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P344 Real-world effectiveness of tofacitinib in ulcerative colitis: a multi-centre study

R. Ungaro*1, M. Fenster1, C. Dimopoulos1, A. Patel2, P. Deepak3, G. Syal4, A. Yarur5, R. Hirten1, G. Christophi3, A. Khatiwada3, B. Lin5, J-F. Colombel1, C. Ha4, R. Weisshof6, P. Beniwal-Patel5, B. Cohen1, J. Pekow6

1Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, USA, 2Brooke Army Medical Center, Fort Sam Houston, USA, 3Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, USA, 4Cedars-Sinai Medical Center, Los Angeles, USA, 5Medical College of Wisconsin, Milwaukee, USA, 6Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago, Chicago, USA

Background

We aimed to describe the real-world effectiveness of tofacitinib in ulcerative colitis (UC).

Methods

We analysed a retrospective, multi-centre cohort from six centres in the USA. UC patients started on tofacitinib (10 mg BID) for active disease were included. Primary outcome was clinical response (>50% reduction in symptoms) at Week 8 as determined by physician global assessment. Secondary outcomes included clinical remission (no symptoms) at Week 8, clinical response/remission at Week 16 and endoscopic healing (defined as Mayo endoscopic score ≤1 or absence of erosions/ulcerations) within 6 months of initiating tofacitinib. Descriptive statistics and Fisher exact tests were performed. Logistic regression assessed predictors of Week 8 response. A multi-variable model was created using backward elimination.

Results

A total of 123 UC patients were included with a median age of 38 years (IQR 27–46) and 5 years disease duration (IQR 2–9). 56.1% were men and 60.2% had pancolitis. 28.5% were bio-naïve while 40.7% had been exposed to both anti-tumour necrosis factor (anti-TNF) biologics and vedolizumab (VDZ). Ninety-six patients completed 8 weeks of tofacitinib. 60.8% had clinical response and 13.5% clinical remission at Week 8. At Week 16 (total n = 74), 55.4% had clinical response and 48.6% clinical remission. 64.9% (total n = 57) had endoscopic healing. A larger proportion of bio-naïve patients achieved clinical response with no difference between those exposed to both anti-TNF and VDZ or either alone (Table 1). Patients with prior exposure to 2 biologic classes (anti-TNF and VDZ) had lower rates of endoscopic healing compared with bio-naïve and 1 biologic class exposure (Table 1). Bio-naïve status and higher albumin were associated with greater chance of Week 8 response while pancolitis, baseline endoscopic Mayo score 3, concomitant steroids at start of tofacitinib, and male gender were associated with lower chance of response (Table 2). In multi-variable analysis, bio-naïve status (aOR 5.50, 95% CI 1.71–17.65), concomitant steroids (aOR 0.25, 95% CI 0.07–0.83), and male gender (aHR 0.25, 95% CI 0.08–0.83) were associated with Week 8 response.

Conclusion

Tofacitinib is effective at inducing clinical response in a real-world clinical setting. Prior exposure to biologics is associated with reduced chance of clinical response and endoscopic healing.

Table 1. Tofacitinib response rates by prior biologic exposure. (*p = 0.007, **p < 0.001, *** p < 0.001. Patients who discontinued tofacitinib before Week 8 or 16 were considered non-responders.)

Prior biologic exposure statusClinical response Week 8*Clinical response Week 16**Endoscopic healing by 6 months***
Bio-Naïve81.8% (total n = 33)81.3% (total n = 32)87.1% (total n = 31)
Prior exposure to 1 class (Anti-TNF or VDZ)44% (total n = 25)36.4% (total n = 22)57.1% (total n = 14)
Prior exposure to 2 classes (Anti-TNF and VDZ)55.3% (total n = 38)35% (total n = 20)16.7% (total n = 12)

Table 2. Baseline variables significantly associated with tofacitinib clinical response at Week 8 OR: odds ratio; CI: confidence interval.

Univariable logistic regression variableOR (95% CI)p-value
Bio-Naïve4.50 (1.64–12.37)0.004
Pancolitis (ref = limited colitis)0.34 (0.14–0.86)0.02
Albumin (g/dl)2.63 (1.02–6.80)0.046
Mayo endoscopic score 3 (ref=score 2)0.27 (0.10–0.72)0.01
Male (ref=female)0.28 (0.11–0.70)0.007
Concurrent steroids at start of tofacitinib0.22 (0.08–0.58)0.002