Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial.
Thaçi D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M.
Lancet. 2015 Oct 7. pii: S0140-6736(15)00388-8. doi: 10.1016/S0140-6736(15)00388-8. [Epub ahead of print]
- Atopic Dermatitis (AD) is one of the main skin problems on the eczema spectrum of diseases. Unlike psoriasis, the inflammation is triggered by activation of other pathways, through the cytokines Interleukin 4 (IL-4) and IL-13 ( in psoriasis other cytokines are involved which include TNF alpha and IL-22)
- Understanding of the pathogenesis is the rationale behind the development of a new specific therapy against AD in its moderate to severe form. A short summary of pathogenesis is available HERE.
- In this Phase 2 multicenter prospective study published in the Lancet:
- 426 patients were randomized into groups corresponding to the different treatment regimens (subcutaneous injections): 300 mg once a week, 300 mg every 2 weeks, 200 mg every 2 weeks, 300 mg every 4 weeks, 100 mg every 4 weeks, or placebo once a week for 16 weeks
- measurement of AD scores at baseline and up to 16 weeks:
- EASI (Eczema Assessment Severity Index): To read more about the EASI score, click HERE .
- Results show a reduction of EASI severity score at all dose regimens (compared with placebo):
- 300 mg once a week (-74%)
- 300 mg every 2 weeks (-68%)
- 200 mg every 2 weeks (-65%)
- 300 mg every 4 weeks (-64%)
- 100 mg every 4 weeks (-45%)
- *placebo (-18%)
- Side effects concerned 258 (81%) of 318 patients given dupilumab, the most frequent being nasopharyngitis (28% of side effects). This proportion (26%) was similar in the placebo group, where side effects were reported in 49 (80%) of the 61 patients
- The first biologic for AD has arrived and we hope it will bring relief to patients in this difficult to manage chronic burden
- Contrarily to cyclosporine, good results are matched with few side effects. (To read about treatent recommendations, click HERE)
- Sadly, the problem in the current neoliberal environment and thus increasingly strained health systems, costs for this chronic condition will have to be weighed against results as all biologics are expensive; a term called efficiency. It is something which doctors and patients should NOT have to worry about.
*The reduction in the EASI score in the placebo group can be attributed to the chronic relapsing-remitting course of AD.
Article selection: Prof Dr Jean-Hilaire Saurat – dermatologist. Geneva, Switzerland