Results of the REFLEX study1 show that the number of people with rheumatoid arthritis (RA) achieving clinical remission from their disease doubled over three successive treatment courses with MabThera (rituximab) when used in combination with methotrexate (from 8.8% achieving clinical remission* after the first course to 17.6% after the third course). These data confirm that MabThera may continue to improve RA symptoms with each subsequent course of treatment, maximising patient response in those with severe RA who have failed to respond adequately to tumour necrosis factor (TNF) inhibitors, the most commonly prescribed first-line biologic therapy for RA.
The study also revealed almost twice as many people with RA achieved a 70% improvement in their symptoms after their third course of treatment compared to their first course of treatment (increase in ACR70* response from 14% to 25.7%). The results of the long term follow up to the pivotal REFLEX study, involving 2578 patients, are being presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco.
"These results clearly demonstrate that prolonged treatment with MabThera leads to an improvement in symptoms for people with rheumatoid arthritis who do not respond adequately to TNF inhibitor therapy," said Professor Paul Emery, arc Professor of Rheumatology, University of Leeds, Leeds Teaching Hospitals Trust. "The striking improvement in remission signifies the important place it holds in the long-term treatment of RA".
Long-term treatment also shown to reduce joint damage
Additional data demonstrate that long-term treatment with MabThera continues to significantly inhibit the progression of joint damage (compared with placebo) over a period of two years in those people with RA who do not respond to TNF inhibitor therapy.2 This was measured using X rays. Joint damage can lead to severe disability and pain in people with RA, therefore the inhibition of structural damage is a major goal of treatment. In people with RA who do not respond to TNF inhibitor therapy, MabThera is the first and only therapy to have demonstrated a reduction in joint structural damage.
Data demonstrate long-term safety
Six-year follow-up data also presented at the ACR annual meeting prove that MabThera continues to demonstrate a consistent safety profile over several courses of treatment. The safety profile remained constant with the number of infections, including serious infection events, being low (4.31/100 pt-years (95% CI: 3.77-4.92)). These results add to the wealth of data contributing to MabThera's safety profile in RA with 5013 patient-years of follow-up now collected.3