Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study
Objective To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the US (SUNSTONE [Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Ina...
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| Veröffentlicht in: | Arthritis care & research (2010) 2019-08, Vol.71 (8), p.993-1003 |
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| creator | Winthrop, Kevin L. Saag, Kenneth Pei, Jinglan Jahreis, Angelika Abdulky, M. Ahmed, A. Alloway, J. Alper, J. Arora, M. Askari, A. Baca, S. Bacha, D. Bagheri, S. Bennett, R. Bognar, M. Bohan, A. Boniske, C. Box, E. Brennan, T. Chaudhary, K. Chauhan, A. Cima, M. Conaway, D. Dao, K. Dean, J. Diegel, R. Dugowson, C. Eggebeen, A. Fischer, A. Foad, B. Fondal, M. Fraser, S. Fraser, A. Freeman, P. Golombek, S. Greenwald, M. Hakim, C. Hallegua, D. Hirsh, J. Huntwork, J. Husni, M. Jones, R. Kanagasegar, S. Kappes, J. Kelly, G. Kim, J. Klashman, D. Knee, C. Krick, G. Krug, H. Lakhanpal, S. Lang, T. Lee, Y. Levine, J. Lipstate, J. Malinak, J. Marcus, R. Mehta, C. Melton, G. Metyas, S. Miller, K. Moidel, R. Moore, C. Mossell, J. Murphy, F. Nami, A. Neuwelt, C. Nguyen, P. Pegram, S. Penmetcha, M. Peterson, L. Portnoff, K. Rezaian, M. Rice, D. Ridley, D. Rivadeneira, A. Roane, G. Rocca, P. Saikali, W. Saitta, M. Sankoorikal, A. Saway, P. Shergy, W. Shiel, W Shurmur, R. Sikes, D. Singhal, A. Stupi, A. Sullivan, N. Sylvester, R. Tabechian, D. Tagoe, C. Thakker, S. Thakur, N. Toth, M. Trostle, D. Venuturupalli, R. Weiss, D. Winn, D. Yung, C. |
| description | Objective
To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the US (SUNSTONE [Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti‐TNF Therapy] registry).
Methods
In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard‐of‐care follow‐up visits at least every 6 months. The primary outcome was the incidence of protocol‐defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic events, seizures, deaths, and pregnancies. Post hoc analyses assessed outcomes by concomitant medication use.
Results
Overall, 989 patients (safety‐evaluable population) received ≥1 dose of rituximab, with a total follow‐up of 3,844 patient‐years (mean duration 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% confidence intervals [95% CIs]) for significant infections, cardiovascular or thrombotic events, and seizures were 8.87 (95% CI 7.98–9.86), 1.95 (95% CI 1.56–2.45), and 0.18 (95% CI 0.09–0.38) per 100 patient‐years, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality rate 1.66 per 100 patient‐years [95% CI 1.30–2.13]). The most common causes of death were infections (n = 19), malignancy (n = 14), and cardiovascular events (n = 13). Eight pregnancies were reported in 7 patients.
Conclusion
In patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long‐term systemic steroid treatment. |
| doi_str_mv | 10.1002/acr.23781 |
| format | Article |
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To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the US (SUNSTONE [Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti‐TNF Therapy] registry).
Methods
In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard‐of‐care follow‐up visits at least every 6 months. The primary outcome was the incidence of protocol‐defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic events, seizures, deaths, and pregnancies. Post hoc analyses assessed outcomes by concomitant medication use.
Results
Overall, 989 patients (safety‐evaluable population) received ≥1 dose of rituximab, with a total follow‐up of 3,844 patient‐years (mean duration 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% confidence intervals [95% CIs]) for significant infections, cardiovascular or thrombotic events, and seizures were 8.87 (95% CI 7.98–9.86), 1.95 (95% CI 1.56–2.45), and 0.18 (95% CI 0.09–0.38) per 100 patient‐years, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality rate 1.66 per 100 patient‐years [95% CI 1.30–2.13]). The most common causes of death were infections (n = 19), malignancy (n = 14), and cardiovascular events (n = 13). Eight pregnancies were reported in 7 patients.
Conclusion
In patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long‐term systemic steroid treatment.</description><identifier>ISSN: 2151-464X</identifier><identifier>EISSN: 2151-4658</identifier><identifier>DOI: 10.1002/acr.23781</identifier><identifier>PMID: 30295434</identifier><language>eng</language><publisher>Atlanta: Wiley Subscription Services, Inc</publisher><subject>Immunotherapy ; Infections ; Malignancy ; Monoclonal antibodies ; Observational studies ; Original ; Patients ; Rheumatoid Arthritis ; Rituximab ; Safety ; Seizures ; Targeted cancer therapy ; Tumor necrosis factor ; Tumor necrosis factor-TNF</subject><ispartof>Arthritis care & research (2010), 2019-08, Vol.71 (8), p.993-1003</ispartof><rights>2018, American College of Rheumatology</rights><rights>2019 American College of Rheumatology</rights><rights>2018, The Authors. published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3871-4378b0612f6af0c23d1d36579adaee16633847b620e8576d40d17e99fc7e05773</citedby><cites>FETCH-LOGICAL-c3871-4378b0612f6af0c23d1d36579adaee16633847b620e8576d40d17e99fc7e05773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Facr.23781$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Facr.23781$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids></links><search><creatorcontrib>Winthrop, Kevin L.</creatorcontrib><creatorcontrib>Saag, Kenneth</creatorcontrib><creatorcontrib>Pei, Jinglan</creatorcontrib><creatorcontrib>Jahreis, Angelika</creatorcontrib><creatorcontrib>Abdulky, M.</creatorcontrib><creatorcontrib>Ahmed, A.</creatorcontrib><creatorcontrib>Alloway, J.</creatorcontrib><creatorcontrib>Alper, J.</creatorcontrib><creatorcontrib>Arora, M.</creatorcontrib><creatorcontrib>Askari, A.</creatorcontrib><creatorcontrib>Baca, S.</creatorcontrib><creatorcontrib>Bacha, D.</creatorcontrib><creatorcontrib>Bagheri, S.</creatorcontrib><creatorcontrib>Bennett, R.</creatorcontrib><creatorcontrib>Bognar, M.</creatorcontrib><creatorcontrib>Bohan, A.</creatorcontrib><creatorcontrib>Boniske, C.</creatorcontrib><creatorcontrib>Box, E.</creatorcontrib><creatorcontrib>Brennan, T.</creatorcontrib><creatorcontrib>Chaudhary, K.</creatorcontrib><creatorcontrib>Chauhan, A.</creatorcontrib><creatorcontrib>Cima, M.</creatorcontrib><creatorcontrib>Conaway, D.</creatorcontrib><creatorcontrib>Dao, K.</creatorcontrib><creatorcontrib>Dean, J.</creatorcontrib><creatorcontrib>Diegel, R.</creatorcontrib><creatorcontrib>Dugowson, C.</creatorcontrib><creatorcontrib>Eggebeen, A.</creatorcontrib><creatorcontrib>Fischer, A.</creatorcontrib><creatorcontrib>Foad, B.</creatorcontrib><creatorcontrib>Fondal, M.</creatorcontrib><creatorcontrib>Fraser, S.</creatorcontrib><creatorcontrib>Fraser, A.</creatorcontrib><creatorcontrib>Freeman, P.</creatorcontrib><creatorcontrib>Golombek, S.</creatorcontrib><creatorcontrib>Greenwald, M.</creatorcontrib><creatorcontrib>Hakim, C.</creatorcontrib><creatorcontrib>Hallegua, D.</creatorcontrib><creatorcontrib>Hirsh, J.</creatorcontrib><creatorcontrib>Huntwork, J.</creatorcontrib><creatorcontrib>Husni, M.</creatorcontrib><creatorcontrib>Jones, R.</creatorcontrib><creatorcontrib>Kanagasegar, S.</creatorcontrib><creatorcontrib>Kappes, J.</creatorcontrib><creatorcontrib>Kelly, G.</creatorcontrib><creatorcontrib>Kim, J.</creatorcontrib><creatorcontrib>Klashman, D.</creatorcontrib><creatorcontrib>Knee, C.</creatorcontrib><creatorcontrib>Krick, G.</creatorcontrib><creatorcontrib>Krug, H.</creatorcontrib><creatorcontrib>Lakhanpal, S.</creatorcontrib><creatorcontrib>Lang, T.</creatorcontrib><creatorcontrib>Lee, Y.</creatorcontrib><creatorcontrib>Levine, J.</creatorcontrib><creatorcontrib>Lipstate, J.</creatorcontrib><creatorcontrib>Malinak, J.</creatorcontrib><creatorcontrib>Marcus, R.</creatorcontrib><creatorcontrib>Mehta, C.</creatorcontrib><creatorcontrib>Melton, G.</creatorcontrib><creatorcontrib>Metyas, S.</creatorcontrib><creatorcontrib>Miller, K.</creatorcontrib><creatorcontrib>Moidel, R.</creatorcontrib><creatorcontrib>Moore, C.</creatorcontrib><creatorcontrib>Mossell, J.</creatorcontrib><creatorcontrib>Murphy, F.</creatorcontrib><creatorcontrib>Nami, A.</creatorcontrib><creatorcontrib>Neuwelt, C.</creatorcontrib><creatorcontrib>Nguyen, P.</creatorcontrib><creatorcontrib>Pegram, S.</creatorcontrib><creatorcontrib>Penmetcha, M.</creatorcontrib><creatorcontrib>Peterson, L.</creatorcontrib><creatorcontrib>Portnoff, K.</creatorcontrib><creatorcontrib>Rezaian, M.</creatorcontrib><creatorcontrib>Rice, D.</creatorcontrib><creatorcontrib>Ridley, D.</creatorcontrib><creatorcontrib>Rivadeneira, A.</creatorcontrib><creatorcontrib>Roane, G.</creatorcontrib><creatorcontrib>Rocca, P.</creatorcontrib><creatorcontrib>Saikali, W.</creatorcontrib><creatorcontrib>Saitta, M.</creatorcontrib><creatorcontrib>Sankoorikal, A.</creatorcontrib><creatorcontrib>Saway, P.</creatorcontrib><creatorcontrib>Shergy, W.</creatorcontrib><creatorcontrib>Shiel, W</creatorcontrib><creatorcontrib>Shurmur, R.</creatorcontrib><creatorcontrib>Sikes, D.</creatorcontrib><creatorcontrib>Singhal, A.</creatorcontrib><creatorcontrib>Stupi, A.</creatorcontrib><creatorcontrib>Sullivan, N.</creatorcontrib><creatorcontrib>Sylvester, R.</creatorcontrib><creatorcontrib>Tabechian, D.</creatorcontrib><creatorcontrib>Tagoe, C.</creatorcontrib><creatorcontrib>Thakker, S.</creatorcontrib><creatorcontrib>Thakur, N.</creatorcontrib><creatorcontrib>Toth, M.</creatorcontrib><creatorcontrib>Trostle, D.</creatorcontrib><creatorcontrib>Venuturupalli, R.</creatorcontrib><creatorcontrib>Weiss, D.</creatorcontrib><creatorcontrib>Winn, D.</creatorcontrib><creatorcontrib>Yung, C.</creatorcontrib><title>Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study</title><title>Arthritis care & research (2010)</title><description>Objective
To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the US (SUNSTONE [Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti‐TNF Therapy] registry).
Methods
In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard‐of‐care follow‐up visits at least every 6 months. The primary outcome was the incidence of protocol‐defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic events, seizures, deaths, and pregnancies. Post hoc analyses assessed outcomes by concomitant medication use.
Results
Overall, 989 patients (safety‐evaluable population) received ≥1 dose of rituximab, with a total follow‐up of 3,844 patient‐years (mean duration 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% confidence intervals [95% CIs]) for significant infections, cardiovascular or thrombotic events, and seizures were 8.87 (95% CI 7.98–9.86), 1.95 (95% CI 1.56–2.45), and 0.18 (95% CI 0.09–0.38) per 100 patient‐years, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality rate 1.66 per 100 patient‐years [95% CI 1.30–2.13]). The most common causes of death were infections (n = 19), malignancy (n = 14), and cardiovascular events (n = 13). Eight pregnancies were reported in 7 patients.
Conclusion
In patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long‐term systemic steroid treatment.</description><subject>Immunotherapy</subject><subject>Infections</subject><subject>Malignancy</subject><subject>Monoclonal antibodies</subject><subject>Observational studies</subject><subject>Original</subject><subject>Patients</subject><subject>Rheumatoid Arthritis</subject><subject>Rituximab</subject><subject>Safety</subject><subject>Seizures</subject><subject>Targeted cancer therapy</subject><subject>Tumor necrosis factor</subject><subject>Tumor necrosis 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Inc</general><scope>24P</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>NAPCQ</scope><scope>5PM</scope></search><sort><creationdate>201908</creationdate><title>Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study</title><author>Winthrop, Kevin L. ; Saag, Kenneth ; Pei, Jinglan ; Jahreis, Angelika ; Abdulky, M. ; Ahmed, A. ; Alloway, J. ; Alper, J. ; Arora, M. ; Askari, A. ; Baca, S. ; Bacha, D. ; Bagheri, S. ; Bennett, R. ; Bognar, M. ; Bohan, A. ; Boniske, C. ; Box, E. ; Brennan, T. ; Chaudhary, K. ; Chauhan, A. ; Cima, M. ; Conaway, D. ; Dao, K. ; Dean, J. ; Diegel, R. ; Dugowson, C. ; Eggebeen, A. ; Fischer, A. ; Foad, B. ; Fondal, M. ; Fraser, S. ; Fraser, A. ; Freeman, P. ; Golombek, S. ; Greenwald, M. ; Hakim, C. ; Hallegua, D. ; Hirsh, J. ; Huntwork, J. ; Husni, M. ; Jones, R. ; Kanagasegar, S. ; Kappes, J. ; Kelly, G. ; Kim, J. ; Klashman, D. ; Knee, C. ; Krick, G. ; Krug, H. ; Lakhanpal, S. ; Lang, T. ; Lee, Y. ; Levine, J. ; Lipstate, J. ; Malinak, J. ; Marcus, R. ; Mehta, C. ; Melton, G. ; Metyas, S. ; Miller, K. ; Moidel, R. ; Moore, C. ; Mossell, J. ; Murphy, F. ; Nami, A. ; Neuwelt, C. ; Nguyen, P. ; Pegram, S. ; Penmetcha, M. ; Peterson, L. ; Portnoff, K. ; Rezaian, M. ; Rice, D. ; Ridley, D. ; Rivadeneira, A. ; Roane, G. ; Rocca, P. ; Saikali, W. ; Saitta, M. ; Sankoorikal, A. ; Saway, P. ; Shergy, W. ; Shiel, W ; Shurmur, R. ; Sikes, D. ; Singhal, A. ; Stupi, A. ; Sullivan, N. ; Sylvester, R. ; Tabechian, D. ; Tagoe, C. ; Thakker, S. ; Thakur, N. ; Toth, M. ; Trostle, D. ; Venuturupalli, R. ; Weiss, D. ; Winn, D. ; Yung, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3871-4378b0612f6af0c23d1d36579adaee16633847b620e8576d40d17e99fc7e05773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Immunotherapy</topic><topic>Infections</topic><topic>Malignancy</topic><topic>Monoclonal antibodies</topic><topic>Observational studies</topic><topic>Original</topic><topic>Patients</topic><topic>Rheumatoid Arthritis</topic><topic>Rituximab</topic><topic>Safety</topic><topic>Seizures</topic><topic>Targeted cancer therapy</topic><topic>Tumor necrosis factor</topic><topic>Tumor necrosis factor-TNF</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Winthrop, Kevin L.</creatorcontrib><creatorcontrib>Saag, Kenneth</creatorcontrib><creatorcontrib>Pei, Jinglan</creatorcontrib><creatorcontrib>Jahreis, Angelika</creatorcontrib><creatorcontrib>Abdulky, M.</creatorcontrib><creatorcontrib>Ahmed, A.</creatorcontrib><creatorcontrib>Alloway, J.</creatorcontrib><creatorcontrib>Alper, J.</creatorcontrib><creatorcontrib>Arora, M.</creatorcontrib><creatorcontrib>Askari, A.</creatorcontrib><creatorcontrib>Baca, S.</creatorcontrib><creatorcontrib>Bacha, D.</creatorcontrib><creatorcontrib>Bagheri, S.</creatorcontrib><creatorcontrib>Bennett, R.</creatorcontrib><creatorcontrib>Bognar, M.</creatorcontrib><creatorcontrib>Bohan, A.</creatorcontrib><creatorcontrib>Boniske, C.</creatorcontrib><creatorcontrib>Box, E.</creatorcontrib><creatorcontrib>Brennan, T.</creatorcontrib><creatorcontrib>Chaudhary, K.</creatorcontrib><creatorcontrib>Chauhan, A.</creatorcontrib><creatorcontrib>Cima, M.</creatorcontrib><creatorcontrib>Conaway, D.</creatorcontrib><creatorcontrib>Dao, K.</creatorcontrib><creatorcontrib>Dean, J.</creatorcontrib><creatorcontrib>Diegel, R.</creatorcontrib><creatorcontrib>Dugowson, C.</creatorcontrib><creatorcontrib>Eggebeen, A.</creatorcontrib><creatorcontrib>Fischer, A.</creatorcontrib><creatorcontrib>Foad, B.</creatorcontrib><creatorcontrib>Fondal, M.</creatorcontrib><creatorcontrib>Fraser, S.</creatorcontrib><creatorcontrib>Fraser, A.</creatorcontrib><creatorcontrib>Freeman, P.</creatorcontrib><creatorcontrib>Golombek, S.</creatorcontrib><creatorcontrib>Greenwald, M.</creatorcontrib><creatorcontrib>Hakim, C.</creatorcontrib><creatorcontrib>Hallegua, D.</creatorcontrib><creatorcontrib>Hirsh, J.</creatorcontrib><creatorcontrib>Huntwork, J.</creatorcontrib><creatorcontrib>Husni, M.</creatorcontrib><creatorcontrib>Jones, R.</creatorcontrib><creatorcontrib>Kanagasegar, S.</creatorcontrib><creatorcontrib>Kappes, J.</creatorcontrib><creatorcontrib>Kelly, G.</creatorcontrib><creatorcontrib>Kim, J.</creatorcontrib><creatorcontrib>Klashman, D.</creatorcontrib><creatorcontrib>Knee, C.</creatorcontrib><creatorcontrib>Krick, G.</creatorcontrib><creatorcontrib>Krug, H.</creatorcontrib><creatorcontrib>Lakhanpal, S.</creatorcontrib><creatorcontrib>Lang, T.</creatorcontrib><creatorcontrib>Lee, Y.</creatorcontrib><creatorcontrib>Levine, J.</creatorcontrib><creatorcontrib>Lipstate, J.</creatorcontrib><creatorcontrib>Malinak, J.</creatorcontrib><creatorcontrib>Marcus, R.</creatorcontrib><creatorcontrib>Mehta, C.</creatorcontrib><creatorcontrib>Melton, G.</creatorcontrib><creatorcontrib>Metyas, S.</creatorcontrib><creatorcontrib>Miller, K.</creatorcontrib><creatorcontrib>Moidel, R.</creatorcontrib><creatorcontrib>Moore, C.</creatorcontrib><creatorcontrib>Mossell, J.</creatorcontrib><creatorcontrib>Murphy, F.</creatorcontrib><creatorcontrib>Nami, A.</creatorcontrib><creatorcontrib>Neuwelt, C.</creatorcontrib><creatorcontrib>Nguyen, P.</creatorcontrib><creatorcontrib>Pegram, S.</creatorcontrib><creatorcontrib>Penmetcha, M.</creatorcontrib><creatorcontrib>Peterson, L.</creatorcontrib><creatorcontrib>Portnoff, K.</creatorcontrib><creatorcontrib>Rezaian, M.</creatorcontrib><creatorcontrib>Rice, D.</creatorcontrib><creatorcontrib>Ridley, D.</creatorcontrib><creatorcontrib>Rivadeneira, A.</creatorcontrib><creatorcontrib>Roane, G.</creatorcontrib><creatorcontrib>Rocca, P.</creatorcontrib><creatorcontrib>Saikali, W.</creatorcontrib><creatorcontrib>Saitta, M.</creatorcontrib><creatorcontrib>Sankoorikal, A.</creatorcontrib><creatorcontrib>Saway, P.</creatorcontrib><creatorcontrib>Shergy, W.</creatorcontrib><creatorcontrib>Shiel, W</creatorcontrib><creatorcontrib>Shurmur, R.</creatorcontrib><creatorcontrib>Sikes, D.</creatorcontrib><creatorcontrib>Singhal, A.</creatorcontrib><creatorcontrib>Stupi, A.</creatorcontrib><creatorcontrib>Sullivan, N.</creatorcontrib><creatorcontrib>Sylvester, R.</creatorcontrib><creatorcontrib>Tabechian, D.</creatorcontrib><creatorcontrib>Tagoe, C.</creatorcontrib><creatorcontrib>Thakker, S.</creatorcontrib><creatorcontrib>Thakur, N.</creatorcontrib><creatorcontrib>Toth, M.</creatorcontrib><creatorcontrib>Trostle, D.</creatorcontrib><creatorcontrib>Venuturupalli, R.</creatorcontrib><creatorcontrib>Weiss, D.</creatorcontrib><creatorcontrib>Winn, D.</creatorcontrib><creatorcontrib>Yung, C.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Arthritis care & research (2010)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Winthrop, Kevin L.</au><au>Saag, Kenneth</au><au>Pei, Jinglan</au><au>Jahreis, Angelika</au><au>Abdulky, M.</au><au>Ahmed, A.</au><au>Alloway, J.</au><au>Alper, J.</au><au>Arora, M.</au><au>Askari, A.</au><au>Baca, S.</au><au>Bacha, D.</au><au>Bagheri, S.</au><au>Bennett, R.</au><au>Bognar, M.</au><au>Bohan, A.</au><au>Boniske, C.</au><au>Box, E.</au><au>Brennan, T.</au><au>Chaudhary, K.</au><au>Chauhan, A.</au><au>Cima, M.</au><au>Conaway, D.</au><au>Dao, K.</au><au>Dean, J.</au><au>Diegel, R.</au><au>Dugowson, C.</au><au>Eggebeen, A.</au><au>Fischer, A.</au><au>Foad, B.</au><au>Fondal, M.</au><au>Fraser, S.</au><au>Fraser, A.</au><au>Freeman, P.</au><au>Golombek, S.</au><au>Greenwald, M.</au><au>Hakim, C.</au><au>Hallegua, D.</au><au>Hirsh, J.</au><au>Huntwork, J.</au><au>Husni, M.</au><au>Jones, R.</au><au>Kanagasegar, S.</au><au>Kappes, J.</au><au>Kelly, G.</au><au>Kim, J.</au><au>Klashman, D.</au><au>Knee, C.</au><au>Krick, G.</au><au>Krug, H.</au><au>Lakhanpal, S.</au><au>Lang, T.</au><au>Lee, Y.</au><au>Levine, J.</au><au>Lipstate, J.</au><au>Malinak, J.</au><au>Marcus, R.</au><au>Mehta, C.</au><au>Melton, G.</au><au>Metyas, S.</au><au>Miller, K.</au><au>Moidel, R.</au><au>Moore, C.</au><au>Mossell, J.</au><au>Murphy, F.</au><au>Nami, A.</au><au>Neuwelt, C.</au><au>Nguyen, P.</au><au>Pegram, S.</au><au>Penmetcha, M.</au><au>Peterson, L.</au><au>Portnoff, K.</au><au>Rezaian, M.</au><au>Rice, D.</au><au>Ridley, D.</au><au>Rivadeneira, A.</au><au>Roane, G.</au><au>Rocca, P.</au><au>Saikali, W.</au><au>Saitta, M.</au><au>Sankoorikal, A.</au><au>Saway, P.</au><au>Shergy, W.</au><au>Shiel, W</au><au>Shurmur, R.</au><au>Sikes, D.</au><au>Singhal, A.</au><au>Stupi, A.</au><au>Sullivan, N.</au><au>Sylvester, R.</au><au>Tabechian, D.</au><au>Tagoe, C.</au><au>Thakker, S.</au><au>Thakur, N.</au><au>Toth, M.</au><au>Trostle, D.</au><au>Venuturupalli, R.</au><au>Weiss, D.</au><au>Winn, D.</au><au>Yung, C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study</atitle><jtitle>Arthritis care & research (2010)</jtitle><date>2019-08</date><risdate>2019</risdate><volume>71</volume><issue>8</issue><spage>993</spage><epage>1003</epage><pages>993-1003</pages><issn>2151-464X</issn><eissn>2151-4658</eissn><abstract>Objective
To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the US (SUNSTONE [Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti‐TNF Therapy] registry).
Methods
In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard‐of‐care follow‐up visits at least every 6 months. The primary outcome was the incidence of protocol‐defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic events, seizures, deaths, and pregnancies. Post hoc analyses assessed outcomes by concomitant medication use.
Results
Overall, 989 patients (safety‐evaluable population) received ≥1 dose of rituximab, with a total follow‐up of 3,844 patient‐years (mean duration 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% confidence intervals [95% CIs]) for significant infections, cardiovascular or thrombotic events, and seizures were 8.87 (95% CI 7.98–9.86), 1.95 (95% CI 1.56–2.45), and 0.18 (95% CI 0.09–0.38) per 100 patient‐years, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality rate 1.66 per 100 patient‐years [95% CI 1.30–2.13]). The most common causes of death were infections (n = 19), malignancy (n = 14), and cardiovascular events (n = 13). Eight pregnancies were reported in 7 patients.
Conclusion
In patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long‐term systemic steroid treatment.</abstract><cop>Atlanta</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30295434</pmid><doi>10.1002/acr.23781</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2151-464X |
| ispartof | Arthritis care & research (2010), 2019-08, Vol.71 (8), p.993-1003 |
| issn | 2151-464X 2151-4658 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6806017 |
| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Immunotherapy Infections Malignancy Monoclonal antibodies Observational studies Original Patients Rheumatoid Arthritis Rituximab Safety Seizures Targeted cancer therapy Tumor necrosis factor Tumor necrosis factor-TNF |
| title | Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study |
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