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  4. Omvoh® (mirikizumab): Pregnancies in the Ulcerative Colitis and Crohn's Disease Clinical Trials
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Omvoh ® ▼ (mirikizumab)

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Omvoh® (mirikizumab): Pregnancies in the Ulcerative Colitis and Crohn's Disease Clinical Trials

With limited data from the use of mirikizumab in pregnant women, it is preferable to avoid use during pregnancy. Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.

UK_cFAQ_MIR501B_MIR511_PREGNANCY_FERTILITY_NURSING_PREGNANCY_OUTCOMES_UC_CD
UK_cFAQ_MIR501B_MIR511_PREGNANCY_FERTILITY_NURSING_PREGNANCY_OUTCOMES_UC_CDen-GB

Content overview

Information from the Summary of Product Characteristics

LUCENT and VIVID Clinical Study Protocols

Pregnancies During the Mirikizumab Clinical Studies

  • Pregnancies in Mirikizumab-Exposed Study Participants 
  • Pregnancies in Partners of Male Study Participants Exposed to Mirikizumab

Background Risk

Mirikizumab Pregnancy Registry Information

References

Information from the Summary of Product Characteristics

For information on pregnancy, as well as on the related topics of contraception, breastfeeding and fertility, please refer to the Omvoh Summary of Product Characteristics, in particular the section on1

  • 4.6 Fertility, pregnancy and lactation

In the clinical trials, several women became pregnant while using mirikizumab. Below you will find more information about these pregnancies in ulcerative colitis and Crohn's disease clinical trials.

LUCENT and VIVID Clinical Study Protocols

Per the protocol for the LUCENT and VIVID clinical trials, women of childbearing potential were required to

  • test negative for pregnancy within 24 hours prior to mirikizumab exposure, and
  • either agree to remain abstinent or use 2 effective methods of contraception for the entirety of the study.2,3

Any pregnancy that occurred during study participation required permanent discontinuation.2,3

Pregnancies During the Mirikizumab Clinical Studies

Pregnancies in Mirikizumab-Exposed Study Participants 

As of October 4, 2023, 36 women exposed to mirikizumab became pregnant during an ulcerative colitis, Crohn's disease, or psoriasis clinical study.3 For details, please see Pregnancies in Female Participants Exposed to Mirikizumab. 

Pregnancies in Female Participants Exposed to Mirikizumab3

Outcome

Number of Events (n)

Crohn's disease (N=11)

Normal outcomea

4

Elective abortion

1

Spontaneous abortion

4

Unknown, lost to follow-up

1

Pregnancy still ongoing

1

Ulcerative colitis (N=11)

Normal outcomeb

2

Elective abortion

2

Spontaneous abortion

1

Unknown, lost to follow-up

2

Pregnancy still ongoing

3

Birth defectc

1

Psoriasis (N=14)

Normal outcome

9

Elective abortion

2

Spontaneous abortion

0

Unknown, lost to follow-up

3

All Mirikizumab (N=36)

Normal outcome

15

Elective abortion

5

Spontaneous abortion

5

Unknown, lost to follow-up

6

Pregnancy still ongoing

4

Birth defectc

1

Abbreviations: n = number of events; N = number of participants in the specified category.

aOne of the 4 cases was a low-weight birth with a healthy baby.

bOne of the 2 cases was a preterm birth with a healthy baby.

cThe birth defect was Treacher Collins syndrome.

Pregnancies in Partners of Male Study Participants Exposed to Mirikizumab

As of October 4, 2023, 52 partners of male participants became pregnant during the male participants' participation in a mirikizumab clinical study for ulcerative colitis, Crohn's disease, or psoriasis.3 For details, please see Pregnancies in Partners of Male Participants Exposed to Mirikizumab.

Pregnancies in Partners of Male Participants Exposed to Mirikizumab3

Outcome

Number of Events (n)

Crohn's disease (N=12)

Normal outcome

9

Elective abortion

0

Spontaneous abortion

0

Unknown, lost to follow-up

2

Pregnancy still ongoing

1

Ulcerative colitis (N=18)

Normal outcome

7

Elective abortion

0

Spontaneous abortion

6

Unknown, lost to follow-up

4

Pregnancy still ongoing

1

Psoriasis (N=22)

Normal outcome

14

Elective abortion

1

Spontaneous abortion

2

Unknown, lost to follow-up

4

Birth defecta

1

All Mirikizumab (N=52)

Normal outcome

30

Elective abortion

1

Spontaneous abortion

8

Unknown lost to follow-up

10

Pregnancy still ongoing

2

Birth defecta

1

Abbreviations: n = number of events; N = number of participants in the specified category.

aThis was a preterm birth and the baby had Wolf–Hirschhorn syndrome.

Background Risk

All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.3

In the US general population, in clinically recognized pregnancies the estimated background risk of

  • major birth defects is 2% to 4%, and
  • miscarriage is 15% to 20%.3

Among patients with inflammatory bowel disease, results from observational studies indicate that the incidence of 

  • congenital malformations ranges from 2.7% to 9.0%, and 
  • spontaneous abortions ranges from 3% to 17%.3

Among patients with Crohn's disease, results from observational studies indicate that the incidence of 

  • congenital malformations ranges from 1.9% to 8.6%, and 
  • spontaneous abortions ranges from 4.4% to 15.9%.3

Mirikizumab Pregnancy Registry Information

There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mirikizumab during pregnancy in the United States.3

Information regarding a mirikizumab pregnancy exposure registry outside the United States is not currently available.3

References

1Omvoh 300 mg concentrate for solution for infusion [summary of product characteristics] Eli Lilly Nederland B.V., The Netherlands (UK)

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

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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: 26 January 2025

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