Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial

Abstract

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.

Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase‐3, randomized, placebo‐controlled trial

“…The safety results from this study are consistent with the known adalimumab safety profile, although the serious infection rate for adalimumab was higher than in other adalimumab trials evaluating patients with moderate‐to‐severe psoriasisand with moderate‐to‐severe psoriasis of the hands and feet . Safety results over 52 weeks were comparable to those after 26 weeks of adalimumab treatment . No unexpected safety risk was identified .…”

“…The anti‐TNF‐α agent adalimumab [Humira (AbbVie Inc, North Chicago, IL, USA)] has demonstrated efficacy and safety up to 28 weeks for the treatment of nail psoriasis in studies of patients with moderate‐to‐severe psoriasis and PsA . A phase‐3, randomized, controlled trial of adalimumab treatment of patients with moderate‐to‐severe plaque psoriasis and concomitant fingernail psoriasis reported efficacy and safety results from the first 26 weeks . Here, we report long‐term efficacy and safety results from the second 26‐week, open‐label extension (OLE) portion of that trial.…”

“…This was a phase‐3, multicenter, double‐blind, randomized, parallel‐arm, placebo‐controlled trial . In the initial 26‐week Period A, patients were randomized in a 1 : 1 ratio to 40‐mg adalimumab every other week (starting at Week 1, after an 80 mg dose at Week 0) or to placebo.…”

“…As previously described, enrolment criteria included BSA ≥10% or ≥5% with a total modified Nail Psoriasis Severity Index (mNAPSI) score ≥20; target fingernail mNAPSI score of ≥8; a score of at least moderate severity for the Physician's Global Assessment for Fingernail Psoriasis (PGA‐F) and the Physician's Global Assessment for Skin Psoriasis (PGA‐S) scores; and a score of >3 for the Nail Psoriasis Physical Functioning Severity (NPPFS) score or Nail Psoriasis Pain Numeric Rating Scale (NRS) score. Patients were not allowed previous adalimumab treatment or concomitant treatment for nail psoriasis during the study.…”

“…Other efficacy analyses across 52 weeks included per cent improvement from baseline in total‐fingernail NAPSI, achievement of total‐fingernail mNAPSI score of 0 and achievement of at least 50% improvement in the scalp component of the Brigham Scalp Nail Inverse Palmo‐Plantar Psoriasis Index [B‐SNIPI50 (scalp)] relative to baseline for patients with baseline scalp psoriasis score of ≥6 (assessed only for patients in US and Puerto Rico). A description of the methods that were used in this study to score nail disease has been published . Patient‐reported outcomes across 52 weeks included the following scores: improvement from baseline in Nail Psoriasis Pain numerical rating scale (NRS) using a scale of 0 (no pain) to 10 (severe pain); mean change from baseline in Nail Psoriasis Physical Functioning Severity (NPPFS) score, which measured the impact of fingernail psoriasis on the ability to perform physical tasks, using a scale of 0 (none) to 10 (severe); mean change from baseline in Nail Assessment of Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) score, which measured the impact of nail psoriasis on hands and/or feet in terms of patient suffering and ability to function, using a scale of 0 (no effect) to 4 (very much of an effect) for each question; and mean change from baseline in Nail Psoriasis Quality of Life (Nail Ps QoL), which measured the impact of nail psoriasis on patient quality of life, using a scale of 0 (none) to 10 (severe).…”