Celgene Phase III study OTEZLA for psoriatic arthritis meets primary endpoint -
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG) announced today the results of additional analysis of clinical trials of phase III OTEZLA, oral, selective inhibitor of phosphodiesterase Society 4 (PDE4). These included long-term (52 weeks) analysis of the palace 1, 2 and 3 trials of the impact of OTEZLA on the disease activity of psoriatic arthritis, the safety and tolerability, in addition to 16 weeks of analysis of the productivity of separate working PALACE 1. results were presented at the European League Against Rheumatism annual Congress (EULAR 2014) in Paris, France.
"people with psoriatic arthritis live with persistent symptoms of this painful disease," said Georg Schett, MD, Ph.D., director of the Department of Internal Medicine III -. Rheumatology and Immunology , university hospital Erlangen, Germany. "These analyzes data to one year PALACE tests suggest that, on the basis of efficacy and safety data we have seen to date, OTEZLA has the potential to help patients long term management of manifestations of their psoriatic arthritis. "
PALACE 1, PALACE 2 and PALACE 3: disease activity measures
long-term (52 weeks) the results of three studies have shown that OTEZLA treatment with improved measures of disease activity in PsA, including tender and swollen joints compared to placebo at 16 weeks. disease activity was assessed using the activity score of disease 28 joint count (DAS28), as measured by the protein C-reactive (CRP), psoriatic arthritis modified response Criteria (PsARC) response and good to moderate European League Against Rheumatism (EULAR) answer. the three measures of disease activity demonstrated sustained improvement through week 52 among patients who were treated continuously with OTEZLA
PALACE 1, PALACE 2 and PALACE 3 :. 52 weeks pooled safety data
results of long-term safety of an analysis of pooled data from the PALACE 1, 2 and 3 trials (including 1493 patients) not identified new safety outcomes for patients with psoriatic arthritis who were treated with OTEZLA to 52 weeks, compared with the safety results 24 weeks previously reported. The nature, frequency and severity of adverse events (AEs) were comparable across periods of 24 weeks and 52 weeks.
Most adverse events were mild or moderate. Discontinuation due to adverse events was low (20 mg BID OTEZLA, 7.5 percent; OTEZLA 30 mg BID, 8.3 percent) and mostly occurred in the first 24 weeks of treatment. The incidence and severity of adverse events were comparable across periods of 24 weeks and 52 weeks. The most frequently reported adverse events were nausea, diarrhea, headache, infection of the upper respiratory tract and nasopharyngitis. Serious AEs occurred in 6.8 percent of patients receiving 20 mg BID OTEZLA and 7.2 percent of patients receiving 30 mg BID OTEZLA. One death occurred (OTEZLA 20 mg BID) due to multiple organ failure not suspected to be related to treatment.
exposure adjusted incidence rates per 100 subject-year major adverse cardiac events, serious infections, including opportunistic infections or malignancies were comparable to placebo.
Similar to 24 weeks of data previously PALACE 1, 2 and 3, 52 weeks of the data does not indicate the need for laboratory monitoring with OTEZLA treatment.
PALACE 1: labor productivity
The results of an analysis of labor productivity of 261 PALACE 1 patients showed that treatment with OTEZLA increased labor productivity and improve working limitations compared to placebo at 16 weeks. Patients in this study completed the work Limitation Questionnaire (WLQ) -a 25-item questionnaire that assessed the impact of chronic health problems on job performance and productivity at baseline and week 16. Four categories of work limitations, physical demands, mental demands, time management requirements and output requests, were used to calculate the index of WLQ.
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