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Omvoh ® ▼ (mirikizumab)
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How do I taper patients off corticosteroids after they respond to Omvoh® (mirikizumab)?
This response provides recommended schedule for tapering oral corticosteroids in eligible patients in the LUCENT clinical trial program.
Content overview
Patients Eligible for Corticosteroid Tapering
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-2.1
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 clinical response was achieved at week 12 of extended induction, or
- if the patient experienced symptomatic improvement, based on the investigator's opinion, at any time after initiating extended induction dosing.1
Corticosteroid Tapering Procedure
Oral Corticosteroids Other Than Budesonide or Beclomethasone
Corticosteroid Tapering Procedure in the LUCENT Clinical Trial Program shows the recommended schedule for tapering oral corticosteroid therapy other than budesonide extended release tablets (budesonide MMX) or beclomethasone dipropionate (gastro-resistant prolonged release tablet).1
If the oral corticosteroid dose is... |
Then... |
>10 mg/day prednisone or equivalent |
taper daily dose by 5 mg/week until receiving 10 mg/day, and then continue tapering at 2.5 mg/week until 0 mg/day. |
≤10 mg/day prednisone or equivalent |
taper daily dose by 2.5 mg/week until 0 mg/day. |
aOther than budesonide extended release tablets or beclomethasone dipropionate.
Oral Budesonide
The recommended schedule for tapering oral budesonide extended release tablets (budesonide MMX) 9 mg/day is to reduce tablets to 9 mg every other day for 2 weeks, followed by 9 mg every third day for 2 weeks, and then discontinue.1
Oral Beclomethasone
The recommended schedule for tapering oral beclomethasone dipropionate (gastroresistant prolonged-release tablet) 5 mg/day is to reduce tablets to 5 mg every other day for 4 weeks, and then discontinue.1
Recurrence of Clinical Symptoms During Corticosteroid Taper
In the LUCENT clinical trial program, if a patient experienced recurrence of clinical symptoms during the corticosteroid taper,
- the taper could be paused, and/or
- the corticosteroid dose could be increased to the original dose but not be greater than the dose at induction baseline.1
Attempts to reinitiate the corticosteroid taper were to begin within 2 weeks of the interruption.1
References
1D'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 May 2023