Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Inflammatory Bowel Disease Center, Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.
J Crohns Colitis. 2021 Dec 18;15(12):2011-2021. doi: 10.1093/ecco-jcc/jjab100.
Multiple adalimumab [ADA] biosimilars are now approved for use in inflammatory bowel disease [IBD]; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the ADA biosimilar SB5 in IBD patients following a switch from the ADA originator [SB5-switch cohort] or after start of SB5 [SB5-start cohort].
We performed an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira underwent an elective switch to SB5. We identified all these patients in a biological prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, C-reactive protein [CRP], drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected.
In total, 481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [IQR 8.6-15.2]) and 225 in the SB5-start cohort [median follow-up: 8.3 months [4.2-12.8]). Of the SB5-switch cohort, 70.8% remained on SB5 beyond 1 year; 90/256 discontinued SB5, mainly due to adverse events [46/90] or secondary loss of response [37/90]. In the SB5-start cohort, 81/225 discontinued SB5, resulting in SB5-drug persistence of 60.3% beyond 1 year. No differences in clinical remission [p = 0.53], CRP [p = 0.80], faecal calprotectin [p = 0.40] and ADA trough levels [p = 0.55] were found between baseline, week 26 and week 52 following switch. Injection site pain was the most frequently reported adverse event.
Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
目前已有多种阿达木单抗 [ADA] 生物类似药获批用于炎症性肠病 [IBD]；然而，其有效性和安全性数据仍然有限。我们旨在研究 ADA 生物类似药 SB5 在 IBD 患者中的长期疗效，这些患者是从 ADA 原研药转换而来（SB5-转换队列），还是在开始使用 SB5 后（SB5-起始队列）。
我们在一家三级 IBD 转诊中心进行了一项观察性队列研究。所有接受 Humira 治疗的 IBD 患者均进行了选择性 SB5 转换。我们在一个前瞻性注册所有 ADA 起始和停药日期（包括商品名）的生物处方数据库中确定了所有这些患者。收集了 IBD 表型、C 反应蛋白 [CRP]、药物持久性、ADA 药物和抗体水平以及粪便钙卫蛋白的数据。
共有 481 例患者接受 SB5 治疗，其中 256 例患者在 SB5-转换队列（中位随访时间：13.7 个月 [IQR 8.6-15.2]），225 例患者在 SB5-起始队列（中位随访时间：8.3 个月 [4.2-12.8]）。在 SB5-转换队列中，70.8%的患者在 1 年以上继续使用 SB5；256 例中有 90 例停用 SB5，主要原因是不良事件 [46/90]或继发治疗应答丧失 [37/90]。在 SB5-起始队列中，225 例中有 81 例停用 SB5，导致 SB5 药物的持久性在 1 年以上为 60.3%。在转换后第 26 周和第 52 周与基线相比，临床缓解[p = 0.53]、CRP [p = 0.80]、粪便钙卫蛋白[p = 0.40]和 ADA 谷值水平[p = 0.55]均无差异。注射部位疼痛是最常报告的不良事件。
在这项随访时间超过 12 个月的研究中，从 ADA 原研药转换为 SB5 似乎是有效和安全的。
