acne inversa acne inversa
Conditions
Interventions
Bimekizumab (Bimzelx)
Sponsors
UCB Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis (assessed by the treating physician) of moderate to severe HS2. Patients for whom the physician’s decision has been made to initiate treatment withbimekizumab, in usual clinical practice conditions and in compliance with the bimekizumabSmPC.3. Patient’s age = 18 years4. Patients are treatment naïve to bimekizumab on the date of providing data consent(enrollment)5. Patients have the necessary language skills and the ability to read, understand, and thewillingness to complete the questionnaires electronically as per physician’s judgement.6. Evidence of a personally signed and dated data consent document indicating that the patienthas been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: 1. Patient is participating in an ongoing interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Based on the protocol document, the primary study parameter and outcome of the Hi-LiGHT study investigating bimekizumab treatment for hidradenitis suppurativa patients is:The proportion of patients achieving an IHS4-55 response (55% reduction in International Hidradenitis Suppurativa Severity Score System [IHS4] score from the Baseline Visit) at 6 months after the Baseline Visit.Specifically, the primary objective is stated as:"To describe HS severity as measured by the clinical outcome International Hidradenitis Suppurativa Severity Score System (IHS4)-55 (ie, 55% reduction in IHS4 score from the Baseline Visit) at 6 months after the Baseline Visit, in patients who are newly prescribed bimekizumab during routine clinical practice."The study will assess this primary outcome at the 6 month time point (Observational Point 6) compared to baseline in adult patients with moderate to severe hidradenitis suppurativa who are newly prescribed bimekizumab in routine clinical practice. | — |
Secondary
| Measure | Time frame |
|---|---|
| Based on the protocol document, the primary study parameter and outcome of the Hi-LiGHT study investigating bimekizumab treatment for hidradenitis suppurativa patients is:The proportion of patients achieving an IHS4-55 response (55% reduction in International Hidradenitis Suppurativa Severity Score System [IHS4] score from the Baseline Visit) at 6 months after the Baseline Visit.Specifically, the primary objective is stated as:"To describe HS severity as measured by the clinical outcome International Hidradenitis Suppurativa Severity Score System (IHS4)-55 (ie, 55% reduction in IHS4 score from the Baseline Visit) at 6 months after the Baseline Visit, in patients who are newly prescribed bimekizumab during routine clinical practice."The study will assess this primary outcome at the 6 month time point (Observational Point 6) compared to baseline in adult patients with moderate to severe hidradenitis suppurativa who are newly prescribed bimekizumab in routine clinical practice. Based on the protocol, the secondary outcomes of the Hi-LiGHT study investigating bimekizumab treatment for hidradenitis suppurativa patients include:Clinical HS outcomes over a 24-month period after the Baseline Visit, including:IHS4 score and IHS4-55/75/90/100 responsesHiSCR response for HiSCR50/75/90/100Number of lesions (nodules, abscesses, draining tunnels) and change from baselinePatient-reported outcomes over a 24-month period, including:Disease severity and symptoms measured by PGI-S-HS and HSSQHealth-related quality of life measured by DLQI and HiSQOLTreatment satisfaction measured by TSQM-9Patient benefit measured by PBIWork productivity measured by WPAI-SHPPatient characteristics at Baseline Visit, including demographics, previous treatment, disease level, burden of disease, and comorbidities.These secondary outcomes aim to provide a comprehensive assessment of clinical response, patient-reported outcomes, and patient characteristics in hidradenitis suppurativa patients treated w | — |
Countries
Austria, Denmark, France, Germany, Greece, Italy, Netherlands, Spain
Contacts
Public ContactJT Tasset
Parexel Nederland
Outcome results
None listed