006 Comparison of alitretinoin vs. psoralen plus ultraviolet A as first-line treatments for chronic severe hand eczema: results from the ALPHA trial

Abstract Severe chronic hand eczema resistant to topical corticosteroid treatment is an important cause of morbidity and occupational disability. There uncertainty regarding the best approach currently no pathway generally accepted by UK dermatologists. The primary aim ALPHA trial was compare alitretinoin immersion psoralen plus ultraviolet A (PUVA) as a first-line therapy in terms disease activity at 12 weeks after planned start treatment. We conducted prospective, multicentre, open-label, two-arm parallel group, adaptive randomized controlled trial. natural logarithm Hand Eczema Severity Index (HECSI) + 1 chosen endpoint so relative effect could be estimated. In total, 514 participants were required detect fold change 1.3 (5% two-sided significance level, 80% power, 20% attrition). Participants : minimization or PUVA for 12–24 weeks. intention-to-treat population consisted 441 participants: 220 (49.9%) allocated 221 (50.1%) PUVA. 212 (96.4%) 196 (88.7%) received least one dose. statistically significant benefit compared with weeks, estimated 0.66 [95% confidence interval (CI) 0.52–0.82; P < 0.001]. evidence difference 24 52 Of those PUVA, 59% 61%, respectively, observed achieve clear/almost clear assessment during period. Alitretinoin more cost-effective than Limitations include differences compliance differential missing data levels. 145 (65.9%) 53 (24.0%) comply (≥ breaks > 7 days first weeks). Thus, twice-weekly attendance not most participants. However, this represents standard care run pragmatic using standard-of-care settings interventions. further limitation that long-term effects treatments complicated permitted use second-line phase; therefore, conclusions are therapies. conclude that, therapy, patients on showed rapid improvement superiority treated week 12, but later time points. Future studies will need address benefits given complex pathways.