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司库奇尤单抗可能诱发强直性脊柱炎或银屑病关节炎患者发生炎症性肠病。

Secukinumab as a potential trigger of inflammatory bowel disease in ankylosing spondylitis or psoriatic arthritis patients.

机构信息

Department of Academic Rheumatology, King's College London, London.

Department of Rheumatology, Brighton and Sussex University Hospital, Brighton.

出版信息

Rheumatology (Oxford). 2021 Nov 3;60(11):5233-5238. doi: 10.1093/rheumatology/keab193.

Abstract

OBJECTIVE

Real-world secukinumab gastrointestinal-related adverse events (GIRAE) data during treatment for AS and PsA are lacking. We aimed to obtain this through baseline evaluation of pre-existing IBD rates and predictors of GIRAE.

METHODS

Patient electronic and paper records commencing secukinumab from 10 UK hospitals between 2016 and 2019 were reviewed. GIRAE after initiation were defined as: definite [objective evidence of IBD (biopsy proven), clear temporal association, resolution of symptoms on drug withdrawal, no alternative explanation felt more likely], probable (as per definite, but without biopsy confirmation) or possible (gastrointestinal symptoms not fulfilling definite or probable criteria).

RESULTS

Data for all 306 patients started on secukinumab were analysed: 124 (40.5%) AS and 182 (59.5%) PsA. Twenty-four of 306 (7.8%) experienced GIRAE after starting secukinumab. Amongst patients who developed GIRAE, four (1.3%) had definite, seven (2.3%) probable and 13 (4.2%) possible IBD. All definite cases were patients with AS and stopped secukinumab; two had pre-existing IBD and two (0.7%) were de novo cases of which one required surgical intervention. Seven patients (2.3%) had pre-existing diagnoses of IBD prior to initiation, of which five patients experienced GIRAE.

CONCLUSION

Absolute rates of new IBD in patients starting secukinumab are low. The majority of patients developing new GIRAE did not develop objective evidence of IBD or stop therapy. For patients with pre-existing IBD and AS the risk of GIRAE is much higher, and prescribing alternatives should be considered.

摘要

目的

缺乏治疗 AS 和 PsA 时使用司库奇尤单抗的真实世界胃肠道相关不良事件(GIRAE)数据。我们旨在通过对现有 IBD 发生率和 GIRAE 预测因素的基线评估来获得这些数据。

方法

回顾了 2016 年至 2019 年间,10 家英国医院开始使用司库奇尤单抗的患者电子和纸质病历。启动后出现的 GIRAE 定义为:确诊[有 IBD 的客观证据(活检证实)、明确的时间关联、停药后症状缓解、没有其他更可能的解释]、可能(符合确诊标准,但无活检确认)或可能(不符合确诊或可能标准的胃肠道症状)。

结果

分析了开始使用司库奇尤单抗的所有 306 名患者的数据:124 名(40.5%)AS 和 182 名(59.5%)PsA。在开始使用司库奇尤单抗后,有 24 名(7.8%)患者出现 GIRAE。在发生 GIRAE 的患者中,有 4 名(1.3%)为确诊病例,7 名(2.3%)为可能病例,13 名(4.2%)为可能病例。所有确诊病例均为 AS 患者,停止使用司库奇尤单抗;其中 2 例有预先存在的 IBD,2 例(0.7%)为新发病例,其中 1 例需要手术干预。在开始使用司库奇尤单抗之前,有 7 名(2.3%)患者有预先存在的 IBD 诊断,其中 5 名患者出现 GIRAE。

结论

开始使用司库奇尤单抗的患者新发 IBD 的绝对发生率较低。大多数出现新 GIRAE 的患者并未出现 IBD 的客观证据或停止治疗。对于患有预先存在的 IBD 和 AS 的患者,GIRAE 的风险要高得多,应考虑替代药物。

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