title: Assessment of the adjuvant effect of tacrolimus in the management of pemphigus vulgaris: A randomized controlled trial.
abstract: Introduction: To investigate the therapeutic efficacy of tacrolimus compared with azathioprine in the treatment of pemphigus vulgaris.
  
  
  METHODS
  About 23 patients received prednisolone and azathioprine, and 23 patients prednisolone and tacrolimus for 6 months. Pemphigus activity scores, the time that new bulla formation stopped, the time corticosteroid was tapered, cumulative steroid dosage and medication side effects were analyzed.
  
  
  RESULTS
  In the control group, the new bulla formation was ceased after a mean ± SD of 11.8 ± 4.7 days, and steroid tapering was done after a mean ± SD of 28.3 ± 5.45 days. Of the 23 patients receiving prednisolone and tacrolimus, the new bulla formation was ceased after a mean ± SD of 12.9 ± 5.26 days, and steroid tapering was done after a mean ± SD of 28.2 ± 5.39 days. About 8.6% of patients did not reach remission in each group. In patients receiving azathioprine, life-threatening side effects were seen in 1 (4.7%), moderate side effects in 2 (9.5%) and mild side effects in 1 (4.7%). In patients receiving tacrolimus, moderate side effect was seen in 1 (5%) and mild in 1 (5%).
  
  
  CONCLUSIONS
  Tacrolimus effects are comparable to azathioprine as pemphigus vulgaris adjuvant treatment, also it has less severe side effects. Trial registration No. IRCT2012073010450N1 available at www.IRCT.ir.
authors.affiliation: Molecular Dermatology Research Center, Shiraz University of Medical Sciences , Shiraz , Iran.
authors.forename: Ladan
authors.initials: L
authors.lastname: Dastgheib
authors.forename: Maryam Sadat
authors.initials: MS
authors.lastname: Sadati
authors.forename: Mohammad
authors.initials: M
authors.lastname: Baghernejhad
mesh_terms: D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010392:Pemphigus / Q000188:drug therapy* / Q000473:pathology; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011239:Prednisolone; D001379:Azathioprine; D016559:Tacrolimus
keywords: Autoimmune; azathioprine; bullous disease