Comparative effectiveness of low versus high dose upadacitinib as maintenance treatment in patients with ulcerative colitis: a real-world cohort study from the United States.

Abstract

Background: There is limited real-word data comparing efficacy of low dose upadacitinib (UPA) to high dose UPA as maintenance therapy for ulcerative colitis (UC).

Methods: This was a retrospective cohort study utilizing the U.S. Collaborative Network in adults ≥18 years old with UC who initiated UPA 15 mg compared to 30 mg for maintenance therapy between April 2022 and December 2023. The primary outcome was a composite of intravenous steroid use, oral steroid use, or colectomy from 12 to 60 weeks from the index UPA prescription. Propensity score matching (PSM) was performed for demographics, co-morbid conditions, laboratory, and IBD medication history. Cox proportional hazard model was used to identify predictors of failure.

Results: Among 1110 patients on UPA maintenance therapy, 361 (32.5%) were on 15 mg and 749 (67.5%) were on 30 mg. After PSM, there was no difference in the composite outcome of steroid use or colectomy between the 15-mg UPA cohort versus 30 mg cohort (35.3% vs 35.6%; aHR 0.95, 0.71-1.24, P = .8). There was no difference in IV steroid use, oral steroid use or change in therapy between the two cohorts. There was no difference in the proportion of patients who achieved a fecal calprotectin of <250 μg/g (55.8% vs 63.5%, P = .33). Recent oral or IV steroid use and rheumatoid arthritis were associated with failure of both 15 mg and 30 mg UPA.

Conclusion: Our study indicates that 15 mg UPA shows similar efficacy as 30 mg UPA for maintenance treatment in a subset of patients with UC.