Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, HS, secukinumab, NIS, LHUs
Brief summary
The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on secukinumab, healthcare resource utilization and the economic impact of HS in Italy.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Study participants eligible for inclusion in this study must meet all the following criteria: 1\. Male and Female patients who provide written informed consent and privacy form (ICF\&PF) to participate in the study. 2\. Aged ≥ 18 years at ICF\&PF signature. 3. Patients with moderate or severe HS (IHS4 and/or Hurley staging system, as assessed by the investigators) at index date. 4\. The start of secukinumab is within 30 days after the ICF\&PF signature (enrolment), as per local standard clinical practice. Patients were not treated with secukinumab before enrolment within the Managed Access Program (MAP). The initiation of secukinumab is based on dermatologist's own practice, regardless of study participation. For HRU and economic burden only: 5\. Patients who provide written ICF\&PF to allow the use of secondary (administrative) data for the purposes of this study. 6\. Patients with more than 12 months of residence inside the area of competence of the LHU (applicable only to study sites associated with the 6 LHUs).
Exclusion criteria
Study participants meeting any of the following criteria are not eligible for inclusion in this study: 7\. Participation in an ongoing clinical trial. 8. Any medical or psychological condition that may prevent study participation, based on practitioners' decision-making. For HRU and economic burden only: 9\. Patients will be excluded if the unique identifier does not allow them to be identified in the LHU administrative databases related to the site where they were enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period. | Baseline,6 months and 1 and 1,5 years after initiation of secukinumab | Proportion of patients achieving International Hidradenitis Suppurativa Severity Score System 55% reduction(IHS4-55) during the observational period. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | The proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing (q4w / q2w regimen), at 6 months, 1 and 1.5 years after initiation of secukinumab treatment. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS |
| Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100) | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS |
| Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75) | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | The Hidradenitis Suppurativa Clinical Response (HiSCR) is defined as a ≥ 50% reduction in total AN count (abscesses + inflammatory nodules), and no increase in abscesses or draining tunnels when compared with baseline. |
| Number, type, and localization of HS lesions | baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment | lesion spread is defined as total abscess and inflammatory nodule count (AN) or draining fistulae in a body region not seen at baseline |
| Change of total abscess and inflammatory nodule count | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | — |
| Proportion of patients receiving up-titration | Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Proportion of patients receiving up-titration (q4w-to-q2w) of secukinumab |
| Proportion of patients receiving down-titration | within 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Proportion of patients receiving down-titration (q2w-to-q4w) of secukinumab |
| Time to up-titration and down-titration | Up to 1.5 years | Time to up-titration (q4w-to-q2w) and down-titration (q2w-to-q4w) of secukinumab |
| Proportion of patients switching from q4w to q2w treatment | 6 months and 1.5 years after initiation of secukinumab treatment | Proportion of patients switching from q4w to q2w treatment with secukinumab after dose reduction. |
| Proportion of patients who receive more than one up- and/or down-titration | within 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Proportion of patients who receive more than one up- and/or down-titration of secukinumab |
| Demographics of adult patients with moderate or severe HS | Baseline | Descriptive statistics will be performed |
| Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score. | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment |
| Change in DLQI score from baseline | Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab | The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment |
| Clinical characteristics of adult patients with moderate to severe HS | Up to 1.5 years | Clinical characteristics of adult patients with HS moderate or severe |
| Proportion of patients with new draining tunnel | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Proportion of patients with new draining tunnel(s) (fistulae/sinuses) |
| Number of areas affected and proportion of patients with additional area involvement | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | — |
| Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab | Up to 1.5 years | Proportion of patient as per clinical practice |
| Time of initiation of concomitant medications | Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Time of initiation of concomitant medications (after the initiation of secukinumab) |
| Duration of treatment with concomitant medications | Up to 1.5 years | Duration of treatment with concomitant medications in a flexible dosing regimen of secukinumab |
| Proportion of patients undergoing tapering of concomitant medications | Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Proportion of patients undergoing tapering of concomitant medications in a flexible dosing regimen of secukinumab. |
| Number and type of surgical interventions | 6 months, 1 and 1.5 years after initiation of secukinumab | number and type of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home) in a flexible dosing regimen of secukinumab (q4w and q2w) |
| Reason for surgical intervention | Up to 1.5 years after initiation of secukinumab | — |
| Duration of discontinuation/pause of secukinumab treatment before surgery | Up to 1.5 years after initiation of secukinumab | — |
| Duration of discontinuation/pause of secukinumab treatment after surgery | Up to 1.5 years after initiation of secukinumab | — |
| Reduction in the number of surgical procedures | Up to 1.5 years after initiation of secukinumab | — |
| Identification of potential predictors using multivariable analysis | Up to 1.5 years after initiation of secukinumab treatment | — |
| Descriptive statistics of pain | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | Descriptive statistics of pain (Numerical Skin Pain Rating Scale). |
| Proportion of patients achieving a 30% reduction of Pain Numerical Rating scale (NRS30) | 6 months, 1 and 1.5 years after initiation of secukinumab treatment | The Numerical Skin Pain Rating Scale (NRS) is a scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her worst skin pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).To assess this, the patient should concentrate on the worst pain that his/her skin lesions has generated during the previous 24 hours. NRS30 is a specific threshold used in the assessment of pain reduction in patients with HS. It is defined as a ≥30% and ≥2-point reduction in skin pain on the NRS. |
| Number of patients with secukinumab AEs in routine clinical practice | Up to 1.5 years after initiation of secukinumab treatment | Number of patients with secukinumab adverse events (AEs) in routine clinical practice |
| Hospital Anxiety and Depression Scale [HADS] score | 6 months, 1 and 1.5 years after secukinumab initiation | The HADS is a widely used screening tool that helps to identify possible or probable instances of anxiety and depression among patients in non-psychiatric hospital settings. It consists of 14 items, with 7 items related to anxiety (HADS-A) and 7 related to depression (HADS-D), collecting how the patient was feeling in the previous week. Each item is scored from 0 to 3, leading to a maximum score of 21 for each subscale. The HADS is beneficial because it excludes somatic symptoms, which might be caused by physical health problems rather than psychological conditions. It is a quick, reliable, and valid measure that can be self-administered, making it a practical tool for clinicians. |
| Healthcare Resource Utilization of adult patients with HS | 2 months before and 12 months after secukinumab treatment initiation | describe Healthcare Resource Utilization of adult patients with HS 12 months before and 12 months after secukinumab treatment initiation with administrative claims data |
| Costs of HS covered by the Italian National Health System | 12 months before and 12 months after secukinumab treatment initiation | Costs of HS covered by the Italian National Health System (Servizio Sanitario Nazionale, SSN) with administrative Claims data |
| Direct costs not covered by the SSN and indirect costs of HS | 12 months before and 12 months after secukinumab treatment initiation | Direct costs not covered by the SSN and indirect costs of HS evaluated through a structured interview between physicians and patients. |
| Analysis on HS-related surgeries per patient and related direct costs covered by SSN | 12 months after secukinumab treatment initiation | HS-related surgeries and estimate direct costs of HS-related surgeries covered by the SSN during the period from the date of first HS diagnosis to 12 months after secukinumab treatment initiation with administrative Claims data |
Countries
Italy
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed