Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, HS, secukinumab, Germany, NIS
Brief summary
The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.
Detailed description
The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany. In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.
Interventions
OTHERsecukinumab
Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment: 1. Patients who provide written informed consent to participate in the study 2. Male and female patients with ≥18 years of age 3. Diagnosis of clinically unequivocal moderate to severe HS 4. Patients for whom a therapy with secukinumab is medically indicated 5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study 6. Treatment with secukinumab according to the latest version of SmPC 7. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit
Exclusion criteria
Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients: 1. Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC 2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation 3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab 4. Previous exposure to IL-17 inhibitors 5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving up-titration | Up to 24 months | Proportion of patients receiving up-titration (q4w-to-q2w) |
| Proportion of patients receiving down-titration | Up to 24 months | Proportion of patients receiving down-titration (q2w-to-q4w) |
| Time to up-titration and down-titration | Up to 2 years | Time to up-titration and down-titration |
| Duration of q4w treatment with secukinumab after dose reduction | Up to 2 years | Duration of q4w treatment with secukinumab after dose reduction |
| Proportion of patients who receive more than one up-and/or down titration | Up to 24 months | Proportion of patients who receive more than one up-and/or down titration |
| Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab | Up to 2 years | Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab |
| Number and type of surgical interventions | Up to 2 years | Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient |
| Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) | Up to 24 months | The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. 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 |
| mean change of International Hidradenitis Suppurativa Severity Score System (IHS4) | Up to 24 months | The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. 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 a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire | Up to 24 months | 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 such as eczema, psoriasis, acne, and viral warts. The 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) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment. |
| Mean reduction of Abscesses and inflammatory nodules (AN) count | Up to 24 months | Mean reduction of Abscesses and inflammatory nodules (AN) count |
| Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30) | Up to 24 months | The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their 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 pain that his/her skin lesions generate. The Patient's Global Assessment of Skin Pain - NRS will be completed by the subject electronically via a web-based application or in paper form. |
Countries
Germany
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed