Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry

Completed

• Conditions: Psoriasis; Psoriatic Arthritis

• Registration Number: NCT06172426
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Primary Completion: 2022-12-07
• Study Completion: 2022-12-07
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1171

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab	Up to 11.5 years

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)	Baseline
Health Assessment Questionnaires - Disability Index (HAQ-DI)	Baseline	The HAQ-DI is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Ethnicity	Baseline
Height	Baseline
Prior treatments	Baseline
Psoriasis Area and Severity Index (PASI)	Baseline	The Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Weight	Baseline
Comorbidities	Baseline
Time from secukinumab initiation to the first PsA diagnosis	Up to 11.5 years
Age	Baseline
Gender	Baseline
Region	Baseline
Insurance type	Baseline
Hard-to-treat locations	Baseline
Dermatology Life Quality Index (DLQI)	Baseline	The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of skin disease on quality of life. The DLQI is rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30, and higher scores indicate more severe impact on quality of life.
Body Surface Area (BSA)	Baseline

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland