INTRODUCTION Microscopic colitis (MC) is a chronic inflammatory disease of the colon that causes non-bloody, watery diarrhea occurs up to 15 times daily in the presence of normal-appearing mucosa in the colon. There are two main subtypes of MC based on histopathologic features, collagenous colitis (CC) and lymphocytic colitis (LC)1. Treatment of each subtype is similar and should be determined by the severity of symptoms. Some patients suffer severe symptoms despite maximum dosage of budesonide, in these cases biologic therapies should be considered. Vedolizumab, a monoclonal antibody that targets α4β7-integrin, is a gut-specific biologic with an exceptional safety profile. Here, we report our experience with vedolizumab for severe, refractory MC. METHODS Eleven patients presenting to the University of Kentucky with severe microscopic colitis refractory to maximum budesonide and Imodium therapy were treated with vedolizumab. Vedolizumab was given at standard induction dosing (300mg IV at week 0, 2 and 6, and then every 8 weeks). RESULTS Of the eleven patients included in this study, seven reported subjective symptomatic improvement on vedolizumab monotherapy, with four patients attaining less than 3 stools per day. Of the remaining four patients, one continues to do well on vedolizumab and budesonide combination therapy while another developed a rash after vedolizumab induction and treatment was stopped. The third patient was transitioned from vedolizumab to adalimumab and is now well controlled symptomatically and the final patient has not reached symptomatic remission of her disease. Interestingly, of the seven patients who displayed symptomatic improvement with vedolizumab monotherapy, 5/7 patients also showed improvement in albumin levels. DISCUSSION Vedolizumab use in refractory microscopic colitis is increasingly recognized as a conceivable therapy for symptomatic improvement and disease remission. Our case series corroborates these findings, as the majority of our patients reported overall improved quality of life. Vedolizumab binds to the α4β7-integrin and prevent adhesion to its ligand, MAdCAM-1, which causes downstream prevention of T-cell adhesion. Although the exact pathophysiology of microscopic colitis remains largely unidentified, it has been postulated that exposure to a luminal antigen may trigger an inflammatory cascade, leading to activation of CD8 T suppressor cells that attack and cause luminal damage to enterocytes2. This hypothesis is supported by vedolizumab’s mechanism of action and proposed efficacy in MC. Due to low volume studies, the data supporting vedolizumab use in refractory microscopic colitis remains limited, and further studies are needed to elucidate the its potential as a first-line therapy. However, based on our experience, we recommend considering vedolizumab for patients suffering from refractory MC.
INTRODUCTION Clostridium difficile infection (CDI) is the most common infectious cause of nosocomial diarrhea, comprising 10-20% of all cases. CDI is a significant complication for IBD patients. Not only can CDI induce IBD flare, IBD patients also experience significantly higher CDI recurrence when compared to the general population. New monoclonal antibody (mAB) therapies, such as bezlotoxumab, have improved management of recurrent CDI (rCDI). The MODIFY I/II trial included 44 patients with known IBD, 28 of which received bezlotoxumab. Among these 28 patients, there was a 27.2% absolute reduction in the incidence of rCDI. Encouraged by these results, we recently prescribed bezlotoxumab in a UC patient with rCDI and herein report our experience. CASE REPORT A 21-year-old female with a history of ulcerative colitis (UC) diagnosed in 2017 presented for treatment of rCDI. Her first episode of CDI occurred in 2019 during an active UC flare treated with steroids and infliximab induction. CDI was successfully treated with a four-week course of 125mg oral vancomycin twice daily followed by once daily for an additional four weeks. She had a recurrent episode of CDI one year after her initial infection while on vedolizumab for UC treatment. She was treated with 125mg oral vancomycin, four times daily, and tapered down by one dose over a four-month period. Two years after her initial CDI, she developed worsening non-bloody diarrhea, nausea, and anorexia with weight loss. She again tested positive for C. difficile via glutamate dehydrogenase antigen and PCR for toxin B. Fecal calprotectin was 2190 mg/g. She was treated with 14-day course fidaxomicin 200mg BID and a single infusion of bezlotoxumab 10mg/kg. Treatment for UC was not adjusted. At follow up one month later, her symptoms had resolved and fecal calprotectin normalized (17 mg/g). Six months later, she remains asymptomatic. DISCUSSION Recurrent CDI is a frequent culprit for inducing IBD flares, and is difficult to manage. Fecal transplant (FMT) is an option for rCDI, but often entails logistical challenges and risks cross-contamination of endoscopic facilities. Bezlotoxumab is an appealing option for rCDI as a single dose medication with few reported side effects in the MODIFY clinical trials. While the number of IBD patients in the MODIFY trial was small, results were promising. In our patient, bezlotoxumab quickly resolved her rCDI and IBD flare without need for alteration or escalation of her biologic therapy, and she has remained asymptomatic for six months. This case corroborates the prospect that bezlotoxumab positively affects the clinical outcomes of UC patients with rCDI compared to those on repetitive antimicrobial therapy and/or FMT without mAB therapy. Further investigation into the long-term efficacy of this therapy is merited for the IBD patient population in the real-world setting.
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