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Early introduction of selective immunosuppressive therapy associated with favorable clinical outcomes in patients with immune checkpoint inhibitor-induced colitis.

ABSTRACT: BACKGROUND:Current treatment guidelines for immune-mediated colitis (IMC) recommend 4 to 6?weeks of steroids as first-line therapy, followed by selective immunosuppressive therapy (SIT) (infliximab or vedolizumab) in patients who do not respond to steroids. We assessed the effect of early SIT introduction and number of SIT infusions on clinical outcomes. METHODS:We performed a retrospective review of patients with IMC who received SIT at The University of Texas MD Anderson Cancer Center between January and December 2018. Logistic regression analyses were used to assess associations between clinical outcomes and features of IMC. RESULTS:Of the 1459 patients who received immune checkpoint inhibitors, 179 developed IMC of any grade; 84 of these 179 patients received SIT. Of the 84 patients who received SIT, 79% were males, and the mean age was 60?years (standard deviation, 14). Compared with patients who received SIT >?10?days after IMC onset, patients who received early SIT (?10?days) required fewer hospitalizations (P?=?0.03), experienced steroid taper failure less frequently (P?=?0.03), had fewer steroid tapering attempts (P?

SUBMITTER: Abu-Sbeih H

PROVIDER: S-EPMC6444537 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Early introduction of selective immunosuppressive therapy associated with favorable clinical outcomes in patients with immune checkpoint inhibitor-induced colitis.

Abu-Sbeih Hamzah H Ali Faisal S FS Wang Xuemei X Mallepally Niharika N Chen Ellie E Altan Mehmet M Bresalier Robert S RS Charabaty Aline A Dadu Ramona R Jazaeri Amir A Lashner Bret B Wang Yinghong Y

Journal for immunotherapy of cancer 20190402 1

<h4>Background</h4>Current treatment guidelines for immune-mediated colitis (IMC) recommend 4 to 6 weeks of steroids as first-line therapy, followed by selective immunosuppressive therapy (SIT) (infliximab or vedolizumab) in patients who do not respond to steroids. We assessed the effect of early SIT introduction and number of SIT infusions on clinical outcomes.<h4>Methods</h4>We performed a retrospective review of patients with IMC who received SIT at The University of Texas MD Anderson Cancer ...[more]

PMID: 30940209

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Project description:BackgroundImmune-mediated diarrhea and colitis (IMDC) can limit immune checkpoint inhibitors (ICIs) treatment, which is efficacious for advanced malignancies. Steroids and infliximab are commonly used to treat it. These agents induce systemic immunosuppression, with its associated morbidity. We assessed clinical outcomes of vedolizumab as an alternative treatment for IMDC.MethodsWe analyzed a retrospective case series of adults who had IMDC refractory to steroids and/or infliximab and received vedolizumab from 12/2016 through 04/2018.ResultsTwenty-eight patients were included. The median time from ICI therapy to IMDC onset was 10?weeks. Fifteen patients (54%) had grade 2 and 13 (46%) had grade 3 or 4 IMDC. Mucosal ulceration was present in 8 patients (29%), and nonulcerative inflammation was present in 13 (46%). All patients had features of active histologic inflammation; 14 (50%) had features of chronicity, and 10 (36%) had features of microscopic colitis concurrently. The mean duration of steroid therapy was 96?days (standard deviation 74?days). Nine patients received infliximab in addition to steroids and their IMDC was refractory to it. Among these, the duration of steroid use was 131?days compared with 85?days in patients who did not receive infliximab. Likewise, patients who failed infliximab before vedolizumab had a clinical success rate of 67% compared to 95% for patients that did not receive infliximab. The median number of vedolizumab infusions was 3 (interquartile range 1-4). The mean duration of follow-up was 15?months. Twenty-four patients (86%) achieved and sustained clinical remission. Repeat endoscopic evaluation was performed in 17 patients. Endoscopic remission was attained in 7 (54%) of the 13 patients who had abnormal endoscopic findings initially; 5/17 patients (29%) reached histologic remission as well.ConclusionsVedolizumab can be appropriate for the treatment of steroid-refractory IMDC, with favorable outcomes and a good safety profile.

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Early introduction of selective immunosuppressive therapy associated with favorable clinical outcomes in patients with immune checkpoint inhibitor-induced colitis.

Publications

Early introduction of selective immunosuppressive therapy associated with favorable clinical outcomes in patients with immune checkpoint inhibitor-induced colitis.

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