Twenty-six weeks of treatment with adalimumab was associated with improvements in a number of fingernail psoriasis outcomes compared with placebo, according to recent study findings.
In the phase 3 study, 217 patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis were randomly assigned 40 mg adalimumab every other week or placebo. There were 109 patients in the active therapy group and 108 patients in the placebo group.
A minimum of a 75% improvement in the Nail Psoriasis Severity Index (NAPSI 75) by week 26 of treatment was the primary outcome. Secondary endpoints included total-fingernail and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician’s Global Assessment.
The final analysis included 188 patients who were treated through 26 weeks or matriculated to the open-label period of the study
Results indicated a 46.6% NAPSI75 response rate for adalimumab and a 3.4% response rate for placebo (P < .001).
Total NAPSI rates were 56.2% for the study drug and 11.5% for placebo (P < .001), while the mean percent improvement in NAPSI at 26 weeks was 54.6% in the adalimumab arm and 14.4% in the placebo arm.
Nail Psoriasis Quality of Life scores improved from 3.1 at week 16 to 3.3 at 26 weeks for adalimumab and from 0.4 to 0.6 for placebo (P < .001).
Serious adverse event rates were 7.3% in the adalimumab arm and 4.6% for placebo, while serious infections also occurred slightly more frequently with adalimumab (3.7% vs. 1.9%).
“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,” the researchers concluded. – by Rob Volansky
Disclosure: Elewski reports receiving research from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Incyte, Lilly, Merck, Novan, Novartis, Pfizer, Valeant, and Viament and honoraria for serving as a consultant to Anacor, Celgene, Lilly, Novartis, Pfizer, and Valeant. Please see the full study for a list of all other authors’ relevant disclosures.