Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia

Not yet recruiting

• Conditions: Hidradenitis Suppurativa (HS)

• Registration Number: NCT06785779
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-21
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Study Start: 2025-01-30
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Baseline characteristics - Current or previous use of antibiotic treatment	Baseline	Number of participants with current or previous use of antibiotic treatment including antibiotic type.
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.
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
Baseline characteristics - Previous HS-related treatment	Baseline	Number of participants with Previous HS- related treatment including treatment type
Baseline characteristics - previous HS-related surgeries	Baseline	Number of participants with Previous HS- related surgeries including surgery 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