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Mycophenolate Mofetil Benefits Patients With Pemphigus Vulgaris: Presented at EADV

By Jenny Powers

BERLIN -- October 13, 2009 -- Mycophenolate mofetil (MMF) offers an effective and well-tolerated long-term treatment for patients with mild to moderate pemphigus vulgaris (PV) researchers reported here at the 18th Congress of the European Academy of Dermatology and Venereology (EADV).

PV is a somewhat rare bullous autoimmune disorder of the skin and mucous membranes, but is characterised by a steadfast progression and a high mortality rate. The progression may be slowed by high-dose corticosteroid therapy, but long-term use of these agents is not tolerated.

An international team of researchers headed by Stefan Beissert, MD, University of Münster, Münster, Germany, conducted the first multicentre trial of mycophenolate mofetil as an alternative to steroid treatment for PV. The results of the study were presented here on October 8.

The primary endpoint of this 52-week study was to determine the efficacy and safety of MMF in achieving remission -- defined as "no new persistent lesions at 1 year that were present at week 48, plus prednisone dose of 10 mg/day or less from weeks 48-52."

The secondary endpoints were time to initial response, time to relapse, steroid tapering, and adverse events.

The MMF arm was comprised of 58 patients; 21 received 2 g/day, 37 received 3 g/day, and 36 patients received prednisone plus placebo. The study was completed by 79.3% of the MMF patients and 80.6% of the placebo subjects.

The response to treatment was similar in both the MMF group and the placebo group: 40 responders of 58 (69.0%) versus 23 out of 36 (63.9%), respectively (P = .66). An initial response was seen sooner, however, in MMF-treated patients, who also demonstrated later relapse time and were stable for more mean days with 10 mg/day prednisone compared with placebo subjects.

Both groups had similar incidences of adverse events, but MMF patients reported fewer serious adverse events (4 of 58 patients [6.9%] vs 4 of 36 patients [11.1%]) and fewer adverse events leading to withdrawal (1 out of 58 patients [1.7%] vs 3 out of 36 patients [8.3%]).

Dr. Beissert and colleagues concluded that this first international, placebo-controlled study demonstrated promise for the use of MMF in the treatment of patients with mild to moderate PV, and that MMF was well tolerated.

Funding for this study was provided by Vifor Pharma as part of the Roche-Aspreva Collaboration Agreement.

[Presentation title: Mycophenolate Mofetil - a Well-Tolerated, Long-Term Treatment Option for Active Pemphigus Vulgaris: Results From the First International, Double-Blind, Placebo-Controlled Trial. Abstract P144]

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