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

Novartis Pharmaceuticals758 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

758

Conditions

Axial Spondyloarthritis Psoriatic Arthritis

Interventions

secukinumabDRUG

all patients who received secukinumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Valencia, Spain

Outcomes

Primary Outcomes

Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment

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.

Time frame: month 6