GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis.
Rituxan [package insert]. South San Francisco, CA: Biogen and Genentech USA, Inc.
Rituxan [package insert]. South San Francisco, CA: Biogen and Genentech USA, Inc.
Stone JH, Merkel PA, Spiera R, et al; for RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232.
Stone JH, Merkel PA, Spiera R, et al; for RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232.
Stone JH, Hoffman GS, Merkel PA, et al; for International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Wegener's granulomatosis: modification of the Birmingham Vasculitis Activity Score. Arthritis Rheum. 2001;44(4):912-920.
Stone JH, Hoffman GS, Merkel PA, et al; for International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Wegener's granulomatosis: modification of the Birmingham Vasculitis Activity Score. Arthritis Rheum. 2001;44(4):912-920.
Silverman GJ, Weisman S. Rituximab therapy and autoimmune disorders: prospects for anti-B cell therapy. Arthritis Rheum. 2003;48(6):1484-1492.
Silverman GJ, Weisman S. Rituximab therapy and autoimmune disorders: prospects for anti-B cell therapy. Arthritis Rheum. 2003;48(6):1484-1492.
Mease PJ, Cohen S, Gaylis NB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial. J Rheumatol. 2010;37:917-927.
Mease PJ, Cohen S, Gaylis NB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial. J Rheumatol. 2010;37:917-927.
Guillevin L, Pagnoux C, Karras A, et al. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014;371(19):1771-1780.
Guillevin L, Pagnoux C, Karras A, et al. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014;371(19):1771-1780.
Specks U, Merkel PA, Seo P, et al; for RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013;369(5):417-427.
Specks U, Merkel PA, Seo P, et al; for RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013;369(5):417-427.
Genovese MC, Breedveld FC, Emery P, et al. Safety of biological therapies following rituximab treatment in rheumatoid arthritis patients. Ann Rheum Dis. 2009;68(12):1894-1897.
Genovese MC, Breedveld FC, Emery P, et al. Safety of biological therapies following rituximab treatment in rheumatoid arthritis patients. Ann Rheum Dis. 2009;68(12):1894-1897.
Genovese MC, et al. Presented at American College of Rheumatology; November 6-11, 2010; Atlanta, GA. Poster 403.
Genovese MC, et al. Presented at American College of Rheumatology; November 6-11, 2010; Atlanta, GA. Poster 403.
Cohen SB, Keystone E, Genovese MC, et al. Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate. Ann Rheum Dis. 2010;69(6):1158-1161.
Cohen SB, Keystone E, Genovese MC, et al. Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate. Ann Rheum Dis. 2010;69(6):1158-1161.
Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806.
Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806.
Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54(5):1390-1400.
Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54(5):1390-1400.
Keystone E, Emery P, Peterfy CG, et al. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Ann Rheum Dis. 2009;68:216-221.
Keystone E, Emery P, Peterfy CG, et al. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Ann Rheum Dis. 2009;68:216-221.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37(3):558-567.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37(3):558-567.
Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010;69(9):1629-1635.
Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010;69(9):1629-1635.
Bingham CO III, Looney RJ, Deodhar A, et al. Immunization responses in rheumatoid arthritis patients treated with rituximab; results from a controlled clinical trial. Arthritis Rheum. 2010;62(1):64-74.
Bingham CO III, Looney RJ, Deodhar A, et al. Immunization responses in rheumatoid arthritis patients treated with rituximab; results from a controlled clinical trial. Arthritis Rheum. 2010;62(1):64-74.
Rubbert-Roth A, Tak PP, Zerbini C, et al. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a phase III randomized study (MIRROR). Rheumatology (Oxford). 2010;49(9):1683-1693.
Rubbert-Roth A, Tak PP, Zerbini C, et al. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a phase III randomized study (MIRROR). Rheumatology (Oxford). 2010;49(9):1683-1693.
Tak PP, Rigby WF, Rubbert-Roth A, et al; for the IMAGE Investigators. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. 2011;70(1):39-46.
Tak PP, Rigby WF, Rubbert-Roth A, et al; for the IMAGE Investigators. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. 2011;70(1):39-46.
Greenwald MW, Shergy WJ, Kaine JL, et al. Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. Arthritis Rheum. 2011;63(3):622-632.
Greenwald MW, Shergy WJ, Kaine JL, et al. Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. Arthritis Rheum. 2011;63(3):622-632.
Haraoui B, Bokarewa M, Kallmeyer I, Bykerk VP; for the RESET Investigators. Safety and effectiveness of rituximab in patients with rheumatoid arthritis following an inadequate response to 1 prior tumor necrosis factor inhibitor: the RESET Trial. J Rheumatol. 2011;38(12):2548-2556.
Haraoui B, Bokarewa M, Kallmeyer I, Bykerk VP; for the RESET Investigators. Safety and effectiveness of rituximab in patients with rheumatoid arthritis following an inadequate response to 1 prior tumor necrosis factor inhibitor: the RESET Trial. J Rheumatol. 2011;38(12):2548-2556.
Keystone EC, Cohen SB, Emery P, et al. Multiple courses of rituximab produce sustained clinical and radiographic efficacy and safety in patients with rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors: 5-year data from the REFLEX study. J Rheumatol. 2012;39(12):2238-2246.
Keystone EC, Cohen SB, Emery P, et al. Multiple courses of rituximab produce sustained clinical and radiographic efficacy and safety in patients with rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors: 5-year data from the REFLEX study. J Rheumatol. 2012;39(12):2238-2246.
van Vollenhoven RF, Emery P, Bingham CO, et al. Presented at: European League Against Rheumatism Conference; June 12-15, 2013; Madrid, Spain. Poster SAT0131.
van Vollenhoven RF, Emery P, Bingham CO, et al. Presented at: European League Against Rheumatism Conference; June 12-15, 2013; Madrid, Spain. Poster SAT0131.
Data on file, EULAR 2018 PePRS. Genentech USA, Inc.
Data on file, EULAR 2018 PePRS. Genentech USA, Inc.
Joly C, Maho-Vaillant M, Prost-Squarcioni C, et al. First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicenter, parallel-group, open-label randomized trial. Lancet. 2017;389(10083):2031-2040.
Joly C, Maho-Vaillant M, Prost-Squarcioni C, et al. First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicenter, parallel-group, open-label randomized trial. Lancet. 2017;389(10083):2031-2040.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Long-term safety of rituximab: 6-year follow-up of the rheumatoid arthritis (RA) clinical trials and re-treatment population. Presented at: American College of Rheumatology Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Poster 361.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Long-term safety of rituximab: 6-year follow-up of the rheumatoid arthritis (RA) clinical trials and re-treatment population. Presented at: American College of Rheumatology Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Poster 361.
van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB. Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol. 2015;42(10):1761-1766.
van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB. Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol. 2015;42(10):1761-1766.
Data on file, DANCER Trial CSR. Genentech USA, Inc.
Data on file, DANCER Trial CSR. Genentech USA, Inc.
Data on file, REFLEX Trial CSR. Genentech USA, Inc.
Data on file, REFLEX Trial CSR. Genentech USA, Inc.
Data on file, FDA approval letter, 02/2006. Genentech USA, Inc.
Data on file, FDA approval letter, 02/2006. Genentech USA, Inc.
Data on file, Label update approval letter, 01/2008. Genentech USA, Inc.
Data on file, Label update approval letter, 01/2008. Genentech USA, Inc.
Data on file, Label update approval letter, 10/2009. Genentech USA, Inc.
Data on file, Label update approval letter, 10/2009. Genentech USA, Inc.
Data on file, FDA approval letter, 04/2011. Genentech USA, Inc.
Data on file, FDA approval letter, 04/2011. Genentech USA, Inc.
Data on file, Label update approval letter, 09/2019. Genentech USA, Inc.
Data on file, Label update approval letter, 09/2019. Genentech USA, Inc.
Brogan P, Cleary G, Hersh AO, et al. Presented at the 2018 American College of Rheumatology/American College of Rheumatology Health Professionals Annual Meeting: October 19-24, 2018; Chicago, IL. Poster Abstract L04.
Brogan P, Cleary G, Hersh AO, et al. Presented at the 2018 American College of Rheumatology/American College of Rheumatology Health Professionals Annual Meeting: October 19-24, 2018; Chicago, IL. Poster Abstract L04.
Data on file, BLA Integrated Summary of Safety.
Data on file, BLA Integrated Summary of Safety.
The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.