杜皮鲁玛
特应性皮炎
医学
湿疹面积及严重程度指数
皮肤病科
皮肤科生活质量指数
不利影响
队列
生活质量(医疗保健)
回顾性队列研究
逻辑回归
过敏
疾病
内科学
免疫学
护理部
作者
Silvia Ferrucci,Simona Tavecchio,Carlo Alberto Maronese,Anna Balato,Eugenia Veronica Di Brizzi,Michela Ortoncelli,Simone Ribero,Giampiero Girolomoni,Martina Maurelli,Anna Belloni Fortina,Francesca Caroppo,Luigi Naldi,Elena Pezzolo,Eustachio Nettis,Francesco Pugliese,Luca Stingeni,Katharina Hansel,Giovanni Rubegni,Laura Calabrese,Filomena Russo
摘要
Abstract Background The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long-term treatment outcomes is currently available to inform clinical decisions. Objectives To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. Methods A multicentre, retrospective, dynamic cohort study was conducted to assess long-term effectiveness and safety of dupilumab in patients with moderate-to-severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria [defined as the simultaneous achievement of a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated. Results In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AEs led to treatment discontinuation in < 1% of patients during the evaluated time periods. Conclusions The high long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate-to-severe AD, regardless of clinical phenotype and course (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.
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