Clinical trial NCT06952465: A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis (PsO)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Participant baseline demographics
timeFrame: Baseline
measure: Participant medical history
timeFrame: Baseline
measure: Incidence of serious infections
timeFrame: Up to 9-years
measure: Incidence of malignancies
timeFrame: Up to 9-years
Secondary outcomes:
measure: Incidence of serious infections excluding COVID-19
timeFrame: Up to 9-years
measure: Incidence of serious infection of COVID-19
timeFrame: Up to 9-years
measure: Incidence of opportunistic infections excluding tuberculosis and herpes zoster
timeFrame: Up to 9-years
measure: Incidence of tuberculosis
timeFrame: Up to 9-years
measure: Incidence of herpes zoster
timeFrame: Up to 9-years
measure: Incidence of malignancies excluding non-melanoma skin cancer
timeFrame: Up to 9-years
measure: Incidence of non-melanoma skin cancer
timeFrame: Up to 9-years
measure: Incidence of solid tumors
timeFrame: Up to 9-years
measure: Incidence of hematologic malignancies
timeFrame: Up to 9-years
measure: Incidence of lymphoma
timeFrame: Up to 9-years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Medical Data Vision, Inc
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: