P0881 Effectiveness and Safety of Tofacitinib in Biologic-Naïve Elderly Patients with Ulcerative Colitis

Abstract Background The prevalence of ulcerative colitis (UC) is increasing in elderly populations, yet real-world data on the efficacy and safety of tofacitinib in this demographic remains limited. This study aimed to evaluate the real-world effectiveness and safety of tofacitinib in elderly patients (≥60 years) with moderate-to-severe UC treated at a tertiary care center in North India. Methods This cohort study was conducted at Dayanand Medical College and Hospital, Ludhiana, from July 2022 to June 2024. Elderly patients (aged ≥60 years) with moderate-to-severe UC refractory to conventional therapies were included. Patients received tofacitinib at a dose of 10 mg twice daily for induction, followed by 5 mg twice daily for maintenance, and were assessed at weeks 8 and 52. The primary outcome was steroid-free remission at both weeks 8 and 52. Secondary outcomes included clinical remission (partial Mayo score ≤1), clinical response (≥3-point reduction in partial Mayo score), and steroid-free remission at individual time points. Adverse events were systematically recorded. Results A total of 35 patients (median age: 64 years, 40% male) were analyzed. Most patients (80%, n=28) had left-sided colitis. The primary outcome of steroid-free clinical remission at both weeks 8 and 52 was achieved in 9 patients (25.71%). At week 8, clinical remission, steroid-free remission, and clinical response were observed in 18 (51.42%), 15 (42.85%), and 22 (62.85%) patients, respectively. At week 52, clinical remission and steroid-free remission were each achieved in 22 (62.85%) patients, while 27 (77.14%) patients demonstrated a clinical response. The most common adverse events included hair loss (17.14%, n=6), sadness of mood (11.42%, n=4), and dyslipidemia (8.57%, n=3). Three patients developed self-limiting herpes zoster infection, and one patient reported bilateral retinal vein occlusion. Conclusion Tofacitinib demonstrated favorable efficacy and safety in biologic-naïve elderly patients with moderate-to-severe UC. These findings highlight its potential as a viable treatment option for this growing and often underrepresented patient population.