EpiDermE, Paris Est Créteil University, Créteil, France.
EPI-PHARE Scientific Interest Group in Epidemiology of Health Products from the French National Agency for the Safety of Medicines and Health Products and the French National Health Insurance, Saint Denis, France.
Br J Dermatol. 2023 Oct 25;189(5):561-568. doi: 10.1093/bjd/ljad248.
Many biologics are available for psoriasis and have been compared in real-life studies based on their persistence (i.e. time between initiation and discontinuation). However, after first-line biologic failure, data are lacking on the choice of second-line biologic among the four available classes [tumour necrosis factor inhibitors (TNFi); interleukin (IL)-12/IL-23 inhibitor (IL-12/IL-23i); IL-17 inhibitors (IL-17i); and IL-23 inhibitors (IL-23i)].
To compare the long-term persistence of available second-line biologics in psoriasis according to prior exposure.
This nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to a hospital discharge database. Participants were adults with psoriasis, defined as having at least two prescriptions of a topical vitamin D derivative within a 2-year period, with initiation of a second-line biologic between 1 January 2015 and 31 December 2021. We included patients who initiated a second-line biologic directly after first-line discontinuation (i.e. without a 'washout' period). The end of follow-up was 30 June 2022. Discontinuation was defined as > 90 days without filling a prescription for the same treatment after the period covered by the previous prescription. Comparison of persistence by biologic class involved using propensity score-weighted Cox models (inverse probability treatment weighting) and adjustment of specific systemic nonbiologics (time-dependent variables).
We included 8693 patients [mean (SD) age 50 (14) years; 50.5% male]; 2824 (32.5%) started TNFi, 1561 (18.0%) IL-12/IL-23i, 2707 (31.1%) IL-17i and 1601 (18.4%) IL-23i. Overall, 1- and 3-year persistence rates were 60% and 30%, respectively. After weighting and adjustment, persistence was longer with IL-12/IL-23i [weighted hazard ratio (HRw) 0.68, 95% confidence interval (CI) 0.62-0.76)], IL-17i (HRw 0.70, 95% CI 0.64-0.78) and IL-23i (HRw 0.36, 95% CI 0.31-0.42) than TNFi, except after first-line IL-17i treatment, with no difference between IL-12/IL-23i, IL-17i and TNFi second-line persistence. Persistence was longer with IL-23i as a second-line treatment than IL-12/IL-23i (HRw 0.53, 95% CI 0.44-0.63) and IL-17i (HRw 0.51, 95% CI 0.44-0.60), regardless of first-line treatment, with no difference seen between IL-12/IL-23i and IL-17i (HRw 0.97, 95% CI 0.87-1.09).
This real-life study suggests the longer persistence of IL-23i than TNFi, IL-17i and IL-12/IL-23i as second-line treatment for psoriasis. Persistence rates for all biologics remained low at 3 years.
有许多生物制剂可用于治疗银屑病,并且已经根据其持久性(即从起始到停药之间的时间)在真实研究中进行了比较。然而,在一线生物制剂治疗失败后,关于在可用的四类生物制剂(肿瘤坏死因子抑制剂[TNFi];白细胞介素[IL]-12/IL-23 抑制剂[IL-12/IL-23i];白细胞介素[IL]-17 抑制剂[IL-17i];和白细胞介素[IL]-23 抑制剂[IL-23i])中选择二线生物制剂的数据尚缺乏。
根据先前的暴露情况,比较银屑病二线生物制剂的长期持久性。
这是一项全国性队列研究,涉及法国医疗保险计划的行政医疗保健数据库与医院出院数据库的链接。参与者为至少有两次局部维生素 D 衍生物处方的银屑病成年人,且在 2015 年 1 月 1 日至 2021 年 12 月 31 日期间开始二线生物制剂治疗。我们纳入了在一线治疗停药后直接开始二线生物制剂治疗的患者(即无“洗脱期”)。随访结束时间为 2022 年 6 月 30 日。停药定义为在以前处方涵盖的期间后,超过 90 天没有开相同治疗的处方。通过生物制剂类别比较持久性时,我们使用了倾向评分加权 Cox 模型(逆概率治疗加权)和调整特定的系统非生物制剂(时间依赖性变量)。
我们纳入了 8693 名患者[平均(标准差)年龄 50(14)岁;50.5%为男性];2824 名(32.5%)开始 TNFi,1561 名(18.0%)IL-12/IL-23i,2707 名(31.1%)IL-17i和 1601 名(18.4%)IL-23i。总体而言,1 年和 3 年的持久率分别为 60%和 30%。经过加权和调整后,IL-12/IL-23i [加权风险比(HRw)0.68,95%置信区间(CI)0.62-0.76]、IL-17i(HRw 0.70,95%CI 0.64-0.78)和 IL-23i(HRw 0.36,95%CI 0.31-0.42)的持久性均长于 TNFi,但在一线 IL-17i 治疗后除外,IL-12/IL-23i、IL-17i 和 TNFi 的二线持久性之间没有差异。IL-23i 作为二线治疗的持久性长于 IL-12/IL-23i(HRw 0.53,95%CI 0.44-0.63)和 IL-17i(HRw 0.51,95%CI 0.44-0.60),无论一线治疗如何,IL-12/IL-23i 和 IL-17i 之间没有差异(HRw 0.97,95%CI 0.87-1.09)。
这项真实研究表明,IL-23i 作为银屑病的二线治疗,其持久性长于 TNFi、IL-17i 和 IL-12/IL-23i。所有生物制剂的 3 年持久率仍然较低。