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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368818
• Other study ID #: CAIN457AGB06
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: June 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age	Age was reported	Baseline
Secondary	Sex	Sex information was reported	Baseline
Secondary	Ethinicity	Ethinicity information was reported	Baseline
Secondary	Employment status	Employment status was reported	Baseline
Secondary	Smoking Characteristics	Smoking characteristics were reported	Baseline
Secondary	Weight	Weight information was reported	Baseline
Secondary	Height	Height information was reported	Baseline
Secondary	Body Mass Index (BMI)	BMI information was reported	Baseline
Secondary	Waist circumference	Waist information was reported	Baseline
Secondary	Absolute Psoriasis Area Severity Index (aPASI) at BL	aPASI scores were reported	Baseline
Secondary	Total Dermatology Life Quality Index (DLQI) at BL	Total DLQI score was reported	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of nails involved	Number of nails involved were reported	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Results for CAIN457AGB06 from the Novartis Clinical Trials Website