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


METHODS
A prospective, multicenter, randomized, nonblinded clinical trial to compare 2 parallel groups of patients with bullous pemphigoid undergoing different treatments.


METHODS
Thirteen departments of dermatology in Germany.


METHODS
Patients with bullous pemphigoid (n = 73) as evidenced by clinical lesions suggestive of bullous pemphigoid, signs of subepidermal blistering on histologic analysis of skin biopsy specimens, linear deposition of IgG and C3 along the dermoepidermal junction, and deposition of autoantibodies at the blister roof in split-skin analysis.


METHODS
Treatment with oral methylprednisolone plus azathioprine (azathioprine group) or oral methylprednisolone plus mycophenolate mofetil (mycophenolate mofetil group).


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


RESULTS
In 38 of 38 patients in the azathioprine group (100%), complete remission was achieved after a mean +/- SD of 23.8 +/- 18.9 days vs 42.0 +/- 55.3 days for 35 of 35 patients in the mycophenolate mofetil group (100%). In the azathioprine group, the median +/- SD total cumulative methylprednisolone dose used was 4967.0 +/- 12 190.7 mg vs 5754.0 +/- 9692.8 mg in the mycophenolate mofetil group. Nine of 38 patients in the azathioprine group (24%) experienced grade 3 or 4 adverse effects vs 6 of 35 patients in the mycophenolate mofetil group (17%). Azathioprine therapy induced significantly elevated liver function test results compared with mycophenolate mofetil (P < .001). Importantly, patients in the azathioprine group showed significantly higher toxicity grades for aspartate aminotransferase (P = .03), alanine aminotransferase (P = .03), and gamma-glutamyltransferase (P = .01) than did those in the mycophenolate mofetil group.


CONCLUSIONS
Mycophenolate mofetil or azathioprine demonstrate similar efficacy during treatment of bullous pemphigoid, and similar cumulative corticosteroid doses were given in both treatment arms to control disease. However, mycophenolate mofetil showed a significantly lower liver toxicity profile than azathioprine therapy.
Beissert
Stefan
S
Department of Dermatology, Von-Esmarch-Strasse 58, D-48149 Münster, Germany. beisser@uni-muenster.de
Werfel
Thomas
T
Frieling
Uta
U
Böhm
Markus
M
Sticherling
Michael
M
Stadler
Rudolf
R
Zillikens
Detlef
D
Rzany
Berthold
B
Hunzelmann
Nicolas
N
Meurer
Michael
M
Gollnick
Harald
H
Ruzicka
Thomas
T
Pillekamp
Hans
H
Junghans
Volker
V
Bonsmann
Gisela
G
Luger
Thomas A
TA
D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D001379:Azathioprine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010349:Patient Compliance; D010391:Pemphigoid, Bullous / Q000188:drug therapy*; D012008:Recurrence; D012074:Remission Induction
D000305:Adrenal Cortex Hormones; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D001379:Azathioprine; D008775:Methylprednisolone