Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

University Hospital, Limoges53 enrolled

Overview

The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autoimmune Bullous Dermatose

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> or = 18 years. * Patient treated by Mycophénolate Mofétil (MMF) per os (Cellcept®) for an autoimmune bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according to the recommendations (PNDS Pemphigus and cicatricial pemphigoid HAS 2011) * Patient able to understand the nature, purpose and methodology of the study * Patient affiliated to the French social security system or equivalent * Patient who have signed an informed consent form Exclusion Criteria: * Pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration) * Patient under legal protection. * Patient deprived of freedom * Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.

Locations (3)

CHU de Bordeaux

Bordeaux, France

Hôpital Avicenne - AP-HP

Paris, France

CHU de Rouen

Rouen, France

Outcomes

Primary Outcomes

Evaluation of the Bayesian estimator performance

The evaluation of the Bayesian estimator performance will be based on its capacity to predict MPA AUC (Area Under the Curve), expressed as the bias (%) and the precision (root mean square error; RMSE) between the predicted AUC calculated using a limited number of samples performed in the first 4 hours post dosing and the observed AUC estimated using the reference method (trapezoidal rule method). A Bland Altman curve will be constructed.

Time frame: 8 hours