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

Novartis

Status: Completed

Conditions: Plaque Psoriasis

Treatments: Other: Secukinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05368818

CAIN457AGB06

Details and patient eligibility

About

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.

Full description

The BADBIR data was current up until the 31st August 2019 for this analysis.

Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.

Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.

Index date: Initiation of secukinumab treatment within the BADBIR database.

Enrollment: 767 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria for the biologic cohort:

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

Inclusion criteria for the PsA biologic cohort:

• 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.

Exclusion criteria

• The patient did not meet the criteria stated above.

Trial design

767 participants in 2 patient groups

All patients

Description:

Included all patients prescribed an on-label secukinumab dose

Treatment:

Other: Secukinumab

Patients with Psoriatic Arthritis (PsA)

Description:

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

Treatment:

Other: Secukinumab