Comprehensive long-term clinical success achieved in difficult-to-treat patients following just two administrations, two weeks apart
San Diego, U.S.A.: Roche today announced positive results of the Phase III REFLEX study, evaluating the efficacy and safety of MabThera in patients with rheumatoid arthritis (RA), who have had an inadequate response to anti-TNF biologic therapy. The data were presented today at the American College of Rheumatology meeting in San Diego, California and demonstrate that MabThera (rituximab) significantly improved all efficacy measures of rheumatoid arthritis (RA) for six months following a single course of just two administrations. MabThera provided relief to almost three times as many patients compared to placebo. Currently these difficult-to-treat patients, who represent at least 30% of all those treated with existing biologic therapy, are left with few treatment alternatives.
These data herald the start of a unique way to treat RA, a common condition affecting over 21 million people worldwide, in which the immune system attacks the joints, often causing severe swelling, pain, fatigue and disability. Traditionally, biologic therapy is focussed on blocking the action of an immune system molecule called TNF while MabThera is the first and only RA treatment to target specific types of immune cells, called B cells. B cells play a key role in the chain of inflammatory events that ultimately lead to the damage of bone and cartilage in the joints, characteristic of RA. Moreover, MabThera's long-term treatment success was achieved following just 2 administrations, 2 weeks apart, providing a highly convenient regimen. Presenting the results, Dr Stanley Cohen, M.D. Lead REFLEX investigator and Clinical Professor, Department of Internal Medicine at the University of Texas Southwestern Medical School, Dallas, commented, "These data will be of great interest to both physicians and patients, since they suggest that MabThera may offer patients the opportunity of at least six months relief of their symptoms with just two infusions. We observed MabThera responses as being consistently greater across the broad range of measures we looked at, in particular tender and swollen joint counts and fatigue."
Significant improvements across all symptom parameters
The results of the six-month analysis show that MabThera in combination with methotrexate (MTX), a standard RA treatment, was highly effective, producing statistically significantly higher response rates compared to MTX plus placebo: 51% of patients achieved 20% improvement in signs and symptoms (ACR201 ), compared to 18% with MTX alone. The difference in the two groups was apparent after 8 weeks and sustained for the duration of the study after only 2 infusions of MabThera, two weeks apart. Over the six-month period, more than five times as many patients in the MabThera group achieved a 50% improvement in signs and symptoms compared to MTX alone (ACR50: 27% vs 5%), and twelve times more MabThera patients achieved a 70% improvement (ACR70: 12% vs 1%).
Safety Consistent with Earlier Studies
Overall the MabThera regimens were well tolerated. Adverse events experienced were consistent with those noted in earlier studies of MabThera in RA. The most frequently reported adverse events in the study were primarily infusion-related, comparable to placebo and mild-to-moderate in intensity. Serious adverse events were similar in both treatment groups (7% in the MabThera group and 10% in the placebo group).
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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