Third phase III study with OTEZLA to demonstrate statistically significant improvements versus placebo for the primary and key secondary endpoints at week 16
More patients achieved a PASI-75 response at week 32 than at week 16 for those randomized to OTEZLA at baseline and those switched from etanercept to OTEZLA at week 16
In a post-hoc analysis of PASI-75 at week 16, there was no statistically significant difference between OTEZLA and etanercept
No new safety signals identified through week 32 for OTEZLA
SUMMIT, N.J.--(BUSINESS WIRE / ME NewsWire)-- 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 at a late-breaker presentation at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California.
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.
At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI)-75 response [primary endpoint; 40 percent with OTEZLA (n=33/83), 12 percent with placebo (n=10/84), P<0.0001]. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo [48 percent with etanercept (n=40/83), 12 percent with placebo (n=10/84), P<0.0001].
A post-hoc analysis revealed no significant difference between OTEZLA and etanercept (P=0.2565) in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
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.
Among patients randomized to OTEZLA at baseline, more patients achieved a PASI-75 response at week 32 than at week 16 [53 percent (n=44/83) vs. 40 percent (n=33/83), respectively]. Among patients who switched from etanercept to OTEZLA at week 16, more patients achieved a PASI-75 response at week 32 than at week 16 [61 percent (n=51/83) vs. 48 percent (n=40/83), respectively].
The safety and tolerability data for OTEZLA observed in the LIBERATE study were consistent with previously reported data from six other phase III studies of OTEZLA in psoriatic arthritis or psoriasis; no new safety signals were observed. Adverse events reported in at least five percent of patients taking OTEZLA in the LIBERATE study were diarrhea, nausea, vomiting and headache (including tension headache). No new safety or tolerability issues were observed between weeks 16 and 32 in patients who switched from etanercept to OTEZLA at week 16.
“Nearly half of psoriasis patients are not satisfied with their current treatment,” said Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum Hamburg, Germany. “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 LIBERATE study is ongoing.
