Randomized double blind trial of prednisolone and azathioprine, vs. prednisolone and placebo, in the treatment of pemphigus vulgaris. (15th October 2012)

• Record Type: Journal Article
• Authors: Chams‐Davatchi, C.; Mortazavizadeh, A.; Daneshpazhooh, M.; Davatchi, F.; Balighi, K.; Esmaili, N.; Akhyani, M.; Hallaji, Z.; seirafi, H.; Mortazavi, H.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 27:Number 10(2013:Oct.)
• Page Start: 1285
• Page End: 1292
• Publication Date: 2012-10-15
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/j.1468-3083.2012.04717.x
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <p> <bold>Background </bold> The classic treatment for pemphigus vulgaris is prednisolone. Immunosuppressive drugs can be used in association.</p> <p> <bold>Objective </bold> To compare the efficacy of Azathioprine in reducing the Disease Activity Index (DAI).</p> <p> <bold>Patients and methods </bold> A double blind randomized controlled study was conducted on 56 new patients, assigned to two therapeutic groups: (i) prednisolone plus placebo; (ii) prednisolone plus Azathioprine. Patients were checked regularly for 1 year. 'Complete remission' was defined as healing of all lesions after 12 months, and prednisolone <7.5 mg daily, (DAI ≤ 1). Analysis was done by 'Intention To Treat' (ITT) and 'Treatment Completed Analysis' (TCA).</p> <p> <bold>Results </bold> Both groups were similar in age, gender, disease duration, and DAI. Primary endpoint: By ITT and TCA, the mean DAI improved in both groups with no significant difference between them. The difference became significant for the last trimester (3 months; ITT: <italic>P</italic> = 0.033, TCA: <italic>P</italic> = 0.045). Secondary endpoint: The total steroid dose decreased significantly in both groups, with no significant difference between them, except for the last trimester (ITT: <italic>P</italic> = 0.011, TCA: <italic>P</italic> = 0.035). The mean daily steroid dose decreased gradually in both groups becoming statistically significant in favour of azathioprine, in the last trimester, especially at 12th months (ITT: <italic>P</italic> = 0.002, TCA: <italic>P</italic> = 0.005). Complete remission was significant at 12 months only for TCA (AZA/Control: 53.6%/39.9%, <italic>P</italic> = 0.043).</p> <p> <bold>Limitations </bold> Sample size was rather small to demonstrate all differences. Other limitations include the choice of primary and secondary endpoints and the unavailability to measure thiopurine methyltransferase activity.</p> <p> <bold>Conclusion </bold> Azathioprine helps to reduce prednisolone dose in long‐run.</p> </abstract>