Efficacy and Safety of Ustekinumab in Japanese Patients with Severe Atopic Dermatitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2 Study

Summary

Background

Ustekinumab, a fully human monoclonal antibody against interleukin-12/23, may be potentially effective for severe atopic dermatitis (AD) treatment.

Objectives

To evaluate efficacy and safety of ustekinumab 45 mg and 90 mg in severe AD patients.

Methods

In this placebo-controlled, randomised, phase 2 study, adult Japanese patients (aged 20–65 years) with severe or very severe AD entered a 12-week double-blind treatment period to receive (1:1:1) ustekinumab 45 mg, 90 mg or placebo subcutaneous injections at weeks 0 and 4; follow-up until week 24. Primary efficacy endpoint was percent change from baseline in Eczema Area and Severity Index (EASI) score at week 12. Major secondary efficacy endpoints: proportion of patients achieving EASI-50, EASI-75, Investigator's Global Assessment score 0-1, change from baseline Atopic Dermatitis Itch Scale and Dermatology Life Quality Index, all at week 12.

Results

79 patients were randomised (ustekinumab 45 mg: n=24, 90 mg: n=28, placebo: n=27). Ustekinumab treatment showed nonsignificant improvement in least-square mean change from baseline EASI score at week 12 (45 mg: –38.2%, 95% confidence interval [CI] –21.02; 19.51, p<0.94 and 90 mg: –39.8%, 95% CI, -21.84; 17.14, p<0.81) versus placebo (–37.5%). Nonsignificant improvement in major secondary efficacy endpoints was also observed in both ustekinumab groups versus placebo. The most common (>2 patients) treatment-emergent adverse events were nasopharyngitis (similar incidence among all groups); and worsened AD (higher in placebo vs ustekinumab groups).

Conclusion

Ustekinumab at 45 mg and 90 mg did not demonstrate meaningful efficacy in Japanese patients with severe AD. The treatment was generally well-tolerated.

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