New data1 presented at the European League Against Rheumatism
(EULAR) annual meeting revealed that when rheumatoid arthritis (RA) patients do not respond to a
TNF inhibitor, a commonly used class of drugs in RA, it is more effective to treat them with MabThera
(rituximab), than to use a second TNF inhibitor therapy.1 This calls into question the practice of
'cycling' between anti TNFs, and provides evidence that supports preliminary NICE guidance where
anti TNF switching has not been recommended.
This data shows that MabThera,with a different mode of action to anti-TNFs, may benefit patients
earlier in their treatment pathway. Instead of having to take an alternative anti-TNF, a potentially less
effective treatment, using time and NHS budget and risking irreversible damage to their joints, they
could benefit from MabThera (rituximab).
The studyi was conducted among 300 patients who had previously not responded to TNF inhibitor
therapy. Data at six months showed that MabThera achieved a significantly larger reduction in disease
activity (DAS28) than a subsequent anti-TNF agent in patients who had ceased anti-TNF therapy due to
lack of efficacy (reduction in DAS28 by 1.55 versus 1.03).
"These findings confirm that switching to an alternative biological agent, such as rituximab, in the
subset of RA patients who don't respond to a first anti-TNF agent, can provide major benefits", said
Professor Rob Moots, Aintree University Hospitals "In patients with persistent active disease despite
anti-TNF therapy, these data suggest that switching to rituximab might be more effective than switching
to an alternative anti-TNF agent."
Inhibition of joint damage
New data from another study, REFLEX3, also presented at EULAR, demonstrate that MabThera
continues to significantly inhibit the progression of joint damage caused by RA over a period of two
years in those patients who do not respond to TNF inhibitor therapy4. X-ray evidence at two years
showed that the narrowing of joint spaces and appearance of new bone erosions were reduced by more
than 50% in patients receiving MabThera and methotrexate (a commonly used RA drug) compared to
patients receiving methotrexate alone (Total Sharp Score increase of 1.14 versus 2.81 respectively,
p
A new study has been described, assessing the preference (based on a range of treatment preferences
and key drivers of choice) for the benefits of a drug modelled on MabThera relative to those of drugs
modelled on entanercept Enbrel) and abatacept (Orencia) as a biologic therapy for the treatment of RA.
The new data presented at EULAR identified that RA patients prefer treatments with infrequent dosing.
The study found that patients favour a treatment model
led on MabThera which offers symptom control
with less frequency in needing to have treatment.6.
About Rheumatoid Arthritis and MabThera
Rheumatoid arthritis is an autoimmune disease characterised by inflammation that leads to stiff, swollen
and painful joints. Current treatments include disease-modifying drugs (DMARDS) and biologic
therapy such as the TNF inhibitor drugs.
MabThera is a first-in-class therapy that selectively targets B cells early in the inflammatory cascade of
rheumatoid arthritis. B cells are known to play a key role in the inflammation associated with
rheumatoid arthritis and MabThera breaks 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, and may provide an innovative new treatment even in patients with severe and longstanding
disease. MabThera has a strong heritage in the treatment of a form of lymphatic cancer called
non-Hodgkin's lymphoma (NHL) and the treatments safety profile has now been established in more
than a million patient exposures over the last nine years in oncology and more recently rheumatoid
arthritis.
MabThera is indicated, in combination with methotrexate, for the treatment of adults with severe
rheumatoid arthritis who cannot tolerate or do not respond to anti-TNF therapy.
Safety Profile
The majority of adverse events are mild to moderate in severity. In trials adverse drug reactions
occurred with at least a 2% difference compared to the control arm. The most frequent adverse events
are infusion reactions which occurred in 15% patients following the first infusion of rituximab and 5%
in placebo patients. Fewer reactions are observed with second and subsequent infusions. Severe infusion
reactions are uncommon and their frequency is reduced by the use of concomitant IV steroids.
About Roche in Rheumatoid Arthritis
Roche has prioritised research and development of new treatments for auto-immune diseases, including
rheumatoid arthritis. Following the launch of MabThera® (rituximab) for RA in 2006 there are a
number of projects in development ensuring a rich pipeline including compounds in Phase I, II and III
clinical trials. Tocilizumab is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal
antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical
need. This treatment is not yet licenced in Europe and is the result of a research collaboration by Roche
and Chugai , and is being co-developed globally. Ocrelizumab, a fully humanised anti-CD20 antibody,
is just entering Phase III development for RA.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for
the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading
healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics.
Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of
cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more
at rocheuk
A summary of product characteristics is available at rocheuk
References
1 - Finckh, A et al. Which subgroup of rheumatoid arthritis patients benefit most from switching to rituximab versus alternative anti-TNF agents after previous failure to anti-TNF agent? Abstract OP-0249, EULAR 2008
2 - DAS28 is a measurement score used to assess whether a patient shows an improvement in disease activity. DAS28 provides a number on a scale from 0 to 10 which indicates the current activity of the disease.
3 - A Randomised Evaluation oF Long-term Efficacy of rituXimab in RA
4 - Cohen, S et al. Continued inhibition of structural damage in rheumatoid arthritis patients treated with rituximab at 2 tears:
REFLEX study. Abstract THU0167, EULAR 2008
5 - As measured by the mean increase from baseline in Total Sharp Score (TSS), an x-ray measurement of change in joint damage
6 - Ostor, AJK et al. Patient preference for rituximab as a treatment for rheumatoid arthritis: a study using discrete choice analysis. Abstract AB0375, EULAR 2008
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