Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Completed

• Conditions: Axial Spondyloarthritis; Psoriatic Arthritis
• Interventions: Drug: secukinumab

• Registration Number: NCT05677542
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 758

Inclusion Criteria

• Aged ≥ 18 years.
• Diagnosed with axSpA or PsA.
• Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
• Had at least 3 months follow up from first bDMARD administration.
• Patients with EHRs.

Exclusion Criteria

• Receiving bDMARD within a clinical trial from January 2018 to data collection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriatic Arthritis Patients	secukinumab	Patients with Psoriatic Arthritis
Axial Spondyloarthritis Patients	secukinumab	Patients with Axial Spondyloarthritis

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment	month 6	Disease control was defined as: For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score \< 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1 was used.; For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score \< 14. If DAPSA was not available, Disease activity score 28 (DAS-28) \< 3.2 was used.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Valencia, Spain