SUMMIT (dpa-AFX) - Celgene International Sàrl, a wholly owned subsidiary of Celgene Corp. (CELG), announced that long-term safety findings from ongoing clinical trials of apremilast, the Company's oral, selective inhibitor of phosphodiesterase 4 or PDE4, were presented at the European Academy of Dermatology and Venereology or EADV Annual Congress in Vienna, Austria.
Analyses of pooled 156-week (3-year) safety data from the ESTEEM 1 and 2 and PALACE 1-3 trials were presented, which included patients with moderate to severe plaque psoriasis (ESTEEM) and active psoriatic arthritis (PALACE) who were treated with apremilast 30 mg twice-daily. Patients with psoriatic arthritis were treated with OTEZLA alone or in combination with concomitant disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate.
Pooled 3-year data analyses from ESTEEM 1 and 2 and PALACE 1-3 trials showed no increase in incidence of adverse events, no new safety signals and improved tolerability with exposure to apremilast up to 156 weeks.
The rates of major adverse cardiovascular events, malignancies and serious infections for apremilast were comparable to placebo up to 16 weeks and remained low with prolonged exposure.
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