A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

A Cohort Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis Using Administrative Health Claims Database

The purpose of this study is to further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib; Biological: Any biologic treatment for psoriasis

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 171-0021
    • Local Institution
  • Tokyo, Japan
    • Medical Data Vision, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients identified from the Japanese healthcare claims database with psoriasis who have initiated either deucravacitinib or any biologic treatment for psoriasis

Description

Inclusion Criteria:

• Participants with prescriptions in deucravacitinib or any biologics as comparator group during the indexing period.
• Participants with at least one confirmed diagnosis of disease code for psoriasis within 12 months prior to the index date.
• Aged 18 years or older at the index date

Exclusion Criteria:

• Participants with prescription in deucravacitinib or any biologics as comparator group prior to the index date.
• Participants with fewer than 12 months of available claim records prior to the index date.
• Participants with no claims record within 1-year after the index date (no visit after the index date).
• Specific for serious infection: Participants who had at least one disease code of hospitalized infection in the 60 days period before the index date.
• Specific for malignancy: Participants who had at least one disease code of malignancy prior to the index date

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Participants receiving deucravacitinib treatment	Drug: Deucravacitinib; As per product label
Cohort 2; Participants receiving biologics treatment for psoriasis	Biological: Any biologic treatment for psoriasis; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant medical history	Baseline
Participant baseline demographics	Baseline
Incidence of serious infections	Up to 9-years
Incidence of malignancies	Up to 9-years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of serious infections excluding COVID-19	Up to 9-years
Incidence of serious infection of COVID-19	Up to 9-years
Incidence of opportunistic infections excluding tuberculosis and herpes zoster	Up to 9-years
Incidence of tuberculosis	Up to 9-years
Incidence of herpes zoster	Up to 9-years
Incidence of malignancies excluding non-melanoma skin cancer	Up to 9-years
Incidence of non-melanoma skin cancer	Up to 9-years
Incidence of solid tumors	Up to 9-years
Incidence of hematologic malignancies	Up to 9-years
Incidence of lymphoma	Up to 9-years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): November 30, 2031
• Study Completion (Estimated): November 30, 2031

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis (PsO)
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes