Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study

Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.

Abstract

Background: Chronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment.

Objective: The aim of the study was to assess the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis.

Methods: Patients who completed a 12-week, phase II, dose-ranging clinical trial received brodalumab 210 mg every 2 weeks in an open-label extension study. Efficacy was assessed by static physician's global assessment (sPGA) and psoriasis area and severity index (PASI). Quality of life, assessed by dermatology life quality index (DLQI), and safety were also evaluated.

Results: Overall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. Over 5 years, one adverse event of suicidal ideation was reported, no suicides occurred, and no new safety signals emerged.

Conclusions: Brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout 5 years of treatment. CLINICALTRIALS.

Gov identifier: NCT01101100.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Female
  • Humans
  • Interleukin-17 / antagonists & inhibitors
  • Interleukin-17 / immunology
  • Long-Term Care / methods
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures*
  • Psoriasis / complications
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Psoriasis / psychology
  • Quality of Life*
  • Severity of Illness Index
  • Skin / drug effects
  • Skin / immunology
  • Skin / pathology
  • Suicidal Ideation
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • IL17A protein, human
  • Interleukin-17
  • brodalumab

Associated data

  • ClinicalTrials.gov/NCT01101100