Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, HS, secukinumab, NIS, Saudi Arabia
Brief summary
This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.
Detailed description
This is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (EMRs) and patient-reported outcomes questionnaires (TSQM, DLQI, and NPRS-11) to evaluate patient-reported satisfaction and early QoL experiences among HS adult patients who are newly administering Secukinumab as per routine clinical practice. Data will be captured from both data sources (EMRs and Questionnaires) at the following time points (+/- 1 month): * Baseline (index date: initiation of Secukinumab), * 24 weeks. This is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative HS population across Saudi Arabia.
Interventions
OTHERSecukinmab
This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
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
1. Male or Female adult patients ≥18 years of age at the time of data collection. 2. Patient with a confirmed diagnosis of active moderate to severe HS. 3. Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label. 4. Patients can be using antibiotics or have undergone surgery as per routine clinical practice. 5. Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.
Exclusion criteria
1. Patients not fulfilling any of the above-mentioned inclusion criteria. 2. Patient's refusal to be included in the study or refusal to sign the ICF. 3. A history of off-label indication uses of biological treatment or JAK inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score in the Treatment Satisfaction Questionnaire (TSQM) | Week 24 | TSQM questionnaire consists of 14 questions with a score ranging from 0 to 100. The questionnaire has four subscales, effectiveness (3 questions), side Effects (5 questions), convenience (3 questions) and global Satisfaction (3 questions). TSQM scoring is calculated by each subscale, which ranges from 0 to 100, with higher scores indicating higher patient satisfaction with medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11) | Baseline, week 24 | NPRS-11 is a subjective measure representing pain intensity in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain) |
| Baseline characteristics-age | Baseline | Age at baseline (years) |
| Baseline characteristics - Ethnicity | Baseline | Assessment of Participant's ethnicity |
| Baseline characteristics - Socio-economic status | Baseline | Assessment of socio-economic status |
| Baseline characteristics - smoking status | Baseline | Assessment of smoking status |
| Baseline characteristics - Family history of HS | Baseline | Number of participants with family history of HS |
| Baseline characteristics - Duration of the disease | Baseline | Time since- symptom onset and/or diagnosis |
| Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire | Baseline, week 24 | The DLQI is a valid 10-item instrument used to measure the impact of skin diseases on a patient's quality of life. Each question is scored on a scale of 0 to 3, with 0 indicating not at all and 3 indicating very much. The total score ranges from 0 to 30, with a higher score indicating a greater impact on the patient's quality of life. |
| Baseline characteristics - previous HS-related surgeries | Baseline | Number of participants with Previous HS- related surgeries including surgery type |
| Baseline characteristics - Current or previous use of antibiotic treatment | Baseline | Number of participants with current or previous use of antibiotic treatment including antibiotic type. |
| Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment | Baseline | Time from diagnosis to start the first treatment and Time from diagnosis to start of Secukinumab |
| Baseline characteristics - concomitant medications | Baseline | Assessment of concomitant medications |
| Baseline characteristics - Hurley Stage | Baseline | Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe) |
| Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula | Baseline | Number of inflammatory nodules, abscesses and draining tunnels/fistula |
| Baseline characteristics - Previous HS-related treatment | Baseline | Number of participants with Previous HS- related treatment including treatment type |
Countries
Saudi Arabia
Contacts
Primary ContactNovartis Pharmaceuticals
Backup ContactNovartis Pharmaceuticals
Outcome results
None listed