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Completed

NCT Number: 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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

secukinumab

Other

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

Other names: Cosentyx

Primary outcomes

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

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

    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

Secondary outcomes

  1. Age

    Time frame: Baseline

    Age was reported

  2. Sex

    Time frame: Baseline

    Sex information was reported

  3. Ethinicity

    Time frame: Baseline

    Ethinicity information was reported

  4. Employment status

    Time frame: Baseline

    Employment status was reported

  5. Smoking Characteristics

    Time frame: Baseline

    Smoking characteristics were reported

  6. Weight

    Time frame: Baseline

    Weight information was reported

  7. Height

    Time frame: Baseline

    Height information was reported

  8. Body Mass Index (BMI)

    Time frame: Baseline

    BMI information was reported

  9. Waist circumference

    Time frame: Baseline

    Waist information was reported

  10. Absolute Psoriasis Area Severity Index (aPASI) at BL

    Time frame: Baseline

    aPASI scores were reported

  11. Total Dermatology Life Quality Index (DLQI) at BL

    Time frame: Baseline

    Total DLQI score was reported

  12. DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline

    Time frame: Baseline

    DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline were reported

  13. DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline

    Time frame: Baseline

    DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline were reported

  14. DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline

    Time frame: Baseline

    DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline were reported

  15. DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline

    Time frame: Baseline

    DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline were reported

  16. DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline

    Time frame: Baseline

    DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline were reported

  17. Number of Biologic naïve/experienced patients

    Time frame: Baseline

    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.

  18. Number of Psoriatic Arthritis (PsA) patients

    Time frame: Baseline

    Patients were classified as Psoriatic Arthritis using the 'PsoriaticArthritis' flag in the Baseline_Psoriasis tables. (0=No, 1=Yes, Null=not entered).

  19. Time to PsA diagnosis

    Time frame: Baseline

    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'.

  20. Number of patients with No PsA and nail involvement

    Time frame: Baseline

    Patients were classified as having nail involvement using the 'NailsNumber' variable from the Baseline_Psoriasis table

  21. Number of nails involved

    Time frame: Baseline

    Number of nails involved were reported

  22. Number of patients with at least one Comorbidity

    Time frame: Baseline

    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".

  23. Number of patients with five most common comorbidities at BL

    Time frame: Baseline

    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

  24. Frequency of on-label 300mg prescription

    Time frame: Baseline

    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.

  25. Proportion of PsA subjects with a total DLQI score of >10

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

    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.

  26. Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3

    Time frame: 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 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.

  27. Proportion of Psoriasis patients with an aPASI score of 0, <=1, <=2 or <=3

    Time frame: 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 at each 6-month interval up to 24 months (window of +/-60 days), stratified by patients being biologic naive or biologic experienced was reported.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 10, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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