Adults with moderate to severe atopic dermatitis (AD) have demonstrated sustained clinical improvement and drug tolerability when treated with the anti–interleukin (IL)-22 monoclonal antibody fezakinumab, according to the results of a phase 2a, multicenter, randomized, placebo-controlled, double-blind study (ClinicalTrials.gov identifier: NCT01941537) published in the Journal of the American Academy of Dermatology.
The investigators sought to evaluate the efficacy and safety associated with the use of fezakinumab in adults with moderate to severe AD.
A total of 60 patients were enrolled in the study; 40 received treatment with intravenous fezakinumab monotherapy every 2 weeks for 10 weeks and 20 received placebo. Follow-up assessments took place through 20 weeks. The primary end point was the Scoring Atopic Dermatitis (SCORAD) change from baseline at 12 weeks.
Mean SCORAD decline at 12 weeks was 13.8±2.7 in the fezakinumab arm vs 8.0±3.1 in the placebo arm, which did not reach statistical significance (P =.134). In patients with severe AD (baseline SCORAD ≥50), however, the SCORAD decline was significantly greater with fezakinumab than with placebo at 12 weeks (21.6±3.8 vs 9.6±4.2, respectively; P =.029) and at 20 weeks (27.4±3.9 vs 11.5±5.1, respectively; P =.010).
At 12 weeks, improvements in body-surface area were significantly greater with fezakinumab compared with placebo in the entire population (ie, patients with moderate to severe AD; 12.4%±2.4% vs 6.2%±2.7%, respectively; P =.009) and for Investigator Global Assessment in patients with severe AD (0.7±0.2 vs 0.3±0.1, respectively; P =.034).
All participants’ scores demonstrated progressive improvements at 10 weeks (last dosing) until the end of the study (20 weeks). The most common adverse event reported was upper respiratory tract infection.
The investigators concluded that the progressive clinical improvements reported with fezakinumab vs placebo in this study open a novel therapeutic paradigm for patients with AD — particularly patients with severe disease — who have the largest unmet need for better treatments.
Guttman-Yassky E, Brunner PM, Neumann AU, et al. Efficacy and safety of fezakinumab (an anti-IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional treatments – a randomized, double-blind, phase 2a trial [published online January 15, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.01.016