Abstract | BACKGROUND: OBJECTIVES: METHODS: TRANSFIGURE, a double-blind, randomized, placebo-controlled, parallel-group, multicentre phase IIIb study in 198 patients, investigated secukinumab 150 mg and 300 mg in patients with moderate-to-severe nail psoriasis. RESULTS: At week 16, the primary endpoint Nail Psoriasis Severity Index (NAPSI) was met, demonstrating superiority of secukinumab to placebo. The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of -73·3% and -63·6% with secukinumab 300 mg and 150 mg, respectively. At 2·5 years, secukinumab demonstrated sustained clinically significant reductions in total mean Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) quality-of-life (QoL) scores of -52·4% and -18·1%, and 70% and 71% of patients achieved a weighted NAPPA Patient Benefit Index global score of ≥ 2 with secukinumab 300 mg and 150 mg, respectively. Patients showed considerable improvements in the EuroQol 5-Dimension health status questionnaire at 2·5 years, reporting a decrease in pain and discomfort. No new safety findings were observed. CONCLUSIONS:
Secukinumab demonstrated strong and clinically meaningful efficacy for up to 2·5 years in nail psoriasis, with significant sustained QoL improvements and a favourable safety profile.
|
Authors | K Reich, J Sullivan, P Arenberger, S Jazayeri, U Mrowietz, M Augustin, B Elewski, R You, P Regnault, J A Frueh |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 184
Issue 3
Pg. 425-436
(03 2021)
ISSN: 1365-2133 [Electronic] England |
PMID | 32479641
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | © 2020 British Association of Dermatologists. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- secukinumab
|
Topics |
- Antibodies, Monoclonal, Humanized
- Double-Blind Method
- Humans
- Psoriasis
(drug therapy)
- Quality of Life
- Severity of Illness Index
- Treatment Outcome
|