Cyclosporine Rescue in Vedolizumab Patients with Steroid-Refractory Severe Ulcerative Colitis: A Case Series

Abstract

Ulcerative colitis (UC) is characterized by relapsing and remitting episodes of colonic mucosal inflammation presenting as urgency, hematochezia, and abdominal pain. Approximately 20 to 30% of patients with UC will require colectomy for acute complications or for medically intractable disease. Patients who are primary or secondary nonresponders to anti-tumor necrosis factor medications may respond to anti-integrin therapy with vedolizumab (VDZ) or cyclosporine. We report a case series of 4 patients with steroid-refractory, TNF-nonresponders with severe UC who were treated with rescue intravenous cyclosporine during VDZ therapy. Four patients were admitted for cyclosporine infusion between 2015 and 2016. Prior to initiating cyclosporine, all patients were excluded for C. difficile infection and underwent flexible sigmoidoscopies. Cyclosporine infusion was given at a dose of 2 mg/kg for 7 days, titrated by level, with transition to an oral cyclosporine taper on discharge with continuation of VDZ maintenance or induction. All patients tolerated IV cyclosporine without major complications. The c-reactive protein level and Mayo score decreased in all patients. Patient 1 started VDZ 7 months prior to cyclosporine infusion with partial response. She was tapered off cyclosporine as an outpatient while continuing VDZ. After several months, she developed recurrent frequent loose bloody bowel movements. Patient 2 started VDZ 6 months prior to cyclosporine infusion. He responded well to cyclosporine and was tapered off as an outpatient while remaining on VDZ. Repeat colonoscopy 3 months post-cyclosporine demonstrated endoscopic healing. Patient 3 had been on IV steroids for 3 days before receiving cyclosporine, which led to complete resolution of blood in stool and diarrhea. She started VDZ two weeks after discharge and tapered off prednisone and cyclosporine. Colonoscopy after 2 months on VDZ revealed resolution or healing of most ulcerations. Patient 4 initially had a partial response to cyclosporine treatment. However, she soon developed recurrent bloody bowel movements with sigmoidoscopy showing severe inflammation and deep ulcerations. The patient ultimately underwent an ileal pouch-anal anastomosis. Treatment of patients with refractory severe UC remains difficult and controversial. We present 4 patients who received cyclosporine with VDZ. Two patients demonstrated endoscopic healing. There were no adverse events or serious infections in this series.