Hidradenitis Suppurativa
Conditions
Brief summary
This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.
Detailed description
This is a 24-week longitudinal single-arm prospective study based on data collected from EMRs along with patient-reported outcomes questionnaires (TSQM and DLQI) to evaluate patient-reported satisfaction and early quality of life experiences among HS patients who are newly initiated on Secukinumab. We will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative HS population across the United Arab Emirates. The data will be collected using an electronic Case Report Form (eCRF) from both data sources (Electronic Medical Report and Questionnaires).
Interventions
OTHERSecukinumab
This is an observational study. There is no treatment allocation.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3) * Male or Female adult patients ≥ 18 years of age at the time of data collection * Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent) * Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion. * Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion. * Agreed to sign an informed consent to be able to fill in the questionnaires.
Exclusion criteria
* Patients not fulfilling any of the abovementioned inclusion criteria. * Patient's refusal to be included in the study or refusal to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire | At Week 24 | TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction. 4 Domains: Effectiveness Side Effects Convenience Global Satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire | Baseline, Week 24 | DLQI is a questionnaire designed to measure the impact of skin conditions on a patient's health-related quality of life. It contains 10 simple, self-administered questions. Focuses on the past week's experiences related to the skin condition. Each question uses a 4-point Likert scale: "Not at all," "A little," "A lot," "Very much." |
| Change from baseline in the Numerical Rating Scale (NRS) | Baseline, Week 24 | The NRS is commonly used for measuring pain intensity and is well validated. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain imaginable). |
| Age (years) | Baseline | Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
| Gender (male/female) | Baseline | Characteristics of HS patients started on Secukinumab |
| Ethnicity | Baseline | Characteristics of HS patients started on Secukinumab |
| Weight (kilogram) | Baseline | Characteristics of HS patients started on Secukinumab |
| Height (meters) | Baseline | Characteristics of HS patients started on Secukinumab |
| Socio-economic status | Baseline | Characteristics of HS patients started on Secukinumab |
| Smoking status | Baseline | Characteristics of HS patients started on Secukinumab |
| Duration of the disease (time since diagnosis) | Baseline | Characteristics of HS patients started on Secukinumab |
| Previous HS-related treatment | Baseline | Characteristics of HS patients started on Secukinumab |
| Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab | Baseline | Characteristics of HS patients started on Secukinumab |
| Hurley Stage | Baseline | Characteristics of HS patients started on Secukinumab |
| Number of inflammatory nodules, number of abscesses, and fistulas | Baseline | Characteristics of HS patients started on Secukinumab |
| Previous HS-related surgeries | Baseline | Characteristics of HS patients started on Secukinumab |
| Previous use of biologic treatment | Baseline | Characteristics of HS patients started on Secukinumab |
| Previous and current use of antibiotics treatment | Baseline | Characteristics of HS patients started on Secukinumab |
Countries
United Arab Emirates
Outcome results
None listed