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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Secukinumab

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.

• Study Type: Observational
• Enrollment (Actual): 767

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; Included all patients prescribed an on-label secukinumab dose	Other: Secukinumab; Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source; Other Names: Cosentyx
Patients with Psoriatic Arthritis (PsA); Included patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table	Other: Secukinumab; Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age was reported	Baseline
Sex	Sex information was reported	Baseline
Ethinicity	Ethinicity information was reported	Baseline
Employment status	Employment status was reported	Baseline
Smoking Characteristics	Smoking characteristics were reported	Baseline
Weight	Weight information was reported	Baseline
Height	Height information was reported	Baseline
Body Mass Index (BMI)	BMI information was reported	Baseline
Waist circumference	Waist information was reported	Baseline
Absolute Psoriasis Area Severity Index (aPASI) at BL	aPASI scores were reported	Baseline
Total Dermatology Life Quality Index (DLQI) at BL	Total DLQI score was reported	Baseline
DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline	DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline were reported	Baseline
DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline	DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline were reported	Baseline
DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline	DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline were reported	Baseline
DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline	DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline were reported	Baseline
DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline	DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline were reported	Baseline
Number of Biologic naïve/experienced patients	Patients were listed as being previously experienced to a biologic treatment if a drug name listed in 'Biologics_Drugname', was listed as a 'DrugName' in the DrugPastTherapy table. If a patient had no record of a biologic drugname in the DrugPastTherapy table, the patient was recorded as biologic naive.	Baseline
Number of Psoriatic Arthritis (PsA) patients	Patients were classified as Psoriatic Arthritis using the 'PsoriaticArthritis' flag in the Baseline_Psoriasis tables. (0=No, 1=Yes, Null=not entered).	Baseline
Time to PsA diagnosis	Time to PsA onset was calculated using the 'PsoriaticArthritisOnset' variable from the FupPsoriasis table and 'YearOnset' from the Baseline Psoriasis table. The time to PsA diagnosis was reported as the difference between 'PsoriaticArthritisOnset' minus 'YearOnset'.	Baseline
Number of patients with No PsA and nail involvement	Patients were classified as having nail involvement using the 'NailsNumber' variable from the Baseline_Psoriasis table	Baseline
Number of nails involved	Number of nails involved were reported	Baseline
Number of patients with at least one Comorbidity	Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity".	Baseline
Number of patients with five most common comorbidities at BL	Comorbidities were derived from the MedDRA Preferred Term (PT) variable in the BaselineComorbidities table. If a patient recorded at least one comorbidity, listed within the available data, this patient was recorded as "Has a comorbidity". The top 5 comorbidities at baseline were determined via highest frequency of occurrence by cohort and were reported for each subgroup	Baseline
Frequency of on-label 300mg prescription	Frequency of on-label 300mg prescription was categorized into the following, N/A (new convention for licensed dose), Once a week (induction), Once monthly & Once every four weeks. To determine if the patients were on-label, confirmation was required that the right dosage was being given; patients were included as on-label if they reported a dose value of 300 using the 'Dose' and the unit mg with the 'DoseUnit' variable in the DrugBiologicTherapy table. The frequency of prescription was assessed using the 'Frequency' variable and mapped in accordance with the following categories: N/A (new convention for licensed dose), Once a week (induction), Once monthly, once every four weeks or Not reported.	Baseline
Proportion of PsA subjects with a total DLQI score of >10	Proportion of PsA subjects with a total DLQI score of >10 at baseline achieving a score of 0 or 1 at 6-month intervals to 24 months (window of +/- 60 days), stratified by none, any, <5 nails, ≥5 nails or all nails involved at baseline was reported.	throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3	Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by none, any, <5 nails, ≥5 nails or all nails involved at baseline was reported.	throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3	Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3 at each 6-month interval up to 24 months (window of +/-60 days), stratified by patients being biologic naive or biologic experienced was reported.	throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CAIN457AGB06 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Secukinumab,; UK; Cosentyx,; Quality of Life,
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457AGB06