Favorable Outcomes Combining Vedolizumab With Other Biologics or Tofacitinib for Treatment of Inflammatory Bowel Disease.

ABSTRACT

Background: Combining advanced therapies may improve outcomes in inflammatory bowel disease (IBD), but there are little data on the effectiveness and safety of this approach. Methods: We examined outcomes of patients who received vedolizumab in combination with another biologic or tofacitinib between 2016 and 2020. Results: Fourteen patients (10 ulcerative colitis [UC], 3 Crohn disease, 1 indeterminate colitis) received a combination of advanced therapies. Vedolizumab was combined with tofacitinib in 9 patients, ustekinumab in 3, and adalimumab in 2. Median follow-up on combination therapy was 31 weeks. Normalization of C-reactive protein (CRP) or fecal calprotectin (<5 mg/L and <150 µg/g, respectively) was achieved in 56% (5/9) and 50% (4/8) of patients. Paired median CRP decreased from 14 mg/L to <5 mg/L with combination therapy (n = 9, P = 0.02), and paired median calprotectin from 594 µg/g to 113 µg/g (n = 8, P = 0.12). Among patients with UC, paired median Lichtiger score decreased from 9 to 3 (n = 7, P = 0.02). Prednisone discontinuation was achieved in 67% (4/6) of prednisone-dependent patients. There were 4 infections 2 required hospitalization (rotavirus, Clostridium difficile), and 2 did not (pneumonia, sinusitis). During follow-up, 5/14 patients discontinued combination therapy (2 nonresponse; 1 improvement and de-escalation; 1 noninfectious adverse effect; 1 loss of coverage). Conclusions: In this retrospective case series of a cohort with refractory IBD, combining vedolizumab with other biologics or tofacitinib improved inflammatory markers, reduced clinical disease activity and steroid use, and was well tolerated.