Positive Results from Rituxan Clinical Trial in Rheumatoid Arthritis

Strategic Insights -

A recent clinical trial of Rituxan (Rituximab) in rheumatoid arthritis (RA) has yielded positive results, demonstrating a greater proportion of patients achieving American College of Rheumatology (ACR) 20, 50, and 70 response rates compared to placebo. The trial, known as the dose-ranging assessment international clinical evaluation of Rituximab in RA (DANCER), involved 465 patients who were inadequately responding to methotrexate (MTX) and had failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs). The results showed that Rituxan provided clinically and statistically significant improvement in RA symptoms compared to placebo.

Key Takeaways:

  • The DANCER study evaluated the efficacy and safety of two doses of Rituxan in combination with MTX and explored the role of corticosteroids in patients with RA.
  • 54% and 55% of patients in the two Rituxan groups achieved ACR 20 response rates, compared to 28% in the placebo group.
  • 33% and 34% of patients in the two Rituxan groups achieved ACR 50 response rates, compared to 13% in the placebo group.
  • 13% and 20% of patients in the two Rituxan groups achieved ACR 70 response rates, compared to 5% in the placebo group.
  • The benefits of Rituxan were independent of short-course corticosteroids, which were given in all previous Rituxan RA trials.
  • The most frequently reported adverse events in the study were primarily infusion-related and mild-to-moderate in intensity, including headache, nausea, and rigors.
  • Intravenous corticosteroid premedication appeared to reduce the incidence and severity of first infusion reactions.
  • Rituxan therapy had no significant impact on immunoglobulin levels or acquired immunity.

Statistics:

  • 465 patients were enrolled in the DANCER study.
  • 54% and 55% of patients in the two Rituxan groups achieved ACR 20 response rates.
  • 33% and 34% of patients in the two Rituxan groups achieved ACR 50 response rates.
  • 13% and 20% of patients in the two Rituxan groups achieved ACR 70 response rates.
  • 28% of patients in the placebo group achieved ACR 20 response rates.
  • 13% of patients in the placebo group achieved ACR 50 response rates.
  • 5% of patients in the placebo group achieved ACR 70 response rates.
  • 35% of patients in the Rituxan groups experienced infections, compared to 28% in the placebo group.
  • The rate of serious infections was low and was similar across the treatment groups.

Sources:

  • Genentech, Inc.
  • Biogen Idec
  • Roche
  • Health & Medicine Week editors
  • NewsRx.com