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FDA Approves Rayos for Rheumatoid Arthritis and Other Diseases

The efficacy of Rayos in the treatment of RA was assessed in the CAPRA-2 trial, a double-blind, placebo-controlled, randomized, 12-week trial in 350 patients with active disease. The patients’ ages ranged from 27 to 80 years (median age, 57 years). Enrolled patients were not being treated with corticosteroids but had received non-biologic disease-modifying antirheumatic drugs (DMARDs) for at least 6 months prior to receipt of the study medication and had shown an incomplete response to DMARD therapy alone. Patients were randomly assigned to treatment with Rayos 5 mg (n = 231) or placebo (n = 119) administered at 10 p.m. in addition to their DMARD therapy.

Results from the CAPRA-2 trial demonstrated:

  • A statistically significant improvement in ACR20 response criteria, the primary study endpoint, for patients who were treated with Rayos compared with the placebo group (47% vs. 29%, respectively; P = 0.001).
  • A statistically significant improvement in ACR50 response criteria, a secondary endpoint, with Rayos compared with placebo (22% vs. 10%, respectively; P = 0.007).
  • Improvement in ACR70 response criteria, a secondary endpoint, with Rayos versus placebo (7% vs. 3%, respectively; P = 0.0984).

Results from the CAPRA-2 study were published in the Annals of the Rheumatic Diseases.

Rayos, known as Lodotra in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of Rayos is different, with an approximately 4-hour lag time from that of immediate-release prednisone formulations. In clinical trials studying the use of Rayos in RA, patients were administered the drug at 10 p.m. with food. Given the delayed-release profile of Rayos, this helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night. While the pharmacokinetic profile of Rayos differs in terms of lag time from immediate-release prednisone, its absorption, distribution, and elimination processes are comparable.

For more information, visit the Horizon Pharma Web site.

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