A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus.
OBJECTIVE
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of pemphigus.


METHODS
A prospective, multicenter, randomized, nonblinded clinical trial to compare 2 parallel groups of patients with pemphigus (pemphigus vulgaris and pemphigus foliaceus) treated with oral methylprednisolone plus azathioprine or oral methylprednisolone plus mycophenolate mofetil. Settings Thirteen departments of dermatology in Germany. Patients We included patients with pemphigus vulgaris (n = 33) or pemphigus foliaceus (n = 7) evidenced by clinical lesions suggestive of pemphigus, intraepidermal blistering on histological analysis of skin biopsy specimens, intercellular deposition of IgG within the epidermis, and immunoblot analysis findings for antidesmoglein 3 and/or antidesmoglein 1 autoantibodies.


METHODS
The cumulative total methylprednisolone doses and rate of remission. Secondary outcome measures were safety profiles and duration of remission.


RESULTS
In 13 (72%) of 18 patients with pemphigus receiving oral methylprednisolone and azathioprine, complete remission was achieved after a mean +/- SD of 74 +/- 127 days compared with 20 (95%) of 21 patients receiving oral methylprednisolone and mycophenolate mofetil in whom complete remission occurred after a mean +/- SD of 91 +/- 113 days. The total median cumulative methylprednisolone dose used was 8916 mg (SD, +/-29 844 mg) in the azathioprine group compared with 9334 mg (SD, +/-13 280 mg) in the mycophenolate group. In 6 (33%) of 18 patients treated with azathioprine, grade 3 or 4 adverse effects were documented in contrast to 4 (19%) of 21 patients who received mycophenolate mofetil. Conclusion Mycophenolate mofetil and azathioprine demonstrate similar efficacy, corticosteroid-sparing effects, and safety profiles as adjuvants during treatment of pemphigus vulgaris and pemphigus foliaceus.
Beissert
Stefan
S
Department of Dermatology, University of Münster, Münster, Germany.
Werfel
Thomas
T
Frieling
Uta
U
Böhm
Markus
M
Sticherling
Michael
M
Stadler
Rudolf
R
Zillikens
Detlev
D
Rzany
Berthold
B
Hunzelmann
Nicolas
N
Meurer
Michael
M
Gollnick
Harald
H
Ruzicka
Thomas
T
Pillekamp
Hans
H
Junghans
Volker
V
Luger
Thomas A
TA
D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001379:Azathioprine / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D005858:Germany; D006801:Humans; D007168:IMP Dehydrogenase / Q000037:antagonists & inhibitors; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010392:Pemphigus / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D007168:IMP Dehydrogenase; D009173:Mycophenolic Acid; D001379:Azathioprine; D008775:Methylprednisolone