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Improvements in PASI scores and disease-related quality of life observed at week 16 were maintained at week 52 in patients randomized to OTEZLA at baseline and in patients who switched from etanercept to OTEZLA at week 16
An exploratory analysis suggested improvements in itching observed at week 16 were also maintained at week 52 in patients in both groups
No new safety signals or clinically meaningful changes in laboratory values for OTEZLA identified through week 52
BOUDRY, Switzerland -- (BUSINESS WIRE) --
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today 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 (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015.
“Many patients with moderate to severe plaque psoriasis need treatment options that can help in managing multiple facets of the disease, including itching and impact on disease-related quality of life,” said Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum Hamburg, Germany. “The encouraging findings presented at EADV add to the growing body of data which suggest that treatment benefits observed with OTEZLA at week 16 are maintained through week 52 of treatment.”
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. Primary findings were previously presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
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