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

AbstractUNLABELLED:
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.
AuthorsLadan Dastgheib, Maryam Sadat Sadati, Mohammad Baghernejhad
JournalThe Journal of dermatological treatment (J Dermatolog Treat) Vol. 26 Issue 1 Pg. 90-3 (Feb 2015) ISSN: 1471-1753 [Electronic] England
PMID24552352 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
Chemical References
  • Glucocorticoids
  • Immunosuppressive Agents
  • Prednisolone
  • Azathioprine
  • Tacrolimus
Topics
  • Adult
  • Aged
  • Azathioprine (administration & dosage, adverse effects, therapeutic use)
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Glucocorticoids (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Immunosuppressive Agents (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Pemphigus (drug therapy, pathology)
  • Prednisolone (administration & dosage, adverse effects, therapeutic use)
  • Prospective Studies
  • Tacrolimus (administration & dosage, adverse effects, therapeutic use)
  • Treatment Outcome
  • Young Adult

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