Long-term outcome of a clinical trial comparing methotrexate to cyclophosphamide for remission induction of early systemic ANCA-associated vasculitis
Arthritis & Rheumatism, 05/31/2012
Faurschou M et al. – In the NORAM cohort, no difference in occurrence of major adverse events was observed between treatment–groups during long–term follow–up. First–line treatment with methotrexate was associated with less effective disease control than cyclophosphamide–based induction–therapy.Methods
- Outcome questionnaires were sent to investigators who had recruited patients to the NORAM trial.
- Patients treated with methotrexate for induction of remission (n=49) were compared to cyclophosphamide–treated patients (n=46) with respect to immunosuppressive therapy during follow–up, relapse–free survival, mortality, and occurrence of other clinical events.
- The median duration of follow–up was 6.0 (range: 0.1–10.8) years.
- One patient developed end–stage renal disease, and 11 died.
- The number of patients affected by serious infections, malignancies or severe organ–failure did not differ between treatment–groups, and no difference in mortality was observed.
- The duration of corticosteroid therapy was longer in the methotrexate–group during the 18 months of the trial (p=0.005).
- During subsequent follow–up, patients in the methotrexate–group were exposed to corticosteroids, cyclophosphamide, and other immunosuppressive agents (azathioprine, methotrexate, and/or mycophenolate mofetil) for longer periods than those in the cyclophosphamide–group (p=0.004; p=0.037; and p=0.031, respectively).
- The cumulative relapse–free survival tended to be lower in the methotrexate–group (p=0.056).