Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Study Overview
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Brief Summary
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Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity. BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time. Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months. Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

Detailed Description
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The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid

Official Title
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Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Conditions
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Bullous Pemphigoid

Intervention / Treatment
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* Drug: Ustekinumab


Participation Criteria
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Eligibility Criteria
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inclusion criteria : patient with bullous pemphigoid patient aged between 18 and 90 patient with Karnofsky Performance score > 60% patient agreed to participate to the study exclusion criteria : patient with allergy to corticosteroids patient with allergy to ustekinumab patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus malignancy < 5 years prior to inclusion pregnant or nursing (lactating) women, or women of child-bearing potential active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion history or presence of infection with hepatitis B or C. history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm ustekinumab<br>Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids | Drug: Ustekinumab<br>* Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions) | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bullous pemphigoid, ustekinumab, superpotent topical corticosteroids, efficacy, safety