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Omvoh ® ▼ (mirikizumab)
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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
Information from the label regarding the use of corticosteroids
Corticosteroids allowed in LUCENT-1 study
- Oral corticosteroids indicated for ulcerative colitis
- Corticosteroids for non-ulcerative colitis indications
Information from the label regarding the use of corticosteroids
No interaction studies have been performed. 1
In ulcerative colitis studies, concomitant use of corticosteroids did not influence the safety of mirikizumab.1
Population pharmacokinetic data analyses indicated that the clearance of mirikizumab was not impacted by concomitant administration of corticosteroids in patients with ulcerative colitis.1
Corticosteroids allowed in LUCENT-1 study
Oral corticosteroids indicated for ulcerative colitis
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.
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
Corticosteroids allowed in LUCENT-2 study
Oral corticosteroids indicated for ulcerative colitis
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
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
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
Corticosteroids for non-ulcerative colitis indications
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.
2D'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 March 2023