Quality of life gains seen with mirikizumab regardless of prior biologic failure for CD

Mirikizumab helps improve health-related quality of life (HRQoL) in Crohn’s disease (CD) patients, including those who have not had success with a biologic therapy, according to data from the phase III VIVID-1 study.

Compared with placebo, mirikizumab was associated with significantly greater changes in Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline to week 12 both among patients who had experienced prior treatment failure with a biologic (bio-failed subgroup; least squares mean [LSM] difference, 19.4; p<0.001) and among those who had not (no-bio-failure subgroup; LSM difference, 19.4; p<0.001). These changes persisted through week 52 (LSM difference, 30.4 and 25.9, respectively; p<0.001 for both). [AIBD 2024, abstract S43]

IBDQ response rates at weeks 12 and 52 were also higher with mirikizumab vs placebo in the bio-failed (difference, 26.4 and 49.4, respectively; composite, 36.2; p<0.001 for both) and no-bio-failure (difference, 21.5 and 37.1, respectively; composite, 19.4; p<0.001 for both) subgroups. Likewise, mirikizumab led to higher IBDQ remission rates than placebo at both timepoints in the bio-failed (difference, 26.8 and 42.5, respectively; composite, 31.5; p<0.001 for both) and no-bio-failure (difference, 22.7 and 35.6, respectively; composite, 23.5; p<0.001) subgroups.

Results for the Work Productivity and Activity Impairment Questionnaire (WPAI): CD scores were similar. Compared with placebo, mirikizumab was associated with greater changes in all WPAI: CD scores in the bio-failed subgroup at week 12 (LSM difference, –7.9 to –11.1; p<0.05 for both) and week 52 (LSM difference, –8.8 to –21.6; p<0.001 for both).

At week 12, absenteeism and activity impairment improved with mirikizumab vs placebo in the no-bio-failure subgroup (LSM difference, –6.9 and –7.9, respectively; p<0.05 for both). Furthermore, at week 52, mirikizumab was associated with significant improvements in presenteeism, work impairment, and activity impairment compared with placebo in the no-bio-failure subgroup (LSM difference, –9.1 to –10.5; p<0.05 for both).

“The phase III, active-controlled, VIVID-1 study showed the efficacy of mirikizumab, an anti-IL-23p19 antibody, vs placebo and ustekinumab in adults with moderately-to-severely active CD. Co-primary and gated-secondary outcomes, including comparisons with ustekinumab, are presented elsewhere,” the investigators said. [Lancet 2024;404:2423-2436]

The present data demonstrate that the beneficial effect of mirikizumab on HRQoL was generally consistent across patient subgroups, making the drug a valuable treatment option for patients with moderately-to-severely active CD, they added.

VIVID-1 included 1,150 adult patients with moderately-to-severely active Crohn's disease and previous inadequate response, loss of response, or intolerance to one or more approved biological therapies or conventional therapies. These patients were randomly assigned to receive mirikizumab 900 mg intravenously at weeks 0, 4, and 8, then 300 mg subcutaneously every 4 weeks from weeks 12 to 52; ustekinumab about 6 mg/kg intravenously at week 0, then 90 mg subcutaneously every 8 weeks from weeks 8 to 52; or placebo. 

For the present analysis, the investigators used data from mirikizumab-treated patients (n=579) and those who received (n=199) placebo who did or did not experience treatment failure with a biologic.