11/06/2008 2:02:09 CET
BASEL, Switzerland, June 11 /PRNewswire/ --
-- New Data Also Proves MabThera's Inhibition of Joint Damage is Maintained Over Two Years
A recent study(1) has called into question the practice of putting rheumatoid arthritis (RA) patients onto a second tumour necrosis factor (TNF) inhibitor therapy, a commonly used class of RA drugs, when they do not respond to the first TNF inhibitor.
The study, presented at the EULAR annual meeting (European League Against Rheumatism) in Paris, revealed that when RA patients do not respond to a TNF inhibitor, it is more effective to treat them with MabThera (rituximab), an RA drug with a different mode of action, than to use a second TNF inhibitor therapy.(1)
The study was conducted among 300 patients who had previously not responded to TNF inhibitor therapy. It analyzed the improvement in the disease activity score (DAS28)(2) of patients receiving MabThera compared to patients receiving an alternative TNF inhibitor. Data at six months showed that MabThera achieved a significantly larger reduction in disease activity (DAS28) than a subsequent TNF inhibitor in patients who had interrupted TNF inhibitor therapy due to lack of efficacy (reduction in DAS28 by 1.55 versus 1.03)(1).
"These findings are significant because they confirm the benefit of 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", said Dr Axel Finckh, Rheumatology Division, University of Geneva, Switzerland, presenting the results."In patients with persistent active disease despite anti-TNF therapy, our data suggest that switching to rituximab is more effective than switching to an alternative anti-TNF agent."
Inhibition of joint damage
New data from another study, REFLEX(3), 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 therapy(4). 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 (Genant-modified Sharp Score increase of 1.14 versus 2.81 respectively, p<0.0001)(5). MabThera consistently inhibited progression of joint damage since 89% of MabThera-treated patients who did not show progression the first year had no progression the second year.
Damage to the structure of joints ultimately causes joint destruction and contributes to joint deformity and loss of mobility. The inhibition of joint structural damage is therefore a major goal of treatment. In patients who do not respond to TNF inhibitor therapy MabThera is the first and only therapy to have demonstrated a reduction in joint structural damage.
Reporting on the significance of these data, Professor Edward Keystone, Rheumatology Department at the University of Toronto, Canada, said, "We know that many patients suffer the debilitating effects of joint damage and it is extremely promising to see that MabThera continues to inhibit the progression of this damage over time, therefore improving the quality of life of our patients. This was a very important study since MabThera is the only agent that has ever been evaluated and shown to inhibit radiographic progression among patients who have not responded to TNF inhibitor therapy."
Additional data presented at EULAR identified that RA patients prefer treatments with infrequent administration. Based on a range of treatment preferences and key drivers of choice, the study found that patients favour a treatment like MabThera which offers symptom control with extended interval time between treatment administrations, therefore providing minimum disruption to a patient's life(6).
Notes to Editors
About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan(R).
For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit http://www.thenewsmarket.com/roche.
To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at http://www.mabthera-ra.com
All trademarks used or mentioned in this release are legally protected.
(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 the total Genant-modified Sharp Score, 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
For further information, please contact: Roche, Federico Maiardi (on site), Associate International Communications Manager, Tel: +41-79-264-3978; Cohn & Wolfe, Rebecca Hibble (on site), Tel: +44-781-309-6161, Huong Nguyen (UK), Tel: +44-207-331-5332