Multicenter Spanish study on vedolizumab intravenous to subcutaneous switch in patients with inflammatory bowel disease in clinical remission.

Abstract

Background and aims: Despite the established use of intravenous (IV) vedolizumab for treating inflammatory bowel disease, there's growing interest in exploring the advantages of the novel subcutaneous (SC) route. However, comprehensive real-world evidence regarding the extended safety and effectiveness of it remains scarce.

Methods: IBD patients on IV vedolizumab treatment across 24 Spanish hospitals who were in clinical remission were given the option to transition to SC injections where this formulation was available or to remain on IV, while those in centers without access to SC vedolizumab remained on IV therapy. Data encompassing clinical disease activity, biochemical markers, adverse events, treatment persistence, and disease-related outcomes were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48.

Results: We identified 207 patients, with 23 excluded due to not being in clinical remission, resulting in a final inclusion of 184 patients. Of these, 53 (28.8%) remained on IV vedolizumab, while 131 (71.2%) transitioned to SC. There were 108 (58.7%) patients with ulcerative colitis and 76 (41.3%) with Crohn's disease. Both groups exhibited comparable demographic characteristics except for Crohn's disease behavior: non-inflammatory non-stricturing pattern (B1 Montreal classification) that was predominant among patients who transitioned to the SC (p=0.023). No differences were observed in drug persistence (log rank test p=0.82). Clinical, biochemical and fecal calprotectin remission at the different time-points were comparable at each time point with the exemption of clinical remission at week 12 favoring SC over IV. Drug intensification occurred in 24.5% of the patients on IV versus none on SC, p<0.0001. Safety was consistent with previously reported with no differences among groups 13 (8%) SC and IV 1 (2.1%), p=0.059; and most of them being mild in nature.

Conclusions: Transitioning from IV to SC vedolizumab in patients with IBD in remission showed comparable effectiveness in maintaining disease remission and persistence. Patients on IV are more likely to need drug intensification during follow-up.