Rituximab not superior to conventional therapy for remission induction in EGPA

The use of rituximab falls short of demonstrating superiority over a conventional remission induction strategy in patients diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA), reveals a study.

Overall, 105 participants were randomized to treatment with glucocorticoids plus rituximab (1 g 2 weeks apart) or the conventional strategy (glucocorticoids alone or in combination with cyclophosphamide in severe forms) for induction remission.

Of the patients, 33 (63.5 percent) in the rituximab group and 32 (60.4 percent) in the control group achieved the primary endpoint of remission, defined as a Birmingham Vasculitis Activity Scor (BVAS), version 3, of 0 and a prednisone dose of 7.5 mg/d or less at day 180 (relative risk, 1.05, 95 percent confidence interval, 0.78–1.42; p=0.75). Results were comparable at day 360.

The mean duration of remission was 48.5 weeks with rituximab and 49.1 weeks with the conventional strategy (p=0.41). The rates of all relapse and major relapse did not significantly differ between groups.

Furthermore, no statistically significant between-group difference was noted in the average daily glucocorticoid dose and in the rates of adverse events.

This phase III, multicentre, randomized, controlled, superiority trial was conducted in France. Patients with a diagnosis of EGPA, newly diagnosed or relapsing disease at the time of screening, with active disease defined as BVAS of ≥3, were included.

The study was limited by its design, which was inappropriate to answer the question of equivalence between rituximab and cyclophosphamide in patients with severe EGPA.

“EGPA is an eosinophilic antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis,” the investigators said. “Rituximab has emerged as the standard of care in other types of ANCA-associated vasculitis, but controlled studies on its use in EGPA are yet lacking.”