Evaluation of the efficasy of intralesional rituximab injection for remision of recalcitrant lesions in the patients with pemphigus vulgaris.

Tehran University of Medical Sciences0 个研究点目标入组 20 人开始时间: 待定最近更新: 2018年7月16日

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•suffering from pemphigus vulrais, confirmed by clinical, histoligical and immunological criteria.
•Skin or mucosal lesions with maximum diameter of 6 cm or 20 cm2 which are recalcitrant (means continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/d of prednisone equivalent with or without any of the following agents: cyclophosphamide 2 mg/kg/d for 12 weeks; azathioprine 2.5 mg/kg/d for12 weeks (if thiopurine s-methyltransferase level is normal); methotrexate 20 mg/wk for 12 weeks; or mycophenolate mofetil 3 g/d for 12 weeks.).
•Insufficient response to three times intralesional injection of triamcinolone acetonide or topical super potent corticosteroid for at least 1 month.
•no new lesion in recent 12 weeks.
•no cardiac or infectious contraindication to rituximab.
•oral steroid usage of <= 20 mg/d.

•Patients with active lesions (expansion of previous old lesions or new lesions in recent 12 weeks).
•Contraindications to rituximab (including hepatitis B, hepatitis C, progressive neurologic disease, angina, arrhythmia, herpes virus infection, CMV infection, acute pneumonia, renal diseases, lactation, hyperphosphatemia, hypocalcemia, hyperkalemia, anemia, low platelet or leukocyte count.
•Injection of intravenous rituximab in recent 6 months.

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