Bellinato Francesco, Gisondi Paolo, Mason Elena, Ricci Paolo, Maurelli Martina, Girolomoni Giampiero
Section of Dermatology and Venereology, Department of Medicine, University of Verona, Piazzale A. Stefani 1, 37126, Verona, Italy.
Dermatol Ther (Heidelb). 2022 Jun;12(6):1303-1311. doi: 10.1007/s13555-022-00732-y. Epub 2022 Apr 27.
The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated.
To investigate drug survival of adalimumab biosimilars in patients with chronic plaque psoriasis and factors associated with its discontinuation.
We carried out a retrospective observational study including all consecutive patients with chronic plaque psoriasis who initiated adalimumab biosimilar MSB11022 (Idacio), ABP501 (Amgevita), or SB5 (Imraldi) between 1 January 2018 and 1 January 2021. The 1-year drug survival of adalimumab biosimilar and independent factors associated with its discontinuation were investigated. Cox regression models were fit to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the risk of adalimumab discontinuation. A propensity score matching (PSM) model was adopted as sensitivity analysis.
The study involved a total of 410 patients with follow-up of 549.84 person-years, 271 (66.1%) men, a mean (SD) age of 51.8 (14.5) years, and a baseline PASI of 14.54 (5.02). Among adalimumab biosimilars, 250 (61%) patients received MSB11022, 98 (24%) received ABP501, and 62 (15%) received SB5. Drug survival of adalimumab biosimilars at 1 year was 81.5% in the overall study population. Obesity was associated with increased risk of adalimumab discontinuation (HR = 2.01; 95% CI 1.33-3.03), whereas psoriatic arthritis (aHR = 0.32; 95% CI 0.16-0.64) and receiving adalimumab as first systemic treatment (aHR = 0.44; 95% CI 0.27-0.70) were associated with lower risk.
The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator.
阿达木单抗生物类似药在银屑病患者中的实际疗效鲜有研究。
研究阿达木单抗生物类似药在慢性斑块状银屑病患者中的药物留存率及其停药相关因素。
我们开展了一项回顾性观察性研究，纳入了2018年1月1日至2021年1月1日期间开始使用阿达木单抗生物类似药MSB11022（依达西奥）、ABP501（安进维达）或SB5（英利昔）的所有连续性慢性斑块状银屑病患者。研究了阿达木单抗生物类似药的1年药物留存率及其停药相关独立因素。采用Cox回归模型估计阿达木单抗停药风险的调整风险比（aHR）及95%置信区间（CI）。采用倾向得分匹配（PSM）模型进行敏感性分析。
该研究共纳入410例患者，随访549.84人年，其中男性271例（66.1%），平均（标准差）年龄51.8（14.5）岁，基线银屑病面积和严重程度指数（PASI）为14.54（5.02）。在阿达木单抗生物类似药中，250例（61%）患者使用MSB11022，98例（24%）使用ABP501，62例（15%）使用SB5。在整个研究人群中，阿达木单抗生物类似药1年的药物留存率为81.5%。肥胖与阿达木单抗停药风险增加相关（HR = 2.01；95% CI 1.33 - 3.03），而银屑病关节炎（aHR = 0.32；95% CI 0.16 - 0.64）和首次接受阿达木单抗全身治疗（aHR = 0.44；95% CI 0.27 - 0.70）与较低风险相关。
阿达木单抗生物类似药在银屑病患者中的实际疗效与先前报道的原研药一致。
