Skip to main content
OpenTrials
Completed

NCT Number: NCT06172426

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 11.5 years

Secondary outcomes

  1. Time from secukinumab initiation to the first PsA diagnosis

    Time frame: Up to 11.5 years

  2. Age

    Time frame: Baseline

  3. Gender

    Time frame: Baseline

  4. Region

    Time frame: Baseline

  5. Insurance type

    Time frame: Baseline

  6. Ethnicity

    Time frame: Baseline

  7. Weight

    Time frame: Baseline

  8. Height

    Time frame: Baseline

  9. Body mass index (BMI)

    Time frame: Baseline

  10. Prior treatments

    Time frame: Baseline

  11. Hard-to-treat locations

    Time frame: Baseline

  12. Comorbidities

    Time frame: Baseline

  13. Dermatology Life Quality Index (DLQI)

    Time frame: 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.

  14. Health Assessment Questionnaires - Disability Index (HAQ-DI)

    Time frame: 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).

  15. Psoriasis Area and Severity Index (PASI)

    Time frame: 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).

  16. Body Surface Area (BSA)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2023
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.