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.
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
767
Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source
Novartis Investigative Site
East Hanover, New Jersey, United States
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
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019 )
Age
Age was reported
Time frame: Baseline
Sex
Sex information was reported
Time frame: Baseline
Ethinicity
Ethinicity information was reported
Time frame: Baseline
Employment status
Employment status was reported
Time frame: Baseline
Smoking Characteristics
Smoking characteristics were reported
Time frame: Baseline
Weight
Weight information was reported
Time frame: Baseline
Height
Height information was reported
Time frame: Baseline
Body Mass Index (BMI)
BMI information was reported
Time frame: Baseline
Waist circumference
Waist information was reported
Time frame: Baseline
Absolute Psoriasis Area Severity Index (aPASI) at BL
aPASI scores were reported
Time frame: Baseline
Total Dermatology Life Quality Index (DLQI) at BL
Total DLQI score was reported
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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'.
Time frame: 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
Time frame: Baseline
Number of nails involved
Number of nails involved were reported
Time frame: 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".
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: throughout the study, approximately 4 years (1st July 2015 to 31st August 2019)
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