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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 1171

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Novartis

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort
BADBIR secukinumab cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Height		Baseline
Weight		Baseline
Gender		Baseline
Age		Baseline
Ethnicity		Baseline
Body mass index (BMI)		Baseline
Time from secukinumab initiation to the first PsA diagnosis		Up to 11.5 years
Region		Baseline
Insurance type		Baseline
Prior treatments		Baseline
Hard-to-treat locations		Baseline
Comorbidities		Baseline
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
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
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
Body Surface Area (BSA)		Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457A2026