B0350 - Mirikizumab Improves Work Productivity and Activity Impairment Questionnaire Scores in Moderately-to-Severely Active UC: The LUCENT-1 and LUCENT-2 Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies

Introduction: This analysis compares mirikizumab (miri) to placebo (PBO) for improvement in the Work Productivity and Activity Impairment Questionnaire Ulcerative Colitis (WPAI:UC) in participants of LUCENT-1 and LUCENT-2, phase 3 clinical trials who had moderately-to-severely active UC and had failed prior conventional or biologic therapies.

Methods: 1162 patients (pts) in LUCENT‑1 12‑week induction study were randomized 3:1 to receive 300mg miri or PBO intravenously once every 4 weeks (Q4W). 544 pts who completed induction and achieved Modified Mayo Score (MMS) Clinical Response with miri were rerandomized 2:1 in LUCENT‑2 to a 40W maintenance treatment of miri 200mg or PBO subcutaneously Q4W for a total of 52W treatment. Randomization was stratified by previous biologic therapy failure, baseline (BL) corticosteroid use, and region. Stratification for LUCENT‑1 included BL disease activity, and LUCENT‑2 included LUCENT‑1 clinical remission status. WPAI:UC scores between 0%-100% were calculated from pts‑reported measurements, with a higher score indicating greater impairment. Evaluations of the WPAI:UC domain of overall activity impairment included all respondents, while domains of absenteeism, presenteeism, and work productivity loss required employment at the time of the analyses. Changes from W0 BL at W12 (induction) and W40 (maintenance; 52W treatment) were evaluated by analysis of covariance. Stratification factors and BL scores were used as covariates. Results were reported as least squares mean differences (LSM diff) of miri vs PBO.

Results: At BL, 60.67% (N=705) of pts reported employment. At W12 of induction, activity impairment, absenteeism, presenteeism, and work productivity loss were significantly reduced from BL in miri treated pts vs PBO (Table). Of the pts who achieved W12 MMS Clinical Response, those who continued receiving miri had sustained improvements in the WPAI:UC change from BL at W40 of maintenance vs those who received PBO, including activity impairment, presenteeism, and work productivity loss. Absenteeism was not significantly different between treatment groups at W40 (52W treatment).

Discussion: Compared to PBO, miri treatment provided statistically significant improvements in work productivity and activity impairment as measured by the WPAI:UC. Improvements were observed during induction and maintenance therapy in pts with moderately-to-severely active UC who had failed prior conventional or biologic therapies.