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Rituximab Effective in Rheumatoid Arthritis: Presented at EULAR

By Paula Moyer

BERLIN, GERMANY -- June 16, 2004 -- The biologic therapy rituximab (Rituxan) is effective in the treatment of refractory rheumatoid arthritis, according to study findings.

Reporting here June 10th at the European Congress of Rheumatology, principal investigator John C. Edwards, MD, a consultant with Cambridge Rheumatology at University College London in London, United Kingdom, said "Although the importance of B-cell depletion therapy is well established in the treatment of non-Hodgkin's lymphoma, it has only been considered in inflammatory disease in the last 5." He continued, "We've seen early evidence of significant efficacy recently in a randomized controlled trial.".

He and coinvestigators at University College recruited 37 patients with rheumatoid arthritis to participate in a long-term program of repeated B-cell depletion therapy with rituximab. In the last 5 years, the patients have received a total of 65 treatments. In this time, 1 patient showed inadequate depletion, defined as less than an ACR20 response after 15 months of treatment. Three patients, who had coexistent psoriasis, had no improvement in psoriatic lesions, Dr. Edwards said.

The investigators found that 80% of seropositive patients had adequate control of rheumatoid arthritis, and that seronegative patients were unresponsive to rituximab therapy. During the treatment period, patients did not develop secondary resistance to treatment, he continued.

During the 5-year follow up, consisting of 85 patient-years, the investigators have documented 8 febrile episodes with pulmonary symptoms, all of which resolved with antibiotic therapy. Four of the infections may have been either late immunological reactions to therapy or disease-associated, he said, noting that, as with TNF-alpha blockers, patients may be more susceptible to respiratory infections.

Other adverse reactions included 1 suspected joint prosthesis infection, which was sterile on culture, and 3 occurrences of breast carcinoma in patients who received concomitant cyclophosphamide, including 2 cases of ductal carcinoma in situ. One case may have pre-dated therapy.

Treatment has influenced certain immunoglobulin levels, and cumulative effects may increase with usage, Dr. Edwards said. Three patients who have received 3 courses of therapy in rapid succession developed undetectable serum immunoglobulin-M (IgM) levels during treatment. However, reductions in IgG levels have been modest, with adequate antibacterial antibody levels, Dr. Edwards said.


[Presentation title: Anti-CD20 For Rheumatoid Arthritis. Abstract SP0073]

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