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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Incidence of hepatic-related events in LUCENT clinical trials
The incidence of hepatic-related events was 1.6% in patients who received mirikizumab in the LUCENT-1 induction study and 3.1% in induction responders who received mirikizumab in the 40-week LUCENT-2 maintenance study.
Content overview
Special warnings and precautions from the label
Cases of drug-induced liver injury (including one case meeting Hy’s Law criteria) occurred in patients receiving mirikizumab in clinical trials.1
- Liver enzymes and bilirubin should be evaluated at baseline and monthly during induction (including extended induction period, if applicable). Thereafter, liver enzymes and bilirubin should be monitored (every 1 ‑ 4 months) according to standard practice for patient management and as clinically indicated.
If increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) are observed and drug‑induced liver injury is suspected, mirikizumab must be discontinued until this diagnosis is excluded.1
Treatment-emergent hepatic events in the LUCENT-1 and LUCENT-2 clinical trials
LUCENT-1
LUCENT-2
Mirikizumab induction responders
Of the patients who responded to induction therapy with mirikizumab and participated in the 40-week maintenance study, LUCENT-2, hepatic-related adverse events were reported in
Mirikizumab induction nonresponders
Patients who did not achieve a clinical response to either mirikizumab or placebo during the 12-week induction phase of LUCENT-1 received open-label extended induction treatment with an additional 3 doses of mirikizumab 300 mg infused intravenously every 4 weeks for the first 12 weeks of LUCENT-2.6
- 6 patients (1.9%) in this population experienced a hepatic-related adverse event.6
Patients who achieved a clinical response with extended induction therapy compared with LUCENT-1 baseline received open-label maintenance dosing with mirikizumab 200 mg injected subcutaneously every 4 weeks through week 40 of LUCENT-2.6
- 3 patients (1.8%) experienced a hepatic-related adverse event.6
Hepatic enzyme elevations in the LUCENT-1 and LUCENT-2 clinical trials
Hepatic Enzyme Elevations in the LUCENT-1 Induction and LUCENT-2 Maintenance Clinical Studies shows the proportions of patients who received mirikizumab in the ulcerative colitis clinical development program, including the placebo-controlled and open-label induction and maintenance periods, and had hepatic enzyme elevations.
Parametera |
LUCENT-1 |
LUCENT-2 |
||
Week 12 |
Week 40b |
|||
MIRI 300 mg IV (N=958) |
PBO IV (N=321) |
MIRI 200 mg SC (N=389) |
PBO SC (N=192) |
|
ALT |
||||
Increased ≥3 times ULN |
4 (0.4) |
2 (0.6) |
3 (0.8) |
1 (0.5) |
Increased ≥5 times ULN |
1 (0.1) |
1 (0.3) |
3 (0.8) |
0 |
AST |
||||
Increased ≥3 times ULN |
4 (0.4) |
0 |
4 (1.0) |
1 (0.5) |
Increased ≥5 times ULN |
2 (0.2) |
0 |
3 (0.8) |
0 |
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; IV = intravenous; MIRI = mirikizumab; PBO = placebo; SC = subcutaneous; ULN = upper limit of normal.
aData are presented as n (%).
bRepresenting a total of 52 weeks of continuous therapy.
One patient who received open-label extended induction therapy with mirikizumab in the LUCENT-2 study experienced an increase in alanine aminotransferase and total bilirubin levels meeting Hy's Law criteria. The patient discontinued mirikizumab and the event resolved.6
The LUCENT study data continue to be finalized and this information will be updated with any additional findings.
Dose adjustments in patients with hepatic impairment
Mirikizumab has not been studied in these patient populations.1
- These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary.
Population pharmacokinetic analysis showed that total bilirubin (range of 1.5 to 29 µmol/L) did not affect mirikizumab pharmacokinetics.1
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohns Colitis. 2022;16(suppl 1):i028-i029. European Crohn's and Colitis Organisation abstract OP26. https://doi.org/10.1093/ecco-jcc/jjab232.025
3D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO Virtual); February 16-19, 2022.
4Dubinsky MC, Irving PM, Li X, et al. Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study. Poster presented at: Digestive Disease Week; May 24, 2022; San Diego, CA.
5Dubinsky MC, Irving PM, Li X, et al. Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study. Abstract presented at: Digestive Disease Week; May 24, 2022; San Diego, CA.
6D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 30 May 2023