Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.

Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab in Routine Clinical Practice in the United Arab Emirates: ILLUMINATE-HS, a Prospective Patient Surve

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Other: Secukinumab

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).

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Novartis Investigative Site
  • Ras al-Khaimah, United Arab Emirates
    • Novartis Investigative Site
  • Sharjah city, United Arab Emirates
    • Novartis Investigative Site
  • United Arab Emirates
    • Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab; Patients who are newly initiated on treatment with Secukinumab	Other: Secukinumab; This is an observational study. There is no treatment allocation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire	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	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire	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."	Baseline, Week 24
Change from baseline in the Numerical Rating Scale (NRS)	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).	Baseline, Week 24
Age (years)	Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab	Baseline
Gender (male/female)	Characteristics of HS patients started on Secukinumab	Baseline
Ethnicity	Characteristics of HS patients started on Secukinumab	Baseline
Weight (kilogram)	Characteristics of HS patients started on Secukinumab	Baseline
Height (meters)	Characteristics of HS patients started on Secukinumab	Baseline
Socio-economic status	Characteristics of HS patients started on Secukinumab	Baseline
Smoking status	Characteristics of HS patients started on Secukinumab	Baseline
Duration of the disease (time since diagnosis)	Characteristics of HS patients started on Secukinumab	Baseline
Previous HS-related treatment	Characteristics of HS patients started on Secukinumab	Baseline
Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab	Characteristics of HS patients started on Secukinumab	Baseline
Hurley Stage	Characteristics of HS patients started on Secukinumab	Baseline
Number of inflammatory nodules, number of abscesses, and fistulas	Characteristics of HS patients started on Secukinumab	Baseline
Previous HS-related surgeries	Characteristics of HS patients started on Secukinumab	Baseline
Previous use of biologic treatment	Characteristics of HS patients started on Secukinumab	Baseline
Previous and current use of antibiotics treatment	Characteristics of HS patients started on Secukinumab	Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; secukinumab
• Other Study ID Numbers: CAIN457AAE02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No