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, 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 (Genant-modified Sharp Score increase of 1.14 versus 2.81 respectively, p
Patient preference
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 life6.
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®.
For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit thenewsmarket/roche.
To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at mabthera-ra
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6, a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at roche.
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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 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
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