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

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.

It is defined as at least 25% increase in AN counts with a minimum increase of 2 relative to baseline

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.

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.

This will be assessed using a descriptive questionnaire that aimed at measuring the patient's health care resource utilization and economic impact of HS.

The HSPtGA consists in one question that evaluates how one patient ranked the severity of HS at the time of the routine visit.

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.

This is a comprehensive system for measuring health status and health-related quality of life and for producing utility scores.

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.

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.

The HSSA questionnaire includes 9 questions that evaluate the symptoms an HS participant may experience associated with HS.

The HSIA questionnaire includes 18 questions that evaluate the impacts an HS participant may experience associated with HS.

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.

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.