Comparing Patient Reported Outcomes among Anti-TNF Experienced Patients with Ulcerative Colitis Initiating Vedolizumab versus Tofacitinib

Abstract

Abstract Background Primary and secondary non-response to Anti-Tumor Necrosis Factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy. Objective We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient reported outcomes (PROs). Methods We conducted a prospective cohort study nested within the Crohn’s & Colitis Foundation’s IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or ustekinumab and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO-2, treatment persistence, and need for colectomy. Results We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P=0.04), but not Fatigue (P=0.53,) was lower among tofacitinib initiators. A trend towards higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups. Conclusion Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared to vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.