Upadacitinib associated with long-term improvement in atopic dermatitis

More than 80% of patients with severe atopic dermatitis experienced significant improvement after treatment with upadacitinib compared with placebo, according to a study.

“Primary results from the Measure Up 1 and Measure Up 2 studies demonstrated upadacitinib efficacy and safety through 16 weeks in patients with atopic dermatitis,” Eric L. Simpson, MD, of the department of dermatology at Oregon Health & Science University, and colleagues wrote. “Longer-term outcomes remain unknown.”

The Measure Up studies are ongoing double-blind, placebo-controlled, replicate phase 3 trials being conducted at more than 150 centers assessing 52-week efficacy and safety in patients with severe AD.

Treatment interventions for the adults and adolescents in the study series included 15 mg or 30 mg of once daily upadacitinib (Rinvoq, AbbVie) or placebo. The full cohort from the two trials included 1,609 patients (mean age, 33.8 years; standard deviation, 15.6; 45.2% women).

At 16 weeks, the Measure Up 1 researchers randomly assigned 273 patients to the 15 mg dose and 270 to 30 mg, while the subsequent Measure Up 2 included 260 patients treated with 15 mg and 268 treated with 30 mg. Patients initially assigned placebo in the first 16 weeks were then randomly assigned to one of the two upadacitinib doses, with 121 patients in Measure Up 1 and 123 patients in Measure Up 2 receiving the 15 mg dose, while 120 and 121, respectively, received 30 mg.

Efficacy was defined by 75% improvement in the Eczema Area and Severity Index and validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a grade improvement of 2 or greater.

Results showed that between weeks 16 and 52, the 15 mg dose achieved EASI-75 in 82% (95% CI, 77%-86.9%) of patients from Measure Up 1 and 79.1% (95% CI, 73.9%-84.4%) from Measure Up 2. For the 30 mg dose, 84.9% (95% CI, 80.3%-89.5%) of patients in Measure Up 1 and 84.3% (95% CI, 79.6%-89%) from Measure Up 2 achieved the primary endpoint.

Regarding the vIGA-AD score outcome, the 15 mg dose yielded improvement in 59.2% (95% CI, 52.9%-65.5%) of patients from Measure Up 1 and 52.6% (95% CI, 46.2%-59.1%) from Measure Up 2. For the 30 mg dose, the result was reached by 62.5% (95% CI, 56.3%-68.7%) from the first trial and 65.1% (95% CI, 58.9%-71.2%) from the second.

There were more treatment-associated discontinuations in the 30 mg dose than in the 15 mg dose.

No new safety signals were observed.

“In this analysis of follow-up data from two randomized clinical trials, longer-term treatment of adolescents and adults with moderate to severe atopic dermatitis with upadacitinib demonstrated a favorable benefit-risk profile, with sustained efficacy responses through 52 weeks.”