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

Coltoff, Alexander; Lancman, Guido; Kim, Sara; Steinberg, Amir

doi:10.1038/s41409-018-0094-8

Cited by 23 publications

(28 citation statements)

References 13 publications

(19 reference statements)

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“…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. Most patients experienced decreased abdominal pain and stool output after 4 weeks, suggestive of some clinical benefit; despite this, 8 of the 9 patients died at a median of 22 days (range, 6 to 107 days) of follow-up.…”

Section: Discussionmentioning

confidence: 93%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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

Fløisand

Lazarevic

Maertens

et al. 2019

Biology of Blood and Marrow Transplantation

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A B S T R A C T Allogeneic hematopoietic cell transplantation (allo-HCT) can be curative in patients with hematologic malignancies but carries a significant risk of graft-versus-host disease (GVHD). There are no standard treatments for steroid-refractory (SR) gastrointestinal (GI) acute GVHD (aGVHD). This multicenter, international, retrospective medical record review aimed to evaluate the off-label use of vedolizumab, a gut-selective immunomodulator, for treating SR GI aGVHD. Data were collected from patients' medical records; criteria for extraction included no more than 1 allo-HCT and at least 1 dose of vedolizumab as treatment for SR GI aGVHD (ie, stage 1 to 4 GI aGVHD following 1 previous treatment regimen(s) containing 1 mg/kg methylprednisolone or equivalent). Descriptive analyses of response rate, overall survival (OS), and serious adverse effects (SAEs) were performed. Twenty-nine patients were identified from 7 sites who had received 1 to 10 doses of vedolizumab 300 mg i.v. (median 3 doses) as treatment for SR GI aGVHD. The overall response rate at 6 to 10 weeks after vedolizumab initiation was 64%, and OS at 6 months was 54%. There were 29 SAEs, including 12 infections; 3 SAEs were considered possibly related to vedolizumab, 2 of which were infections. Thirteen SAEs were fatal, 1 of which was possibly vedolizumabrelated. There were 8 nonserious infections and 1 serious infection with confirmed GI origin in 8 patients; there was no apparent pattern in the timing of these infections relative to the initiation of vedolizumab treatment. Further data on the efficacy and safety of vedolizumab in this setting from prospective trials are needed.

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Section: Discussionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

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

Fløisand

Lazarevic

Maertens

et al. 2019

Biology of Blood and Marrow Transplantation

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“…Another retrospective case series also described a high mortality rate following vedolizumab therapy for gastrointestinal SR-aGVHD: Of nine patients with multiple-siteinvolvement, six died before the 4-week follow-up, and only one patient survived past 2 months. However, patients surviving past the 4-week follow-up did experience some clinical response [91].…”

Section: Vedolizumabmentioning

confidence: 98%

Section: Vedolizumabmentioning

confidence: 99%

“…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].…”

Section: Vedolizumabmentioning

confidence: 99%

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

2020

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Acute graft-versus-host disease (aGVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (alloHCT) and is a major cause of morbidity and mortality. Systemic steroid therapy is the first-line treatment for aGVHD, although about half of patients will become refractory to treatment. As the number of patients undergoing alloHCT increases, developing safe and effective treatments for aGVHD will become increasingly important, especially for those whose disease becomes refractory to systemic steroid therapy. This paper reviews current treatment options for patients with steroidrefractory aGVHD and discusses data from recently published clinical studies to outline emerging therapeutic strategies.

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Successful treatment of steroid‐refractory gastrointestinal acute graft‐versus‐host disease with adjuvant vedolizumab therapy in a pediatric allogeneic stem cell transplant recipient

Pai

Abu‐Arja

Auletta

et al. 2020

Pediatric Blood & Cancer

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LETTER TO THE EDITOR around D +224 she was diagnosed with pulmonary GVHD and therefore received photopheresis (biweekly) and ruxolitinb (5 mg twice daily). Ruxolitinb was discontinued due to lack of response and intolerance. She then received eight infusions of mesenchymal stromal cells (2 × 10 6 MSCs/kg) again with no response. On D +266 post-BMT, she commenced treatment intravenous vedolizumab (6 mg/kg: 200 mg) and received three doses on weeks 0, 2, and 6. She tolerated the infusions and experienced no side effects. She had a partial response on day 7 (stage one GI, grade II aGVHD) and complete response (grade 0 aGVHD) on day nine from the first and second dose of vedolizumab, respectively. Fecal calprotectin decreased from 1285 𝜇g/g (0-50 𝜇g/g) pre-vedolizumab to 295 𝜇g/g post-vedolizumab. The patient suffered no infectious complications. She is now 34 months post-BMT with no GI symptoms, gaining weight with a performance score of 90% and 99% donor chimerism in whole blood, CD3, and CD33 fractions. Her pulmonary GVHD responded to ibrutinib (started 23 months post-BMT). The clinical improvement seen in our single patient demonstrates that vedolizumab may be effective in children with SRaGVHD.Given the unmet need for novel therapies to treat SRaGVHD in children, 10 prospective pediatric studies using vedolizumab seems to be a reasonable option to pursue.

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

Cited by 23 publications

References 13 publications

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

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

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

Successful treatment of steroid‐refractory gastrointestinal acute graft‐versus‐host disease with adjuvant vedolizumab therapy in a pediatric allogeneic stem cell transplant recipient

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