SUMMIT (dpa-AFX) - Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (CELG), announced that results from its ongoing phase III LIBERATE trial evaluating Otezla (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis were presented as a late-breaker at the 24th European Academy of Dermatology and Venereology or EADV Congress in Copenhagen, Denmark, October 7-11, 2015.
The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous (SC) etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16 during an open label extension phase.
As shown at AAD, at week 16, 40 percent (33/83) of patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvements compared with 12 percent (10/84) of patients on placebo in the primary endpoint, Psoriasis Area and Severity Index (PASI)-75 response (P<0.0001). Statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg compared with placebo [48 percent (n=40/83) vs. 12 percent (n=10/84), respectively, P<0.0001].
New findings presented at EADV showed that 51 percent (42/83) of patients randomized to OTEZLA at baseline and 55 percent of patients who switched from etanercept to OTEZLA at week 16 (46/83) achieved PASI-75 at week 52.
Based on an exploratory analysis, OTEZLA also improved pruritus (itching), one of the most common and bothersome symptoms of psoriasis, as measured by a visual analog scale (0 mm=no itch at all; 100 mm=worst itch imaginable). Significantly greater improvements in itching scores were seen at week 16 for patients treated with OTEZLA 30 mg twice daily (decrease of 38 mm; 95% confidence interval [CI]: -45 to -31 mm) compared with placebo (decrease of 26 mm; CI: -34 to -19 mm). Improvement in pruritus was observed as early as week 2 in patients receiving OTEZLA. Lower itching scores were also observed in patients who received weekly injections of etanercept 50 mg from baseline to week 16.
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