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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The patient did not meet the criteria stated above.
结局指标
主要结局
Proportion of patients reporting high/very high QoL changes from Baseline (BL) (from 2 or 3 at BL to 0)
时间窗: 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
次要结局
- Height(Baseline)
- Absolute Psoriasis Area Severity Index (aPASI) at BL(Baseline)
- Sex(Baseline)
- Employment status(Baseline)
- Smoking Characteristics(Baseline)
- Waist circumference(Baseline)
- Total Dermatology Life Quality Index (DLQI) at BL(Baseline)
- Proportion of PsA patients with an aPASI score of 0, <=1, <=2 or <=3(throughout the study, approximately 4 years (1st July 2015 to 31st August 2019))
- Ethinicity(Baseline)
- DQLI Domain - 2) embarrassment and/or self-consciousness - proportion of those who reported high or very high at baseline(Baseline)
- Number of patients with at least one Comorbidity(Baseline)
- Age(Baseline)
- Weight(Baseline)
- Body Mass Index (BMI)(Baseline)
- Number of Biologic naïve/experienced patients(Baseline)
- Time to PsA diagnosis(Baseline)
- Number of patients with No PsA and nail involvement(Baseline)
- Number of nails involved(Baseline)
- Frequency of on-label 300mg prescription(Baseline)
- DQLI Domain - 5) social and leisure activities - proportion of those who reported high or very high at baseline(Baseline)
- DQLI Domain - 7) work/study - proportion of those who reported high or very high at baseline(Baseline)
- DQLI Domain - 8) problems relating to partner, friends, and relatives - proportion of those who reported high or very high at baseline(Baseline)
- DQLI Domain - 9) sexual difficulties - proportion of those who reported high or very high at baseline(Baseline)
- Number of patients with five most common comorbidities at BL(Baseline)
- Number of Psoriatic Arthritis (PsA) patients(Baseline)
- Proportion of PsA subjects with a total DLQI score of >10(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(throughout the study, approximately 4 years (1st July 2015 to 31st August 2019))