Despite the potential for reduced therapeutic efficacy in patients with obesity treated for psoriasis, there appears to be no difference in efficacy or safety outcomes between patients with and without obesity treated with brodalumab for moderate to severe plaque psoriasis, study results published in the British Journal of Dermatology reports.1
The study was a post hoc analysis of the phase 3 multicenter randomized AMAGINE-2 and AMAGINE-3 trials.2,3 In the trials, patients with moderate to severe plaque psoriasis were randomly assigned to 210 mg brodalumab every 2 weeks (n=248), ustekinumab (n=316), or placebo (n=123). Patients were categorized into obese and non-obese based on having a body mass index of <30 kg/m2 (n=406) and ≥30 kg/m2 (n=281), respectively.
At 12 weeks, patients treated with brodalumab continued to receive the monoclonal antibody, ustekinumab-treated patients continued to receive ustekinumab, and patients who received placebo switched to the brodalumab treatment regimen. Efficacy of therapy was assessed with the physician-rated Psoriasis Area and Severity Index (PASI) and Static Physician’s Global Assessment.
There were only minimal differences in the PASI 75 and PASI 100 responses between the groups with and without obesity at week 12, suggesting comparable skin clearance rates in both populations. Responses to the PASI were 6% to 17% lower in the continuous ustekinumab subgroup in patients with vs without obesity. The researchers observed greater PASI responses with continuous brodalumab vs continuous ustekinumab in patients with normal weight (P =.002) and patients with obesity (P =.001).
In addition, comparable PASI 100% improvement rates were observed at week 12 in patients with and without obesity. While the exposure-adjusted rate of treatment-emergent adverse events (TEAEs) was lower in patients with obesity (366.3 per 100 patient-years) vs patients without obesity (404.4 per 100 patient-years) in the continuous brodalumab group, safety outcomes were comparable across treatments and between body mass index groups.
Study limitations include the post hoc analysis, as well as allowing patients to switch to brodalumab from placebo during maintenance.
“The data reported herein from AMAGINE-2 and AMAGINE-3 suggest that brodalumab can be equally useful for the treatment of psoriasis” in patients with and without obesity, the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. The analysis for this study was funded by Ortho Dermatologics.
1. Hsu S, Green LJ, Lebwohl MG, et al. Comparable efficacy and safety of brodalumab in obese and non-obese patients with psoriasis: Analysis of 2 randomized controlled trials [published online July 5, 2019]. Br J Dermatol. doi:10.1111/bjd.18327
2. ClinicalTrials.gov. Study of efficacy and safety of brodalumab compared with placebo and ustekinumab in moderate to severe plaque psoriasis subjects (AMAGINE-2). NCT01708603. https://clinicaltrials.gov/ct2/show/NCT01708603 Accessed August 5, 2019.
3. ClinicalTrials.gov. Study of efficacy and safety of brodalumab compared with placebo and ustekinumab in moderate to severe plaque psoriasis subjects (AMAGINE-3). NCT01708629. Accessed August 5, 2019.