DECISA Project (DErmatology Clinics in Italy: Survey on Alitretinoin): A real-life retrospective cohort multicenter study on 438 subjects with chronic hand eczema

Dermatol Ther. 2021 May;34(3):e14911. doi: 10.1111/dth.14911. Epub 2021 Mar 9.

Abstract

Alitretinoin is the only systemic agent approved to treat moderate-severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. No nationwide Italian data regarding real-life efficacy, safety, and tolerability of treatment are available. The DECISA project (DErmatology Clinics in Italy: Survey on Alitretinoin) retrospectively examined data from a registry including 15 Dermatology Clinics authorized to prescription of alitretinoin for CHE patients. Disease severity was assessed at baseline, and after 3 and 6 months of treatment, using the 5-point Physician Global Assessment (PGA) and the modified Total Lesion-Symptoms-Severity (mTLSS) scores. Between November 2010 and July 2018, data of 248 male and 190 female patients (mean age 49.71 ± 13.20 years) treated with alitretinoin were collected. Of them, 43.2% had irritant contact dermatitis, 22.2% allergic contact dermatitis, 18.0% atopic dermatitis, 16.7% mixed (irritant/allergic) type of eczema. At 3 months, the 420 re-evaluated patients showed significantly reduced mTLSS and PGA (P < .0000001 vs baseline for both); PGA was clear/almost clear in 35.6% of cases. At 6 months, the 341 re-evaluated patients showed significant (P < .0000001) improvement of mTLSS and PGA vs baseline and 3 months (PGA clear/almost clear: 41.4%). Relapses occurred in 125 patients; 58 underwent an additional course of alitretinoin, with similarly good results. No relevant safety issues were reported; 86 patients experienced adverse effects, which forced 40 to prematurely stop treatment. The DECISA project results confirm the real-life efficacy, safety and tolerability of alitretinoin in the treatment of moderate to severe CHE refractory to standard topical therapies.

Keywords: alitretinoin; chronic hand eczema; real-life study; retrospective study.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Alitretinoin
  • Chronic Disease
  • Dermatologic Agents* / adverse effects
  • Dermatology*
  • Eczema* / diagnosis
  • Eczema* / drug therapy
  • Female
  • Hand Dermatoses* / diagnosis
  • Hand Dermatoses* / drug therapy
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • Tretinoin / adverse effects

Substances

  • Dermatologic Agents
  • Alitretinoin
  • Tretinoin