P1124 Efficacy of Combination Therapy with Biologics and Tacrolimus as Remission Induction for Refractory Ulcerative Colitis: A Retrospective Study

Abstract Background In recent years, various therapeutic agents have become available for ulcerative colitis (UC); however, some refractory cases fail to achieve remission with monotherapy using biologics or tacrolimus (TAC). For such cases, combination therapy (CTx) with TAC and biologics is sometimes employed to induce remission. This study investigated patient characteristics, remission induction rate, colectomy rate at 12 weeks, and adverse events in patients who received CTx. Methods We retrospectively analyzed 30 patients with refractory ulcerative colitis (UC) who received initial combination therapy (CTx) with tacrolimus (TAC) and biologics at our institution between April 2009 and May 2025.The following were evaluated: (1) patient characteristics, (2) remission induction rate and background factors in remission and non-remission groups, (3) colectomy rate at 12 weeks after remission induction, and (4) adverse events associated with CTx. Results The remission induction rate was 70% (21/30). Female sex and lower CAI before CTx were significantly associated with remission (P < 0.05). The colectomy rate at 12 weeks after remission induction was 9.5% (2/21). Adverse events included renal dysfunction (n = 9), tremor (n = 5), headache (n = 1), nausea (n = 1), influenza A (n = 1), and cytomegalovirus antibody positivity (n = 3), but no severe adverse events were observed. Conclusion It was suggested that combination therapy with tacrolimus and biologics could be one of the options for induction therapy in refractory ulcerative colitis. Reference: Marcus Harbord, Rami Eliakim, Dominik Bettenworth et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management, Journal of Crohn’s and Colitis, Volume 11, Issue 7, 1 July 2017, Pages 769–784 Conflict of interest: Dr. Ito, Ayumi: There is no conflict of interest. Koroku, Miki: No conflict of interest Yonezawa, Maria: There is no conflict of interest. Yousuke, Nakai: No conflict of interest