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).
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.
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