Source: Cancer Immunity  |  Posted 9 years ago

Weekly methotrexate is well tolerated for long-term maintenance of remission in patients with generalised Wegener's granulomatosis.

Nevertheless, close monitoring of these patients is critical, warns a study from Germany.

In the study, one-third of the patients, whether or not they were still on concomitant glucocorticoids (GC), relapsed during ongoing methotrexate (MTX) treatment.

The fact that more than half of the relapses affected the kidney underscores the need for monitoring.

Dr. Eva Reinhold-Keller and colleagues from the Medical University of Lubeck, Lubeck, and the Medical School of Hannover, Hannover, Germany, did this open-label, prospective study to examine long-term efficacy of low-dose intravenous MTX, with and without GC, for remission of this condition.

Participants were 71 patients (41 men and 30 women) with initially generalised Wegener's granulomatosis (WG).

After induction of remission by cyclophosphamide and GC, patients received low-dose methotrexate at 0.3 mg/kg body weight once weekly.

At study onset, 55 of the 71 patients (77.5 percent) were on low-dose GC (mean 5.9 mg/day), which was tapered during the study.

The patients all underwent interdisciplinary staging, first at three-month and later at six-month intervals. This was for assessment of disease activity and extent, as well as for side effects. End points were the first relapse or the end of study (January 2001).

In the mean 25.2-month follow-up, 26 patients (36.6 percent) relapsed after a mean of 19.4 months. Of these 26 patients, 17 (65.4 percent) had terminated GC therapy at time of relapse.

Rates of relapse did not differ among patients with and without concomitant GC at study start. Relapses occurred mainly in the initially involved organ systems, preferentially in the ear, nose and throat tract in 18 of 26 patients and the kidney in 16 of 26 patients. One renal relapse presented as rapid, progressive glomerulonephritis with lethal outcome.

Further, 14 relapses were accompanied by a significant rise in creatinine values. In 15 of the 26 relapsed patients, relapse was paralleled or preceded by a significant rise of antineutrophil cytoplasmic antibody titer. Two patients quit MTX prematurely because of persistent leukopenia.