Celgene: OTEZLA phase III study for psoriatic arthritis meets primary endpoint

Jun 11 2014

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of additional analyses from the phase III clinical trials of OTEZLA, the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4). These included long-term (52-week) analyses from the PALACE 1, 2 and 3 trials of the impact of OTEZLA on psoriatic arthritis disease activity, safety and tolerability, in addition to a separate 16-week work productivity analysis from PALACE 1. The findings 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, M.D., Ph.D., director of the Department of Internal Medicine III - Rheumatology and Immunology, University Hospital Erlangen, Germany. "These analyses of one-year data from the PALACE trials suggest that, based on the efficacy and safety data we've seen to-date, OTEZLA has the potential to help patients for the long-term management of manifestations of their psoriatic arthritis."

PALACE 1, PALACE 2 and PALACE 3: Measures of Disease Activity

Long-term (52-week) results from three studies demonstrated that treatment with OTEZLA improved measures of psoriatic arthritis disease activity, including tender and swollen joints, compared with placebo at 16 weeks. Disease activity was evaluated using the Disease Activity Score of 28 joint counts (DAS-28), as measured by the level of C-reactive protein (CRP), modified Psoriatic Arthritis Response Criteria (PsARC) response and good or moderate European League Against Rheumatism (EULAR) response. All three measurements of disease activity demonstrated sustained improvements through week 52 among patients who were continuously treated with OTEZLA.

PALACE 1, PALACE 2 and PALACE 3: Pooled 52-week Safety Data

Long-term safety results from an analysis of pooled data from the PALACE 1, 2 and 3 trials (including 1,493 patients) identified no new safety findings for patients with psoriatic arthritis who were treated with OTEZLA for up to 52 weeks, compared with the previously reported 24-week safety results. The nature, incidence and severity of adverse events (AEs) were comparable through the 24-week and 52-week periods.

Most AEs were mild or moderate in severity. Discontinuation due to AEs was low (OTEZLA 20 mg BID, 7.5 percent; OTEZLA 30 mg BID, 8.3 percent) and primarily occurred in the first 24 weeks of treatment. The incidence and severity of AEs were comparable through the 24-week and 52-week periods. The most commonly reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis. Serious AEs occurred in 6.8 percent of patients receiving OTEZLA 20 mg BID and 7.2 percent of patients receiving OTEZLA 30 mg BID. One death occurred (OTEZLA 20 mg BID) due to multiorgan failure not suspected to be treatment-related.

Exposure-adjusted incidence rates per 100 subject years of major adverse cardiac events, serious infections, including opportunistic infections or malignancies, were comparable with those of placebo.

Similar to 24-week data previously reported from PALACE 1, 2 and 3, the 52-week data do not indicate a need for laboratory monitoring with OTEZLA treatment.

PALACE 1: Work Productivity

The results of a work productivity analysis of 261 patients from PALACE 1 demonstrated that treatment with OTEZLA increased work productivity and improved work limitations compared with 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 conditions on work performance and productivity—at baseline and week 16. Four categories of work limitations, physical demands, mental demands, time management demands and output demands, were used to calculate the WLQ index.

Source: Celgene International Sàrl