Boni E Elewski1, Martin M Okun2, Kim Papp3, Christopher S Baker4, Jeffrey J Crowley5, Gérard Guillet6, Murali Sundaram7, Yves Poulin8, Yihua Gu9, Ziqian Geng9, David A Williams9, Phoebe A Rich10. 1. University of Alabama at Birmingham School of Medicine, Birmingham, Alabama. Electronic address: beelewski@gmail.com. 2. Fort Healthcare, Fort Atkinson, Wisconsin. 3. K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada. 4. Skin and Cancer Foundation Inc and Probity Medical Research, Carlton, Victoria, Australia. 5. Bakersfield Dermatology, Bakersfield, California. 6. Hopital La Miletrie, Service de Dermatologie, CHU Poitiers, Poitiers, France. 7. Janssen Scientific Affairs, Horsham, Pennsylvania. 8. Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, Québec, Canada; Laval University, Québec City, Québec, Canada. 9. AbbVie Inc, North Chicago, Illinois. 10. Oregon Health and Science University Hospital, Portland, Oregon.
Abstract
BACKGROUND: Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. OBJECTIVE: This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. METHODS: Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). RESULTS: Of the 217 randomized patients (108 receivedplacebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. LIMITATIONS: Patients with less than 5% BSA involvement were not eligible for enrollment. CONCLUSIONS: After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.
RCT Entities:
BACKGROUND: Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. OBJECTIVE: This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. METHODS:Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). RESULTS: Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. LIMITATIONS: Patients with less than 5% BSA involvement were not eligible for enrollment. CONCLUSIONS: After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.
Authors: B E Elewski; C S Baker; J J Crowley; Y Poulin; M M Okun; B Calimlim; Z Geng; O Reyes Servin; P A Rich Journal: J Eur Acad Dermatol Venereol Date: 2019-09-04 Impact factor: 6.166