Comparable efficacy and safety of brodalumab in obese and nonobese patients with psoriasis: analysis of two randomized controlled trials

Br J Dermatol. 2020 Apr;182(4):880-888. doi: 10.1111/bjd.18327. Epub 2019 Oct 16.

Abstract

Background: Obesity is associated with psoriasis and negatively affects response to therapy.

Objectives: To evaluate the efficacy and safety of brodalumab in nonobese vs. obese patients with psoriasis.

Methods: This is a post hoc analysis of the prospective, phase III, multicentre, randomized, placebo- and active-comparator-controlled AMAGINE-2 and AMAGINE-3 trials, in which patients were randomized to treatment with brodalumab 210 mg every 2 weeks, ustekinumab or placebo for a 12-week induction phase. At week 12, patients who received brodalumab 210 mg every 2 weeks continued brodalumab, those treated with ustekinumab continued ustekinumab, and those who received placebo switched to brodalumab 210 mg every 2 weeks. Patients were categorized by body mass index (BMI) category (< 30 or ≥ 30 kg m-2 ) and efficacy was evaluated using the physician-rated Psoriasis Area and Severity Index and static Physician's Global Assessment instruments.

Results: In total, 281 of 687 patients (40·9%) were obese. Skin clearance was comparable across BMI subgroups in brodalumab-treated patients. Psoriasis Area and Severity Index 100% improvement rates in nonobese and obese patients at week 12 were 54·1% and 49·5%, respectively, and at week 52 they were 72·6% and 64·8%, respectively. Week 12 ustekinumab responses were lower than brodalumab responses and were 6-17% lower in obese than in nonobese patients. No appreciable differences in overall safety were observed between nonobese and obese patients.

Conclusions: The efficacy and safety of brodalumab did not differ between patients with moderate-to-severe psoriasis who had a BMI < 30 kg m-2 or a BMI ≥ 30 kg m-2 .

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal* / adverse effects
  • Antibodies, Monoclonal, Humanized
  • Double-Blind Method
  • Humans
  • Obesity / complications
  • Prospective Studies
  • Psoriasis* / complications
  • Psoriasis* / drug therapy
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index
  • Treatment Outcome
  • Ustekinumab / adverse effects

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • brodalumab
  • Ustekinumab