US-based pharmaceutical firm Celgene has reported positive results from an ongoing Phase III LIBERATE trial of its oral, selective inhibitor of phosphodiesterase 4 (PDE4), Otezla (apremilast), in patients with moderate to severe plaque psoriasis.
A total of 250 patients who had no prior exposure to a biological therapy were included in the LIBERATE trial, which evaluated the clinical efficacy and safety of either oral Otezla 30mg twice daily or weekly subcutaneous (SC) etanercept 50mg compared with placebo at week 16.
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LIBERATE is a Phase IIIb, multicentre, randomised, placebo-controlled, double-blind, double-dummy trial and its primary objective was to evaluate the clinical efficacy and safety of oral Otezla 30mg twice daily compared with placebo at week 16.
The trial’s secondary objectives included the evaluation of the clinical efficacy and safety of etanercept 50mg SC once weekly (QW) compared with placebo at week 16 as well as the evaluation of the relative safety of a crossover from etanercept to Otezla 30mg twice daily, as compared with Otezla dosed since week 0, after week 16.
At week 16, patients receiving Otezla 30mg twice daily showed statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI)-75 response.
SCIderm Research Institute and Dermatologikum Hamburg Dr Kristian Reich said: "Nearly half of psoriasis patients are not satisfied with their current treatment.
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By GlobalData"The positive results from a third Otezla phase III psoriasis trial demonstrating efficacy and consistent safety of Otezla through 32 weeks further supports the potential for this therapy to have an impact on the needs of patients suffering from this chronic and debilitating disease."
The company said that treatment with Otezla also resulted in statistically significant and clinically meaningful improvement versus placebo at week 16 in secondary endpoints, including static physician global assessment (sPGA) of clear or almost clear and Dermatology Quality of Life Index (DLQI) score change.
The safety and tolerability data for Otezla observed in the LIBERATE trial were consistent with previously reported data from six other Phase III trials of Otezla in psoriatic arthritis or psoriasis.
