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NCT07881783
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Conditions: Plaque Psoriasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3718
Sponsor: Novartis Pharmaceuticals
Summary
The main aim of this study is to assess whether secukinumab treatment retention over 12 months in adult patients with moderate-to-severe plaque PsO receiving secukinumab in combination with a GLP-1 RA is non-inferior to that in patients receiving secukinumab monotherapy. The study will also evaluate adherence, long-term treatment retention, and healthcare resource utilization.
Eligibility Criteria
Inclusion criteria:
1. Age ≥18 years at index date.
2. At least one International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis code for plaque PsO (L40.0) in the 12 months prior to or on the index date; further specificity ensured by ≥2 diagnosis codes ≥30 days apart.
3. ≥12 months of continuous medical and pharmacy enrollment prior to the index date, with an allowable enrollment gap of up to 60 days.
4. A new user of secukinumab: no claim for secukinumab in the 12-month baseline period. Evidence of the prescription or administration of at least one dose of secukinumab (index date).
5. Concurrent-therapy cohort only: evidence of at least one prescription or administration claim for a GLP-1 RA (semaglutide, tirzepatide, lixisenatide, liraglutide, exenatide, or dulaglutide) within 28 days before or after the secukinumab index date. Evidence of gradual titration is permitted.
6. Monotherapy cohort only: no claim for any GLP-1 RA in the 12 months prior to and including the index date.
7. At least one medical or pharmacy claim after the index date.
Exclusion criteria:
1. Missing or invalid patient identifier, year of birth, or sex in the data source.
2. Evidence of another biologic therapy approved for PsO with exposure overlapping the secukinumab index date. Patients switching from a prior biologic to secukinumab are allowed if the prior biologic was discontinued before the index date and there is no overlapping claim or administration on the index date.
3. At least one diagnosis code for type 1 diabetes mellitus (T1DM) during the 12-month baseline period or on the index date.
Source: ClinicalTrials.gov (NCT07881783). StuddyBuddy aggregates publicly available trial information.