Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Omvoh® (mirikizumab): Combination with other non-biologic ulcerative colitis treatments
In the mirikizumab phase 3 studies for adults with moderately to severely active ulcerative colitis, stable doses of concomitant non-biologic ulcerative colitis therapies were permitted.
Content overview
Concomitant ulcerative colitis therapy in LUCENT clinical trials
LUCENT-1
LUCENT-1 is a 12-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study of mirikizumab, a p19-directed anti-interleukin-23 (anti-IL-23) antibody. The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active ulcerative colitis (UC), with a modified Mayo score of 4 to 9 points and centrally read Mayo endoscopic subscore ≥2, who had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.1
Patients were permitted to use stable doses of
- aminosalicylates (5-ASAs)
- immunomodulatory agents, such as
- 6-mercaptopurine (6-MP)
- azathioprine (AZA), or
- methotrexate (MTX), and
- oral corticosteroids, such as
- prednisone ≤20 mg/day or equivalent
- budesonide Multi-Matrix System 9 mg/day, or
- beclomethasone dipropionate 5 mg/day.1
At induction baseline in the mirikizumab-treated group,
- 40.4% of patients were receiving oral corticosteroids
- 24.3% were receiving immunomodulators, and
- 74.4% were receiving 5-ASAs.1
Clinical remission at week 12
Subgroup analysis for clinical remission at week 12 with or without baseline immunomodulator or oral corticosteroid use can be found in Subgroup Analysis of Clinical Remission at Week 12 in LUCENT-1.
Baseline Medication Usea |
MIRI 300 mg IV Q4W |
PBO IV Q4W |
Risk Differenceb |
Corticosteroidsc |
|||
Yes |
71/351 (20.2) |
19/113 (16.8) |
3.4 (-4.7 to 11.5) |
No |
139/517 (26.9) |
20/181 (11.0) |
15.8 (9.9 to 21.8) |
Immunomodulatorsd |
|||
Yes |
40/211 (19.0) |
11/69 (15.9) |
3.0 (-7.1 to 13.1) |
No |
170/657 (25.9) |
28/225 (12.4) |
13.4 (8.0 to 18.9) |
Abbreviations: 6-MP = 6-mercaptopurine; IV = intravenous; MIRI = mirikizumab; MMX = Multi-Matrix System; PBO = placebo; Q4W = every 4 weeks.
aData presented as n/N (%) unless otherwise stated.
bPercent difference (95% CI) vs PBO IV Q4W.
cSuch as stable doses of prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone dipropionate 5 mg/day.
dSuch as stable doses of 6-MP, azathioprine, or methotrexate.
LUCENT-2
LUCENT-2 is a 40-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled, maintenance study that evaluated the safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, conducted in adult patients with moderately to severely active UC who completed the LUCENT-1 study.1
Patients on concomitant UC therapies during LUCENT-1 were required to continue on stable doses of oral 5-ASAs and immunomodulatory agents (6-MP, AZA, MTX) in LUCENT-2.1
For LUCENT-2, patients receiving corticosteroids at LUCENT-1 baseline and who achieved clinical response in LUCENT-1 required corticosteroid tapering.1
Clinical remission at week 40
Subgroup analysis for clinical remission at week 40 (52 weeks of continuous therapy) with or without baseline immunomodulator or oral corticosteroid use can be found in Subgroup Analysis of Clinical Remission at Week 40 in LUCENT-2.
Baseline Medication Useb |
MIRI 200 mg SC Q4W |
PBO SC Q4W |
Risk Differencec |
Corticosteroidsd |
|||
Yes |
61/135 (45.2) |
12/68 (17.6) |
27.5 (15.2-39.9) |
No |
121/230 (52.6) |
33/111 (29.7) |
22.9 (12.2-33.6) |
Immunomodulatorse |
|||
Yes |
39/78 (50.0) |
11/39 (28.2) |
21.8 (3.8-39.8) |
No |
143/287 (49.8) |
34/140 (24.3) |
25.5 (16.4-34.7) |
Abbreviations: 6-MP = 6-mercaptopurine; MIRI = mirikizumab; MMX = Multi-Matrix System; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
aRepresenting a total of 52 weeks of continuous therapy.
bData presented as n/N (%) unless otherwise stated.
cPercent difference (95% CI) vs PBO SC Q4W.
dSuch as stable doses of prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone dipropionate 5 mg/day.
eSuch as stable doses of 6-MP, azathioprine, or methotrexate.
Drug interaction studies
No interaction studies have been performed. 3
In ulcerative colitis studies, concomitant use of corticosteroids or oral immunomodulators did not influence the safety of mirikizumab.3
Population pharmacokinetic data analyses indicated that the clearance of mirikizumab was not impacted by
- concomitant administration of 5‑ASAs (5‑aminosalicylic acid),
- corticosteroids or
- oral immunomodulators (azathioprine, mercaptopurine, thioguanine, and methotrexate)
in patients with ulcerative colitis.3
References
1D'Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. https://doi.org/10.1056/NEJMoa2207940
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ 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