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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Concomitant medications allowed in LUCENT clinical trials
In LUCENT-1, patients were permitted to use stable doses of oral 5-ASAs, immunomodulators, and oral corticosteroids for UC. In LUCENT-2, patients could continue their 5-ASA and immunomodulator therapies but were required to taper off oral corticosteroids.
Content overview
Combined Therapy with Omvoh
Mirikizumab is a humanized IgG4 monoclonal antibody. It can be assumed that it is catabolically degraded into small peptides and amino acids in the same way as endogenous IgGs. In the pivotal study, various drugs were allowed, while other drugs were not allowed to be used.1 Details are described below.
Complete information on the interaction profile as well as a complete description of the pivotal studies and their results can be found in the Omvoh Summary of Product Characteristics in the sections 1
- 4.5 Interaction with other medicinal products and other forms of interaction
- 5.1 Clinical efficacy and safety
Below you will find more information on how many patients in the clinical trial for ulcerative colitis received the study medication in combination and which combination or concomitant medication was generally allowed or not allowed.
LUCENT-1
Concomitant medications allowed in LUCENT-1
In LUCENT-1, patients were permitted to use stable doses of
- oral 5-aminosalicylates (5-ASAs) such as sulfasalazine for ulcerative colitis (UC)
- immunomodulatory agents for UC, such as
- 6-mercaptopurine (6-MP)
- azathioprine (AZA), or
- methotrexate (MTX), and
- oral corticosteroids for UC, such as
- prednisone ≤20 mg/day or equivalent
- extended-release budesonide 9 mg/day, or
- beclomethasone dipropionate 5 mg/day.2
Additional medications allowed in LUCENT-1 included
- corticosteroids for non-UC indications, such as
- to treat adrenal insufficiency
- as premedication for investigational product infusion, or
- locally administered corticosteroids including inhaled, intranasal, intraarticular, or topical
- antidiarrheals such as loperamide or diphenoxylate with atropine
- low-dose or baby aspirin of 75-162.5 mg, and
- nonlive - killed, inactivated, or subunit - vaccines.2
Baseline concomitant medications of interest in LUCENT-1
At induction baseline in the mirikizumab treatment group of LUCENT-1,
- 40% of patients were receiving oral corticosteroids
- 24% of patients were receiving immunomodulators, and
- 74% of patients were receiving 5-ASAs.3
At induction baseline in the placebo-treated group of LUCENT 1,
- 38% of patients were receiving oral corticosteroids
- 23% of patients were receiving immunomodulators, and
- 74% of patients were receiving 5-ASAs.3
Concomitant medications prohibited in LUCENT-1
A list of prohibited medications in LUCENT-1 is provided in Prohibited Medications in LUCENT-1 and LUCENT-2.
Drug Class |
Examples |
Anti-TNF antibodies |
|
Anti-integrin antibodies |
|
Agents depleting B or T cells |
|
Immunomodulatory medications |
|
Rectally administered 5-ASA therapies |
|
Rectally administered investigational preparations for UC |
|
Rectally administered corticosteroids |
|
IV corticosteroids for UC |
|
Systemic corticosteroids for non-UC indications (oral or IV) |
|
Oral budesonide standard formulationa |
|
Any investigational therapy |
|
Interferon therapy |
|
Leukocyte apheresis |
|
Anti-IL-12p40 antibodies |
|
Anti-IL-23p19 antibodies |
|
Bacillus Calmette-Guerin vaccine |
|
Live attenuated vaccines |
|
Abbreviations: 5-ASA = 5-aminosalicylic acid; IL = interleukin; IV = intravenous; JAK = Janus kinase; MMX = Multi Matrix System; NP = not provided; TNF = tumor necrosis factor; UC = ulcerative colitis.
aThat is not the oral budesonide extended-release tablet formulation (budesonide MMX).
LUCENT-2
Concomitant medications allowed in LUCENT-2
Patients on concomitant UC therapies during LUCENT-1 were required to continue on stable doses of oral 5-ASAs and immunomodulatory agents (eg, 6-MP, AZA, or MTX) in LUCENT‑2.2
In LUCENT-2, patients who received corticosteroids at LUCENT-1 baseline and achieved clinical response in LUCENT-1 required corticosteroid tapering.2
Additional medications allowed in LUCENT-2 included
- corticosteroids for non-UC indications
- to treat adrenal insufficiency
- as premedication for investigational product infusion, or
- locally administered corticosteroids such as inhaled, intranasal, intraarticular, or topical
- antidiarrheals such as loperamide or diphenoxylate with atropine
- low-dose or baby aspirin of 75-162.5 mg, and
- nonlive - killed, inactivated, or subunit - vaccines.2
Baseline concomitant medications of interest in LUCENT-2
Induction responders
During the maintenance phase of LUCENT-2, of the mirikizumab induction responders rerandomized to mirikizumab 200 mg or placebo via subcutaneous injection,
- 37.5% of patients in the mirikizumab group were receiving oral corticosteroids and 20.5% were receiving immunomodulators, and
- 41.9% of patients in the placebo group were receiving oral corticosteroids and 22.3% were receiving immunomodulators.4
Induction nonresponders
During the open-label extended induction period of LUCENT-2, of the mirikizumab induction nonresponders who received open-label mirikizumab 300 mg via intravenous infusion,
- 46.3% of patients were receiving oral corticosteroids, and
- 27.2% of patients were receiving immunomodulators.4
Delayed clinical responders
During the open-label maintenance period of LUCENT-2, of the mirikizumab delayed clinical responders who received open‑label mirikizumab 200 mg via subcutaneous injection,
- 35.4% of patients were receiving oral corticosteroids, and
- 21.5% of patients were receiving immunomodulators.4
Loss of response cohort
Of the 365 mirikizumab induction responders at week 12 of LUCENT-1, only 19 patients (5.2%) experienced a loss of response during mirikizumab maintenance therapy and received open‑label rescue therapy with mirikizumab 300 mg infused intravenously every 4 weeks.5
Of these 19 patients in the loss of response cohort in LUCENT-2,
- 4 patients (21.1%) were receiving oral corticosteroids, and
- 3 patients (15.8%) were receiving immunomodulators.4
Concomitant medications prohibited in LUCENT-2
The list of medications prohibited in LUCENT-2 were the same as the medications prohibited in LUCENT-1 as presented in Prohibited Medications in LUCENT-1 and LUCENT-2.2
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (UK)
2D'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
3Dubinsky MC, Clemow DB, Gibble TH, et al. Clinical effect of mirikizumab treatment on bowel urgency in patients with moderately to severely active ulcerative colitis and the clinical relevance of bowel urgency improvement for disease remission. Crohns Colitis 360. 2023;5(1):otac044. https://doi.org/10.1093/crocol/otac044
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Sands BE, D'Haens G, Clemow DB, et al. Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. 2024;30(12):2245-2258. https://doi.org/10.1093/ibd/izae024
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
▼ 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: 22 October 2025