Clinical trial NCT06172426: Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
Official title: Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 1171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab
timeFrame: Up to 11.5 years
Secondary outcomes:
measure: Time from secukinumab initiation to the first PsA diagnosis
timeFrame: Up to 11.5 years
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Region
timeFrame: Baseline
measure: Insurance type
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Prior treatments
timeFrame: Baseline
measure: Hard-to-treat locations
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline
measure: Health Assessment Questionnaires - Disability Index (HAQ-DI)
timeFrame: Baseline
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline
measure: Body Surface Area (BSA)
timeFrame: Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: