The Food and Drug Administration (FDA) has approved updated labeling for Rituxan (rituximab; Genentech) to include information on follow up treatment for patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction therapy. Rituxan, a CD20-directed cytolytic antibody, was initially approved for GPA and MPA, in combination with glucocorticoids, in 2011.
The approval for follow up treatment was based on data from an open-label, prospective, active-controlled study (MAINRITSAN) involving 115 patients in disease remission (86 with GPA, 24 with MPA, 5 with renal-limited ANCA-associated vasculitis). Patients were randomized to receive azathioprine or rituximab; the primary endpoint of the study was the occurrence of major relapse, defined by the reappearance of clinical or laboratory signs of vasculitis activity that could lead to organ failure or damage, or could be life-threatening, through month 28.
Results showed the observed cumulative incidence rate of first major relapse during the 28 months was lower in patients treated with rituximab compared with azathioprine (5% vs 29%, respectively). In addition, the safety profile was found to be consistent with that previously seen in this patient population.
“Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”
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