Efficacy and safety of dupilumab for moderate‐to‐severe atopic dermatitis: A systematic review for the EAACI biologicals guidelines
Ioana Agache, Yang Song, Margarita Posso, Pablo Alonso‐Coello, Claudio Rocha, Iván Solà, Jessica Beltrán, Cezmi A. Akdiş, Mübeccel Akdiş, Knut Brockow, Tomás Chivato, Stefano Del Giacco, Thomas Eiwegger, Kilian Eyerich, Ana M. Giménez‐Arnau, Jan Gutermuth, Emma Guttman‐Yassky, Marcus Maurer, Graham S. Ogg, Peck Y. Ong, Liam O’Mahony, Jürgen Schwarze, Thomas Werfel, Carlos Canelo‐Aybar, Óscar Palomares, Marek Jutel
Abstract
This systematic review evaluates the efficacy, safety and economic impact of dupilumab compared to standard of care for uncontrolled moderate-to-severe atopic dermatitis (AD). Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important AD-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Seven RCTs including 1845 subjects >12 years treated with dupilumab 16 to 52 weeks were evaluated. For adults, there is high certainty that dupilumab decreases SCORAD (MD -30,72; 95% CI -34,65% to -26,79%) and EASI-75 (RR 3.09; 95% CI 2.45 to 3.89), pruritus (RR 2.96; 95% CI 2.37 to 3.70), rescue medication (RR 3.46; 95% CI 2.79 to 4.30), sleep disturbance (MD -7.29; 95% CI -8.23 to -6.35) and anxiety/depression (MD -3.08; 95% CI -4.41 to -1.75) and improves quality of life (MD -4.80; 95% CI -5.55 to -4.06). The efficacy for adolescents is similar. Dupilumab-related adverse events (AEs) slightly increase (low certainty). The evidence for dupilumab-related serious AE is uncertain. The incremental cost-effectiveness ratio ranged from 28 500 £ (low certainty) to 124 541 US$ (moderate certainty). More data on long-term safety are needed both for children and for adults, together with more efficacy data in the paediatric population. Registration: PROSPERO (CRD42020153645).