Background/Purpose: Inflammatory bowel disease (IBD) causes a wide range of symptomology frequently leading to co-management of disease activity between gastroenterologist and rheumatologists. Recently in efforts to optimize treatment, there has been interest in using combination biological therapy with vedolizumab.

Methods: A retrospective single center study was performed on individual patients, between the ages 18 to 80, treated with combination therapy with vedolizumab and any other biological (etanercept, adalimumab, golimumab, certolizumab, infliximab, ustekinumab, JAK inhibitors) between 2014 and May 2021. Patients were identified through a database search via diagnosis code and medication list review with subspecialty clinics. Individual patient charts were then reviewed to confirm IBD diagnosis and use of combination therapy during their time of follow-up at this institution. Additional data was abstracted regarding baseline characteristics, infections, cancer diagnoses, and mortality.

Results: Sixteen patients meeting the study criteria for a complete retrospective chart review were identified. The mean age at initiation of combination therapy was 39.8 years of age. 56% of the patients were male. 81.2% of the patients were diagnosed with Crohn’s disease and 18.8% with ulcerative colitis. 56.25% had complaints of joint pain and 37.5% were evaluated by rheumatology. Dual biological therapy was initiated for IBD control in 75% of patients and for joint pain in 25% of patients. 69% received adalimumab, 44% received ustekinumab, and 6% received certolizumab. One of the patients received adalimumab then transitioned to ustekinumab. The mean duration of dual biological therapy was 11.9 months. 14 of 16 patients remained on dual therapy during the duration of the study. One patient developed antibodies against adalimumab which lead to discontinuation. One patient had to discontinue dual therapy due to insurance authorization. The minimum duration of combination therapy was 1 month and the maximum duration was 22 months. Seven total infections occurred in 4 patients (25%). Serious infections requiring hospitalization or IV antibiotics occurred in two patients (12.5%). None of the patients developed a new diagnosis of cancer or experienced a reoccurrence of cancer. No deaths occurred during the time of follow-up.

Conclusion: This retrospective study reviewing 16 cases of patients treated with vedolizumab and dual biological combination therapy demonstrates additional data regarding infection, cancer, and mortality rates. Further studies are needed to better characterize and evaluate the safety profile of vedolizumab combination therapy in IBD patients for intestinal and extra-intestinal manifestations.

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-the-safety-of-vedolizumab-in-combination-with-other-immunosuppression-biological-therapy-in-patients-with-inflammatory-bowel-disease/