx Heart Risk Persists One Year After Stopping Use
A new international study found that Merck's pain killer Vioxx (rofecoxib), which the drug company voluntarily withdrew from the market in 2004, found
that a near two-fold increased risk of heart, stroke and death persisted for up to one year after stopping use.
The study was the work of Dr Robert Bresalier, a professor of medicine at the MD Anderson Cancer Center in Houston, Texas, and colleagues from other research
centres in the US, Canada, Spain and the UK, is published in the 14 October 2008 issue of The Lancet.
In this latest study, Bresalier and colleagues found that the "risk was increased close to twofold, and the risk persisted for approximately a year",
according to a statement reported in the Washington Post.
But, "the good news is that, after a year, the risk seemed to go back down toward normal," Bresalier told the press.
Vioxx (rofecoxib) is a type of non-steroidal anti-inflammatory drug (NSAID). Specifically, it is a cox-2 inhibitor that targets an enzyme involved in
inflammation, the cyclooxygenase 2 (cox-2) enzyme. It was approved by the US Food and Drug Administration in 1999 for the treatment of osteoarthritis, acute
pain conditions, and dysmenorrhoea. But in 2004, Merck withdrew it because of concerns about raised risk of heart attack, stroke and death.
Other less targeted NSAIDs include ibuprofen and naproxen.
Bresalier said that he and other experts believed that all non-aspirin NSAIDs raised the risk of cardiovascular events.
"In fact, it seems to be a class effect for most if not all NSAIDs," said Bresaliers, adding that:
"There is a dose-dependent risk with Celebrex [an NSAID made by Pfizer] as well, whose magnitude was not that much different from Vioxx."
For the study, Bresalier and colleagues followed up participants who took part in the international trial APPROVe that compared Vioxx to placebo for 3 years.
APPROVe was a multicentre, randomized, placebo controlled, double blind trial involving nearly 2,600 patients with a history of colorectal adenomas (growths
or polyps in the colon) who were recruited at 108 centres worldwide during 2000 and 2001.
APPROVe, which was designed to see if Vioxx could reduce the recurrence of colon growths or polyps, was stopped in 2004 because of increased risk of heart
attack and stroke. But Bresalier and colleagues were able to get in touch with 84 per cent of the participants and follow their progress for another year
after their treatment stopped.
The analysis looked for the combined incidence of "non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular, haemorrhagic, and
unknown causes", wrote the authors.
The results showed that a year after they stopped using Vioxx, the participants still carried a 79 per cent higher risk of heart attack, stroke or death
compared to the participants who had been on placebo during the 3 year trial.
The risk of heart attack or stroke for participants on Vioxx during the trial was double that of the participants on placebo for up to year after the trial,
while the risk of death was up by 31 per cent compared to placebo.
Bresalier and colleagues said this was consistent with the increased risk observed in the trial, where the risk of having a cardiovascular event for the
participants taking Vioxx was double that of participants taking placebo.
Merck said in a statement reported by Reuters that:
"Using limited data from a prematurely terminated study needs to be interpreted very cautiously and in the context of the rest of the data from the extensive
clinical development program for Vioxx."
Bresalier and colleagues did find that Vioxx reduced the incidence of colon polyps.
Speaking to the press about NSAIDs, Bresalier said for people taking them only intermittently, for short term pain relief for example, the risk would most
likely be very small. Taking one or two pills is not going likely to give you a heart attack, and for the majority of people taking NSAIDs, they are safe
and effective. But you need to be more careful about taking high doses over a long period:
"If you have a history of cardiovascular disease, speak to your doctor to understand the relative risks and benefits. If you're somebody who really needs to
take these drugs because of chronic pain or severe arthritis, be aware of the issues. But you shouldn't be afraid to take these drugs if you need them," said
Bresalier, according to the Washington Post.
"Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial."
John A Baron, Robert S Sandler, Robert S Bresalier, Angel Lanas, Dion G Morton, Robert Riddell, Erik R Iverson, and David L DeMets.
The Lancet Early Online Publication, 14 October 2008.
DOI:10.1016/S0140-6736(08)61490-7
Click here for
Abstract.
Source: Journal Abstract, Washington Post, Reuters.
Written by: , PhD.
View drug information on Vioxx.
that a near two-fold increased risk of heart, stroke and death persisted for up to one year after stopping use.
The study was the work of Dr Robert Bresalier, a professor of medicine at the MD Anderson Cancer Center in Houston, Texas, and colleagues from other research
centres in the US, Canada, Spain and the UK, is published in the 14 October 2008 issue of The Lancet.
In this latest study, Bresalier and colleagues found that the "risk was increased close to twofold, and the risk persisted for approximately a year",
according to a statement reported in the Washington Post.
But, "the good news is that, after a year, the risk seemed to go back down toward normal," Bresalier told the press.
Vioxx (rofecoxib) is a type of non-steroidal anti-inflammatory drug (NSAID). Specifically, it is a cox-2 inhibitor that targets an enzyme involved in
inflammation, the cyclooxygenase 2 (cox-2) enzyme. It was approved by the US Food and Drug Administration in 1999 for the treatment of osteoarthritis, acute
pain conditions, and dysmenorrhoea. But in 2004, Merck withdrew it because of concerns about raised risk of heart attack, stroke and death.
Other less targeted NSAIDs include ibuprofen and naproxen.
Bresalier said that he and other experts believed that all non-aspirin NSAIDs raised the risk of cardiovascular events.
"In fact, it seems to be a class effect for most if not all NSAIDs," said Bresaliers, adding that:
"There is a dose-dependent risk with Celebrex [an NSAID made by Pfizer] as well, whose magnitude was not that much different from Vioxx."
For the study, Bresalier and colleagues followed up participants who took part in the international trial APPROVe that compared Vioxx to placebo for 3 years.
APPROVe was a multicentre, randomized, placebo controlled, double blind trial involving nearly 2,600 patients with a history of colorectal adenomas (growths
or polyps in the colon) who were recruited at 108 centres worldwide during 2000 and 2001.
APPROVe, which was designed to see if Vioxx could reduce the recurrence of colon growths or polyps, was stopped in 2004 because of increased risk of heart
attack and stroke. But Bresalier and colleagues were able to get in touch with 84 per cent of the participants and follow their progress for another year
after their treatment stopped.
The analysis looked for the combined incidence of "non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular, haemorrhagic, and
unknown causes", wrote the authors.
The results showed that a year after they stopped using Vioxx, the participants still carried a 79 per cent higher risk of heart attack, stroke or death
compared to the participants who had been on placebo during the 3 year trial.
The risk of heart attack or stroke for participants on Vioxx during the trial was double that of the participants on placebo for up to year after the trial,
while the risk of death was up by 31 per cent compared to placebo.
Bresalier and colleagues said this was consistent with the increased risk observed in the trial, where the risk of having a cardiovascular event for the
participants taking Vioxx was double that of participants taking placebo.
Merck said in a statement reported by Reuters that:
"Using limited data from a prematurely terminated study needs to be interpreted very cautiously and in the context of the rest of the data from the extensive
clinical development program for Vioxx."
Bresalier and colleagues did find that Vioxx reduced the incidence of colon polyps.
Speaking to the press about NSAIDs, Bresalier said for people taking them only intermittently, for short term pain relief for example, the risk would most
likely be very small. Taking one or two pills is not going likely to give you a heart attack, and for the majority of people taking NSAIDs, they are safe
and effective. But you need to be more careful about taking high doses over a long period:
"If you have a history of cardiovascular disease, speak to your doctor to understand the relative risks and benefits. If you're somebody who really needs to
take these drugs because of chronic pain or severe arthritis, be aware of the issues. But you shouldn't be afraid to take these drugs if you need them," said
Bresalier, according to the Washington Post.
"Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial."
John A Baron, Robert S Sandler, Robert S Bresalier, Angel Lanas, Dion G Morton, Robert Riddell, Erik R Iverson, and David L DeMets.
The Lancet Early Online Publication, 14 October 2008.
DOI:10.1016/S0140-6736(08)61490-7
Click here for
Abstract.
Source: Journal Abstract, Washington Post, Reuters.
Written by: , PhD.
View drug information on Vioxx.
среда, 22 июня 2011 г.
Emisphere Announces Recruitment Phase III Study For Oral Osteoarthritis Treatment
Emisphere
Technologies, Inc. (Nasdaq: EMIS) announced that Novartis Pharma AG
and Nordic Bioscience have completed recruitment for a multi-center Phase
III study exploring the safety and efficacy of an oral formulation of
salmon calcitonin using Emisphere's proprietary Eligen Technology to treat
patients with osteoarthritis of the knee. This study, which will be used to
support the filing with health authorities worldwide, includes more than
1,100 patients between 51 and 80 years old with a medical history and
symptoms of knee osteoarthritis. The study will be conducted mainly in
Europe and is estimated to complete second half 2010.
Osteoarthritis ("OA") is a clinical syndrome in which low-grade
inflammation results in joint pain, caused by a wearing-away of cartilage
that cushions the joints and the destruction or decrease of synovial fluid
that lubricates those joints. As OA progresses, pain can result when the
patient bears weight upon the joints, including walking and standing. OA is
the most common form of arthritis, and affects nearly 21 million people in
the United States, accounting for 25% of visits to primary care physicians,
and half of all non-steroidal anti-inflammatory drug prescriptions. It is
estimated that 80% of the population will have radiographic evidence of OA
by age 65.
"The problems associated with osteoarthritis will escalate as the
population ages," said Michael V. Novinski, President and Chief Executive
Officer of Emisphere. "This Phase III study aims at demonstrating that oral
salmon calcitonin, in combination with our Eligen drug delivery technology,
may contribute to solving this problem, and also shows that Emisphere is a
valuable partner in drug development."
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and
improved delivery of therapeutic molecules using its Eligen Technology.
These molecules and compounds could be currently available or in
development. Such molecules are usually delivered by injection; in many
cases, their benefits are limited due to poor bioavailability, slow on-set
of action or variable absorption. The Eligen Technology can be applied to
the oral route of administration as well other delivery pathways, such as
buccal, rectal, inhalation, intra-vaginal or transdermal. The website is:
emisphere.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615)
filed on March 13, 2008 and our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, filed on August 11, 2008.
Emisphere Technologies, Inc
emisphere
Technologies, Inc. (Nasdaq: EMIS) announced that Novartis Pharma AG
and Nordic Bioscience have completed recruitment for a multi-center Phase
III study exploring the safety and efficacy of an oral formulation of
salmon calcitonin using Emisphere's proprietary Eligen Technology to treat
patients with osteoarthritis of the knee. This study, which will be used to
support the filing with health authorities worldwide, includes more than
1,100 patients between 51 and 80 years old with a medical history and
symptoms of knee osteoarthritis. The study will be conducted mainly in
Europe and is estimated to complete second half 2010.
Osteoarthritis ("OA") is a clinical syndrome in which low-grade
inflammation results in joint pain, caused by a wearing-away of cartilage
that cushions the joints and the destruction or decrease of synovial fluid
that lubricates those joints. As OA progresses, pain can result when the
patient bears weight upon the joints, including walking and standing. OA is
the most common form of arthritis, and affects nearly 21 million people in
the United States, accounting for 25% of visits to primary care physicians,
and half of all non-steroidal anti-inflammatory drug prescriptions. It is
estimated that 80% of the population will have radiographic evidence of OA
by age 65.
"The problems associated with osteoarthritis will escalate as the
population ages," said Michael V. Novinski, President and Chief Executive
Officer of Emisphere. "This Phase III study aims at demonstrating that oral
salmon calcitonin, in combination with our Eligen drug delivery technology,
may contribute to solving this problem, and also shows that Emisphere is a
valuable partner in drug development."
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and
improved delivery of therapeutic molecules using its Eligen Technology.
These molecules and compounds could be currently available or in
development. Such molecules are usually delivered by injection; in many
cases, their benefits are limited due to poor bioavailability, slow on-set
of action or variable absorption. The Eligen Technology can be applied to
the oral route of administration as well other delivery pathways, such as
buccal, rectal, inhalation, intra-vaginal or transdermal. The website is:
emisphere.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615)
filed on March 13, 2008 and our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, filed on August 11, 2008.
Emisphere Technologies, Inc
emisphere
вторник, 21 июня 2011 г.
Potential Fix For Damaged Knees Identified By Study
Investigators from Hospital for Special Surgery have shown that a biodegradable scaffold or plug can be used to treat patients with damaged knee cartilage. The study is unique in that it used serial magnetic resonance imaging (MRI) and newer quantitative T2 mapping to examine how the plug incorporated itself into the knee. The research, abstract 8372, was presented during the annual meeting of the American Orthopedic Society for Sports Medicine, June 9-12, in Keystone, Colo.
"The data has been encouraging to support further evaluation of this synthetic scaffold as a cartilage repair technique," said Asheesh Bedi, M.D., a fellow in sports medicine and shoulder surgery at Hospital for Special Surgery who was involved with the study. Dr. Bedi performed analysis of MRI scans of patients primarily treated by Riley Williams, M.D., director of the Institute for Cartilage Repair at Hospital for Special Surgery. "The Trufit plug has been designed to have mechanical properties that are similar to cartilage and bone," Dr. Bedi said.
Damage to so-called articular cartilage can occur in various ways, ranging from direct trauma in a motor vehicle accident to a noncontact, pivoting event on the soccer field. "Articular cartilage lacks the intrinsic properties of healing - you are essentially born with the articular cartilage that you have," Dr. Bedi said. Left untreated, these injuries can increase loads placed on the remaining intact cartilage and increase the risk of progression to degenerative arthritis. One way to treat patients with symptomatic chondral lesions is an OATS procedure, in which cartilage is transferred from one portion of the knee to treat another. Because this is a "robbing Peter to pay Paul" situation, researchers at Hospital for Special Surgery set out to examine whether they could use a biodegradable plug, the Trufit CB plug, to fill the donor site. The goal was to monitor how the plug incorporated itself into the knee and to evaluate the quality of the repair cartilage.
The Trufit plug has two layers. The top layer has properties similar to cartilage and the lower layer has properties similar to bone. The bilayered structure has mechanical properties that approximately match the adjacent cartilage and bone. Surgeons inserted the plug in the knees of 26 patients with donor lesions from OATS procedures and followed up with imaging studies (with MRI and T2-mapping) at various intervals for a period of 39 months.
"Quantitative MRI, when combined with morphologic assessment, allows us to understand the natural history of these repair techniques and define those patients who are most likely to benefit from the surgery," said Hollis Potter, M.D., chief of the Division of Magnetic Resonance Imaging, director of Research in the Department of Radiology and Imaging at Hospital for Special Surgery and lead author of the study. "We gain knowledge about the biology of integration with the host tissue, as well as the repair tissue biochemistry, all by a noninvasive imaging technique."
"What we found was that the plug demonstrated a predictable process of maturation on imaging studies that paralleled the biology of their incorporation," Dr. Bedi said. "With increasing postoperative duration, the repair tissue demonstrated encouraging properties with T2-values that resembled native articular cartilage."
Dr. Williams, Dr. Bedi and other surgeons at Hospital for Special Surgery are involved in ongoing studies to investigate the efficacy of the TruFit plug in treating primary cartilage defects as well. "What is unique about this study is that we have serial MRI with T2 mapping at various time points after surgery, which allows us to really examine the natural history of plug incorporation," Dr. Bedi said.
Dr. Williams believes that there is a role for scaffold-based cartilage repair strategies in the treatment of symptomatic cartilage lesions. "It is our hope that we can successfully treat these cartilage problems over the long term, thus restoring normal knee function and slowing the progression of knee arthritis," Dr. Williams said.
Other authors involved in the study are Li Foong Foo, M.D., and the Cartilage Study Group.
Source:
Phyllis Fisher
Hospital for Special Surgery
"The data has been encouraging to support further evaluation of this synthetic scaffold as a cartilage repair technique," said Asheesh Bedi, M.D., a fellow in sports medicine and shoulder surgery at Hospital for Special Surgery who was involved with the study. Dr. Bedi performed analysis of MRI scans of patients primarily treated by Riley Williams, M.D., director of the Institute for Cartilage Repair at Hospital for Special Surgery. "The Trufit plug has been designed to have mechanical properties that are similar to cartilage and bone," Dr. Bedi said.
Damage to so-called articular cartilage can occur in various ways, ranging from direct trauma in a motor vehicle accident to a noncontact, pivoting event on the soccer field. "Articular cartilage lacks the intrinsic properties of healing - you are essentially born with the articular cartilage that you have," Dr. Bedi said. Left untreated, these injuries can increase loads placed on the remaining intact cartilage and increase the risk of progression to degenerative arthritis. One way to treat patients with symptomatic chondral lesions is an OATS procedure, in which cartilage is transferred from one portion of the knee to treat another. Because this is a "robbing Peter to pay Paul" situation, researchers at Hospital for Special Surgery set out to examine whether they could use a biodegradable plug, the Trufit CB plug, to fill the donor site. The goal was to monitor how the plug incorporated itself into the knee and to evaluate the quality of the repair cartilage.
The Trufit plug has two layers. The top layer has properties similar to cartilage and the lower layer has properties similar to bone. The bilayered structure has mechanical properties that approximately match the adjacent cartilage and bone. Surgeons inserted the plug in the knees of 26 patients with donor lesions from OATS procedures and followed up with imaging studies (with MRI and T2-mapping) at various intervals for a period of 39 months.
"Quantitative MRI, when combined with morphologic assessment, allows us to understand the natural history of these repair techniques and define those patients who are most likely to benefit from the surgery," said Hollis Potter, M.D., chief of the Division of Magnetic Resonance Imaging, director of Research in the Department of Radiology and Imaging at Hospital for Special Surgery and lead author of the study. "We gain knowledge about the biology of integration with the host tissue, as well as the repair tissue biochemistry, all by a noninvasive imaging technique."
"What we found was that the plug demonstrated a predictable process of maturation on imaging studies that paralleled the biology of their incorporation," Dr. Bedi said. "With increasing postoperative duration, the repair tissue demonstrated encouraging properties with T2-values that resembled native articular cartilage."
Dr. Williams, Dr. Bedi and other surgeons at Hospital for Special Surgery are involved in ongoing studies to investigate the efficacy of the TruFit plug in treating primary cartilage defects as well. "What is unique about this study is that we have serial MRI with T2 mapping at various time points after surgery, which allows us to really examine the natural history of plug incorporation," Dr. Bedi said.
Dr. Williams believes that there is a role for scaffold-based cartilage repair strategies in the treatment of symptomatic cartilage lesions. "It is our hope that we can successfully treat these cartilage problems over the long term, thus restoring normal knee function and slowing the progression of knee arthritis," Dr. Williams said.
Other authors involved in the study are Li Foong Foo, M.D., and the Cartilage Study Group.
Source:
Phyllis Fisher
Hospital for Special Surgery
понедельник, 20 июня 2011 г.
European Medicines Agency Recommends Restricted Use For Piroxicam
The European Medicines Agency (EMEA) has recommended restrictions on the
use of piroxicam-containing medicinal products because of the risk of
gastrointestinal side effects and serious skin reactions. The Agency's
Committee for Medicinal Products for Human Use (CHMP) concluded that
piroxicam should no longer be used for treatment of short-term painful
and inflammatory conditions. Piroxicam can still be prescribed for the
symptomatic relief of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis. However it should not be the first choice of
non-steroidal anti-inflammatory drug (NSAID) treatment in these
conditions.
Prescription of piroxicam should always be initiated by a physician
experienced in the treatment of patients with inflammatory or
degenerative rheumatic diseases and treatment should be used in the
lowest dose (no more than 20 mg per day) and for the shortest duration
possible. In any case, the treatment should be reviewed after the first
14 days of starting.
In addition, the CHMP recommended new contraindications and strengthened
warnings for piroxicam, further details of which are provided in a
separate question-and-answer document.
Topical medicines containing piroxicam are not concerned by these
restrictions.
Further to the request of the European Commission, the CHMP initiated a
full assessment of the benefits and risks of piroxicam in September
2006, because a review of non-selective NSAIDs showed that piroxicam
could be associated with a higher risk of gastrointestinal side effects
and serious skin reactions than other non-selective NSAIDs.
The CHMP recommendations will now be forwarded to the European
Commission for adoption of a legally binding decision, applicable in all
EU Member States.
1. The safety review was conducted in accordance with Article 31 of
the Community code on human medicinal products (Directive 2001/83/EC as
amended).
2. More information about the recommendations for piroxicam is
available in a separate question- and-answer document here
here.
3. A press release announcing the start of the procedure for
piroxicam can be found
here.
4. More information about the review of NSAIDs can be found
here.
5. This press release, together with other information about the
work of the EMEA, may be found on the EMEA website:
European Medicines Agency (EMEA)
use of piroxicam-containing medicinal products because of the risk of
gastrointestinal side effects and serious skin reactions. The Agency's
Committee for Medicinal Products for Human Use (CHMP) concluded that
piroxicam should no longer be used for treatment of short-term painful
and inflammatory conditions. Piroxicam can still be prescribed for the
symptomatic relief of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis. However it should not be the first choice of
non-steroidal anti-inflammatory drug (NSAID) treatment in these
conditions.
Prescription of piroxicam should always be initiated by a physician
experienced in the treatment of patients with inflammatory or
degenerative rheumatic diseases and treatment should be used in the
lowest dose (no more than 20 mg per day) and for the shortest duration
possible. In any case, the treatment should be reviewed after the first
14 days of starting.
In addition, the CHMP recommended new contraindications and strengthened
warnings for piroxicam, further details of which are provided in a
separate question-and-answer document.
Topical medicines containing piroxicam are not concerned by these
restrictions.
Further to the request of the European Commission, the CHMP initiated a
full assessment of the benefits and risks of piroxicam in September
2006, because a review of non-selective NSAIDs showed that piroxicam
could be associated with a higher risk of gastrointestinal side effects
and serious skin reactions than other non-selective NSAIDs.
The CHMP recommendations will now be forwarded to the European
Commission for adoption of a legally binding decision, applicable in all
EU Member States.
1. The safety review was conducted in accordance with Article 31 of
the Community code on human medicinal products (Directive 2001/83/EC as
amended).
2. More information about the recommendations for piroxicam is
available in a separate question- and-answer document here
here.
3. A press release announcing the start of the procedure for
piroxicam can be found
here.
4. More information about the review of NSAIDs can be found
here.
5. This press release, together with other information about the
work of the EMEA, may be found on the EMEA website:
European Medicines Agency (EMEA)
воскресенье, 19 июня 2011 г.
Lupus More Severe In Patients With Southern European Ancestry
Systemic lupus erythematosus (SLE) patients with a higher percentage of ancestry from southern Europe have more severe disease manifestations, according to new research presented at EULAR 2008, the Annual Congress of the European League Against Rheumatism in Paris, France.
According to the results of the research, northern European ancestry is shown to be associated with the relatively milder mucocutaneous (skin) manifestations of SLE, whereas southern European ancestry contributes to more severe manifestations of the disorder such as nephritis (inflammation of the kidneys) and increased production of specific autoantibodies (antibodies that fail to recognise and therefore attack the body's own cells, tissues or organs).
SLE is a complex autoimmune disease characterised by chronic inflammation and damage to body tissues, which occurs as a result of the production of abnormal antibodies that target and cause damage to cells of the patient's body, including immune cells. SLE has the potential to affect a variety of areas of the body, including the heart, lungs, kidneys, joints, and/or nervous system. The course of the disease is unpredictable, with periods of illness (called flares) alternating with remission. Lupus can occur at any age but is most common in women, particularly of non-European descent. Until now, the relationship between specific European ancestry and SLE severity has not been studied.
Professor Lindsey A Criswell of the University of California, San Francisco, USA, who led the study, said: "Exploring the ancestry and genetic make-up of patients in relation to their disease today helps us to better understand the complex nature of SLE and why it manifests itself differently in different people. This study shows a clear correlation between specific European ancestry and SLE disease severity and autoantibody production, which may further assist in understanding the risk factors for this condition and should help us better understand and manage this disease in the future."
Researchers in this study examined 1,270 SLE patients from four independent cohorts who had at least 90% European ancestry according to continental ancestry-informative genetic markers. 1,409 genome-wide markers informative for northern versus southern European ancestry were then analysed to estimate the percentage of northern European ancestry for each subject using the STRUCTURE programme. The association between northern European ancestry and specific SLE subphenotypes, including autoantibody production, nephritis, arthritis and mucocutaneous manifestations was then explored.
Northern European ancestry was positively associated with photosensitivity (odds ratio=2.0, p
Abstract number: AB0147
About EULAR
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.
The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
Diseases of bones and joints, such as rheumatoid arthritis and osteoarthritis cause disability in 4 - 5 % of the adult population and are predicted to rise as people live longer.
As new treatments emerge and cellular mechanisms are discovered, EULAR 2008 brings together more than 12,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders.
To find out more information about the activities of EULAR, visit: eular/
Source: Rory Berrie / Camilla Dormer
European League Against Rheumatism
According to the results of the research, northern European ancestry is shown to be associated with the relatively milder mucocutaneous (skin) manifestations of SLE, whereas southern European ancestry contributes to more severe manifestations of the disorder such as nephritis (inflammation of the kidneys) and increased production of specific autoantibodies (antibodies that fail to recognise and therefore attack the body's own cells, tissues or organs).
SLE is a complex autoimmune disease characterised by chronic inflammation and damage to body tissues, which occurs as a result of the production of abnormal antibodies that target and cause damage to cells of the patient's body, including immune cells. SLE has the potential to affect a variety of areas of the body, including the heart, lungs, kidneys, joints, and/or nervous system. The course of the disease is unpredictable, with periods of illness (called flares) alternating with remission. Lupus can occur at any age but is most common in women, particularly of non-European descent. Until now, the relationship between specific European ancestry and SLE severity has not been studied.
Professor Lindsey A Criswell of the University of California, San Francisco, USA, who led the study, said: "Exploring the ancestry and genetic make-up of patients in relation to their disease today helps us to better understand the complex nature of SLE and why it manifests itself differently in different people. This study shows a clear correlation between specific European ancestry and SLE disease severity and autoantibody production, which may further assist in understanding the risk factors for this condition and should help us better understand and manage this disease in the future."
Researchers in this study examined 1,270 SLE patients from four independent cohorts who had at least 90% European ancestry according to continental ancestry-informative genetic markers. 1,409 genome-wide markers informative for northern versus southern European ancestry were then analysed to estimate the percentage of northern European ancestry for each subject using the STRUCTURE programme. The association between northern European ancestry and specific SLE subphenotypes, including autoantibody production, nephritis, arthritis and mucocutaneous manifestations was then explored.
Northern European ancestry was positively associated with photosensitivity (odds ratio=2.0, p
Abstract number: AB0147
About EULAR
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.
The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
Diseases of bones and joints, such as rheumatoid arthritis and osteoarthritis cause disability in 4 - 5 % of the adult population and are predicted to rise as people live longer.
As new treatments emerge and cellular mechanisms are discovered, EULAR 2008 brings together more than 12,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders.
To find out more information about the activities of EULAR, visit: eular/
Source: Rory Berrie / Camilla Dormer
European League Against Rheumatism
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