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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06172426
• Other study ID #: CAIN457A2026
• Status: Completed
• Start date: November 17, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1171
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

MarketScan® secukinumab cohort:

Inclusion criteria:

• Included patients with at least 1 secukinumab claim between 01 January 2015 and 30 June 2020 (index date is the first secukinumab claim)
• Included patients age =18 years as of the year of index date
• Included patients with at least 1 non-ruleout psoriasis diagnosis during 2 years of pre-index period
• Included patients with continuous medical/pharmacy coverage in the 2-year pre-index period
• Included patients with continuous medical/pharmacy coverage in the 1-year post-index period

Exclusion criteria:

• Excluded patients with any psoriatic arthritis diagnosis during 2 years to 5 years pre-index period, as well as on the index date
• Excluded patients with any biologics/apremilast including secukinumab claim during the 2-year pre-index (excluding index date)
• Excluded patients received other non-secukinumab biologics/apremilast during 6 months post index date period (including index date) (This criterion is only applicable for the secukinumab cohort) BADBIR cohort:

Inclusion criteria:

• Included non-switched patients with secukinumab treatment on or after the enrollment between 01 January 2017 to 01 September 2020
• Non-switched patients are those who did not use other biologics/apremilast treatments on the enrollment date
• Index date will be the date of the first secukinumab treatment date
• Included patients with age = 18 on the index date
• Included patients with psoriasis diagnosis in the pre-index period and index date
• Included patients with = 1 year follow-up period
• Follow-up period is the gap between patient's last visit date and index date

Exclusion criteria:

• Excluded patients with psoriatic arthritis (PsA) prior to and on index date
• Excluded patients with any biologics/apremilast including secukinumab in the baseline period

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab		Up to 11.5 years
Secondary	Time from secukinumab initiation to the first PsA diagnosis		Up to 11.5 years
Secondary	Age		Baseline
Secondary	Gender		Baseline
Secondary	Region		Baseline
Secondary	Insurance type		Baseline
Secondary	Ethnicity		Baseline
Secondary	Weight		Baseline
Secondary	Height		Baseline
Secondary	Body mass index (BMI)		Baseline
Secondary	Prior treatments		Baseline
Secondary	Hard-to-treat locations		Baseline
Secondary	Comorbidities		Baseline
Secondary	Dermatology Life Quality Index (DLQI)	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.	Baseline
Secondary	Health Assessment Questionnaires - Disability Index (HAQ-DI)	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).	Baseline
Secondary	Psoriasis Area and Severity Index (PASI)	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).	Baseline
Secondary	Body Surface Area (BSA)		Baseline