Safety and Efficacy of Combination Treatment With Calcineurin Inhibitors and Vedolizumab in Patients With Refractory Inflammatory Bowel Disease

Christensen, Britt; Gibson, Peter R.; Micic, Dejan; Colman, Ruben J.; Goeppinger, Sarah R.; Kassim, Olufemi; Yarur, Andrés; Weber, Christopher R.; Cohen, Russell D.; Rubin, David T.

doi:10.1016/j.cgh.2018.04.060

Cited by 76 publications

(49 citation statements)

References 28 publications

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“…However, both studies had limitations, including small patient numbers and limited follow‐up time. The earlier study from our group by Christensen et al reported on nine patients with Crohn's disease and 11 patients with ulcerative colitis treated with combination therapy of vedolizumab with either ciclosporin or tacrolimus, and found that by week 14 of treatment, four (44%) patients with Crohn's disease and six (55%) patients with ulcerative colitis were in clinical remission.…”

Section: Discussionmentioning

confidence: 92%

“…There have been two previous studies and a case series of two patients that demonstrated the feasibility of inducing remission with ciclosporin followed by maintenance of remission with vedolizumab. However, both studies had limitations, including small patient numbers and limited follow‐up time.…”

Section: Discussionmentioning

confidence: 99%

“…Vedolizumab's impressive safety data makes it an ideal candidate agent for use as maintenance therapy in combination with the fast‐acting CNIs as induction therapy. Our group previously reported our preliminary data on the potential safety and efficacy of this sequential combination regimen . That study, however, was limited by the small number of patients and heterogeneous population included (11 patients with ulcerative colitis and nine patients with Crohn's disease) and as such encouraged further larger observational cohorts using this treatment strategy.…”

Section: Introductionmentioning

confidence: 99%

“…Our group previously reported our preliminary data on the potential safety and efficacy of this sequential combination regimen. 11 That study, however, was limited by the small number of patients and heterogeneous population included (11 patients with ulcerative colitis and nine patients with Crohn's disease) and as such encouraged further larger observational cohorts using this treatment strategy. In this study, by enrolling a significant number of subsequent patients with steroid-refractory ulcerative colitis, we are now able to cumulatively report on long-term safety and efficacy in a more homogenous population.…”

Section: Introductionmentioning

confidence: 99%

“…tolerated in our cohort, with relatively few adverse events.The strength of this study includes its large cohort of patients, larger than all previously reported studies combined, as well as the long median follow-up of over 2 years.There have been two previous studies11,12 and a case series of two patients 13 that demonstrated the feasibility of inducing remis-sion with ciclosporin followed by maintenance of remission with vedolizumab. However, both studies had limitations, including small patient numbers and limited follow-up time.…”

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confidence: 99%

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Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid‐refractory ulcerative colitis

Ollech

Dwadasi

Rai

et al. 2019

Aliment Pharmacol Ther

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Summary Background Following induction therapy with a calcineurin inhibitor (CNI) in severe ulcerative colitis, transitioning to vedolizumab as maintenance therapy could be an option. Aim To report on the largest cohort of patients successfully induced with CNIs who were transitioned to vedolizumab maintenance therapy. Methods This is a retrospective observational study of adult patients with severe steroid‐refractory ulcerative colitis. Patients were included if they were induced with a CNI followed by maintenance therapy with vedolizumab between January 2014 and December 2018. The primary endpoint was colectomy‐free survival. Secondary endpoints included survival without vedolizumab discontinuation as well as clinical, steroid‐free and biochemical remission at week 14. Results A total of 71 patients (59% male) were treated with vedolizumab after induction therapy with CNIs for severe steroid‐refractory colitis. Patients were followed for a median time of 25 months (IQR 16‐36). Colectomy‐free survival rates from vedolizumab initiation were 93% at 3 months, 67% at 1 year and 55% at 2 years. At the end of induction with vedolizumab at week 14, 50% of patients were in clinical remission, and 62% of patients had a normal CRP. At 1 and 2 years following vedolizumab initiation, 43% and 28% of patients were still on vedolizumab respectively. Vedolizumab was dose escalated to infusions every 4 weeks in 44% of patients. The median time to dose escalation was 5.6 months (IQR 4.1‐8.2). No serious adverse events were recorded in our patient cohort. Conclusions Transitioning to vedolizumab following induction of remission with CNIs is effective and safe.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid‐refractory ulcerative colitis

Ollech

Dwadasi

Rai

et al. 2019

Aliment Pharmacol Ther

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The efficacy of maintenance therapy after remission induction with tacrolimus in ulcerative colitis with and without previous tumor necrosis factor‐α inhibitor

et al. 2019

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Background and Aim Tacrolimus (TAC) is an important therapeutic option for remission induction in patients with refractory ulcerative colitis (UC). However, there is little evidence available on long‐term outcomes and maintenance treatments after TAC therapy, especially in cases with previous tumor necrosis factor‐α (TNF‐α) inhibitor therapy. Methods Long‐term outcomes and remission induction after TAC treatment were retrospectively examined in refractory UC patients with and without previous TNF‐α inhibitor therapy. Results The mean disease activity index and the endoscopic activity index scores decreased significantly during the 12‐week treatment after TAC therapy in both groups, showing a significantly greater decrease in the group without TNF‐α inhibitor therapy than in the group with previous TNF‐α inhibitor therapy. One year or more after TAC therapy, TNF‐α inhibitor and/or azathioprine was used as maintenance therapy in most cases in the group without previous TNF‐α inhibitor treatment, while azathioprine was primarily used in the group with previous TNF‐α inhibitor treatment. Colectomy was performed in 45.5% (5/11) and 15.6% (7/45) of the groups with and without previous TNF‐α inhibitor therapy, respectively, and the group without previous TNF‐α inhibitor treatment had a better colectomy‐free rate than the group with previous TNF‐α inhibitor treatment after TAC therapy on Kaplan–Meier analysis. Conclusions TAC is effective for remission induction in refractory UC patients with and without previous TNF‐α inhibitor treatment. Maintenance medication after TAC therapy is an issue for the future, especially in UC cases with previous TNF‐α inhibitor treatment failure.

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Retrospective investigation of tacrolimus combined with an anti‐tumor necrosis factorα antibody as remission induction therapy for refractory ulcerative colitis: Efficacy, safety, and relapse rate

et al. 2019

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Background and AimCombined therapy with tacrolimus (TAC) and an anti‐tumor necrosis factorα (TNFα) antibody is used to induce remission in ulcerative colitis (UC) patients who have not responded to monotherapy with either drug. We evaluated the efficacy and safety of combined therapy, as well as the relapse rate.MethodsCombined therapy was performed to induce remission in UC patients showing an inadequate response to monotherapy with TAC or an anti‐TNFα antibody. The following items were assessed retrospectively: (i) clinical characteristics, (ii) the remission induction rate, (iii) the relapse rate, and (iv) adverse events.ResultsCombined therapy induced remission in 7 of the 12 patients (58.3%). There were no significant differences in clinical characteristics between the patients with and without the successful induction of remission. However, the number of female patients tended to be higher in the remission group than in the nonremission group. The remission group also showed trends of a lower clinical activity index (Lichtiger index; CAI) on admission and before combined therapy and a lower total dose of prednisolone during hospitalization. The 1‐year relapse rate was 33.3%. Adverse events due to combined therapy included renal impairment (n = 2), tremors (n = 2), influenza (n = 1), and a positive cytomegalovirus antibody test (n = 3). None of these events were serious.ConclusionsCombined therapy was effective in more than half of the patients with refractory UC who had not responded to monotherapy. Our findings suggest that combination therapy may be a new, third option for the treatment of refractory UC.

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Safety and Efficacy of Combination Treatment With Calcineurin Inhibitors and Vedolizumab in Patients With Refractory Inflammatory Bowel Disease

Cited by 76 publications

References 28 publications

Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid‐refractory ulcerative colitis

Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid‐refractory ulcerative colitis

The efficacy of maintenance therapy after remission induction with tacrolimus in ulcerative colitis with and without previous tumor necrosis factor‐α inhibitor

Retrospective investigation of tacrolimus combined with an anti‐tumor necrosis factorα antibody as remission induction therapy for refractory ulcerative colitis: Efficacy, safety, and relapse rate

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