Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid

Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.

the main objects are :

1. to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
2. to avoid the use of corticosteroid in long time,
3. to evaluate duration of control disease and side effect with a single cycle of rituximab.

Inclusion Criteria:

• age >= 18 and < 80
• karnofsky >= 50%
• bullous pemphigoid clinical indication
• cortico-dependent bullous pemphigoid in relapse for the second time
• contraception used in female patient
• consent obtained from patient

Exclusion Criteria:

• localized bullous pemphigoid in relapse (<400cm2)
• pemphigoid of pregnancy
• dermatosis with IgA
• pemphigoid with mucous damage
• pregnant woman or nursing mother
• woman able to have a baby and without contraception during the clinical trial period
• age < 18 or > 80
• karnovsky < 50%
• significant disease or uncontrolled disease
• serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
• patient with depletion lymphocytic treatment or with initial rituximab treatment
• unstable angina or ischemic heart disease
• cardiac insufficiency
• cardiac rhythm trouble uncontrolled
• evolutive infection
• immunodepression
• neutrophil polynuclear in blood < 1.5 G/l and /or platelet blood concentration < 75G/l
• positive HIV serology
• positive hepatitis B and / or C serology
• concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
• no consentment
• antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
• antecedent of deep tissue infection occurred the previous year of inclusion