Efficacy and Safety of Ustekinumab in Bullous Pemphigoid (PB-USTE)

CHU de Reims

Status and phase

Completed

Phase 2

Conditions

Bullous Pemphigoid

Treatments

Drug: Ustekinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04117932

PO19083

Details and patient eligibility

About

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.

Full description

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

Enrollment

18 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.