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Analysis of the Risk of Developing Autoimmune Diseases Associated with the Use of Biologic Agents Targeting Type 2 Immunity: An Observational Study Using Routinely Collected Health Data

Analysis of the Risk of Developing Autoimmune Diseases Associated with the Use of Biologic Agents Targeting Type 2 Immunity: An Observational Study Using Routinely Collected Health Data - Association Between Anti-Type 2 Immunity Agents and the Onset of Autoimmune Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057238
Enrollment
1000000
Registered
2025-03-07
Start date
2025-02-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis, Bronchial asthma, Chronic urticaria, Eosinophilic chronic rhinosinusitis

Interventions

None listed

Sponsors

JMDC Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In this study, we will use the JMDC database. Patients diagnosed with atopic dermatitis (AD), bronchial asthma (BA), chronic urticaria (CU), or eosinophilic chronic rhinosinusitis (ECRS) after April 2018 were included. This cutoff date was chosen based on the most recent approval date among the exposure drugs (mepolizumab, benralizumab, dupilumab, and omalizumab). The definition for AD and BA required at least two diagnoses with an interval of 1-12 months, along with related medication, based on a previous validation study. For CU and ECRS, at least two recorded diagnoses with an interval of 1-12 months were required. The first diagnosis was defined as the index date (day 0). After that, patients were required to have continuous enrollment for >=365 days, no history of the exposure drugs, be aged >=18 years, and have at least one visit after day 0. For each outcome, patients with a pre-existing diagnosis of the relevant condition were excluded from the analysis.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
The composite outcome of the following autoimmune diseases: Rheumatoid arthritis, systemic erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, polymyalgia rheumatica, ANCA-associated vasculitis, large vessel vasculitis, polyarteritis nodosa, psoriasis

Secondary

MeasureTime frame
The components of the primary outcome

Countries

Japan

Contacts

Public ContactShoichiro Inokuchi

JMDC Inc. Real World Evidence Division, Pharmaceutical Business Unit

shoichiro.inokuchi.nhy@jmdc.co.jp03-5733-5010

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026