Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

Condition(s) studied

Investigational drug(s) / intervention(s)

Brodalumab: Brodalumab

Matched cohort: Matched cohort

Study summary

This is a phase IV, 12-month observational, prospective, open-label, multi-center study that will be conducted across approximately 50 sites in Canada for an estimated study duration of 32 months. All eligible adult participants who are enrolling into the SILIQ Patient Support Program (PSP) and initiating brodalumab as per routine care may be offered participation in the study. If the participant agrees, their verbal consent and details will be entered into the study platform by the enrolling physician so that the participant can access the electronic informed consent form. Participants who meet the eligibility criteria and provide electronic informed consent will be enrolled in the study. The study observation period will be 12 months (±15 days). Data will be collected on approximately 500 participants across academic and community centers.

Eligibility

Primary outcome measure(s)

• The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation. — baseline, 3 months, 6 months, 12 months
  The Dermatology Life Quality Index (DLQI) measure is self administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories, ranging from 0 (not at all or not relevant) to 3 (very much) assessing the impact of the disease over the last week. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater health-related quality-of-life impairment.
• The percentage change from baseline of the Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) component scores at 3 months, 6 months, and 12 months post-brodalumab initiation. — baseline, 3 months, 6 months, 12 months
  The Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) is a validated self-reported 6-item questionnaire that allows quantitative assessment of the effects of PsO on work productivity, daily activities, and classroom impairment. Scores are calculated as percentages of hours worked and percentages of productivity at work on workdays for respondents who are employed at the time of questionnaire completion.
• The percentage change from baseline of the Health Utility Index (HUI2) at 3 months, 6 months, and 12 months post-brodalumab initiation. — baseline, 3 months, 6 months, 12 months
  The Health Utility Index (HUI2) is a 15-item questionnaire that allows researchers to classify the health status of patients and consists of seven attributes (sensation, mobility, emotion, cognition, self-care, pain, and fertility). Health state levels for descriptive responses are converted to health utilities scores using single- and multi-attribute utility functions that consist of look-up tables and mathematical formulae. Utility values for HUI2 range from -0.03 to 1.00, where a value of 1.00 indicates perfect health and a score of 0.00 corresponds to death. Negative scores represent health states considered to be worse than death.
• The mean Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores at baseline, 3 months, 6 months, and 12 months post-brodalumab initiation. — baseline, 3 months, 6 months, 12 months
  The self-administered Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire is along 4 dimensions: medication effectiveness, side effects of use, convenience of use, and global/overall satisfaction. The scale for TSQM scores ranges from 0 (extremely dissatisfied) to 100 (extremely satisfied).

Trial sites (42)

+ 2 more sites — see the full list on the official registry below.

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