Clinical trial NCT00431119: Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
Official title: A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bullous Pemphigoid
Keywords: bullous autoimmune disease
bullous pemphigoid
immunosuppressants
corticosteroids
mycophenolate mofetil
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2007-02-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.

Detailed description: This multicenter randomized, non-blinded clinical trial compared two parallel groups of patients with bullous pemphigoid treated with oral methylprednisolone in combination with either azathioprine or mycophenolate mofetil. Patients were randomly assigned, irrespective of severity of disease, to receive either 0.5 mg per kg body weight (BW) methylprednisolone (Urbason®, Aventis Pharma, Bad Soden, Germany) with 2 mg per kg BW azathioprine sodium (Imurek®, GlaxoSmithKline, Munich, Germany) once daily or 0.5 mg per kg BW methylprednisolone once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany), given twice daily (2 g/d). The initial dose was maintained until blister formation ceased, crusts as well as erosions disappeared, and re-epithelialization of previous lesions started. The corticosteroid dose was then sequentially reduced by 10 mg every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5 mg-steps every two weeks until 10 mg per day. Afterwards, corticosteroid reduction was performed in 2.5 mg-steps every two weeks until zero. After discontinuation of corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial dosage as monotherapy for an additional 4 weeks. Subsequently, azathioprine was reduced by 0.5 mg per kg BW every four weeks to a dose of 100 mg per day. Thereafter, azathioprine was tapered in 25 mg-steps every four weeks until discontinuation of treatment. Mycophenolate mofetil was reduced in 500 mg/d-steps every four weeks to 1,000 mg per day. From then on the mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until discontinuation of treatment.

Eligibility criteria: Inclusion Criteria:

* clinical lesions suggestive of bullous pemphigoid
* subepidermal blistering upon histological analysis of skin biopsies
* linear deposition of IgG and C3 along the dermo-epidermal junction
* deposition of autoantibodies at the blister roof upon split-skin analysis

Exclusion Criteria:

* treatment with oral or topical corticosteroids, and other immunosuppressive drugs during the previous four weeks

Primary outcomes:
measure: The cumulative total methylprednisolone doses and rate of remission.
Secondary outcomes:
measure: Secondary outcome measures were safety profiles and duration of remission.
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Dermatology, Univ. of Cologne
city: Dresden
country: Germany
facility: Dermatology, Univ. of Dresden
city: Duesseldorf
country: Germany
facility: Dermatology, Univ. of Duesseldorf
city: Goettingen
country: Germany
facility: Dermatology, Univ. of Goettingen
city: Hannover
country: Germany
facility: Dermatology, Univ. Hospital Hannover
city: Kiel
country: Germany
facility: Dermatology, Univ. of Kiel
city: Magdeburg
country: Germany
facility: Dermatology, Univ. of Magdeburg
city: Mannheim
country: Germany
facility: Dermatology, Medical Faculty Mannheim, Univ. of Heidelberg
city: Minden
country: Germany
facility: Dermatology, Municipal Hospital Minden
city: Ulm
country: Germany
facility: Dermatology, Univ. of Ulm
city: Wuerzburg
country: Germany
facility: Dermatology, Univ. of Wuerzburg
Study officials:
affiliation: Dermatology, Univ. of Muenster, Germany
name: Stefan Beissert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of pemphigus. Arch Dermatol. 2006 Nov;142(11):1447-54. doi: 10.1001/archderm.142.11.1447.
citation: Beissert S, Werfel T, Frieling U, Bohm M, Sticherling M, Stadler R, Zillikens D, Rzany B, Hunzelmann N, Meurer M, Gollnick H, Ruzicka T, Pillekamp H, Junghans V, Bonsmann G, Luger TA. A comparison of oral methylprednisolone plus azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid. Arch Dermatol. 2007 Dec;143(12):1536-42. doi: 10.1001/archderm.143.12.1536.