Assessment of the adjuvant effect of tacrolimus in the management of pemphigus vulgaris: A randomized controlled trial

J Dermatolog Treat. 2015 Feb;26(1):90-3. doi: 10.3109/09546634.2013.873763. Epub 2014 Feb 20.

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%).

Conclusion: 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.

Keywords: Autoimmune; azathioprine; bullous disease.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Azathioprine / administration & dosage
  • Azathioprine / adverse effects
  • Azathioprine / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Pemphigus / drug therapy*
  • Pemphigus / pathology
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prednisolone / therapeutic use
  • Prospective Studies
  • Tacrolimus / administration & dosage
  • Tacrolimus / adverse effects
  • Tacrolimus / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Glucocorticoids
  • Immunosuppressive Agents
  • Prednisolone
  • Azathioprine
  • Tacrolimus