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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Safety in elderly patients
The phase 2 and 3 clinical studies of mirikizumab did not include sufficient numbers of patients aged 65 and over to determine any differences from younger adult patients.
Content overview
Dose adjustment in elderly patients
No dose adjustment is required. There is limited information in subjects aged ≥ 75 years.1
Geriatric use in phase 3 ulcerative colitis studies
The safety and efficacy of mirikizumab were evaluated in 2 randomized, double-blind, placebo-controlled clinical studies (1 induction study [LUCENT-1] and 1 maintenance study [LUCENT-2]), in adult patients with moderately to severely active ulcerative colitis (UC) who had inadequate response, loss of response, or failed to tolerate any of the following:
- corticosteroids
- immunomodulators
- biologic therapy, or
- tofacitinib.2
The 12-week intravenous (IV) induction study (LUCENT-1) was followed by the 40-week subcutaneous (SC) randomized withdrawal maintenance study (LUCENT-2) for 52 weeks of continuous therapy.3
No clinically meaningful differences in the pharmacokinetics of mirikizumab were observed in patients 65 years of age and older compared to younger adult patients.2
Safety analysis by age in phase 2 and 3 ulcerative colitis studies
Number of TEAEs in the UC MIRI Exposure Safety Population by Age Group in Phase 2 and 3 Clinical Studies presents an overview of adverse events by age group for adult patients with moderately to severely active ulcerative colitis exposed to mirikizumab in phase 2 and 3 clinical studies.
Parameterb |
<65 Years Old |
65-74 Years Old |
75-84 Years Old |
≥85 Years Old |
Total TEAEs |
972 (72.8) |
70 (72.9) |
10 (90.9) |
0 |
SAEs |
||||
Fatal |
0 |
1 (1.0) |
0 |
0 |
Hospitalization |
102 (7.6) |
11 (11.5) |
4 (36.4) |
0 |
Life-threatening |
6 (0.4) |
2 (2.1) |
0 |
0 |
Disability |
0 |
0 |
0 |
0 |
Other |
14 (1.0) |
2 (2.1) |
0 |
0 |
Total TEAEs leading to study drug D/C |
65 (4.9) |
4 (4.2) |
0 |
0 |
Accidents and injuriesc |
87 (6.5) |
7 (7.3) |
1 (9.1) |
0 |
Infections and infestationsd |
501 (37.5) |
29 (30.2) |
4 (36.4) |
0 |
Nervous system disordersd |
206 (15.4) |
9 (9.4) |
2 (18.2) |
0 |
Psychiatric disordersd |
62 (4.6) |
5 (5.2) |
1 (9.1) |
0 |
Cardiac disordersd |
23 (1.7) |
5 (5.2) |
1 (9.1) |
0 |
Vascular disordersd |
66 (4.9) |
11 (11.5) |
2 (18.2) |
0 |
Hypotension, falls, fracturese |
26 (1.9) |
0 |
1 (9.1) |
0 |
QOL decreasedf |
0 |
0 |
0 |
0 |
Abbreviations: D/C = discontinuation; MedDRA = Medical Dictionary for Regulatory Activities; MIRI = mirikizumab; NEC = not elsewhere classified; QOL = quality of life; SAEs = serious adverse events; TEAEs = treatment-emergent adverse events; UC = ulcerative colitis.
aDefined as all randomized patients who received any amount of study treatment (regardless of whether the patient does not receive the correct treatment, or otherwise does not follow the protocol).
bData presented as n (%).
cStandardized MedDRA query.
dSystem organ class.
eDefined as any MedDRA preferred term that is included in the high-level group term 'Decreased and nonspecific blood pressure disorders and shock', the high-level terms 'Fractures and dislocations NEC', 'Limb fractures and dislocations, 'Pelvic fractures and dislocations', 'Skull fractures, facial bone fractures and dislocations', 'Spinal fractures and dislocations', and 'Thoracic case fractures and dislocations', or the preferred term 'Fall'.
fPreferred term.
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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