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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05677542
Enrollment
758
Registered
2023-01-10
Start date
2021-06-02
Completion date
2021-12-31
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis, Psoriatic Arthritis

Keywords

Axial spondyloarthritis;, Psoriatic Arthritis;, electronic health records;, natural language processing;, artificial intelligence

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.

Interventions

DRUGsecukinumab

all patients who received secukinumab

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatmentmonth 6Disease 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026