Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial Boni E. Elewski, MD, Martin.

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Presentation transcript:

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial Boni E. Elewski, MD, Martin M. Okun, MD, Kim Papp, MD, Christopher S. Baker, MBBS, Jeffrey J. Crowley, MD, Gérard Guillet, MD, Murali Sundaram, PhD, Yves Poulin, MD, Yihua Gu, MS, Ziqian Geng, PhD, David A. Williams, MD, Phoebe A. Rich, MD Journal of the American Academy of Dermatology Volume 78, Issue 1, Pages 90-99.e1 (January 2018) DOI: 10.1016/j.jaad.2017.08.029 Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Study design. ∗Initial dose of adalimumab was 80 mg, followed by 40 mg every other week starting 1 week later. †Starting at week 16, if the psoriasis-affected body surface area increased 25% or more over baseline, patients were rolled over to the open-label extension period. Journal of the American Academy of Dermatology 2018 78, 90-99.e1DOI: (10.1016/j.jaad.2017.08.029) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Patient disposition. The 26-week open-label extension period (period B) is not reported. For those patients who discontinued study participation for more than 1 reason, only the primary reason is listed. BSA, Body surface area; OLE, open-label extension; Ps, psoriasis Journal of the American Academy of Dermatology 2018 78, 90-99.e1DOI: (10.1016/j.jaad.2017.08.029) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Primary efficacy end point. Multiple imputation. Statistically significant at ***P < .001. ADA, Adalimumab; mNAPSI, modified Nail Psoriasis Severity Index; PBO, placebo. *Primary end point was at week 26. Journal of the American Academy of Dermatology 2018 78, 90-99.e1DOI: (10.1016/j.jaad.2017.08.029) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Ranked secondary end points. A, Mean percent improvement in total Nail Psoriasis Severity Index (NAPSI). B, Achievement of total fingernail modified Nail Psoriasis Severity Index (mNAPSI) of 0. C, Mean improvement in nail (psoriasis) Ps pain Numeric Rating Scale (NRS). D, Mean improvement in Nail Psoriasis Physical Functioning Severity (NPPFS). E, Achievement of at least 50% improvement in the scalp component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index among patients with baseline scalp score of 6 or higher (B-SNIPI50). F, Achievement of Physician's Global Assessment of Fingernail Psoriasis (PGA-F) score of 0 or 1 with 2 or more grades of improvement from baseline. *Ranked secondary end points were at week 26; total nail end points were collected only at weeks 16 and 26. Multiple imputation. Statistically significant at ***P < .001 and **P < .01. ADA, Adalimumab; PBO, placebo. Journal of the American Academy of Dermatology 2018 78, 90-99.e1DOI: (10.1016/j.jaad.2017.08.029) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Improvement over time in target fingernail. A, modified Nail Psoriasis Severity Index (mNAPSI75) response rate of at least 75% relative to baseline in target fingernail. B, Mean percent improvement in target fingernail Nail Psoriasis Severity Index (NAPSI). Multiple imputation. Statistically significant at ***P < .001. ADA, Adalimumab; PBO, placebo. Journal of the American Academy of Dermatology 2018 78, 90-99.e1DOI: (10.1016/j.jaad.2017.08.029) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions