A 45-mg induction dose of upadacitinib was associated with significant improvements to patient-reported and health-related quality of life (HRQoL) outcomes that were maintained with upadacitinib maintenance among patients with ulcerative colitis (UC). These findings were published in Inflammatory Bowel Diseases.
The study was a posthoc analysis of data from the U-ACHIEVE Induction and U-ACCOMPLISH trials (ClinicalTrials.gov Identifier: NCT02819635 and NCT03653026), which were randomized, double-blind, placebo-controlled studies. In the induction periods, patients with moderate to severe active UC with a history of inadequate or loss of response to treatment were randomly assigned 2:1 to receive 45 mg oral upadacitinib (n=660) or placebo (n=328) daily for 8 weeks. The patients who achieved clinical response at 8 weeks were randomly assigned 1:1:1 to receive 15 mg (n=148) or 30 mg (n=154) daily oral upadacitinib or placebo (n=149) as maintenance treatment through week 52. Clinical response was defined as at least a 2-point and at least a 30% reduction in the adapted Mayo score and a 1-point or greater decrease in rectal bleeding or a rectal bleeding subscore of less than or equal to 1. The outcomes for this posthoc analysis were HRQoL and patient-reported outcomes (PROs).
The upadacitinib and placebo induction recipients were aged median 41.0 (range, 17-76) and 42.0 (range, 17-76) years; 37.6% and 37.8% were women or girls; 66.7% and 68.3% were White; they had a mean duration [SD] of UC of 7.9[6.8] and 8.2[8.0] years; and 51.5% and 50.9% had a history of inadequate response to biologics, respectively.
The upadacitinib induction recipients reported significant improvements to Ulcerative Colitis Symptoms Questionnaire (UC-SQ) scores at weeks 2 and 8 (P <.001) compared with placebo. These improvements were sustained with upadacitinib maintenance treatment through week 52 compared with placebo (P <.001). The subset of patients who were switched from upadacitinib induction to placebo had a decline in UC-SQ scores from 81.4% at week 8 to 29.7% at week 52.
Similarly, 22.7%, 35.7%, and 42.8% more upadacitinib recipients achieved a meaningful within-person change (MWPC) in Inflammatory Bowel Disease Questionnaire (IBDQ) scores at weeks 2, 8, and 52 compared with placebo (all P <.001), respectively.
These trends were consistent with regard to Work Productivity and Activity Impairment (WPAI), 36-item Short Form Health Questionnaire (SF-36), and European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L) outcomes, with the exception that upadacitinib only tended to be favored with regard to achieving MWPC for absenteeism at week 8 (P =.059). Furthermore, improvements in absenteeism were only observed for 15 mg upadacitinib (P =.028) and not 30 mg upadacitinib (P =.242) recipients compared with placebo at week 52.
The limitations of this study include the posthoc design and the limited diversity of the patient population.
“This post hoc analysis demonstrates that patients with moderately to severely active UC treated with UPA [upadacitinib] 8-week induction treatment achieve benefits across multiple HRQoL measures that are sustained with maintenance UPA treatment to 52 weeks, compared with placebo,” the study authors wrote.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Panés J, Loftus EV Jr, Higgins PDR, et al. Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results. Inflamm Bowel Dis. 2023;izac260. doi:10.1093/ibd/izac260