Dupilumab Is Effective in Patients with Atopic Dermatitis and Inadequate Response, Intolerance, or Contraindication to Cyclosporine: A Systematic Review and Meta-Analysis

Author(s)

Magro F1, Oldani PA2, Vieira Duarte G3, Migliavaca CB4, Gräf D4, Schneider N5, Falavigna M4, Bosnich F1, Barbosa A1, Federico P1, Taminato A1, Guyot P6
1Sanofi, Sao Paulo, SP, Brazil, 2Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil, 3Instituto Bahiano de Imunoterapia, Salvador, Brazil, 4HTAnalyze Consulting and Training, Porto Alegre, Brazil, 5HTAnalyze Consulting and Training, Porto Alegre, RS, Brazil, 6Sanofi, Chilly-Mazarin, France

OBJECTIVES:

To assess the efficacy and safety of dupilumab in adults with moderate to severe atopic dermatitis (AD) and inadequate response, intolerance, or contraindication to cyclosporine.

METHODS:

Search in PubMed, Embase, and Cochrane CENTRAL (from inception to November 2021) for randomized clinical trials assessing dupilumab 300mg Q2W in comparison to placebo (with or without TCS) in adult patients with moderate-to-severe or severe AD was performed. In the identified trials, only patients with inadequate response, intolerance, or contraindication to cyclosporine were identified and selected for further analysis. Study selection and data extraction was conducted by two independent reviewers; discrepancies were solved through consensus or by a third reviewer. Meta-analyses were conducted using random-effects model. Quality of evidence assessed with GRADE.

RESULTS:

1,090 references were identified; of those, four studies (SOLO 1, SOLO 2, LIBERTY AD CHRONOS and LIBERTY AD CAFÉ) were included. Only the LIBERTY AD CAFÉ evaluated exclusively the population of interest. Other studies included broader population, but subgroup analysis for the population of interest was identified. Dupilumab was associated with improvement in all efficacy outcomes in patients with moderate-to-severe/severe AD that had inadequate response, intolerance, or contraindications to cyclosporine. The mean difference between dupilumab and placebo-treated patients in change in EASI from baseline through week 16 was -38.2% (95%CI -46.8 to -29.5), in SCORAD -30.7% (95%CI -36.9 to -24.5), in DLQI -5.5 points (95%CI -6.8 to -4.3), and in POEM -8.3 points (95%CI -10.3 to -6.4). More patients receiving dupilumab achieved EASI-75 (RR 2.49; 95%CI 1.83 to 3.39). Treatment groups had similar overall rates of adverse events (dupilumab: 72.0%; placebo: 69.4%) and serious adverse events (1.9% for each group).

CONCLUSIONS:

Dupilumab improved AD signs and symptoms, patient’s quality-of-life and presented an acceptable safety profile, supporting the use of dupilumab in patients with inadequate response, intolerance, or contraindication to cyclosporine.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)

Code

CO82

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Biologics & Biosimilars

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