Serious infection across biologic-treated patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Rutherford, Andrew I; Subesinghe, Sujith; Hyrich, Kimme L; Galloway, James

doi:10.1136/annrheumdis-2017-212825

Cited by 115 publications

(147 citation statements)

References 19 publications

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“…The data available for the British registry are until 2008 when fewer bDMARDs were available, as opposed to our data, which include more options that became available after 2008 including abatacept, tocilizumab, certolizumab and golimumab . The more recent study by Rutherford et al . does state a higher incidence of SI (5.51 per 100 person years) which is closer to the findings in the present study and perhaps a reflection of the availability of newer agents and consequently more switching.…”

Section: Discussionsupporting

confidence: 57%

“…The most recent study on the incidence of SI in the British register was by Rutherford et al . in 2018.…”

Section: Discussionmentioning

confidence: 99%

“…in 2018. This studied 19 282 patients with 46 771 years of follow up and noted to have a SI incidence rate of 5.51 per 100 person years . This study only included patients on etanercept, infliximab, adalimumab, rituximab, tocilizumab and certolizumab‐pegol and was an update from the 2011 study by Galloway et al .…”

Section: Discussionmentioning

confidence: 99%

“…Another potential explanation for the higher SI rate found in the present study is the high incidence of bDMARD switching. The 2018 study by Rutherford et al . did not provide any information on the number of patients that switched, but the 2011 study by Galloway et al .…”

Section: Discussionmentioning

confidence: 99%

“…Rutherford et al . noted that compared to etanercept, tocilizumab had a higher risk of SI (HR: 1.22, 95% confidence interval: 1.02–1.47) and certolizumab had a lower risk (HR: 0.75, 95% confidence interval: 0.58–0.97).…”

Section: Discussionmentioning

confidence: 99%

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Ten‐year retrospective review of the incidence of serious infections in patients on biologic disease modifying agents for rheumatoid arthritis in three tertiary hospitals in Western Australia

Sharma

Keen

2019

Internal Medicine Journal

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Age and duration of bDMARD use were statistically significant factors associated with an increased risk of SI. Co-morbidities did not play a significant role in increasing the incidence of SI. Patients who were on both glucocorticoids and bDMARDs did not have a significant increase in length of stay when compared with patients who were just on bDMARDs. More research is needed in this area with larger numbers to draw statistically significant conclusions regarding the role of co-morbidities in SI risk and the individual infection risk associated with each bDMARD. This article is protected by copyright. All rights reserved.

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Section: Discussionsupporting

confidence: 57%

“…The most recent study on the incidence of SI in the British register was by Rutherford et al . in 2018.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Ten‐year retrospective review of the incidence of serious infections in patients on biologic disease modifying agents for rheumatoid arthritis in three tertiary hospitals in Western Australia

Sharma

Keen

2019

Internal Medicine Journal

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Infection Risks Among Patients With Multiple Sclerosis Treated With Fingolimod, Natalizumab, Rituximab, and Injectable Therapies

et al. 2020

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IMPORTANCE Although highly effective disease-modifying therapies for multiple sclerosis (MS) have been associated with an increased risk of infections vs injectable therapies interferon beta and glatiramer acetate (GA), the magnitude of potential risk increase is not well established in real-world populations. Even less is known about infection risk associated with rituximab, which is extensively used off-label to treat MS in Sweden. OBJECTIVE To examine the risk of serious infections associated with disease-modifying treatments for MS. DESIGN, SETTING, AND PARTICIPANTS This nationwide register-based cohort study was conducted in Sweden from January 1, 2011, to December 31, 2017. National registers with prospective data collection from the public health care system were used. All Swedish patients with relapsing-remitting MS whose data were recorded in the Swedish MS register as initiating treatment with rituximab, natalizumab, fingolimod, or interferon beta and GA and an age-matched and sex-matched general population comparator cohort were included. EXPOSURES Treatment with rituximab, natalizumab, fingolimod, and interferon beta and GA. MAIN OUTCOMES AND MEASURES Serious infections were defined as all infections resulting in hospitalization. Additional outcomes included outpatient treatment with antibiotic or herpes antiviral medications. Adjusted hazard ratios (HRs) were estimated in Cox regressions. RESULTS A total of 6421 patients (3260 taking rituximab, 1588 taking natalizumab, 1535 taking fingolimod, and 2217 taking interferon beta/GA) were included, plus a comparator cohort of 42 645 individuals. Among 6421 patients with 8600 treatment episodes, the mean (SD) age at treatment start ranged from 35.0 (10.1) years to 40.4 (10.6) years; 6186 patients were female. The crude rate of infections was higher in patients with MS taking interferon beta and GA than the general population (incidence rate, 8.9 [95% CI, 6.4-12.1] vs 5.2 [95% CI, 4.8-5.5] per 1000 person-years), and higher still in patients taking fingolimod (incidence rate, 14.3 [95% CI, 10.8-18.5] per 1000 person-years), natalizumab (incidence rate, 11.4 [95% CI, 8.3-15.3] per 1000 person-years), and rituximab (incidence rate, 19.7 [95% CI, 16.4-23.5] per 1000 person-years). After confounder adjustment, the rate remained significantly higher for rituximab (HR, 1.70 [95% CI, 1.11-2.61]) but not fingolimod (HR, 1.30 [95% CI, 0.84-2.03]) or natalizumab (HR, 1.12 [95% CI, 0.71-1.77]) compared with interferon beta and GA. In contrast, use of herpes antiviral drugs during rituximab treatment was similar to that of interferon beta and GA and lower than that of natalizumab (HR, 1.82 [1.34-2.46]) and fingolimod (HR, 1.71 [95% CI, 1.27-2.32]). CONCLUSIONS AND RELEVANCE Patients with MS are at a generally increased risk of infections, and this differs by treatment. The rate of infections was lowest with interferon beta and GA; among newer treatments, off-label use of rituximab was associated with the highest rate of serious infections. The different risk profiles sh...

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Nonserious Infections in Patients With Rheumatoid Arthritis: Results From the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Bechman

Halai

Yates

et al. 2021

Arthritis & Rheumatology

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Objective To describe the frequency and predictors of nonserious infections (NSI) and compare incidence across biologic agents within the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR‐RA). Methods The BSRBR‐RA is a prospective observational cohort study. An NSI was defined as an infection that did not require hospitalization or intravenous therapy. Infections were captured from clinician questionnaires and patient diaries. Individuals were considered “at risk” from the date of initiation of biologic treatment for up to 3 years. Drug exposure was defined by agent: tumor necrosis factor inhibitor (TNFi), interleukin‐6 (IL‐6) inhibitor, B cell depletion (rituximab), or conventional synthetic disease‐modifying antirheumatic drugs (csDMARDs) alone. A multiple‐failure Cox model was used with multivariable adjustment. Missing data were addressed using multiple imputation. Results There were 17,304 NSI in 8,145 patients, with an event rate of 27.0 per person per year (95% confidence interval [95% CI] 26.6–27.4). Increasing age, female sex, comorbidity burden, glucocorticoid therapy, higher Disease Activity Score in 28 joints, and higher Health Assessment Questionnaire disability index were associated with an increased risk of NSI. There was a significant reduction in NSI risk with csDMARDs compared to biologic treatments. Compared to TNFi, IL‐6 inhibition and rituximab were associated with a higher NSI risk (adjusted hazard ratio 1.45 [95% CI 1.29–1.63] and adjusted hazard ratio 1.28 [95% CI 1.14–1.45], respectively), while the csDMARD cohort had a lower risk (adjusted hazard ratio 0.64 [95% CI 0.59–0.70]). Within the TNFi class, adalimumab was associated with a higher NSI risk than etanercept (adjusted hazard ratio 1.11 [95% CI 1.05–1.17]). Conclusion NSI occur frequently in RA, and predictors mirror those reported with serious infections. All biologics are associated with a greater risk of NSI, with differences observed between agents. While unmeasured confounding must be considered, the magnitude of effect is large, and a relationship between NSI and targeted immunomodulatory therapy likely exists.

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Serious infection across biologic-treated patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Cited by 115 publications

References 19 publications

Ten‐year retrospective review of the incidence of serious infections in patients on biologic disease modifying agents for rheumatoid arthritis in three tertiary hospitals in Western Australia

Ten‐year retrospective review of the incidence of serious infections in patients on biologic disease modifying agents for rheumatoid arthritis in three tertiary hospitals in Western Australia

Infection Risks Among Patients With Multiple Sclerosis Treated With Fingolimod, Natalizumab, Rituximab, and Injectable Therapies

Nonserious Infections in Patients With Rheumatoid Arthritis: Results From the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

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