Lessons Learned from Early Experiences with Vedolizumab for Steroid-Refractory Acute Graft- versus-Host Disease with Gastrointestinal Involvement

Safety and Effectiveness of Vedolizumab in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease: A Retrospective Record Review

“…Responses were observed in all 6 patients, and there were 4 survivors at a median follow-up of 10 months. Bukauskas et al [27] reported outcomes in 6 patients who received vedolizumab as a third-or fourth-line therapy for SR GI aGVHD, 5 of whom died at a median of 32 days (range, 7 to 172 days) of follow-up. Similarly, Coltoff et al [28] reported outcomes in 9 patients treated with vedolizumab for SR aGVHD.…”

“…By inhibiting a 4 b 7 integrin, vedolizumab may interfere with gut-selective T lymphocyte trafficking, and it may be a treatment option for patients with SR GI aGVHD. This has led some clinicians to use vedolizumab off-label in these patients, and published case series have suggested clinical activity in patients with GI aGVHD [27][28][29][30]. The aims of this international, retrospective record review were to further evaluate the real-world use of vedolizumab in the off-label setting for treating patients with SR GI aGVHD, and also to assess key clinical outcomes in these patients, including those related to the safety and effectiveness of vedolizumab therapy.…”

Vedolizumab for treatment of steroid-refractory lower gastrointestinal acute graft-versus-host disease

“…An initial case series [12] reported positive outcomes of vedolizumab for LGI a-GVHD, though a later study [13] reported an observed high mortality rate and low therapeutic utility. The patient baseline characteristics in our case series are decidedly more similar to the patients in the latter study.…”

“…Through inhibition of alloreactive lymphocyte migration to the gut, vedolizumab has shown to be effective in the treatment of inflammatory bowel disease (IBD), both in Crohn's disease [10] and ulcerative colitis (UC) [11]. A case series of patients with LGI a-GVHD treated with vedolizumab described a significant and durable response in the majority of participants [12], though these findings were not replicated in a different study [13]. To further facilitate our understanding of the role of vedolizumab in LGI a-GVHD, we report on the results of patients treated with vedolizumab for LGI a-GVHD at our institution.…”

Treatment and unmet needs in steroid-refractory acute graft-versus-host disease

“…Vedolizumab is a monoclonal antibody that recognizes the integrin α4β7 present on circulating lymphocytes and inhibits their relocation to the gastrointestinal tract [91,92]. Recent case series have reported mixed results for vedolizumab in gastrointestinal SR-aGVHD (Table 2) [91][92][93][94]. Fløisand et al described a case series of six patients with SR-aGVHD with single-site-involvement, in which all patients responded to second-line treatment with vedolizumab; four patients were alive at a median followup of 10 months [92].…”