Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, has 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
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.
Improvements in itching were maintained from week 16 to week 52 (decrease of 36 mm) in patients who received OTEZLA from baseline and in patients who switched from etanercept to OTEZLA at week 16 (decrease of 35 mm).
Treatment with OTEZLA 30 mg twice daily also significantly improved disease-related quality of life (a secondary endpoint) at week 16 compared with placebo. OTEZLA showed a mean improvement from baseline in total Dermatology Life Quality Index (DLQI) score (decrease of 8.7; CI: -10.5 to -6.9) vs. placebo (decrease of 4.9; CI: -6.1 to -3.7) at week 16. A decrease in total DLQI scores was also observed for patients who received weekly injections of etanercept 50 mg from baseline to week 16.
Total DLQI scores were maintained from week 16 to week 52 in patients who received OTEZLA from baseline (decrease of 8.9; CI: -10.8 to -7.0) and in patients who switched from etanercept to OTEZLA at week 16 (decrease of 8.0; CI: -9.7 to -6.4).
The safety and tolerability data for OTEZLA observed in the LIBERATE study were generally consistent with previously reported data from six other phase III studies of OTEZLA in psoriasis or psoriatic arthritis; 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, upper respiratory tract infection, nasopharyngitis, headache and tension headache. No new safety or tolerability issues were observed through week 52 in patients who switched from etanercept to OTEZLA at week 16.
The LIBERATE study is ongoing.