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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
What steroids were allowed in the Omvoh® (mirikizumab) clinical trials?
The LUCENT-1 study allowed approved doses and forms of oral prednisone, budesonide, and beclomethasone if the prescribed dose had been stable for at least 2 weeks prior to the screening endoscopy.
Content overview
Concomitant Use of Corticosteroids With Mirikizumab
Corticosteroids Allowed in LUCENT-1 Study
- Oral Corticosteroids Indicated for Ulcerative Colitis
- Corticosteroids for Non-ulcerative Colitis Indications
Concomitant Use of Corticosteroids With Mirikizumab
Lilly has not conducted systematic interaction studies between mirikizumab and corticosteroids. In ulcerative colitis studies, the safety of mirikizumab was not influenced by a concomitant use of corticosteroids. For complete information, please refer to the Omvoh Summary of Product Characteristics, in particular, sections1
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.8 Undesirable effects
- 5.2 Pharmacokinetic properties
Below, you will find additional information about which corticosteroids were allowed and which were not in the LUCENT-1 and LUCENT-2 clinical trials with Omvoh for treating ulcerative colitis.
Corticosteroids Allowed in LUCENT-1 Study
Oral Corticosteroids Indicated for Ulcerative Colitis
Corticosteroids Allowed in LUCENT-1
If the prescribed dose had been stable for at least 2 weeks before the screening endoscopy and remained stable for the duration of the study, the phase 3 LUCENT-1 study allowed the use of the following oral corticosteroids2:
- prednisone ≤20 mg/day or equivalent
- budesonide extended release tablets 9 mg/day (budesonide MMX®), and
- beclomethasone (gastro-resistant prolonged-release) 5 mg/day.
Corticosteroids Not Allowed in LUCENT-1
The medications that were not allowed in the LUCENT-1 clinical study or 2 weeks prior to the screening endoscopy were
- corticosteroid enemas
- corticosteroid suppositories
- oral budesonide standard formulation, and
- intravenous (IV) corticosteroids.2
Corticosteroids for Non-ulcerative Colitis Indications
The LUCENT-1 clinical trial excluded patients who required systemic corticosteroids to treat conditions other than ulcerative colitis or adrenal insufficiency.2
Corticosteroid premedication for investigational product infusion or locally administered corticosteroids, such as inhaled, intranasal, intra-articular, or topical were allowed.2
Corticosteroids Allowed in LUCENT-2 Study
Oral Corticosteroids Indicated for Ulcerative Colitis
Corticosteroid Tapering for Medications Allowed in LUCENT-1
Patients who entered the induction study, LUCENT-1, receiving corticosteroid therapy for the treatment of their ulcerative colitis and achieved clinical response with mirikizumab began corticosteroid tapering at week 0 of LUCENT-2.2
If a patient cannot tolerate the corticosteroid taper without recurrence of clinical symptoms, then the study personnel
- may pause corticosteroid tapering, or
- may increase the corticosteroid dose up to but not exceed the original dose at induction baseline.2
Attempts to reinitiate corticosteroid tapering were required within 2 weeks of interruption of taper, with the goal to complete the taper no later than week 12 of LUCENT-2.2
Patients who did not achieve clinical response with mirikizumab in the ulcerative colitis induction study, LUCENT-1, and received extended induction therapy with intravenous (IV) mirikizumab in the maintenance study, LUCENT-2, began corticosteroid tapering
- if the patient achieved clinical response at week 12 of extended induction, or
- if the patient experienced symptomatic improvement, based on the opinion of the investigators, at any time after initiating extended induction dosing.2
Corticosteroids Not Allowed in LUCENT-2
The medications that were not allowed throughout the treatment period of LUCENT-2 were
- corticosteroid enemas
- corticosteroid suppositories
- oral budesonide standard formulation, and
- intravenous (IV) corticosteroids.2
Corticosteroids for Non-ulcerative Colitis Indications
The LUCENT-2 clinical trial excluded patients who required systemic corticosteroids to treat conditions other than ulcerative colitis or adrenal insufficiency.2
Local administration of corticosteroids, such as intranasal, inhaled, or intraarticular, were allowed as required for the management of preexisting conditions and adverse events.2
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (GB)
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
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: 09 January 2024