Secukinumab Reduces Psoriasis-associated Pruritus and Regenerates the Cutaneous Nerve Architecture: Results from PSORITUS a Doubleblind, Placebo-controlled, Randomized Withdrawal Phase IIIb Study

Acta Derm Venereol. 2024 Nov 20:104:adv40737. doi: 10.2340/actadv.v104.40737.

Abstract

The occurrence of pruritus in psoriasis was previously underestimated but is a significant burden. Secukinumab (SEC), a monoclonal anti-interleukin-17A antibody, efficiently controls signs of psoriasis, but the effect on pruritus and cutaneous neuroanatomy remained unknown. The primary objective of this study (NCT02362789) was to evaluate the superiority of SEC treatment vs placebo on pruritus intensity (visual analogue scale; VAS). Furthermore, the treatment-dependent course of pruritus in association with absolute Psoriasis Area Severity Index (PASI) score, as well as cutaneous histopathology and neuroanatomy, was assessed. Open-label SEC 300 mg s.c. was administered regularly until week 16. Patients who reached a ≥ 98% PASI reduction (PASI ≥ 98) were randomized to receive either placebo or SEC up to week 32. Punch biopsies were collected from lesional psoriatic (baseline, weeks 16 and 32) and non-lesional (baseline) skin for histopathological and neuroanatomical analyses. VAS scores improved significantly after open-label SEC treatment but relapsed upon placebo (29.92 ± 33.8) compared with SEC (12.30 ± 22.6; p = 0.036). After SEC-dependent improvement in PASI, histopathology, marker expression and neuroanatomy, relapse was observed with treatment discontinuation in all parameters except neuroanatomy. SEC was superior to placebo by efficiently controlling reduced pruritus intensity, clinically normalizing skin lesions, and reversing histopathological abnormalities. The neuroanatomy recovered upon SEC and remained stable even after withdrawal.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized*
  • Antipruritics / pharmacology
  • Biopsy
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pruritus* / drug therapy
  • Pruritus* / etiology
  • Psoriasis* / complications
  • Psoriasis* / drug therapy
  • Severity of Illness Index*
  • Skin* / drug effects
  • Skin* / innervation
  • Skin* / pathology
  • Time Factors
  • Treatment Outcome

Substances

  • secukinumab
  • Antibodies, Monoclonal, Humanized
  • Antipruritics

Grants and funding

Funding sources The study was funded by Novartis Pharma GmbH Germany and supported by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) – FOR 5211 SOMACROSS and FOR 2690 PruSearch. Open access publication was funded by the Open Access Publication Fund of the University of Münster.