If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Omvoh ™ (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the effect of Omvoh™ (mirikizumab-mrkz) 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 level was
- 1556.0 μg/g in the mirikizumab group, and
- 1465.0 μg/g in the placebo group.1
LUCENT-1 and LUCENT-2 studies showed the following results among patients who responded to induction therapy with mirikizumab and continued mirikizumab during the maintenance period. Fecal calprotectin levels decreased more significantly from baseline in the mirikizumab group than in the placebo group at weeks 4 and 12 of the induction period and at week 40 of the maintenance period (p<.001 for all) ().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) |
Between treatment LS mean difference (95% CI)b, µg/g |
NA |
-1164.1 |
-839.6 |
|||
LS mean reduction from baseline, µg/g |
NA |
-698.1d |
-1155.8e |
Abbreviations: ANCOVA = analysis of covariance; IQR = interquartile range; IV = intravenous; LS = least-squares; mBOCF = modified baseline observation carried forward; MIRI = mirikizumab; MMS = Modified Mayo Score; n = number of patients with baseline and postbaseline values at the specified time point; NA = 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 except for patients who discontinued from the study because of an adverse event, in which case the baseline value was carried forward.
cp<.001 vs PBO.
dInduction ANCOVA model with mBOCF includes treatment, baseline value, prior biologic or tofacitinib failure, corticosteroid use at LUCENT-1 baseline, MMS group at baseline, and global region.
eMaintenance ANCOVA model with mBOCF includes treatment, baseline value, prior biologic or tofacitinib failure, corticosteroid use at LUCENT-1 baseline, global region, and clinical remission status at LUCENT-1 week 12.
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 between 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). A significantly greater proportion of patients in the mirikizumab group than in the placebo group had a shift in fecal calprotectin from >250 μg/g at baseline to ≤250 μg/g as early as week 4 (mirikizumab, 19.0%; placebo, 12.5%; p<.05).1,2
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
Change in C-Reactive Protein Levels From Baseline
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) ().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) |
Between treatment LS mean difference (95% CI)b, mg/L |
NA |
-3.7 (-5.0, -2.5)c |
-3.3 (-4.9, -1.7)c |
|||
LS mean reduction from baseline, mg/L |
NA |
-0.85d |
-1.40e |
Abbreviations: ANCOVA = analysis of covariance; IQR = interquartile range; IV = intravenous; LS = least-squares; mBOCF = modified baseline observation carried forward; MIRI = mirikizumab; MMS = Modified Mayo Score; n = number of patients with baseline and postbaseline values at the specified time point; NA = 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 except for patients who discontinued from the study due to an adverse event, in which case the baseline value was carried forward.
cp<.001 vs PBO.
dInduction ANCOVA model with mBOCF includes treatment, baseline value, prior biologic or tofacitinib failure, corticosteroid use at LUCENT-1 baseline, MMS group at baseline, and global region.
eMaintenance ANCOVA model with mBOCF includes treatment, baseline value, prior biologic or tofacitinib failure, corticosteroid use at LUCENT-1 baseline, global region, and clinical remission status at LUCENT-1 week 12.
Shift in C-Reactive Protein Levels
Baseline to Week 12
At week 12, 59.3% of patients who received mirikizumab and 34.7% of patients who received placebo had a shift in CRP from >6 mg/L at baseline to ≤6 mg/L (p<.001 vs placebo).2
Baseline to Week 40
At week 40, 61.2% of mirikizumab induction responders who were rerandomized to mirikizumab and 32.8% of patients who were rerandomized to placebo in LUCENT-2 had a shift in CRP from >6 mg/L at induction baseline to ≤6 mg/L (p<.01).2
Enclosed Prescribing Information
References
The published references below are 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.
2Siegmund 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. Poster presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
Date of Last Review: August 11, 2023