Abstract Background Upadacitinib 45 mg is increasingly used beyond standard induction in inflammatory bowel disease (IBD) as extended induction or re-induction after loss of response. We assessed effectiveness and safety of upadacitinib 45 mg in clinical practice. Methods We performed a single-centre retrospective study including adults with Crohn’s disease (CD) or ulcerative colitis (UC) treated with upadacitinib (UPA) between September 2023 and October 2025. Patients receiving 45 mg beyond the induction period (8 weeks for UC; 12 weeks for CD) were identified, and their characteristics and outcomes were compared with those maintenance treatment with 30 mg/day. Clinical remission (CR) was defined by HBI ≤4 for CD and partial Mayo ≤2 for UC, and biological remission (BR) as faecal calprotectin (CF) 150 µg/g. Results 98 patients received UPA during the study period, of whom 37 (437,76%) received 45 mg/day maintenance regimen afterwards. These included 30 (81,08%) with CD and 7 (18,92%) with UC 83,8 % had failed ≥2 advanced therapies and 51,4% had prior intestinal surgery. Basal characteristics of patients under 45mg/day maintenance therapy (Table 1) included higher rates of prior intestinal surgery, lower albumin serum levels, higher serum levels of fibrinogen and greater biologic exposure (p 0,05). Reasons for 45mg/day maintenance therapy included having achieved partial response after standard induction therapy (50%), secondary loss of response with standard maintenance dose of 30mg (36%) and perianal disease (14%). CR rates were comparable between 45 mg and 30 mg at induction (77% vs 87%; p = 0,21), 6 months (75% vs 83%; p = 0,44) and 12 months (79% vs 90%; p = 0,31). In contrast, BR was lower in the 45 mg group at all timepoints (induction 42% vs 65%; 6 months 48% vs 75%; 12 months 31% vs 81%, p 0,05). Overall, among patients on 45 mg, CR was achieved in 29/37 (78,4%) and BR in 13/32 (41%) at week 12, with sustained CR at week 24 (77.8 %) and week 52 (79 %). Median FC decreased from 781 µg/g (IQR 352-1968) to 120 µg/g (IQR 74–364). Adverse events included infections in 7 (19%), acne in 6 (16, %) and one thrombotic event (2,7%); no adverse event led to treatment discontinuation. There were no significant differences in adverse event rates between patients on 45 mg and 30 mg maintenance (p = 0,74). Conclusion In this real-world IBD cohort, maintenance therapy with upadacitinib 45 mg was useful in achieving and maintaining remission in complex IBD patients with a favourable safety profile. These findings support the role of upadacitinib dose optimisation in selected population of IBD patients and underscore the need for prospective studies to define high-dose treatment duration and de-escalation strategies. Conflict of interest: Algara, Maria: No conflict of interest Suárez-Saro Fernández, Ana: No conflict of interest Garcia Muñoz, Carmen: No conflict of interest Ferreiro Pérez, Elena: No conflict of interest Franchez Martincorena, Beatriz: No conflict of interest Blanco, Alejandro: No conflict of interest Rafael De La Cruz Esteban, David: No conflict of interest López Romero-Salazar, Francisco: No conflict of interest Yela San Bernardino, M. Carmen: No conflict of interest Masedo Gonzalez, Angeles: No conflict of interest Casis Herce, M. Begoña: No conflict of interest Gonzalez Lama, Yago: I have provided scientific advisory / participated in educational activities / received unrestricted research grants / received payments for lecturing from Janssen, Takeda, Pfizer, AbbVie, Lilly, Alfasigma, Ferring, Gilead, Amgen.
Algara et al. (Thu,) studied this question.
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