An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source

NCT05368818 | Completed

• 1 other identifier: CAIN457AGB06
• Study Type: observational
• Target: 767
• Locations: 1 country
• Sites: 1

Brief Summary

This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.

Conditions

Plaque Psoriasis

Keywords

Cosentyx,; Secukinumab,; Quality of Life,; UK

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)

  Patient reported QoL for five specific DLQI domains from baseline up to 24 months of UK/ROI psoriasis patients enrolled in BADBIR who were initiated on secukinumab treatment were reported. Following 5 domains were included: * Embarrassment and/or self conciousness * Social leisure * Work/study * Problems relating to partner, friends and relatives * Sexual difficulties

  throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )

Secondary Outcomes (27)

• Age

  Baseline

• Sex

  Baseline

• Ethinicity

  Baseline

• Employment status

  Baseline

• Smoking Characteristics

  Baseline

Study Arms (2)

All patients

Included all patients prescribed an on-label secukinumab dose

Other: Secukinumab

Patients with Psoriatic Arthritis (PsA)

Included patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table

Other: Secukinumab

Interventions

Secukinumab OTHER

Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source

Also known as: Cosentyx

All patients; Patients with Psoriatic Arthritis (PsA)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The BADBIR registry included patients treated for psoriasis using biologics, conventional systemic therapies, or small molecule immunomodulators

You may qualify if:

• Age ≥18 years at initiation of secukinumab.
• At least one follow-up visit post-registry enrollment.
• On-label dosing of secukinumab of 300mg.
• Age ≥18 years at initiation of secukinumab.
• At least one follow-up visit post-registry enrollment.
• On-label dosing of secukinumab of 300mg.
• Diagnosis of PsA at baseline.

You may not qualify if:

• \- The patient did not meet the criteria stated above.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

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

Location

Related Links

• Results for CAIN457AGB06 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: May 5, 2022
• First Posted: May 10, 2022
• Study Start: December 7, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

US (1)