Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness

Study Overview
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Brief Summary
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This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).

Official Title
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Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on Hidradenitis Suppurativa (HS) Burden of Illness and Health Care Resources Utilization

Conditions
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Hidradenitis Suppurativa (HS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment Need a change in ongoing therapy for any reason, but not limited to inadequate response, intolerance, sub-optimal compliance, or patient preference. Patient will be approached to participate in the study after a decision to change patient's therapy for Humira® is made by the treating physician. Has provided written informed consent (Patient Authorization) for participation in the study Exclusion Criteria: Is participating in a clinical interventional study Was treated with Humira®, or any other biologic agents for HS prior to baseline visit Has any other active skin disease or condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of HS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving adalimumab/ Humira®<br>Participants with HS for whom a change in treatment to Humira® is made by the treating physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24 | The HiSCR measure is defined as at least a 50% reduction in the Abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who experience flare | It is defined as at least 25% increase in AN counts with a minimum increase of 2 relative to baseline | Up to Week 52 | 
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) | The HADS questionnaire includes 14 questions that evaluate the level of anxiety and depression an HS patient may experience associated with HS. A lower score indicates less severity. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in International Index of Erectile Function (IIEF) | The IIEF contains 15 questions that were assigned in 5 domains of male sexuality: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS | This will be assessed using a descriptive questionnaire that aimed at measuring the patient's health care resource utilization and economic impact of HS. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in Patient Global Assessment of HS (HS-PtGA) | The HSPtGA consists in one question that evaluates how one patient ranked the severity of HS at the time of the routine visit. | From Week 0 (baseline) to Week 52 | 
| Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52 | The HiSCR measure is defined as at least a 50% reduction in the Abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. | At Week 52 | 
| Change from Baseline in Health Utility Index Mark 3 (HUI3) | This is a comprehensive system for measuring health status and health-related quality of life and for producing utility scores. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in Female Sexual Function Index (FSFI) | The FSFI questionnaire contains 19 questions that describe the female sexual function in 6 domains. The domains are: desire, arousal, lubrication, orgasm, satisfaction, and pain, which can both be evaluated individually and in their entirety. | From Week 0 (baseline) to Week 52 | 
| Proportion of participants who experience worsening of HS by >= 1 Hurley Stage in >= 1 affected anatomic region | This will be done by evaluating the Hurley Stage using the following description: Stage I: Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II: One or more widely separated recurrent abscesses with tract formation and cicatrization (scars). Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Up to Week 52 | 
| Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) | The HSSA questionnaire includes 9 questions that evaluate the symptoms an HS participant may experience associated with HS. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) | The HSIA questionnaire includes 18 questions that evaluate the impacts an HS participant may experience associated with HS. | From Week 0 (baseline) to Week 52 | 
| Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI: SHP) | The WPAI: SHP evaluates four areas: percent work time missed due to HS, percent impairment while working due to HS, percent overall work impairment due to HS, and percent activity impairment due to HS. | From Week 0 (baseline) to Week 52 | 
| Number of days where participants experience HS flare-up | It is calculated from the day when flare is observed to the day prior to the observation that flare is no longer present. Of note, there could be multiple periods that flares are observed, in which case, the total days from the multiple periods will be used. | Up to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis Suppurativa (HS), Humira®, Canada