Roche reported that MabThera (rituximab) has been approved by the European Commission for the treatment of rheumatoid arthritis (RA) in Europe.
MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or are intolerant to current treatment options including one or more tumour necrosis factor (TNF) inhibitors. MabThera is the first and only selective B cell therapy for RA offering a fundamentally different treatment approach.
B cells play a key role in driving the RA disease process and MabThera is thought to break this process so preventing disease effects and leading to lasting benefits for the patient.
The approval of MabThera is based on the impressive results of the Reflex1 trial where MabThera in combination with methotrexate, was shown to be a highly effective therapy for controlling symptoms and improving the physical and mental health of patients with RA. FDA approval was received in the US earlier this year.
RA is one of the most common forms of autoimmune disease which affects more than 21 million people worldwide, with as many as 3 million sufferers in Europe alone. Currently up to 40 per cent of people with RA who are treated with biologic therapies such as TNF inhibitors, do not have satisfactory outcomes.
"Due to the high number of patients who do not respond or tolerate currently available therapies, there is a great need for novel and effective options", said William M. Burns, CEO of Roche's Pharmaceutical Division. "We are confident that MabThera, Roche's first innovative treatment for RA, will bring relief to patients with this debilitating disease and that our ongoing research and development programmes will yield more therapies for those who need them."
The Reflex study is a multi-centre, randomized, double-blind, placebo-controlled phase III study. In this trial, patients who received an initial course of only two infusions of 1000mg of MabThera two weeks apart, with a stable dose of methotrexate displayed a statistically significant improvement in symptoms (ACR2) measured at 24 weeks, compared to those receiving placebo and methotrexate. Consistent with previous findings, analysis of the Reflex 24-week data did not reveal any unexpected safety signals. Roche continue to monitor the long-term safety of MabThera in all clinical trials.
One year data presented recently at a major European congress (EULAR) showed that MabThera significantly inhibits the structural damage to joints caused by RA in patients who have had an inadequate response to TNF inhibitor therapies. To date no other RA therapy has shown evidence of inhibition of joint structural damage in this patient group. In addition, the question around subsequent treatment courses was answered as patients receiving additional courses did so between 6 and 12 months after the initial course and experienced further improvement of symptoms. Furthermore, remission rates doubled from a DAS283 remission rate of 6 per cent following an initial course to 13 per cent following a second course of MabThera treatment.
A comprehensive phase III clinical development programme is currently underway to further investigate the potential clinical benefit of MabThera in earlier RA, a company release stated.