Abstract

Abstract Background and Aims Inflammatory bowel disease (IBD) is a chronic inflammatory condition requiring treatment with lifelong immunosuppressive treatment. Up to 30% of the patients do not respond to standard medical therapy. There is limited data on the use of combining two biological agents in medically refractory patients. Our aims were to review patients who received two biological agents concurrently for at least 4 weeks or longer to assess for safety and efficacy of this approach. Methods We performed a retrospective study on patients (1–22 years old) being treated at Children’s Mercy Kansas City for IBD who were placed on a combination of two biological agents concurrently for medically refractory disease. Charts of eligible patients were reviewed to abstract demographics, Paris classification, extraintestinal manifestations, concomitant morbidities, drug therapy, surgeries, disease activity scores, outcomes and adverse events related to therapy. Results Nine patients with a median age of 16 (8–19 years) were found to be eligible. Eight were Caucasians and one was of African American origin. Eight patients were diagnosed with Crohn’s disease (CD), and one was thought to have ulcerative colitis (UC) but later found to have CD. Two had celiac disease, 2/9 had growth failure, one each had arthritis and sacroiliitis. Two had ileo-anal pouch and one patient had recurrent macrophage activating syndrome. Indications included partially responsive luminal disease(7), pouchitis (2), perianal fistulizing disease (2), sacroiliitis (1). Five patients were also on an immunomodulator at the time of combination therapy. Only one patient received Anakinra with infliximab whereas rest were on combination of either infliximab or adalimumab with vedolizumab. Four patients achieved remission, two were unresponsive, one had improvement in growth only and two had partial response. One patient developed staphylococcal skin infection but there was no other therapy related adverse events. Conclusions Combination of two biological agents is safe. Further studies are needed to determine the utility of this approach.

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