Fatigue, urgency, and QoL improvements on mirikizumab in Crohn’s disease

In the phase 3 VIVID-1 trial, mirikizumab improved fatigue, bowel urgency, and health-related quality-of-life (QoL) after 12 and 52 weeks, compared with placebo, in patients with moderately to severely active Crohn’s disease (CD).

Prof. Simon Travis (University of Oxford, UK) shared patient-reported outcomes of patients with CD who received mirikizumab (n=579) or a placebo (n=199) in the phase 3 VIVID-1 study (NCT03926130) [1]. Fatigue was measured with the FACIT-fatigue instrument, bowel urgency was assessed with a numeric rating scale, and the Inflammatory Bowel Disease Questionnaire (IBDQ) was used to evaluate health-related QoL.

After 12 weeks of therapy, participants in the mirikizumab arm had an average of 5.86 points improvement in fatigue compared with an average of 2.64 points in participants on placebo (P<0.0001). At week 52, the corresponding figures were 7.47 and 3.08 (P<0.0001). “Already after 12 weeks, patients in the mirikizumab arm achieved the 5-point improvement that is considered a clinically meaningful difference,” emphasised Prof. Travis.

Furthermore, bowel urgency was significantly improved among participants receiving mirikizumab compared with those receiving a placebo at week 12 (-2.44 vs -1.58; P<0.0001) and week 52 (-3.24 vs -1.23; P<0.0001). Finally, the IBDQ scores showed that health-related QoL had also improved in the experimental arm compared with the placebo arm at week 12 (+36.9 vs + 17.4; P<0.000001) and week 52 (+43.8 vs +15.9; P<0.000001). “These improvements were seen across domain scores, such as bowel symptoms, systemic symptoms, emotional function, and social function,” added Prof. Travis (see Figure).

Figure: IBDQ total and domain scores of mirikizumab versus placebo at week 12 and week 52 [1]



CI, confidence interval; IBDQ, Inflammatory Bowel Disease Questionnaire; NRI, non-responder imputation.

In conclusion, in the VIVID-1 trial, mirikizumab was superior to placebo in terms of improving fatigue, bowel urgency, and health-related QoL in patients with CD.

1. Travis S, et al. Mirikizumab improves fatigue bowel urgency, and quality of life in patients with moderately to severely active Crohn’s disease: results from a phase 3 clinical trial. OP12, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April, 202418 April, 2024