For antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitides (AAVs), rituximab(Drug information on rituximab) continues to show safety and efficacy equal to or better than those of cyclophosphamide(Drug information on cyclophosphamide) and azathioprine(Drug information on azathioprine). Three randomized, controlled trials and several observational studies on the question will be discussed at the ACR meeting next week.
A meta-analysis of previous trials concludes that rituximab achieved remission in AAV at least as effectively as standard cyclophosphamide-based treatment. On Monday, Carolina Mejia MD of Mount Sinai Medical Center of Miami will present a poster (Abstract #1543) compiling data from three randomized, controlled trials and also analyzing results of nine non-randomized trials. Rituximab was found more effective than prior standard regimens in achieving remission, preventing relapse, and decreasing ANCA titers.
New results from several trials will also be reported at the ACR meeting:
• Besides proving superior to cyclophosphamide for initial treatment, rituximab appears better than azathioprine for maintaining remission, according to updated results from the prospective, randomized trial known as MAINRITSAN. On Monday, Loic Guillevin MD PhD of Hôpital Cochin in Paris will discuss the latest results of this 28-month trial involving 114 patients with granulomatosis with polyangiitis (86), microscopic polyangiitis (23), and kidney-limited disease (5). The trial was scheduled to close last month. There were 16 major relapses in the azathioprine arm, and 3 deaths. Only 2 patients in the rituximab arm have experienced major relapses, and none have died. (Abstract #1652).
• The same team will also present results from a retrospective cohort study of a group of 80 patients, most of whom had refractory or relapsing AAV. Rituximab also induced remission and seemed better at maintaining remission among these patients. (Abstract #2383).
• In AAV with renal involvement, a single course of rituximab induces and maintains remission as well as 18 months of therapy with cyclophosphamide and azathioprine. On Monday, Duvuru Geetha MD of Johns Hopkins (Abstract #1542) will present these results from the 102 of the 197 patients in the RAVE trial who had BVAS/WG renal scores ≥3.
• Long-term rituximab was “very effective” at inducing remission in granulomatosis with polyangiitis (Wegener's) in a retrospective review to be discussed on Monday by Lama Azar MD of Cleveland Clinic. (Abstract #1544). Of 102 patients, 99 achieved complete remission. Of 21 patients followed more than 2 years, 38% had long-term remission
Two small studies also reveal advantages of rituximab for children with AAV. On Sunday, Marinka Twilt MD will present a case series of six children treated with rituximab and high-dose predisone for severe flares of AAV (Abstract #285). The induction response was significantly higher than with standard treatment. A case series of 15 children from Seattle Children’s Hospital presented by Katharine Moore MD suggests that the drug is safe and effective for severe AAV (Abstract #2596).
Also from ACR2012:
ACR2012 Highlights: Rheumatoid Arthritis Comorbidities and Adverse Events
ACR2012 Highlights: Rheumatoid Arthritis Diagnosis and Prognosis
ACR2012 Highlights: Rheumatoid Arthritis Treatment
“Magic Bullet” Approaching for Systemic JIA: But Which One?
FDA Panel on Biosimilars: Analytics Should Trump Clinical Trials
JAK Inhibitors Newer Than Tofacitinib (and Better?) Wait in the Wings