Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study

Abstract

Secukinumab, a fully human monoclonal antibody neutralizing interleukin‐17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis. Long‐term (3‐year) efficacy and safety of secukinumab in Japanese patients with moderate to severe psoriasis were evaluated in an extension study of a large phase 3 global study ( SCULPTURE ). In the core study, 52 Japanese patients with 75% improvement of Psoriasis Area and Severity Index ( PASI ‐75) response at week 12 were re‐randomized to a fixed interval ( FI ; every 4 weeks) schedule and retreatment as needed ( RAN ), in which patients received placebo until start of relapse, at which time secukinumab was reinitiated. Fifty Japanese patients completed the 52‐week core study, and 47 patients entered the extension study with the same double‐blind regimens up to week 152. All patients in the secukinumab 300 mg FI and seven patients in 150 mg FI groups completed 3 years of treatment. PASI ‐90 and ‐100 at the end of year 3 were achieved in 69.2% and 53.8%, respectively, in 300 mg FI and 42.9% and 42.9%, respectively, in 150 mg FI , indicating high sustained response in 300 mg FI . Mean absolute PASI was continually low in 300 mg FI and numerically higher in 150 mg FI . Dermatology Life Quality Index of 0/1 was maintained by approximately two‐thirds of 300 mg FI patients, and all EuroQoL 5‐Dimension Health Questionnaire domain measures were also improved. FI dosing was consistently more efficacious than RAN . The safety profile of secukinumab remained favorable, with no new safety concerns identified.

Efficacy and safety of risankizumab vs. secukinumab in patients with moderate‐to‐severe plaque psoriasis (IMMerge): results from a phase III, randomized, open‐label, efficacy–assessor‐blinded clinical trial*

“…Overall, the efficacy and safety results observed in this trial are generally consistent with those seen in the other phase III risankizumab efficacy and safety studies, further supporting its benefit‐to‐risk profile for the treatment of moderate‐to‐severe plaque psoriasis 18,23,26–31 . The efficacy and safety of secukinumab observed in this study are also consistent with efficacy and safety findings noted in previous phase III trials, validating its consistent performance in controlled clinical trials 20,23,27,31–33 .…”

Adverse events with IL‐17 and IL‐23 inhibitors for psoriasis and psoriatic arthritis: a systematic review and meta‐analysis of phase III studies

“…The dosing schemes of the trials can differ from the finally licensed product; thus, the expected proportion of patients with AEs might be different in daily practice. Lastly, longer follow‐up than 52 weeks was only available for ixekizumab and secukinumab and thus not included. Strengths of the study are the inclusion of only phase 3 studies which secures a high surveillance of AEs and a uniform reporting of outcomes.…”

Regulation of Filaggrin, Loricrin, and Involucrin by IL-4, IL-13, IL-17A, IL-22, AHR, and NRF2: Pathogenic Implications in Atopic Dermatitis

“…Although the pathogenic significance of IL-17A is not fully understood in AD, IL-17A plays a critical role in the pathogenesis of psoriasis, as indicated by the excellent efficacy of anti-IL-17A biologics for psoriasis [195][196][197][198][199][200][201][202][203][204][205][206]. IL-17A alone may not be sufficient to fully activate the proinflammatory cascade, but it accelerates psoriatic inflammation with the help of other key pathogenic cytokines such as tumor necrosis factor-α (TNF-α), IL-23, and IL-22 [187,[207][208][209].…”