Clinical trial NCT05368818: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Cosentyx,
Secukinumab,
Quality of Life,
UK
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 767
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The BADBIR registry included patients treated for psoriasis using biologics, conventional systemic therapies, or small molecule immunomodulators

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)
timeFrame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Ethinicity
timeFrame: Baseline
measure: Employment status
timeFrame: Baseline
measure: Smoking Characteristics
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Absolute Psoriasis Area Severity Index (aPASI) at BL
timeFrame: Baseline
measure: Total Dermatology Life Quality Index (DLQI) at BL
timeFrame: Baseline
measure: DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline
timeFrame: Baseline
measure: DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline
timeFrame: Baseline
measure: DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline
timeFrame: Baseline
measure: DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline
timeFrame: Baseline
measure: DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline
timeFrame: Baseline
measure: Number of Biologic naïve/experienced patients
timeFrame: Baseline
measure: Number of Psoriatic Arthritis (PsA) patients
timeFrame: Baseline
measure: Time to PsA diagnosis
timeFrame: Baseline
measure: Number of patients with No PsA and nail involvement
timeFrame: Baseline
measure: Number of nails involved
timeFrame: Baseline
measure: Number of patients with at least one Comorbidity
timeFrame: Baseline
measure: Number of patients with five most common comorbidities at BL
timeFrame: Baseline
measure: Frequency of on-label 300mg prescription
timeFrame: Baseline
measure: Proportion of PsA subjects with a total DLQI score of >10
timeFrame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
measure: Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3
timeFrame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
measure: Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3
timeFrame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: