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

Abstract

Summary 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.

Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

“…3,4 Although recent scientific advances have led to highly efficacious treatments for moderate-to-severe psoriasis, lower efficacy has been reported with biologic treatments in patients with comorbid obesity or in those with prior biologic exposure and/or failure. [5][6][7][8][9][10][11][12][13][14][15][16] Thus, there is a need for psoriasis treatments to demonstrate consistently high efficacy regardless of patient demographics or prior biologic therapy.…”

‘COre SUBgroup SETs (COSUBSET)’ initiative is needed

“…Hsu et al . conducted a post hoc analysis to assess the efficacy and safety of brodalumab in obese vs. nonobsese patients with psoriasis . The authors pooled the data of two duplicate phase III trials and evaluated skin clearance and safety in patients who received brodalumab 210 mg every 2 weeks, patients who received ustekinumab and patients who switched at 16 weeks from ustekinumab to brodalumab 210 mg every 2 weeks because of a lack of efficacy.…”

“…Thus, it is crucial to obtain efficacy and safety results for obese patients with psoriasis when assessing a new therapeutic target, which is exactly what Hsu et al . did …”

“…a post hoc analysis, as carried out by Hsu et al .) . In line with the CONSORT statement, subgroup analyses should be prespecified, i.e.…”

“…Hsu et al . not only performed a pooled analysis, but also provided separate data for each trial, allowing for future systematic reviews and meta‐analyses …”