Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study
Identifieur interne : 000678 ( Main/Exploration ); précédent : 000677; suivant : 000679Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study
Auteurs : Kevin L. Winthrop ; Kenneth Saag ; Matthew D. Cascino ; Jinglan Pei ; Ani John ; Angelika Jahreis ; Tmirah Haselkorn ; Daniel E. FurstSource :
- Arthritis Care & Research [ 2151-464X ] ; 2019.
Abstract
To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (
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.
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%
In patients with
Url:
DOI: 10.1002/acr.23781
PubMed: 30295434
PubMed Central: 6806017
Affiliations:
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Long‐Term Safety of Rituximab in Patients With Rheumatoid Arthritis: Results of a Five‐Year Observational Study</title>
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<author><name sortKey="Cascino, Matthew D" sort="Cascino, Matthew D" uniqKey="Cascino M" first="Matthew D." last="Cascino">Matthew D. Cascino</name>
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<author><name sortKey="Pei, Jinglan" sort="Pei, Jinglan" uniqKey="Pei J" first="Jinglan" last="Pei">Jinglan Pei</name>
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<author><name sortKey="John, Ani" sort="John, Ani" uniqKey="John A" first="Ani" last="John">Ani John</name>
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<author><name sortKey="Jahreis, Angelika" sort="Jahreis, Angelika" uniqKey="Jahreis A" first="Angelika" last="Jahreis">Angelika Jahreis</name>
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<author><name sortKey="Haselkorn, Tmirah" sort="Haselkorn, Tmirah" uniqKey="Haselkorn T" first="Tmirah" last="Haselkorn">Tmirah Haselkorn</name>
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<series><title level="j">Arthritis Care & Research</title>
<idno type="ISSN">2151-464X</idno>
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<front><div type="abstract" xml:lang="en"><sec id="acr23781-sec-0001"><title>Objective</title>
<p>To evaluate the long‐term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (<styled-content style="fixed-case" toggle="no">RA</styled-content>
) who had an inadequate response to ≥1 anti–tumor necrosis factor therapy in the <styled-content style="fixed-case" toggle="no">US</styled-content>
(<styled-content style="fixed-case" toggle="no">SUNSTONE</styled-content>
[Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti‐<styled-content style="fixed-case" toggle="no">TNF</styled-content>
Therapy] registry).</p>
</sec>
<sec id="acr23781-sec-0002"><title>Methods</title>
<p>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.</p>
</sec>
<sec id="acr23781-sec-0003"><title>Results</title>
<p>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% <styled-content style="fixed-case" toggle="no">CI</styled-content>
s]) for significant infections, cardiovascular or thrombotic events, and seizures were 8.87 (95% <styled-content style="fixed-case" toggle="no">CI</styled-content>
7.98–9.86), 1.95 (95% <styled-content style="fixed-case" toggle="no">CI</styled-content>
1.56–2.45), and 0.18 (95% <styled-content style="fixed-case" toggle="no">CI</styled-content>
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% <styled-content style="fixed-case" toggle="no">CI</styled-content>
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.</p>
</sec>
<sec id="acr23781-sec-0004"><title>Conclusion</title>
<p>In patients with <styled-content style="fixed-case" toggle="no">RA</styled-content>
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.</p>
</sec>
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</front>
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<name sortKey="Furst, Daniel E" sort="Furst, Daniel E" uniqKey="Furst D" first="Daniel E." last="Furst">Daniel E. Furst</name>
<name sortKey="Haselkorn, Tmirah" sort="Haselkorn, Tmirah" uniqKey="Haselkorn T" first="Tmirah" last="Haselkorn">Tmirah Haselkorn</name>
<name sortKey="Jahreis, Angelika" sort="Jahreis, Angelika" uniqKey="Jahreis A" first="Angelika" last="Jahreis">Angelika Jahreis</name>
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<name sortKey="Pei, Jinglan" sort="Pei, Jinglan" uniqKey="Pei J" first="Jinglan" last="Pei">Jinglan Pei</name>
<name sortKey="Saag, Kenneth" sort="Saag, Kenneth" uniqKey="Saag K" first="Kenneth" last="Saag">Kenneth Saag</name>
<name sortKey="Winthrop, Kevin L" sort="Winthrop, Kevin L" uniqKey="Winthrop K" first="Kevin L." last="Winthrop">Kevin L. Winthrop</name>
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