Research Article
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Year 2023, Volume: 14 Issue: 49, 105 - 110, 31.08.2023
https://doi.org/10.17944/interdiscip.1351896

Abstract

References

  • Grillo-López AJ, White CA, Dallaire BK, Varns CL, Shen CD, Wei A, et al. Rituximab: the first monoclonal antibody approved for the treatment of lymphoma. Curr Pharm Biotechnol. 2000;1(1):1-9. https://doi.org/10.2174/1389201003379059.
  • Engel P, Gómez-Puerta JA, Ramos-Casals M, Lozano F, Bosch X. Therapeutic targeting of B cells for rheu-matic autoimmune diseases. Pharmacol Rev. 2011;63 (1):127-156. https://doi.org/10.1124/pr.109.002006.
  • Cohen SB, Emery P, Greenwald MW, Dougados M, Furie FA, Genovese MC, et al. Rituximab for rheuma-toid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2006;54(9):2793-2806. https://doi.org/ 10.1002/art.22025.
  • Food and Drug Administration. [webpage on the Internet]. Questions and answers on rituximab (added 12/19/2006). Available from: https://wayback.archiveit.org/7993/20170722191606/https://www.fda.gov/Drugs/DrugSafety/Postmarket Drug Safety Information for Patients and Providers/ucm109107.htm. Accessed August 9, 2017.
  • Schioppo T, Ingegnoli F. Current perspective on rituximab in rheumatic diseases. Drug Des Devel Ther. 2017;11:2891-2904. https://doi.org/ 10.2147/DDDT.S139248.
  • Pichler WJ. Adverse side-effects to biological agents. Allergy. 2006;61(8):912-920. https://doi.org/ 10.1111/j.1398-9995.2006.01058.x.
  • Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clin J Oncol Nurs. 2010;14(2): E10-21. https://doi.org/ 10.1188/10.CJON.E10-E21.
  • van Vollenhoven RF, Emery P, Bingham CO 3rd, Keystone EC, Fleischmann R, Furst DE, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37(3):558-567. https://doi.org/ 10.3899/jrheum.090856.
  • Aletaha D, Neogi T, Silman AJ, Funovtis J, Felson DT, Bingham CO 3rd, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism col-laborative initiative. Arthritis Rheum. 2010;62(9):2569-2581. https://doi.org/10.1002/art.27584.
  • Doesseger L, Banholzer ML. Clinical development methodology for infusion-related reactions with mo-noclonal antibodies. 2015:17;4(7):e39. https://doi.org/ 10.1038/cti.2015.14.
  • National Cancer Institute. Common Terminology Criteria for Adverse Events v5.0. (CTCAE) Publish date November 27, 2017. https://ctep.cancer.gov/protocoldevelop-ment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf.
  • van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998;41(10):1845-1850. https://doi.org/10.1002/1529-0131(199810)41:10<1845::AID-ART17>3.0.CO;2-K.
  • Buch MH, Smolen JS, Betteridge N, Breedveld FC, Burmester G, Dörner T, et al. Updated consensus sta-tement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(6):909-920. https://doi.org/ 10.1136/ard.2010.144998.
  • Pritchard CH, Greenwald MW, Kremer JM, Gaylis NB, Rigby W, Zlotnick S, et al. Safety of infusing ri-tuximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study. BMC Musculoskelet Disord. 2014;15:177. https://doi.org/10.1186/1471-2474-15-177.
  • Salmon JH, Perotin JM, Morel J, Dramé M, Cantagrel A, Ziegler LE. Serious infusion-related reaction after rituximab, abatacept, and tocilizumab in rheumatoid arthritis: prospective registry data. Rheumatology (Oxford). 2018;57(1):134-139. https://doi.org/10.1093/rheumatology/kex403.
  • Atzeni F, Turiel M, Capsoni F, Doria A, Meroni P, Sarzi-Puttini S. Autoimmunity and anti-TNF-alpha agents. Ann N Y Acad Sci. 2005;1051:559-569. https://doi.org/10.1196/annals.1361.100.
  • Conti F, Ceccarelli F, Perricone C, Alessandri C, Conti V, Massaro L, et al. Rituximab infusion-related adver-se event rates are lower in patients with systemic lupus erythematosus than in those with rheumatoid arthritis. Rheumatology (Oxford). 2011;50(6):1148-1152. https://doi.org/10.1093/rheumatology/keq436.
  • Rovin BH, Furie B, Latinis K, Looney RJ, Fervenza FC, Guerrero JS, et al. LUNAR Investigator Group. Effi-cacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis As-sessment with Rituximab study. Arthritis Rheum. 2012;64(4):1215-1226. https://doi.org/ 10.1002/art.34359.
  • D’Arena G, Simeon V, Laurenti, Cimminiello M, Innocenti I, Gilio M, et al. Adverse drug reactions after intravenous rituximab infusion is more common in hematologic malignancies than in autoimmune di-sorders and can be predicted by the combination of few clinical and laboratory parameters: results from a retrospective, multicenter study of 374 patients. Leuk Lymphoma. 2017;58(11):2633-2641. https://doi.org/ 10.1080/10428194.2017.1306648.
  • McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of the patients respond to a four-dose treatment program. J Clin Oncol. 1998;16(8):2825-33. https://doi.org/ 10.1200/JCO.1998.16.8.2825.
  • Brown BA, Torabi M. Incidence of infusion-associated reactions with rituximab for treating multiple scle-rosis: a retrospective analysis of patients treated at a US centre. Drug Saf. 2011;34(2):117-123. https://doi.org/ 10.2165/11585960-000000000-00000.
  • Hauser SL, Waubant E, Arnold DL, Wollmer T, Antel J, Fox RJ, et al. B-Cell depletion with rituximab in re-lapsing-remitting multiple sclerosis. N Engl J Med. 2008;358(7):676-88. https://doi.org/10.1056/NEJMoa0706383.
  • Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody the-rapy. Oncologist. 2008;13(6):725-732. https://doi.org/10.1634/theoncologist.2008-0012.
  • Kimby E. Tolerability and safety of rituximab (MabThera). Cancer Treat Rev. 2005;31(6):456-73. https://doi.org/10.1016/j.ctrv.2005.05.007
  • Winkler U, Jensen M, Manzke O, Schulz H, Diehl V, Engert A. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with anti-CD20 monoc-lonal antibody (rituximab, IDEC-C2B8). Blood 1999;94:2217-2224.
  • Frasca D, Diaz A, Romero M, Landin AM, Blomberg BB. Age effects on B cells and humoral immunity in humans. Ageing Res Rev. 2011;10(3):330-335. https://doi.org/10.1016/j.arr.2010.08.004.

The frequency and associated factors of infusion-related reactions to rituximab for patients with rheumatoid arthritis

Year 2023, Volume: 14 Issue: 49, 105 - 110, 31.08.2023
https://doi.org/10.17944/interdiscip.1351896

Abstract

Objectives: Rituximab is an effective biological agent for treating patients with rheumatoid arthritis (RA). Rheumatologists can avoid rituximab therapy because of infusion-related reactions (IRR). There is a lack of data about rituximab-related IRR, especially in rituximab-naïve patients with RA; therefore, we aimed to determine the frequency and associated factors of rituximab-related IRR in these patients.

Methods: Baseline demographic, laboratory, and treatment data were noted. One course of rituximab was used in two infusions to 95 rituximab-naïve patients with RA. Standardized premedication was administered before infusions. Rates, severity, and management of IRR were recorded. Efficacy and infections were also noted if there were.

Results: Ninety-four of 95 patients completed the rituximab course successfully. We observed a total of 23 IRRs in 20 patients. The frequency of IRR was 12.1%, and serious IRR was 0.52%. Grade 1-2-3 IRRs had a rate of 52.2%, 30.4%, and 17.4%, respectively; grade 4 or 5 IRR wasn’t detected. Age <60 years, anti-CCP <200U/ml and absence of biologic agent use before rituximab was significantly higher in patients with IRR than without IRR (p=0.01, p=0.002, p=0.01 respectively). We found out that if only the disease age is above 60 months, it is protective against IRR as per the results of multivariate model analysis.

Conclusion: Results supported that rituximab is a safe biological agent option for patients with RA at secondary central hospitals. Identified risk factors of IRR need to be corroborated in larger studies for safer rituximab therapy.

Ethical Statement

Ethical approval was obtained from Mus Alparslan University Clinical Research Ethical Committee with date 29.10.202 0and number E-79236777-605.99-2541, and Helsinki Declaration rules were followed to conduct this study.

References

  • Grillo-López AJ, White CA, Dallaire BK, Varns CL, Shen CD, Wei A, et al. Rituximab: the first monoclonal antibody approved for the treatment of lymphoma. Curr Pharm Biotechnol. 2000;1(1):1-9. https://doi.org/10.2174/1389201003379059.
  • Engel P, Gómez-Puerta JA, Ramos-Casals M, Lozano F, Bosch X. Therapeutic targeting of B cells for rheu-matic autoimmune diseases. Pharmacol Rev. 2011;63 (1):127-156. https://doi.org/10.1124/pr.109.002006.
  • Cohen SB, Emery P, Greenwald MW, Dougados M, Furie FA, Genovese MC, et al. Rituximab for rheuma-toid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2006;54(9):2793-2806. https://doi.org/ 10.1002/art.22025.
  • Food and Drug Administration. [webpage on the Internet]. Questions and answers on rituximab (added 12/19/2006). Available from: https://wayback.archiveit.org/7993/20170722191606/https://www.fda.gov/Drugs/DrugSafety/Postmarket Drug Safety Information for Patients and Providers/ucm109107.htm. Accessed August 9, 2017.
  • Schioppo T, Ingegnoli F. Current perspective on rituximab in rheumatic diseases. Drug Des Devel Ther. 2017;11:2891-2904. https://doi.org/ 10.2147/DDDT.S139248.
  • Pichler WJ. Adverse side-effects to biological agents. Allergy. 2006;61(8):912-920. https://doi.org/ 10.1111/j.1398-9995.2006.01058.x.
  • Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clin J Oncol Nurs. 2010;14(2): E10-21. https://doi.org/ 10.1188/10.CJON.E10-E21.
  • van Vollenhoven RF, Emery P, Bingham CO 3rd, Keystone EC, Fleischmann R, Furst DE, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010;37(3):558-567. https://doi.org/ 10.3899/jrheum.090856.
  • Aletaha D, Neogi T, Silman AJ, Funovtis J, Felson DT, Bingham CO 3rd, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism col-laborative initiative. Arthritis Rheum. 2010;62(9):2569-2581. https://doi.org/10.1002/art.27584.
  • Doesseger L, Banholzer ML. Clinical development methodology for infusion-related reactions with mo-noclonal antibodies. 2015:17;4(7):e39. https://doi.org/ 10.1038/cti.2015.14.
  • National Cancer Institute. Common Terminology Criteria for Adverse Events v5.0. (CTCAE) Publish date November 27, 2017. https://ctep.cancer.gov/protocoldevelop-ment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf.
  • van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998;41(10):1845-1850. https://doi.org/10.1002/1529-0131(199810)41:10<1845::AID-ART17>3.0.CO;2-K.
  • Buch MH, Smolen JS, Betteridge N, Breedveld FC, Burmester G, Dörner T, et al. Updated consensus sta-tement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(6):909-920. https://doi.org/ 10.1136/ard.2010.144998.
  • Pritchard CH, Greenwald MW, Kremer JM, Gaylis NB, Rigby W, Zlotnick S, et al. Safety of infusing ri-tuximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study. BMC Musculoskelet Disord. 2014;15:177. https://doi.org/10.1186/1471-2474-15-177.
  • Salmon JH, Perotin JM, Morel J, Dramé M, Cantagrel A, Ziegler LE. Serious infusion-related reaction after rituximab, abatacept, and tocilizumab in rheumatoid arthritis: prospective registry data. Rheumatology (Oxford). 2018;57(1):134-139. https://doi.org/10.1093/rheumatology/kex403.
  • Atzeni F, Turiel M, Capsoni F, Doria A, Meroni P, Sarzi-Puttini S. Autoimmunity and anti-TNF-alpha agents. Ann N Y Acad Sci. 2005;1051:559-569. https://doi.org/10.1196/annals.1361.100.
  • Conti F, Ceccarelli F, Perricone C, Alessandri C, Conti V, Massaro L, et al. Rituximab infusion-related adver-se event rates are lower in patients with systemic lupus erythematosus than in those with rheumatoid arthritis. Rheumatology (Oxford). 2011;50(6):1148-1152. https://doi.org/10.1093/rheumatology/keq436.
  • Rovin BH, Furie B, Latinis K, Looney RJ, Fervenza FC, Guerrero JS, et al. LUNAR Investigator Group. Effi-cacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis As-sessment with Rituximab study. Arthritis Rheum. 2012;64(4):1215-1226. https://doi.org/ 10.1002/art.34359.
  • D’Arena G, Simeon V, Laurenti, Cimminiello M, Innocenti I, Gilio M, et al. Adverse drug reactions after intravenous rituximab infusion is more common in hematologic malignancies than in autoimmune di-sorders and can be predicted by the combination of few clinical and laboratory parameters: results from a retrospective, multicenter study of 374 patients. Leuk Lymphoma. 2017;58(11):2633-2641. https://doi.org/ 10.1080/10428194.2017.1306648.
  • McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of the patients respond to a four-dose treatment program. J Clin Oncol. 1998;16(8):2825-33. https://doi.org/ 10.1200/JCO.1998.16.8.2825.
  • Brown BA, Torabi M. Incidence of infusion-associated reactions with rituximab for treating multiple scle-rosis: a retrospective analysis of patients treated at a US centre. Drug Saf. 2011;34(2):117-123. https://doi.org/ 10.2165/11585960-000000000-00000.
  • Hauser SL, Waubant E, Arnold DL, Wollmer T, Antel J, Fox RJ, et al. B-Cell depletion with rituximab in re-lapsing-remitting multiple sclerosis. N Engl J Med. 2008;358(7):676-88. https://doi.org/10.1056/NEJMoa0706383.
  • Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody the-rapy. Oncologist. 2008;13(6):725-732. https://doi.org/10.1634/theoncologist.2008-0012.
  • Kimby E. Tolerability and safety of rituximab (MabThera). Cancer Treat Rev. 2005;31(6):456-73. https://doi.org/10.1016/j.ctrv.2005.05.007
  • Winkler U, Jensen M, Manzke O, Schulz H, Diehl V, Engert A. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with anti-CD20 monoc-lonal antibody (rituximab, IDEC-C2B8). Blood 1999;94:2217-2224.
  • Frasca D, Diaz A, Romero M, Landin AM, Blomberg BB. Age effects on B cells and humoral immunity in humans. Ageing Res Rev. 2011;10(3):330-335. https://doi.org/10.1016/j.arr.2010.08.004.
There are 26 citations in total.

Details

Primary Language English
Subjects Clinical Sciences (Other)
Journal Section Research Articles
Authors

Mete Pekdiker 0000-0003-3089-1564

Early Pub Date August 31, 2023
Publication Date August 31, 2023
Submission Date July 26, 2022
Published in Issue Year 2023 Volume: 14 Issue: 49

Cite

Vancouver Pekdiker M. The frequency and associated factors of infusion-related reactions to rituximab for patients with rheumatoid arthritis. Interdiscip Med J. 2023;14(49):105-10.