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

Abstract

BackgroundFew clinical trials have evaluated long‐term treatment of nail psoriasis with biologics.ObjectiveSafety and efficacy of adalimumab [ADA; Humira AbbVie Inc, North Chicago, IL, USA)] long‐term treatment (52 weeks) was evaluated in a phase‐3, randomized trial in patients with moderate‐to‐severe plaque psoriasis and concomitant moderate‐to‐severe fingernail psoriasis. Results from the first 26 weeks (Period A) have been reported.MethodsPatients receiving 40 mg ADA every other week or placebo in Period A, continued with or switched to 40 mg ADA every‐other‐week treatment in the subsequent 26‐week open‐label extension (OLE) period. Main efficacy evaluations were ≥75% improvement in total‐fingernail modified Nail Psoriasis Severity Index (mNAPSI 75) and achievement of Physician's Global Assessment for Fingernail Psoriasis of clear or minimal disease (PGA‐F 0/1) with a ≥2‐grade improvement from baseline, across the trial for patients who continued ADA from Period A through the OLE (Continuous‐ADA Population). Safety was evaluated during the OLE and for patients receiving ADA at any time during the study (All‐ADA Population).ResultsOf the 217 patients initially randomized in Period A, 188 (86.6%; 94 in each treatment group) entered the OLE after completion of or early escape from Period A. For the Continuous‐ADA Population (N = 109), endpoint achievement rates improved from OLE entry (Week 26) to Week 52, including total‐fingernail mNAPSI 75 (47.4–54.5%); PGA‐F 0/1 (51.1–55.6%) and total‐fingernail mNAPSI = 0 (6.6–17.9%). Serious adverse event and serious infection rates for the All‐ADA Population (N = 203) were 6.9% and 3.4%, respectively.ConclusionsIn this population of psoriasis patients with concomitant, moderate‐to‐severe nail psoriasis, long‐term efficacy and improvement in signs and symptoms of nail disease were demonstrated after every‐other‐week ADA treatment, including incremental improvements in rate of total clearance of nail disease. No new safety risks were identified for patients receiving at least one ADA dose across 52 weeks.

Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis

“…Optimal effect may take up to or exceed 52 weeks of therapy. 16 In UNCOVER-3, continued improvement of fingernail psoriasis was seen in patients treated with ixekizumab through 60 weeks. 12,14 Long-term efficacy and safety of ixekizumab for treatment of moderate-to-severe plaque psoriasis has been reported to 108 weeks.…”

Small Molecules and Biologics in the Treatment of Nail Psoriasis

“…Patients who were randomized to placebo in Period A showed nail improvement once they were switched to ADA, which continued to week 52. The mean improvement in patient-reported outcomes of nail pain NRS, NPPFS, Nail PsO QoL score, and the NAPPA-QoL score also increased from week 26 to week 52 [27][28][29][30]. In conclusion, 52 weeks of biweekly treatment with 40 mg ADA improved nail signs and QoL for patients with moderate to severe nail PsO.…”

“…As a result, patients who were treated with ADA showed statistically significant improvement in signs and symptoms of nail PsO versus those with placebo. In almost half of the patients being treated with ADA (46.6%), NAPSI 75 was seen at week 26 (Period A) [26,27]. A recent publication focusing on the open-label extension of the same trial highlights the results of the study past week 26, up to week 52.…”

“…No new safety risks were identified with ADA treatment in this population. When considering side effects, most were mild or moderate in severity; nasopharyngitis and upper respiratory tract infections were mostly observed [27].…”

Biologics in nail psoriasis: a new trend in treatment?

“…It was not easy, however, to find a publisher, and Willan wrote that ‘The publication has been delayed much beyond the Author's intention, in consequence of the difficulties experienced in a subject entirely new’. I think Willan would have been satisfied that novelty in nail psoriasis long‐term treatment, as presented by the paper written by Elewski et al ., has been published in a journal such as JEADV.…”