Otezla Treatment Shows Long Term Benefits for Plaque Psoriasis

Improvements in itching scores maintained from week 16 to week 52 in patients who received Otezla.

Celgene Corporation recently announced the results of its ongoing phase 3 LIBERATE trial evaluating the selective inhibitor of phosphodiesterase 4 (PDE4), Otezla, in patients with moderate to severe plaque psoriasis.

The results were announced at the 24^th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark.

“Many patients with moderate to severe plaque psoriasis need treatement option that can help in managing multiple facets of the disease, including itching and impact on disease-related quality of life,” said Kristian Reich, MD, 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 safety and efficacy of 1 of 2 treatment options for patients with moderate to severe plaque psoriasis. One was oral Otezla at 30 mg twice daily and the other was weekly subcutaneous etanercept at 50 mg.

Both treatments were compared with a placebo group at week 16 in the cohort of 250 patients who had no previous exposure to a biological therapy. The study also analyzed the safety of switching from etanercept to Otezla after week 16 during an open label extension phase.

It should be noted that the study was not designed to directly compare Otezla with etanercept.

The findings showed that at 16 weeks, 40% of patients receiving Otezla demonstrated statistically significant and clinically meaningful improvements compared with 12% of patients on placebo in the primary endpoint, Psoriasis Area and Severity Index (PASI)-75 response. Forty-eight percent of patients receiving etanercept also gained significant improvements in PASI-75 response.

New findings presented at EADV showed that 51% of patients randomized to Otezla at baseline and 55% of patients who switched from etanercept to Otezla at week 15 achieved PASI-75 at week 52. An exploratory analysis also revealed that Otezla improved itching, one of the most common and bothersome side effects of moderate to severe plaque psoriasis, as measured by a visual analog scale.

At week 16, the scores were most significant for improvements in itching among patients treated with Otezla at 30 mg twice daily. In fact, improvements in itching were observed as early as week 2 in patients receiving the medication.

Lower itching scores were also observed in patients who received weekly injections of etanercept from baseline to week 16. The improvements in itching were maintained from week 16 to week 52 in patients who received Otezla from baseline and in patients who switched from etanercept to Otezla at week 16.

Treatment with Otezla was also related to improved disease-related quality of life, with a mean improvement from baseline in total Dermatology Life Quality Index (DLQI) score compared with placebo at week 16. This improvement was also noted in those who received weekly etanercept from baseline to week 16, and the scores were maintained from week 16 to week 52 in patients who received Otezla or switched from etanercept to Otezla at week 16.

The findings reflect those found in 6 other phase 3 studies of Otezla in psoriasis or psoriatic arthritis; no new safety signals were observed. Side effects of the medication include diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, headache and tension headache, and occurred in 5% of patients taking Otezla.

No new safety or tolerability issues were observed through week 52 in patients who switched from etanercept to Otezla at week 16.