MabThera improves symptoms in rheumatoid arthritis, data suggest
MabThera (rituximab), a monoclonal antibody targeting B cells in the immune system, reduces symptoms in moderate-to-severe rheumatoid arthritis (RA), according to results from the largest study yet to investigate the drug in this indication.
The phase IIb study included 465 patients with RA who had failed prior
treatment with one or more disease-modifying anti-rheumatic drugs, including
biologics, and who were responding inadequately to methotrexate.
Patients were randomised to active treatment with various combinations
of rituximab and glucocorticoids.
Results for the 24-week analysis showed that rituximab achieved symptom
relief in almost twice as many patients compared with placebo. More than
half (54 per cent) of patients on the highest dose (2 x 1,000mg given
two weeks apart) showed a 20 per cent improvement in joint symptoms (assessed
using American College of Rheumatology criteria) compared with 28 per
cent of the placebo group (P<=0.001). An even more profound difference
was noted between the rituximab and placebo groups at the goals of 50
per cent or 70 per cent improvement in symptoms (34 per cent vs 13 per
cent and 20 per cent vs 5 per cent, respectively; all P<=0.001).
The results showed no difference in symptom improvement with or without
steroids, although intravenous steroid premedication reduced the incidence
and severity of infusion reactions associated with the first rituximab
infusion, which was one of the commonest side effects with the drug.
Professor Paul Emery, professor of rheumatology, University of Leeds,
and one of the lead investigators, commented: “The results demonstrate
the benefits of targeting B cells in RA and show MabThera to be effective
in a broad patient population, including those who have received previous
biologic therapy.” |
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