title: A randomized double-blind trial of intravenous immunoglobulin for bullous pemphigoid.
abstract: BACKGROUND
  Patients with steroid-resistant bullous pemphigoid (BP) require an appropriate treatment option.
  
  
  OBJECTIVE
  A multicenter, randomized, placebo-controlled, double-blind trial was conducted to investigate the therapeutic effect of high-dose intravenous immunoglobulin (IVIG; 400mg/kg/day for 5days) in BP patients who showed no symptomatic improvement with prednisolone (≥0.4mg/kg/day) administered.
  
  
  METHODS
  We evaluated the efficacy using the disease activity score on day15 (DAS15) as a primary endpoint, and changes in the DAS over time, the anti-BP180 antibody titer, and safety for a period of 57days as secondary endpoints.
  
  
  RESULTS
  We enrolled 56 patients in this study. The DAS15 was 12.5 points lower in the IVIG group than in the placebo group (p=0.089). The mean DAS of the IVIG group was constantly lower than that of the placebo group throughout the course of observation, and a post hoc analysis of covariance revealed a significant difference (p=0.041). Furthermore, when analyzed only in severe cases (DAS≥40), the DAS15 differed significantly (p=0.046). The anti-BP180 antibody titers showed no difference between the two groups.
  
  
  CONCLUSIONS
  IVIG provides a beneficial therapeutic outcome for patients with BP who are resistant to steroid therapy.
authors.affiliation: Department of Dermatology, Keio University School of Medicine, 35 Shinano-machi, Shinjuku-ku, Tokyo 160-8582, Japan. Electronic address: amagai@med.keio.ac.jp.
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mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001323:Autoantibodies / Q000097:blood; D001324:Autoantigens / Q000276:immunology; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D024041:Non-Fibrillar Collagens / Q000276:immunology; D010391:Pemphigoid, Bullous / Q000276:immunology / Q000628:therapy*; D011239:Prednisolone / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome; D000097805:Collagen Type XVII
chemical_list: D001323:Autoantibodies; D001324:Autoantigens; D005938:Glucocorticoids; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D024041:Non-Fibrillar Collagens; D011239:Prednisolone; D000097805:Collagen Type XVII
keywords: Autoantibody; Autoimmune disease; Bullous pemphigoid; IgG; Intravenous immunoglobulin; Treatment