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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
LUCENT-1
Concomitant medications allowed in LUCENT-1
In LUCENT-1, patients were permitted to use stable doses of
- oral aminosalicylates (5-ASAs) and 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.1
Additional allowed medications in LUCENT-1 included
- corticosteroids for non-UC indications
- to treat adrenal insufficiency
- as premedication for investigational product infusion, or
- locally administered corticosteroids (inhaled, intranasal, intraarticular, or topical)
- antidiarrheals (eg, loperamide or diphenoxylate with atropine)
- low-dose or baby aspirin (75-162.5 mg), and
- nonlive (killed, inactivated, or subunit) vaccines.1
Baseline concomitant medications of interest in LUCENT-1
At induction baseline in the mirikizumab-treated 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.2
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.2
Concomitant medications prohibited in LUCENT-1
A list of prohibited medications in LUCENT-1 can be found 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 = multimatrix system; NA = not applicable; 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 (6-MP, AZA, or MTX) in LUCENT-2.1
In LUCENT-2, patients who received corticosteroids at LUCENT-1 baseline and achieved clinical response in LUCENT-1 required corticosteroid tapering.3
Additional allowed medications in LUCENT-2 were
- corticosteroids for non-UC indications
- to treat adrenal insufficiency
- as premedication for investigational product infusion, or
- locally administered corticosteroids (inhaled, intranasal, intraarticular, or topical)
- antidiarrheals (eg, loperamide or diphenoxylate with atropine)
- low-dose or baby aspirin (75-162.5 mg), and
- nonlive (killed, inactivated, or subunit) vaccines.1
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 subcutaneous (SC) injection,
- 37.5% and 41.9% of patients were receiving oral corticosteroids, respectively, and
- 20.5% and 22.3% of patients were receiving immunomodulators, respectively.1
Induction nonresponders
During the open-label extended induction period of LUCENT 2, of the mirikizumab and placebo induction nonresponders reassigned to open-label mirikizumab 300 mg intravenous infusion,
- 43.2% of patients were receiving oral corticosteroids, and
- 25.9% of patients were receiving immunomodulators.1
Delayed clinical responders
During the open-label maintenance period of LUCENT 2, of the mirikizumab delayed clinical responders receiving open-label mirikizumab 200 mg SC injection,
- 30.4% of patients were receiving oral corticosteroids, and
- 22.2% of patients were receiving immunomodulators.1
Loss of response cohort
During the loss of response rescue period of LUCENT 2, in the loss of response cohort
- 16.9% of patients were receiving oral corticosteroids, and
- 15.3% of patients were receiving immunomodulators.1
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-2.1
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Dubinsky 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
3Dubinsky 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.
▼ 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