Sixty-four percent of patients in the rituximab group reached the study’s endpoint compared with 53% in the CYC group. Rituximab use was considered as effective as CYC for patients with major renal disease or alveolar hemorrhage, Dr. Specks said.
“The primary results show that rituximab is not inferior to cyclophosamide and that there was no difference in treatment response to rituximab or cyclophosamide,” he said. “The treatment response to rituximab was superior to cyclophosamide in patients who entered the trial with a disease flare.”
Dr. Specks said that rituximab is “the first proven alternative” to cyclophosamide for remission induction in patients with severe ANCA-associated vasculitis. “This is of particular importance for patients who present with a severe disease flare or who want to preserve their fertility,” he said.
There are complementary results from the RITUXVAS trial, which Dr. Specks said compared rituximab use plus two infusions of CYC versus IV CYC for six months followed by oral azathioprine. Both patient groups received prednisone. “Over 12 months, one course of rituximab achieves the same results as cyclophosamide followed by azathioprine,” he said.
Rituximab appears to be an effective option for newly diagnosed patients with severe disease and severe relapses and is preferable for younger patients and those with PR3-ANCA, Dr. Specks said. However, he said its use does not come without some words of caution. “Rituximab is an immunosuppressive agent, and the infection risk seems similar to that of carefully monitored cyclophosamide followed by azathioprine,” he said.
The session ended with a review of some sample WG and microscopic polyangiitis case studies, where audience members had the chance to weigh in on how they would treat patients.
Vanessa Caceres is a medical writer in Bradenton, Florida.
References
- Jayne D, Rasmussen N, Andrassy K, et al. A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. N Engl J Med. 2003; 349:36-44.
- Pagnoux C, Mahr A, Hamidou MA, et al. Azathioprine or methotrexate maintenance for ANCA-associated vasculitis. N Engl J Med. 2008;359;2790-2803.
- Hiemstra TF, Walsh M, Mahr A, et al. Mycophenolate mofetil vs azathioprine for remission maintenance in antineutrophil cytoplasmic antibody-associated vasculitis: A randomized controlled trial. JAMA. 2010;304: 2381-2388.
- Silva F, Specks U, Kalra S, et al. Mycophenolate mofetil for induction and maintenance of remission in microscopic polyangiitis with mild to moderate renal involvement—a prospective, open-label pilot trial. Clin J Am Soc Nephrol. 2010;5:445-453.
- Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363: 221-232.
