Long-Term Efficacy Data for Otezla in Plaque Psoriasis Announced

Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.

ESTEEM 1 and 2 are two large pivotal randomized, placebo-controlled studies evaluating Otezla in 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. Approximately 1,250 patients were randomized 2:1 to receive either Otezla 30mg twice daily or placebo 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, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial Otezla randomization and Psoriasis Area and Severity Index (PASI)–75 response (ESTEEM 1) or (PASI)-50 (ESTEEM2).

Analysis of ESTEEM 2 data demonstrated sustained improvements at week 52 among  PASI-50 responders in difficult-to-treat areas such as nails, scalp, palms of the hands, and soles of the feet. In patients who had nail psoriasis at baseline with a Nail Psoriasis Severity Index (NAPSI) ≥1, 45% (78/175) of those patients treated with Otezla 30mg had at least a 50% improvement in NAPSI at week 16 compared to 19%(17/91) with placebo (P<0.0001).

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Of the patients with moderate to very severe scalp psoriasis at baseline, 41% (72/176) of those treated with Otezla 30mg twice daily had a Scalp Physician Global Assessment (ScPGA) score of clear (zero) or minimal (one) at week 16, compared with 17% (16/93) of those treated with placebo (P<0.0001).

Among patients who had moderate to severe psoriasis on their palms and feet at baseline, 65% (17/26) of those treated with Otezla 30mg twice daily had a Palmoplantar Psoriasis Physician Global Assessment (PPPGA) score of zero or one at week 16, compared with 31% (5/16) of those treated with placebo (P=0.0315).

An analysis of PSOR-005, ESTEEM 1 and ESTEEM 2 found that Otezla improved palmoplantar psoriasis in a patients with moderate to severe chronic plaque psoriasis who had palmoplantar involvement. Of those patients who had any palmoplantar psoriasis at baseline (PPPGA score of ≥1), a higher percentage of patients treated with Otezla had PPPGA reduced to clear or almost clear compared with placebo at week 16 in all three trials [PSOR-005: 70% (19/27) vs. 32% (7/22), respectively,P=0.0072; ESTEEM 1: 63% (107/169) vs. 45% (38/85), respectively, P=0.0047; ESTEEM 2: 71% (55/78) vs. 37% (17/46), respectively, P=0.0003].

Among patients who had moderate to severe palmoplantar psoriasis at baseline (PPPGA score of ≥3), a higher percentage of patients treated with Otezla had PPPGA reduced to clear or almost clear compared with placebo at week 16 in PSOR-005 [67% (6/9) vs. 20% (2/10), respectively, P=0.0397] and ESTEEM 2 [65% (17/26) vs. 31% (5/16), respectively, P=0.0315]. There was no significant difference between the Otezla and placebo groups at week 16 in ESTEEM 1 [39% (22/57) vs. 31% (8/26), respectively, P=0.4912].

Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE 4) is already indicated for the treatment of active psoriatic arthritis and for patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

For more information call (908) 673-9000 or visit Celgene.com.

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