In this randomized trial, patients with vasculitides who were in complete remission after initial induction therapy received either rituximab at intervals or daily azathioprine. More patients had ...sustained remission with rituximab than with azathioprine.
Granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis), microscopic polyangiitis, and renal-limited antineutrophil cytoplasm antibody (ANCA)–associated vasculitides are the main ANCA-associated vasculitis variants.
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Although these entities differ in their pathogenesis, genetics, and serotypes, severe forms of ANCA-associated vasculitis share several clinical features and currently have similar treatments.
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A staged therapeutic strategy that combines glucocorticoids and cyclophosphamide to induce remission has dramatically improved survival over the past few decades, but with frequent early and late side effects. The results of two trials (RAVE and RITUXVAS) showed that rituximab was not inferior to daily oral or pulse intravenous cyclophosphamide for the induction . . .
To investigate the effects on health-related quality of life (HRQOL) and functional capability of rituximab vs azathioprine for ANCA-associated vasculitis (AAV) maintenance therapy.
In a 24-month ...phase III randomised-controlled trial, 115 patients over time received rituximab or azathioprine for AAV maintenance therapy. Mean changes of 36-item Short-form Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) scores from baseline were analysed.
Mean improvements of HAQ scores, from baseline to month 24 were significantly better for the rituximab (0.16 points lower) than the azathioprine group (p=0.038). As demonstrated by SF-36, study patients' baseline HRQOL was significantly impaired compared with age- and sex-matched US norms. At month 24, mean changes from baseline of SF-36 physical component score tended to be better for the rituximab group (+3.95 points, p=0.067) whereas mean changes from baseline of the SF-36 mental component score were significantly better for the azathioprine group (+4.23 points, p=0.041).
Azathioprine-treated patients' for AAV maintenance therapy showed a decline in physical abilities when compared to RTX at M24 in the MAINRITSAN trial.
ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644.
