S1208 Real-World Evidence on the Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis in Lebanon

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Introduction: To evaluate the effectiveness and safety of tofacitinib in patients with ulcerative colitis (UC) in clinical practice in Lebanon. Methods: This was a retrospective cross-sectional study. Patients with moderate to severe UC treated with tofacitinib between 2018 and 2021 were included. Patients’ demographics, disease-specific characteristics, clinical assessment at 3 time points (8, 26, and 52 weeks), endoscopic evaluation at 24 weeks, and adverse events were collected. Results: A total of 60 UC patients with a mean (SD) duration of disease of 7.9 ± SD 4.7 years were enrolled. 61.7% of patients had extensive disease, and 58.3% had received ≥ 1 biologic prior to tofacitinib. Clinical remission was reported in 25, 34, and 31 patients (41.7%, 56.7%, and 56.4%) at 8, 26, and 52 weeks respectively (Figure 1). Endoscopic remission (endoscopic Mayo score 0 or 1) was observed in 58.3% of patients. About one-third of patients (31.7%) stopped tofacitinib at 1 year, primarily for lack of efficacy or loss of response, with no significant difference between biologics-naïve and experienced patients (24% vs 37.1% respectively; Table 1). No serious adverse events or deaths were reported. Adverse events were reported in 3 patients (5.0%) - one Clostridioides difficile infection, 1 case of reversible lymphopenia, and 1 case of facial acne. No serious adverse events (AEs) or deaths were noted. On multivariate analysis, biologic-naïve status and reduction or normalization of C-reactive protein (CRP) were associated with clinical remission (OR = 10.87 [95% CI =1.57, 100] and OR = 78.47 [95% CI =2.09, 2940.32], respectively), while reduction or normalization of CRP was associated with endoscopic remission at 1 year (OR = 19.03 [95% CI =1.64, 221.09]). Conclusion: Tofacitinib was effective in the treatment of moderately severe ulcerative colitis in this real-world cohort in Lebanon. Further, the predictors associated with clinical and endoscopic remissions were found to be biologic-naïve status and reduction in CRP. Observed AEs were consistent with the known safety profile. One of the major limitations of this study is the smaller sample size and the retrospective nature of the study (see Figure 1, Table 1).Figure 1.: Persistence on Tofacitinib in the study cohort at 1 year stratified by biologics-exposure. Table 1. - Patient Demographics and Disease Characteristics (n=60) Variables Categories N (%) Sex Male 29 (48.3) Female 31 (51.7) Mean age 34.5 ± 13.0 Smoking Yes 14 (23.3) No 46 (76.7) Duration of disease 2-5 years 24 (40.7) > 5 years 35 (58.3) Missing data 1 (1.7) Mean years since diagnosis (n=59) 7.9 ± 4.7 Prior biologics None 25 (41.7) 1 biologic 18 (30.0) More than one biologic 17 (28.3) Other prior treatment None 5 (8.3) 5 ASA 25 (41.7) Immunomodulator 5 (8.3) 5 ASA and immunomodulator 25 (41.7) Extra-intestinal manifestations None 49 (81.7) Peripheral arthropathy 5 (8.3) Axial Involvement 1 (1.7) Pyoderma Gangrenosum 1 (1.7) Uveitis 1 (1.7) More than 1 manifestation 3 (5.0) Disease extent Ulcerative Proctitis 2 (3.3) Left Sided UC (Distal to Splenic Flexure) 21 (35.0) Extensive (Proximal to Splenic Flexure) 37 (61.7) HZV testing Yes 27 (45.0) No 29 (48.3) Data unavailable 4 (6.7) HZV result (n=27) Positive 22 (81.5) Negative 5 (18.5) Endoscopic mayo score at initiation 3 37 (61.7) 2 20 (33.3) Data unavailable 3 (5.0) Method of Dispensation Ministry of Health 18 (30.0) NSSF 24 (40.0) Self-payer 18 (30.0) Induction dose period in weeks 4 4 (6.7) 8 40 (66.7) 12 4 (6.7) More than 12 6 (10.0) Stayed on same dose as induction 6 (10.0)

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