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Otezla shows sustained clinical response at 2 years in patients with psoriatic arthritis
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Celgene recently released long-term efficacy and safety analysis results for Otezla from the open-label phase of two clinical trials.
The two phase 3, randomized, double-blind clinical trials, PALACE 1 and PALACE 4, included 171 and 201 patients, respectively, with active psoriatic arthritis. PALACE 1 included patients who had previously been treated with oral disease-modifying antirheumatic drugs (DMARDs) and/or biologics, with some patients who failed previous treatment with a tumor necrosis factor (TNF) blocker, whereas PALACE 4 included DMARD-naïve patients. In both studies, patients were randomly assigned to treatment with either Otezla (apremilast, Celgene) or placebo.
In PALACE 1, 84% of patients who completed 52 weeks of therapy with apremilast 30 mg twice daily continued treatment through 2 years. At week 104, 65.3% of patients had achieved an American College of Rheumatology 20 (ACR20) response, according to a company press release. ACR50 and ACR70 responses were seen in 34% and 19.6% of patients, respectively.
In PALACE 4, almost 84% of DMARD-naïve patients who completed 52 weeks of apremilast 30 mg twice daily monotherapy continued therapy through 104 weeks. ACR20 was achieved by 61.4% of patients receiving the monotherapy, according to the release. A response of ACR50 was achieved in 40.7% and of ACR70 in 19.2% of patients.
Improvements in physical function, enthesitis, dactylitis and joint swelling and pain were also sustained through weeks 52 and 104, according to the release.
Most adverse events reported in the second year of treatment were similar to symptoms presented in the first year, including diarrhea, nausea, headache or upper respiratory tract infection, and were reported in about 5% of patients. Discontinuation rates due to adverse events remained the same in both years.
Apremilast was approved by the U.S. Food and Drug Administration in March 2014 for the treatment of adults with active psoriatic arthritis and in Sept. 2014 for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, according to the release.
Reference: www.celgene.com.