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Mirikizumab
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What is the effect of mirikizumab on fecal calprotectin and CRP in patients with ulcerative colitis?
Compared with placebo, mirikizumab was associated with a greater decrease from baseline in fecal calprotectin and C-reactive protein at weeks 12 and 40. The decrease in fecal calprotectin was significant as early as week 4 (p<.001 for all).
Fecal Calprotectin Levels in LUCENT-1 and LUCENT-2
Change in Fecal Calprotectin Levels From Baseline
At induction baseline, the median fecal calprotectin was
- 1556.0 μg/g in the mirikizumab group, and
- 1465.0 μg/g in the placebo group.1
Among patients who responded to induction therapy with mirikizumab and continued mirikizumab during the maintenance period, the study showed significantly greater decrease from baseline in fecal calprotectin in the mirikizumab group than in the placebo group at weeks 4 and 12 of the induction period and week 40 of the maintenance period (p<.001 for all) (Fecal Calprotectin Levels at Baseline and at Weeks 12 and 40 in LUCENT-1 and LUCENT-2).1
Parameter |
LUCENT-1 |
LUCENT-2 |
||||
Baseline |
Week 12 |
Week 40a |
||||
MIRI 300 mg IV (n=722) |
PBO IV (n=243) |
MIRI 300 mg IV (n=722) |
PBO IV (n=243) |
MIRI 200 mg SC |
PBO SC |
|
Median (IQR), µg/g |
1556.0 |
1465.0 |
398.0 (95.0, 1311.0) |
1040.0 |
155.0 |
496.0 |
LS mean (SE)b, µg/g |
3121.4 (176.1) |
2970.1 (303.5) |
1221.9 (129.9) |
2386.0 (206.9) |
1022.9 (172.4) |
1862.6 (221.4) |
LS mean difference (95% CI)b |
N/A |
-1164.1 |
-839.6 |
|||
Abbreviations: ANCOVA = analysis of covariance; IQR = interquartile range; IV = intravenous; LS = least-squares; MIRI = mirikizumab; n = number of patients with baseline and postbaseline values at the specified time point; N/A = not applicable; PBO = placebo; SC = subcutaneous.
aRepresenting a total of 52 weeks of continuous therapy.
bANCOVA model for endpoint measures. Patients with a missing value at the designated time point had their last value carried forward with the exception of patients who discontinued from the study because of an adverse event, in which case the patient's baseline value was carried forward.
cp<.001.
Shift in Fecal Calprotectin Levels
Baseline to Week 12
At induction baseline, the proportion of patients with fecal calprotectin levels greater than 250 μg/g was similar in the mirikizumab group (90.4%) and the placebo group (88.9%).1
At week 12, 34.3% of patients who received mirikizumab and 20.1% of patients who received placebo had a shift in fecal calprotectin from >250 μg/g at baseline to ≤250 μg/g (adjusted risk difference [95% CI], 14.6% [8.3, 20.9]; p<.001).1
Baseline to Week 40
Patients who responded to induction therapy with mirikizumab were rerandomized to receive either mirikizumab 200 mg or placebo subcutaneously (SC) every 4 weeks in the LUCENT-2 maintenance study.1
At week 40, 50.7% of patients who were rerandomized to mirikizumab and 19.3% of patients who were rerandomized to placebo had a shift in fecal calprotectin from >250 μg/g at induction baseline to ≤250 μg/g (adjusted risk difference [95% CI], 29.1% [20.5, 37.7]; p<.001).1
C-Reactive Protein Levels in LUCENT-1 and LUCENT-2
At induction baseline, the median C-reactive protein (CRP) levels were similar between the mirikizumab (4.0 mg/L) and the placebo (4.3 mg/L) groups.1
At week 12 of the induction period and week 40 of the maintenance period, the decrease from baseline in CRP was significantly greater in the mirikizumab group than in the placebo group (p<.001 for both) (C-Reactive Protein Levels at Baseline and at Weeks 12 and 40 in LUCENT-1 and LUCENT-2).1
Parameter |
LUCENT-1 |
LUCENT-2 |
||||
Baseline |
Week 12 |
Week 40a |
||||
MIRI 300 mg IV |
PBO IV |
MIRI 300 mg IV |
PBO IV |
MIRI 200 mg SC |
PBO SC |
|
Median (IQR), mg/L |
4.0 (1.5, 9.5) |
4.3 (1.2, 9.3) |
1.7 (0.7, 4.9) |
3.1 (1.0, 9.0) |
1.4 (0.5, 4.0) |
1.6 (0.7, 5.1) |
LS mean (SE)b, mg/L |
9.3 (0.5) |
9.4 (0.9) |
4.7 (0.4) |
8.4 (0.6) |
3.6 (0.5) |
7.0 (0.7) |
LS mean difference (95% CI)b |
N/A |
-3.7 (-5.0, -2.5)c |
-3.3 (-4.9, -1.7)c |
|||
Abbreviations: ANCOVA = analysis of covariance; IQR = interquartile range; IV = intravenous; LS = least-squares; MIRI = mirikizumab; n = number of patients with baseline and postbaseline values at the specified time point; N/A = not applicable; PBO = placebo; SC = subcutaneous.
aRepresenting a total of 52 weeks of continuous therapy.
bANCOVA model for endpoint measures. Patients with a missing value at the designated timepoint had their last value carried forward with the exception of patients who discontinued from the study due to an adverse event, in which case the patient's baseline value was carried forward.
cp<.001.
Additional Information
Additional safety and efficacy data from the mirikizumab ulcerative colitis registration studies are available in the following document:
Reference
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Siegmund B, Sands BE, Samaan KH, et al. The effect of mirikizumab on fecal calprotectin and c-reactive protein in phase 3 studies of patients with moderately to severely active ulcerative colitis. Abstract presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
Date of Last Review: October 11, 2022