Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

N/AActive Not RecruitingNCT05921994

Novartis Pharmaceuticals436 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

436

Conditions

Hidradenitis Suppurativa

Interventions

secukinumabOTHER

Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (80)

Outcomes

Primary Outcomes

Proportion of patients receiving up-titration

Proportion of patients receiving up-titration (q4w-to-q2w)

Time frame: Up to 24 months

Proportion of patients receiving down-titration

Proportion of patients receiving down-titration (q2w-to-q4w)

Time frame: Up to 24 months

Time to up-titration and down-titration

Time frame: Up to 2 years

Duration of q4w treatment with secukinumab after dose reduction

Time frame: Up to 2 years

Proportion of patients who receive more than one up-and/or down titration

Time frame: Up to 24 months

Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

Time frame: Up to 2 years

Number and type of surgical interventions

Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient

Time frame: Up to 2 years

Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)

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

Data from ClinicalTrials.gov

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Rheinstetten, Baden-Wurttemberg, Germany

Novartis Investigative Site

Haßfurt, Bavaria, Germany

Novartis Investigative Site

Kulmbach, Bavaria, Germany

Novartis Investigative Site

Lauf an der Pegnitz, Bavaria, Germany

Novartis Investigative Site

Nuremberg, Bavaria, Germany

Novartis Investigative Site

Panketal, Brandenburg, Germany

Novartis Investigative Site

Hamburg, Free and Hanseatic City of Hamburg, Germany

Novartis Investigative Site

Lingen, Lower Saxony, Germany

Novartis Investigative Site

Bergen auf Rügen, Mecklenburg-Vorpommern, Germany

...and 70 more locations