Background Despite the established use of intravenous (IV) vedolizumab for treating inflammatory bowel disease (IBD), there's growing interest in exploring the advantages of the novel subcutaneous (SC) administration route. However, comprehensive real-world evidence regarding the extended safety and effectiveness of this approach remains scarce. The aim of the study was to evaluate the effectiveness and safety of vedolizumab SC among IBD patients in clinical remission. Methods Multicenter, observational, retrospective study. IBD patients on IV vedolizumab treatment across 24 Spanish hospitals who were in clinical remission were given the option to switch to SC injections or continue with IV treatment. Data encompassing clinical disease activity (assessed through partial Mayo score, and Harvey-Bradshaw Index), biochemical markers (C-reactive protein and fecal calprotectin), adverse events and treatment persistence were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48. Non-parametric tests were used for comparisons and Kaplan-Meier for survival. Results We identified 166 patients, with 19 excluded due to not being in clinical remission and 8 excluded due to absence of follow-up data, resulting in a final inclusion of 139 patients for analysis. Of these, 36 (25.9%) remained on IV vedolizumab, while 103 (74.1%) switched to SC vedolizumab. Both groups exhibited comparable demographic characteristics including age, gender, disease type, disease duration and extension, previous therapy, presence of extra intestinal manifestations and comorbidities (Table 1). However, there were differences in Crohn’s disease behavior among groups (p=0.013). There were not significant differences in clinical, biochemical and fecal calprotectin remission at week 12, 24 and 48 neither in the overall cohort nor assessing Crohn’s disease or ulcerative colitis separately (Figure 1). At the end of follow-up, median duration 47 weeks (29-49), persistence on the same formulation was 85%,1 (2.8%) patient on IV and 4 (3.9%) on SC withdrew the drug (p=0.810), 5 (4.8%) switched back to IV from SC. Adverse events were reported in 1 (2.8%) IV vs 11 (10.7%) SC vedolizumab (p=0.292), most of them being mild skin reactions to SC injection 3 (2.9%). Conclusion In our study we found that transitioning from IV to SC vedolizumab in patients with IBD in remission showed comparable effectiveness in maintaining disease remission. Switching to SC formulation appears safe with no new safety signals identified and most adverse events being mild.

中文翻译：

---

P989 临床缓解的炎症性肠病患者从静脉注射维多珠单抗改为皮下注射维多珠单抗：GETECCU 的一项多中心研究

背景 尽管静脉注射（IV）维多珠单抗已被用于治疗炎症性肠病（IBD），但人们对探索新型皮下（SC）给药途径的优势越来越感兴趣。然而，关于这种方法的扩展安全性和有效性的全面的现实证据仍然很少。该研究的目的是评估维多珠单抗 SC 在 IBD 临床缓解患者中的有效性和安全性。方法 多中心、观察性、回顾性研究。在西班牙 24 家医院接受静脉注射维多珠单抗治疗且处于临床缓解状态的 IBD 患者可以选择改用皮下注射或继续静脉注射治疗。从基线和周数前瞻性维护的临床记录中回顾性收集包括临床疾病活动性（通过部分 Mayo 评分和 Harvey-Bradshaw 指数评估）、生化标志物（C 反应蛋白和粪便钙卫蛋白）、不良事件和治疗持续性的数据12、24 和 48。非参数检验用于比较，Kaplan-Meier 用于生存。结果 我们确定了 166 名患者，其中 19 名因未达到临床缓解而被排除，8 名因缺乏随访数据而被排除，最终纳入 139 名患者进行分析。其中，36 例 (25.9%) 仍继续使用 IV 维多珠单抗，而 103 例 (74.1%) 则改用 SC 维多珠单抗。两组患者都表现出相似的人口统计学特征，包括年龄、性别、疾病类型、疾病持续时间和延伸、既往治疗、肠道外表现和合并症的存在（表1）。然而，各组间克罗恩病行为存在差异（p=0.013）。在第 12、24 和 48 周时，无论是在整个队列中，还是单独评估克罗恩病或溃疡性结肠炎，临床、生化和粪便钙卫蛋白缓解均没有显着差异（图 1）。随访结束时，中位持续时间为 47 周 (29-49)，同一制剂的持续性为 85%，1 名 (2.8%) 静脉注射患者和 4 名皮下注射患者 (3.9%) 停药 (p=0.810 ), 5 (4.8%) 从 SC 改回 IV。静脉注射维多珠单抗 1 例（2.8%），皮下注射维多珠单抗 11 例（10.7%）（p=0.292）报告了不良事件，其中大多数是皮下注射 3 例（2.9%）的轻微皮肤反应。结论 在我们的研究中，我们发现缓解期 IBD 患者从静脉注射维多珠单抗过渡到皮下注射维多珠单抗在维持疾病缓解方面显示出相当的有效性。改用 SC 制剂似乎是安全的，没有发现新的安全信号，而且大多数不良事件都很轻微。