Effectiveness and Safety of Adalimumab Biosimilar SB5 in Inflammatory Bowel Disease: Outcomes in Originator to SB5 Switch, Double Biosimilar Switch and Bio-Naïve SB5 Observational Cohorts.
Effectiveness and Safety of Adalimumab Biosimilar SB5 in Inflammatory Bowel Disease: Outcomes in Originator to SB5 Switch, Double Biosimilar Switch and Bio-Naïve SB5 Observational Cohorts.
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Adalimumab生物仿制药SB5在炎症性肠病中的有效性和安全性：发起人到SB5开关的结局，双生物仿制药开关和不使用生物的SB5观察群。
DOI：
10.1093/ecco-jcc/jjab100
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发表时间：
2021-12-18
期刊：
影响因子：
--
通讯作者：
Lees CW
中科院分区：
文献类型：
--
作者：
Derikx LAAP;Dolby HW;Plevris N;Lucaciu L;Rees CS;Lyons M;Siakavellas SI;Constantine-Cooke N;Jenkinson P;Su S;O'Hare C;Kirckpatrick L;Merchant LM;Noble C;Arnott ID;Jones GR;Lees CW
多种阿达木单抗[ADA]生物类似药目前已被批准用于炎症性肠病[IBD];然而，有效性和安全性数据仍然很少。我们的目的是研究ADA生物仿制药SB 5在IBD患者中从ADA原研药转换后[SB 5转换队列]或开始SB 5治疗后[SB 5开始队列]的长期结局。我们在三级IBD转诊中心进行了一项观察性队列研究。所有接受修美乐治疗的IBD患者均选择性转换为SB 5。我们在生物处方数据库中识别了所有这些患者，该数据库前瞻性地登记了所有ADA开始和停止日期，包括品牌名称。收集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。总共有481例患者接受了SB 5治疗，SB 5转换队列中有256例（中位随访时间：13.7个月[IQR 8.6-15.2]），SB 5开始队列中有225例[中位随访时间：8.3个月[4.2-12.8]）。在SB 5转换队列中，70.8%的患者在1年后仍接受SB 5治疗; 90/256例患者停用SB 5，主要是由于不良事件[46/90]或继发性应答丧失[37/90]。在SB 5开始队列中，81/225例患者停用SB 5，导致SB 5药物持续性超过1年的比例为60.3%。基线、转换后第26周和第52周之间的临床缓解[p = 0.53]、CRP [p = 0.80]、粪便钙卫蛋白[p = 0.40]和ADA谷水平[p = 0.55]无差异。注射部位疼痛是最常报告的不良事件。在本研究中，从ADA原研药转换为SB 5有效且安全，随访时间超过12个月。
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.
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影响因子：
8
作者：
Lukas, Martin;Malickova, K.;Lukas, Milan
通讯作者：
Lukas, Milan
影响因子：
35.7
作者：
Kennedy, Nicholas A.;Heap, Graham A.;Ahmad, Tariq
通讯作者：
Ahmad, Tariq
影响因子：
29.4
作者：
Hanauer, SB;Sandborn, WJ;Pollack, P
通讯作者：
Pollack, P
影响因子：
29.4
作者：
Colombel, Jean-Frederic;Sandborn, William J.;Pollack, Paul F.
通讯作者：
Pollack, Paul F.
影响因子：
3.1
作者：
Plevris, Nikolas;Jones, Gareth R.;Lees, Charlie W.
通讯作者：
Lees, Charlie W.