Bensalem A, Mulleman D, Paintaud G, Azzopardi N, Gouilleux-Gruart V, Cornec D, Specks U, Ternant D. (2019) Non-Linear Rituximab Pharmacokinetics and Complex Relationship between Rituximab Concentrations and Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in ANCA-Associated Vasculitis: The RAVE Trial Revisited. Randomization was stratified according to clinical site and ANCA type.The remission-induction period was 6 months. Pinterest. The dose was tapered so that by 5 months, all patients who had a remission without disease flares had discontinued glucocorticoids (see the Study visits occurred at baseline; at weeks 1, 2, 3, and 4; and at 2, 4, and 6 months. You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. In-Depth [randomized, controlled study]: The RAVE trial, published in 2010 in NEJM, was a randomized, double-blind, double-dummy, non-inferiority trial examining the efficacy of rituximab in inducing remission of severe ANCA-associated vasculitis. Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services.Members of the Rituximab in ANCA-Associated Vasculitis−Immune Tolerance Network (RAVE-ITN) Research Group are listed in the Appendix.Cyclophosphamide and glucocorticoids have been the cornerstone of remission-induction therapy for severe antineutrophil cytoplasmic antibody (ANCA)−associated vasculitis for 40 years. The loss of ANCA reactivity, as measured by means of direct ELISA, was not significantly associated with attainment of the primary end point.There were no significant differences between the treatment groups in the numbers of total adverse events, serious adverse events, or non−disease-related adverse events, or in the number of participants with at least one non−disease-related adverse event (More patients in the control group than in the rituximab group had one or more of the predefined selected adverse events: 32 (33%) versus 22 (22%) (P=0.01) (Six malignant conditions developed in 5 additional patients after 6 months.

First, adverse events, by their definition, include both disease and treatment complications, including those related to glucocorticoid use. … Clin Pharmacokinet., epub ahead of print. The data committee did not include representatives of either Genentech or Biogen Idec, which provided funding and medications for the study. granulomatosis with polyangiitis (Wegener’s) (GPA). ); University of Alabama–Birmingham, Birmingham (A.T.); Immune Tolerance Network (N.K.T., V.S.-M., M.M.) B-cell counts decreased more slowly in the control group than in the rituximab group and remained detectable, at low levels. The difference between the two groups, however, was not statistically significant. The main objective of this randomized, placebo-controlled clinical trial was to evaluate the safety and efficacy of etanercept (Enbrel; Immunex Corporation), to get patients with WG in remission … The finding that loss of proteinase 3−ANCA production occurred more frequently with rituximab therapy than with cyclophosphamide therapy suggests that these two treatment strategies modulate proteinase 3−producing cells differently.
Approximately 64% of patients in the rituximab group and 53% of the patients in the cyclophosphamide group reached the primary endpoint, and this treatment difference met the criterion for non-inferiority (P<0.001). The study groups were balanced with respect to ANCA type.

PLEASE SEE A HEALTHCARE PROVIDER IN YOUR AREA IF YOU SEEK MEDICAL ADVICE OF ANY SORT. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Information, resources, and support needed to approach rotations - and life as a resident.Valuable tools for building a rewarding career in health care.Information and tools for librarians about site license offerings.The authorized source of trusted medical research and education for the Chinese-language medical community.The most trusted, influential source of new medical knowledge and clinical best practices in the world.Rituximab versus Cyclophosphamide for ANCA-Associated VasculitisRandomization and Inclusion in the Analysis at 6 Months.Baseline Demographic and Clinical Characteristics of the Patients.Treatment Effect According to Prednisone Dose at 6 Months.Randomization and Inclusion in the Analysis at 6 Months.Baseline Demographic and Clinical Characteristics of the Patients.Treatment Effect According to Prednisone Dose at 6 Months. Previous trials have suggested a substantial benefit of plasma exchange in patients with severe kidney disease with respect to reducing the need for dialysis at 12 months. Among these patients, 16 (57%) and 11 (41%), respectively, reached the primary end point (P=0.48).Six patients in the rituximab group and 10 in the control group had severe disease flares. Trials.
There were no significant differences between the groups in the rates of total, severe, or non-disease-related adverse events. Second, 6 months may have been too short a period in which to detect some of the cyclophosphamide-associated adverse events (e.g., infertility). No works may be reproduced without written consent from 2minutemedicine.com.