PALACE 4 trial success for Otezla for Psoriatic Arthritis - Celgene

Celgene International Sàrl, announced results from a long-term (52-week) phase III trial of Otezla (apremilast), in Psoriatic Arthritis patients who have not had prior treatment with systemic or biologic disease-modifying antirheumatic drugs (DMARDs). The data were presented at the European League Against Rheumatism Annual Congress (EULAR 2014) in Paris, France.

PALACE 4: 52-week -Enthesitis and Dactylitis -Results demonstrated that treatment with Otezla monotherapy in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (a count of fingers and toes with inflammation), two key manifestations of Psoriatic Arthritis, resulted in long-term improvements. Results were sustained over 52 weeks in patients initially randomized to Otezla monotherapy and completing 52 weeks of the study. At week 52, median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) decreased by 75.0 percent and 45.9 percent of patients receiving Otezla 30 mg BID achieved a score of 0, indicating no pain at any of the enthesitis sites assessed. Otezla 30 mg BID also resulted in a median 100 percent decrease in dactylitis count. A dactylitis count of 0, indicating no signs of dactylitis, was achieved in 68.8 percent of patients.

PALACE 4: 52-week- Physical Function -The results of a physical function analysis from PALACE 4 demonstrated that 52 weeks of treatment with Otezla monotherapy resulted in sustained improvements for up to 52 weeks, as measured by validated assessment tools. In patients who were treated with Otezla monotherapy continuously through 52 weeks, clinically meaningful improvements were seen at week 16 in the Health Assessment Questionnaire-Disability Index (HAQ-DI), a key instrument measuring physical function, and improvements were sustained for up to 52 weeks. HAQ-DI measures the difficulty patients have performing activities of daily life such as difficulty dressing, walking and eating. The HAQ-DI results were further supported by improvements in the short form health survey version 2 Physical Functioning (SF-36 v2 PF) seen in patients who were treated with Otezla monotherapy continuously through 52 weeks.