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

NCT06172426 | Completed

• 1 other identifier: CAIN457A2026
• Study Type: observational
• Target: 1,171
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab

  Up to 11.5 years

Secondary Outcomes (16)

• Time from secukinumab initiation to the first PsA diagnosis

  Up to 11.5 years

• Age

  Baseline

• Gender

  Baseline

• Region

  Baseline

• Insurance type

  Baseline

Study Arms (2)

MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort

BADBIR secukinumab cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 17, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

CH (1)