Celgene announced the release of new research findings on Otezla (apremilast), a selective inhibitor of phosphodiesterase 4 (PDE4), from the ESTEEM 1 and 2 Phase 3 studies in patients with moderate to severe plaque psoriasis.
ESTEEM 1 and 2 are two randomized, placebo-controlled studies evaluating Otezla in 1250 patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. Patients were randomized 2:1 to receive either Otezla 30mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16–32 in which placebo patients were switched to Otezla 30mg twice daily through week 32. There was also a randomized withdrawal phase for responders from week 32 to week 52 based on their initial Otezla randomization and PASI-75 response.
ESTEEM 1 demonstrated a stable mean PASI improvement of 81–88% between weeks 32 and 52 for those patients who were treated for 52 weeks with Otezla 30mg BID and who achieved a PASI-75 score at week 32 (n=77). These data are consistent with the mean PASI-75 improvement observed between weeks 16 and 32. In the same group of patients, Otezla 30mg BID continued to demonstrate improvements in difficult-to-treat areas affected by plaque psoriasis. Among patients who had nail psoriasis at baseline (n=46), the majority showed meaningful improvement in their nails. A mean percent decrease from baseline in the Nail Psoriasis Severity Index (NAPSI) of 60.2% was observed at week 52. Of those patients who had scalp psoriasis defined as moderate or greater at baseline (n=49), the majority continued to demonstrate meaningful improvement in their scalp psoriasis with 72.9% having reduction of their scalp symptoms to clear or almost clear (ScPGA 0 or 1) at week 52.
In ESTEEM 2, a significantly higher percentage of patients receiving Otezla 30mg BID achieved a PASI-75 response at week 16 (primary endpoint) compared with patients who received placebo (28.8% vs. 5.8%; P<0.0001). The beneficial effects of Otezla on psoriasis in difficult-to-treat areas of scalp, nails, palms and soles were also demonstrated in ESTEEM 2. After 16 weeks of treatment, Otezla 30mg BID demonstrated significantly higher response rates vs. placebo for psoriasis affecting the scalp (ScPGA 0-1: 40.9% vs. 17.2%; P<0.0001), nails (NAPSI-50: 44.6% vs. 18.7%; P<0.0001), and palm and soles (Palmoplantar Physician Global Assessment (PPPGA) 0-1: 65.4% vs. 31.3%; nominal P=0.0315).
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