Département d'études en santé publique, Direction de la stratégie, des études et des statistiques, Caisse Nationale d'Assurance Maladie des Travailleurs Salariés (CNAM), Paris, F-75020, France.
AP-HP, Hôpitaux universitaires Henri Mondor, Département de Dermatologie, UPEC, 51, av du Maréchal de Lattre de Tassigny, Créteil, F-94010, France.
Br J Dermatol. 2019 Jan;180(1):86-93. doi: 10.1111/bjd.16809. Epub 2018 Sep 23.
Long-term clinical effectiveness of biologics in psoriasis is needed.
We aimed to assess the long-term persistence of biologics used to treat psoriasis in a real-life setting.
All adults with psoriasis having been registered in the French National Health Insurance database (SNIIRAM) between 2008 and 2016 were eligible for inclusion. Psoriasis was defined as the fulfilment of at least two prescriptions for topical formulations of a vitamin D derivative within a 2-year period. The study population comprised biologic-naïve patients, i.e. those with a first prescription of etanercept, infliximab, adalimumab or ustekinumab. Persistence of treatment with a biologic was defined as the time interval between initiation and discontinuation.
In this nationwide population-based cohort, 16 545 out of 874 549 patients with psoriasis were biologic-naïve (mean age 48·6 years; males 57·3%, mean follow-up 3·6 years). The mean ± SD length of follow-up for biologic-naïve patients was 3·6 ± 2·4 years. There were 9988 treatment discontinuations. Kaplan-Meier survival analyses revealed a persistence rate of 61·9% for the first, 33·3% for the third and 22·6% for the fifth year. Ustekinumab had a higher persistence rate than the other biologics. This finding should be interpreted with caution, in view of differences in administration between the biologics. About 85% of patients, having discontinued their first biologic, resumed systemic treatment of some type in the following year (biologics in 85% of cases).
Our data suggest that biologics are less effective than physicians have been led to believe in a real-life, nonselected population. Further, long-term disease control requires several courses of different biologics.
长期临床疗效的生物制剂在银屑病中的应用是必要的。
我们旨在评估生物制剂治疗银屑病的长期疗效。
所有在 2008 年至 2016 年期间在法国国家健康保险数据库(SNIIRAM)登记的银屑病成人患者均符合入选条件。银屑病的定义是在 2 年内至少有 2 次外用维生素 D 衍生物处方。研究人群包括生物制剂初治患者,即首次接受依那西普、英夫利昔单抗、阿达木单抗或乌司奴单抗治疗的患者。生物制剂治疗的持续性定义为起始与停药之间的时间间隔。
在这项全国性基于人群的队列研究中,874549 例银屑病患者中有 16545 例(平均年龄 48.6 岁;男性 57.3%,平均随访 3.6 年)为生物制剂初治患者。生物制剂初治患者的平均随访时间为 3.6±2.4 年。有 9988 例治疗中断。Kaplan-Meier 生存分析显示,第一年、第三年和第五年的累积持续率分别为 61.9%、33.3%和 22.6%。乌司奴单抗的持续率高于其他生物制剂。鉴于生物制剂之间的给药差异,该发现应谨慎解读。约 85%的患者在停用首种生物制剂后,在接下来的一年中恢复了某种类型的系统治疗(85%的病例中使用生物制剂)。
我们的数据表明,生物制剂在非选择性人群中的实际疗效不如医生所认为的那样有效。此外,长期的疾病控制需要几种不同生物制剂的疗程。