JEADV Clinical Practice (Sep 2023)

Efficacy of baricitinib 4 mg in patients with moderate‐to‐severe atopic dermatitis previously treated with systemic therapy

  • Antonio Costanzo,
  • Akio Tanaka,
  • Tiago Torres,
  • Bibiana Pérez‐García,
  • Angelina Sontag,
  • Yun‐Fei Chen,
  • Fan Emily Yang,
  • Jill Kolodsick,
  • Hitoe Torisu‐Itakura,
  • Najwa Somani

DOI
https://doi.org/10.1002/jvc2.187
Journal volume & issue
Vol. 2, no. 3
pp. 583 – 589

Abstract

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Abstract Background The Janus kinase (JAK)1/JAK2 inhibitor baricitinib in combination with topical corticosteroids (TCS) improved moderate‐to‐severe atopic dermatitis (AD) in the phase 3 BREEZE‐AD7 trial. Patients with previous systemic therapy may have more severe, treatment‐resistant disease. Objectives To assess the efficacy of baricitinib 4 mg in adults with moderate‐to‐severe AD with and without previous use of systemic therapy. Methods Patients were randomized 1:1:1 to TCS plus once‐daily oral placebo, 2 mg baricitinib or 4 mg baricitinib for 16 weeks. Outcomes were assessed in patients treated with baricitinib 4 mg with and without previous use of systemic therapy (N = 68, N = 43) versus placebo (N = 75, N = 34). Prior use of systemic therapy was defined as treatment of AD with oral corticosteroids, immunosuppressants or biologics. Endpoints included the proportions of patients achieving a vIGA‐AD® score 0 or 1 with >2‐point improvement from baseline, 75% improvement in the Eczema area and severity index score (EASI75), ≥4‐point improvement on the Itch numeric rating scale (NRS) and ≥4‐point improvement in the dermatology life quality index (DLQI). Logistic regression was used to evaluate consistent treatment effects across subgroups. Results At Week 16, among patients with and without previous use of systemics treated with baricitinib 4 mg versus placebo, respectively, vIGA‐AD score (0, 1) was achieved in 27.9% and 34.9% versus 13.3% and 17.6%, EASI75 was met in 47.1% and 48.8% versus 22.7% and 23.5%, Itch NRS ≥ 4‐point improvement was observed in 44.4% and 43.2% versus 14.1% and 33.3% and DLQI ≥ 4‐point improvement was seen in 75.8% and 69.2% versus 52.1% and 54.8%. Consistent treatment effects were observed between patients with or without prior use of systemics (treatment‐by‐subgroup interactions p = 0.085 for Itch NRS, p > 0.1 for all others). Conclusions Baricitinib 4 mg significantly reduced disease severity in AD compared to placebo regardless of prior systemic therapy.

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