Rituximab safe for long-term use in granulomatosis with polyangiitis, microscopic polyangiitis
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The long-term safety of rituximab was consistent with a shorter duration of treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis, according to data published in Arthritis Care & Research.
“Rituximab, in combination with glucocorticoids, is recommended by the European League Against Rheumatism as an alternative to cyclophosphamide for induction of remission of new-onset, organ- or life-threatening GPA or MPA,” Peter A. Merkel, MD, MPH, of the University of Pennsylvania, and colleagues wrote. “Rituximab is also effective for the maintenance of remission in patients with GPA or MPA.”
“Given the improved survival of patients with GPA or MPA over the past decades and the potential short- and long-term toxicities associated with standard-of-care treatments, the Rituximab in ANCA-associated Vasculitis Registry (RaVeR) was developed to address the need for data on the long-term outcomes of patients with GPA or MPA treated with rituximab and other immunosuppressive therapies in routine clinical practice,” they added.
To analyze the long-term safety of rituximab (Rituxan; Genentech, Biogen) in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), Merkel and colleagues conducted the phase 4, openlabel, prospective RaVeR trial. According to the researchers, the study was a post-marketing requirement mandated by the FDA. In the trial, 72 patients with GPA and 25 with MPA received rituximab and were evaluated every 6 months for up to 4 years.
Participants received the drug through a median of eight infusions and were followed for a median of 3.94 years. Outcomes included serious adverse events, infusion-related reactions and serious adverse events of specific interest, such as serious infections, serious cardiac events, serious vascular events and malignancies.
According to the researchers, the estimated incidence rate was 7.11 per 100 patient years (95% CI, 4.55-10.58) for serious infections, 5.03 (95% CI, 2.93-8.06) for serious cardiac events and 2.37 (95% CI, 1.02-4.67) for serious vascular events. No infusion-related reactions or serious adverse events were reported within 24 hours of receiving the drug. Of the nine reported deaths, none were considered to be related to rituximab use, the researchers wrote.
“These results provide important data to providers and patients about the safety of prescribing repeated and extended courses of rituximab, a strategy demonstrated in clinical trials to help maintain remission in ANCA-associated vasculitis,” Merkel told Healio Rheumatology.
“The safety profile of long-term (up to 4 years) follow-up treatment with rituximab in patients with GPA or MPA was consistent with the known overall safety profile of rituximab in patients with GPA or MPA treated for shorter periods,” he and colleagues wrote. “Safety data were also consistent with the known safety profile of rituximab in other autoimmune diseases in which it is approved for use.
“These findings provide clinicians with long-term, practice level safety data for rituximab in the treatment of GPA or MPA.”
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