TY - JOUR
T1 - A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus
AU - Beissert, Stefan
AU - Werfel, Thomas
AU - Frieling, Uta
AU - Böhm, Markus
AU - Sticherling, Michael
AU - Stadler, Rudolf
AU - Zillikens, Detlev
AU - Rzany, Berthold
AU - Hunzelmann, Nicolas
AU - Meurer, Michael
AU - Gollnick, Harald
AU - Ruzicka, Thomas
AU - Pillekamp, Hans
AU - Junghans, Volker
AU - Luger, Thomas
PY - 2006
Y1 - 2006
N2 - Objective: To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of pemphigus. Design: A prospective, multicenter, randomized, non-blinded 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. Main Outcome Measures: 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.
AB - Objective: To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of pemphigus. Design: A prospective, multicenter, randomized, non-blinded 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. Main Outcome Measures: 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.
UR - http://www.scopus.com/inward/record.url?scp=33751248497&partnerID=8YFLogxK
U2 - 10.1001/archderm.142.11.1447
DO - 10.1001/archderm.142.11.1447
M3 - Journal articles
C2 - 17116835
AN - SCOPUS:33751248497
SN - 0003-987X
VL - 142
SP - 1447
EP - 1454
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 11
ER -
