Treating pemphigus vulgaris with prednisone and mycophenolate mofetil: A Multicenter, randomized, placebo-controlled trial

Stefan Beissert, Daniel Mimouni, Amrinder J. Kanwar, Neil Solomons, Veena Kalia, Grant James Anhalt

Research output: Contribution to journalArticle

Abstract

Non-blinded trials of pemphigus vulgaris suggest that mycophenolate mofetil (MMF) may be beneficial. In a prospective, multicenter trial, outpatients with mild or moderate pemphigus vulgaris were randomized to MMF (2 or 3 g day-1) plus oral corticosteroids or placebo plus oral corticosteroids for 52 weeks. The primary end point was the proportion of patients in the placebo and combined MMF groups responding to treatment (absence of new, persistent oral or cutaneous lesions, and prednisone dose 10 mg day-1 from weeks 48 to 52). Of 96 randomized patients, 94 were given treatment and 75 completed the study. Treatment responses occurred in 40 of 58 patients (69.0%) in the combined MMF group and 23 of 36 (63.9%) in the placebo group (P0.6558, 95% confidence interval-17.4 to 27.6). MMF-treated patients showed faster and more durable responses. In post hoc analyses, more patients taking MMF showed sustained responses for 3 or 6 months than did placebo patients. MMF was well tolerated. Although MMF did not show an advantage on the primary end point, there seemed to be a beneficial treatment effect on several secondary end points, including time to response and duration of response. Thus, MMF may be a potentially useful agent in patients with mild or moderate pemphigus vulgaris.JID JOURNAL CLUB ARTICLE: For questions, answers, and open discussion about this article please go to http://www.nature.com/jid/journalclub.

Original languageEnglish (US)
Pages (from-to)2041-2048
Number of pages8
JournalJournal of Investigative Dermatology
Volume130
Issue number8
DOIs
StatePublished - Aug 2010

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Mycophenolic Acid
Pemphigus
Prednisone
Randomized Controlled Trials
Placebos
Adrenal Cortex Hormones
Proxy
Therapeutics
Multicenter Studies
Outpatients
Confidence Intervals
Skin

ASJC Scopus subject areas

  • Dermatology
  • Biochemistry
  • Cell Biology
  • Molecular Biology

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Treating pemphigus vulgaris with prednisone and mycophenolate mofetil : A Multicenter, randomized, placebo-controlled trial. / Beissert, Stefan; Mimouni, Daniel; Kanwar, Amrinder J.; Solomons, Neil; Kalia, Veena; Anhalt, Grant James.

In: Journal of Investigative Dermatology, Vol. 130, No. 8, 08.2010, p. 2041-2048.

Research output: Contribution to journalArticle

Beissert, Stefan ; Mimouni, Daniel ; Kanwar, Amrinder J. ; Solomons, Neil ; Kalia, Veena ; Anhalt, Grant James. / Treating pemphigus vulgaris with prednisone and mycophenolate mofetil : A Multicenter, randomized, placebo-controlled trial. In: Journal of Investigative Dermatology. 2010 ; Vol. 130, No. 8. pp. 2041-2048.
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