Early prediction of therapeutic response can optimise treatment strategies in atopic dermatitis (AD). Baricitinib is approved for moderate-to-severe AD in Europe, Japan and other countries.
To identify early clinical improvements that reliably predict a later clinical response to baricitinib in adults with moderate-to-severe AD.
Using data from one topical corticosteroid combination study and from two monotherapy studies (pooled), we calculated the sensitivity, specificity, and positive and negative predictive values (NPV) of predefined changes in single and combined clinical scores at weeks 2, 4 and 8 to predict clinical response at week 16. Clinical response was defined as Eczema Area and Severity Index (EASI) ≥75% improvement (EASI75), Itch Numeric Rating Scale (NRS) ≥4-point improvement (Itch NRS≥4), or a combination of both.
Composite predictors had higher predictive accuracy than single parameters. Sensitivities and NPVs for ≥50% EASI improvement (EASI50) or Itch NRS ≥3-point improvement (Itch NRS≥3), validated Investigator’s Global Assessment of AD (vIGA-AD) score ≤2 or Itch NRS≥3 ranged from 87% to 97% and 68% to 100%, respectively, at week 4. The predictive accuracy for composite clinical outcomes at week 16 was highest at week 8 (sensitivity: 93%-100%; NPV: 80%-100%). At both weeks 4 and 8, EASI50 or Itch NRS≥3 had higher sensitivity and NPV than vIGA-AD score ≤2 or Itch NRS≥3.
Improvement in signs and symptoms early during treatment with baricitinib 4 mg once daily predicts clinical response at week 16, providing a tool for dermatologists when choosing treatment strategies with patients with moderate-to-severe AD.BREEZE-AD1 (NCT03334396); BREEZE-AD2 (NCT03334422); BREEZE-AD7 (NCT03733301).

© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.