Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid

PR12042*

The study is an observational, multi-center, prospective, non-interventional and open-label data collection study assessing outcomes, treatment patterns, adverse events and costs in patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with a follow-up (observation period) of 1 year for each patient. Four dermatology centres in France will participate. The hypothesis to be answered by the study is that superpotent topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world life as recommended by French guidelines and whether this treatment influences the medical costs by comparison with systemic therapies (e.g. methotrexate or prednisone).

2013-09-26

2018-07-12

2018-12-31

Completed

149

Inclusion Criteria: * Written informed consent from the patient or a legally authorized representative person. * Patients affiliated to social security system * BP newly diagnosed according to the following criteria: i) suggestive clinical features; ii) histological picture of subepidermal blisters with an infiltrate of eosinophils in the superficial dermis; iii) presence of continuous, linear deposits of IgG and C3 deposits along the skin basement membrane zone by direct IF. * Patients: no prior superpotent topical steroid therapy or systemic treatment for BP for more than 2 weeks Exclusion Criteria: * BP in relapse * Pemphigoid of pregnancy

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 149, 'type': 'ACTUAL'}}

2024-02-23