Secukinumab at 150 mg and 300 mg was associated with sustained and long-term improvement in nail psoriasis, improved quality of life (QoL), and a favorable safety profile. This is according to findings from the randomized, double-blind, multicenter phase 3b TRANSFIGURE trial published in the British Journal of Dermatology.
Patients with severe plaque psoriasis with significant nail involvement were randomly assigned to either 300 mg secukinumab (n=66), 150 mg secukinumab (n=67), or placebo (n=65), all of which were administered for 16 weeks. Patients randomly assigned to placebo were re-randomly assigned at week 16 to either 300 mg secukinumab (n=29) or 150 mg secukinumab (n=29). Treatment then commenced for another 2.5 years followed by an 8-week follow-up period without treatment. For this trial, secukinumab and placebo were administered subcutaneously once per week for 5 weeks, followed by every 4 weeks.
The patients in the overall cohort had a Nail Psoriasis Severity Index (NAPSI) ≥16 (mean NAPSI, 42.6), a mean PASI score of 20.3, and had psoriasis that involved ≥4 fingernails (mean, 9.6). Secukinumab demonstrated superiority to placebo at week 16, and the percentage change in NAPSI scores from baseline continued to decline after the end of the first treatment period. The reduction in NAPSI reached a peak at week 64 with secukinumab 150 mg (-71.3%) and at week 116 with secukinumab 300 mg (-76.7%). Over a 2.5-year period, the effect was sustained, and the investigators observed a benefit with secukinumab on nail clearance with a mean improvement in NAPSI of −73.3% with secukinumab 300 mg and -63.6% with secukinumab 150 mg.
Treatment with secukinumab was associated with significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) QoL scores at 2.5 years by −52.4% and −18.1% with secukinumab 300 mg and 150 mg, respectively. This finding, according to the investigators, suggested the treatment was associated with reducing the impact nail psoriasis had on patients’ QoL. At 2.5 years, approximately 70.2% of patients assigned to secukinumab 300 mg and 70.9% of patients assigned to secukinumab 150 mg had a weighted NAPPA Patient Benefit Index global score of ≥2.
In addition, patients reported reduced pain and discomfort at 2.5 years, based on responses to the Euro-QoL 5-Dimension (EQ-5D) Health Status Questionnaire. The percentage of patients who reported moderate to severe pain decreased by approximately 50% at 2.5 years. Responses to the EQ-5D also indicated that patients’ health-related QoL improved over time (absolute change from baseline, 11.2 for secukinumab 300 mg and 12.4 for secukinumab 150 mg).
The researchers of this study suggest their findings reiterate “that secukinumab is an efficacious treatment for multiple manifestations of psoriatic disease” and offers “patients and physicians with a long-term complete treatment option.”
Disclosure: This clinical trial was supported by Novartis. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reich K, Sullivan J, Arenberger P, et al. Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study [published online June 1, 2020]. Br J Dermatol. doi: 10.1111/bjd.19262