Evaluation of the Effectiveness of Secukinumab in Patients With Moderate to Severe Plaque Psoriasis

NCT05344482 | Completed

• 1 other identifier: CAIN457ATR02
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training \& Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021.

Conditions

Plaque Psoriasis

Keywords

Secukinumab,; real life,; PASI,; effectiveness,; anti-IL17

Outcome Measures

Primary Outcomes (1)

• Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52

  PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Assessment of the effectiveness of secukinumab in subjects with moderate to severe plaque psoriasis was performed based on the percentage of patients who had absolute PASI ≤3 at week 52 in Turkey.

  at week 52

Secondary Outcomes (13)

• Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline

  at week 4

• Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline

  at week 16

• Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16

  at week 16 and week 52

• Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline

  at week 52

• Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients

  at week 52

Study Arms (1)

Overall cohort: Secukinumab

Included all the patients treated with secukinumab

Other: Secukinumab

Interventions

Secukinumab OTHER

Included all the patients treated with secukinumab

Overall cohort: Secukinumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adults diagnosed as chronic plaque psoriasis with no previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, whose PASI score was ≥10 before initiation of secukinumab in whom secukinumab had been initiated for at least 52 weeks before data collection date.

You may qualify if:

• A diagnosis of psoriasis
• Age ≥ 18 years at registry baseline.
• Patients with a firm diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
• Secukinumab treatment should be initiated 52 weeks before data collection date
• Moderate to severe plaque psoriasis with PASI score of ≥10 before initiating secukinumab.

You may not qualify if:

• Patients diagnosed with others types of psoriasis (pustular psoriasis, erythrodermic psoriasis etc) are excluded.
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CAIN457ATR02 from the Novartis Clinical Trials Website

MeSH Terms

Interventions

secukinumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: July 9, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

US (1)