Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled.

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Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2) Phoebe Rich, MD, Melinda Gooderham, MD, Hervé Bachelez, MD, PhD, Joana Goncalves, MD, Robert M. Day, PhD, Rongdean Chen, PhD, Jeffrey Crowley, MD Journal of the American Academy of Dermatology Volume 74, Issue 1, Pages 134-142 (January 2016) DOI: 10.1016/j.jaad.2015.09.001 Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Study design of Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and ESTEEM 2 ∗Doses of apremilast were titrated during the first week of administration and at week 16, when placebo patients were switched to apremilast. Dosing was maintained from weeks 16 to 32 (maintenance phase, period B). §Treatment from weeks 32 to 52 (randomized treatment withdrawal phase, period C) was based on the initial treatment assignment and the Psoriasis Area and Severity Index (PASI) response at week 32 (PASI-75 for ESTEEM 1 and PASI-50 for ESTEEM 2). ‡Patients initially randomized to apremilast who achieved PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) response at week 32 and were rerandomized to placebo were switched back to apremilast at time of loss of effect, defined as loss of PASI-75 (ESTEEM 1) or loss of 50% of the PASI improvement obtained at week 32 (ESTEEM 2), but no later than week 52. ||Patients who did not achieve a PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) response at week 32 were able to add topicals and/or ultraviolet (UV) B therapy at week 32 at the discretion of the investigator. Blinding was maintained until all patients discontinued or completed their week 52 visit. BID, Twice daily. Journal of the American Academy of Dermatology 2016 74, 134-142DOI: (10.1016/j.jaad.2015.09.001) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 For patients with nail psoriasis at baseline, mean percent change from baseline in target Nail Psoriasis Severity Index (NAPSI) score at week 16 (placebo-controlled phase, period A) and week 32 (maintenance phase, period B) in Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 (A) and ESTEEM 2 (B), and mean percent change in target nail NAPSI score by Psoriasis Area and Severity Index (PASI) response at week 16 (period A) in patients treated with apremilast 30 mg twice daily (BID) in ESTEEM 1 and ESTEEM 2 (C). Missing values at week 16 were imputed using the last observation carried forward (LOCF) methodology. Patients without an observation at week 32 were considered nonresponders. *P < .0001 versus placebo in ESTEEM 1 and *P = .0052 vs placebo in ESTEEM 2, both based on the χ2 test. PASI-50, ≥ 50% reduction from baseline in PASI score; PASI-75, ≥ 75% reduction from baseline in PASI score; PASI-90, ≥ 90% reduction from baseline in PASI score. Journal of the American Academy of Dermatology 2016 74, 134-142DOI: (10.1016/j.jaad.2015.09.001) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Percentage of patients with moderate to very severe scalp psoriasis at baseline (Scalp Physician Global Assessment [ScPGA] score ≥3) achieving ScPGA score of 0 or 1 at week 16 in Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and ESTEEM 2. Missing values at week 16 were imputed using the last observation carried forward methodology. *P < .0001 versus placebo, based on the χ2 test. BID, Twice daily. Journal of the American Academy of Dermatology 2016 74, 134-142DOI: (10.1016/j.jaad.2015.09.001) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Effect of apremilast 30 mg twice daily in a patient with scalp psoriasis at baseline (Scalp Physician Global Assessment [ScPGA] score = 5) (A) and week 16 (ScPGA score = 0) (B). Journal of the American Academy of Dermatology 2016 74, 134-142DOI: (10.1016/j.jaad.2015.09.001) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Mean percent change from baseline in Nail Psoriasis Severity Index (NAPSI) score over 52 weeks in patients with nail psoriasis (NAPSI score ≥1) at baseline and Psoriasis Area and Severity Index response at week 32 in Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 (A) and ESTEEM 2 (B). BID, Twice daily. Journal of the American Academy of Dermatology 2016 74, 134-142DOI: (10.1016/j.jaad.2015.09.001) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions