Greater Clinical Response Related to Improved Outcomes in Atopic Dermatitis

A higher level of clinical response is associated with greater improvement in patient-reported outcomes (PROs) in atopic dermatitis (AD), including itch, skin pain, sleep, anxiety, depression, and quality of life, according to study results published in Journal of the European Academy of Dermatology and Venereology.

Researchers conducted a post hoc analysis of 3 ongoing clinical trials in adult and adolescent patients with moderate to severe AD to characterize how incremental improvements in clinical response are associated with improvements in other outcome measures.

The ongoing randomized, double-blind, placebo-controlled, phase 3 Measure Up 1, Measure Up 2, and AD Up trials are assessing use of upadacitinib in adolescents and adults aged 12 to 75 years with moderate to severe AD. The participants were randomly assigned in a 1:1:1 ratio receive either oral upadacitinib 15 or 30 mg, or placebo once daily. The AD Up study included the intervention combined with topical corticosteroids.

The post hoc pooled analysis reported results from the first 16 weeks of treatment. Outcome measures included the Eczema Area and Severity Index (EASI) and validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD), as well as 21 other assessments for AD severity, symptoms, impact of AD, and quality of life.

A total of 2392 participants (mean [SD] age, 33.8 [15.3] years; 57.4% men) from the 3 trials were included in the final analysis. At week 16, improvements in EASI and vIGA-AD were associated with improvements in the assessed measures. Correlations between PRO measures and Worst Pruritus Numeric Rating Scale (WP-NRS) were generally numerically greater vs those between PRO measures and EASI and vIGA-AD.

Participants’ mean percentage improvements in SCORing Atopic Dermatitis (SCORAD), objective SCORAD, SCORAD itch, WP-NRS, Patient-Oriented Eczema Measure (POEM), and Atopic Dermatitis Symptom Scale (ADermSS) skin pain, and 7-Item Total Symptom Score (TSS-7) measures were incrementally greater for higher EASI and vIGA-AD responses. The mean percentage improvement was more than 70% for all outcomes except for POEM at EASI scores between 90 and 100, and vIGA-AD scores of almost clear response levels.

Mean percentage improvements in SCORAD sleep, Dermatology Life Quality Index (DLQI), Atopic Dermatitis Impact Scale, and Hospital Anxiety and Depression Scale anxiety and depression subscales were incrementally greater for higher EASI and vIGA-AD responses.

The proportion of participants who had clinically meaningful improvement in clinical and quality of life endpoints was incrementally greater with higher EASI and vIGA-AD response levels. For EASI scores of at least 90 and vIGA-AD scores of clear or almost clear response levels, the proportion of patients who had clinically meaningful improvement was over 90% for POEM and DLQI and at least 74% for the other endpoints.

The findings were similar in the pooled placebo group (n=757), which showed consistent stepwise patterns, although the improvements were generally lower.

Limitations of the study include the fact that the analyses were conducted with clinical trial data for patients with moderate to severe AD and may not be generalizable to all patients with AD, especially those with mild disease.

“We demonstrated that higher response categories of the EASI and vIGA-AD are associated with improvements in other outcome measures that assess a broad spectrum of AD-related signs, symptoms, and effects on quality of life,” the researchers conclude. “Importantly, although the number of outcome measures used was large and diverse, there was notable consistency among the results.”

Disclosure: This research was supported by AbbVie. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.