Study identification

EU PAS number

EUPAS1000000338

Study ID

1000000338

Official title and acronym

The Risk of Serious Infections with Mirikizumab versus Other Biologics among Patients with Ulcerative Colitis: A Secondary Database Study in Japan

DARWIN EU® study

No

Study countries

Japan

Study description

On 27 March 2023, mirikizumab, a monoclonal antibody that binds to and inhibits IL-23, was authorized in Japan for the treatment of adult patients with moderate to severe ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to conventional therapy.

It is reported that UC is associated with an increased risk of infections partially due to impairments of the immune system and use of immunosuppressive medications. Although no increased risk of serious infections comparing mirikizumab and placebo was observed among patients with UC in phase 3 clinical trials, mirikizumab may increase the risk of infections given its pharmacological mechanisms. Furthermore, it is largely unknown whether mirikizumab use, compared with other biologics, is associated with an increased risk of serious infections in routine clinical practice.

Therefore, the objective of this safety study is to examine the incidence of serious infections among patients with a diagnosis of UC who are exposed to mirikizumab compared to patients with a diagnosis of UC who are exposed to other biologics indicated for the treatment of UC in real world clinical practice in Japan.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Jiayi Dong

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only