Predictors for the 5-year risk of serious infections in patients with rheumatoid arthritis treated with anti-tumour necrosis factor therapy: a cohort study in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry

Dartel, S.A.A. van; Fransen, Jaap; Kievit, Wietske; Dutmer, Ellen A J; Brus, H.L.M.; Houtman, Nella M.; Laar, M. A. F. Van De; Riel, P.L.C.M. van

doi:10.1093/rheumatology/kes413

Cited by 40 publications

(36 citation statements)

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“…12-17 24 SIE IRs for bDMARDs in RA clinical trials range from 3.0 to 5.5 per 100 patient-years, 25 and are similar to those reported with tumour necrosis factor inhibitors (TNFi) in RA registries (3.2-4.6 per 100 patient-years). [26][27][28] IRs with tofacitinib were generally consistent with IRs with bDMARDs. [25][26][27][28] Previous studies of registry data revealed a decrease in SIEs with TNFi over time, likely due to discontinuation in patients at increased risk of SIEs, and reduction in risk associated with improvement in function and decreased glucocorticoid use.…”

Section: Discussionmentioning

confidence: 58%

“…[26][27][28] IRs with tofacitinib were generally consistent with IRs with bDMARDs. [25][26][27][28] Previous studies of registry data revealed a decrease in SIEs with TNFi over time, likely due to discontinuation in patients at increased risk of SIEs, and reduction in risk associated with improvement in function and decreased glucocorticoid use. [29][30][31] In contrast, analyses of data from open-label LTE studies suggest that the SIE risk remains stable over time.…”

Section: Discussionmentioning

confidence: 58%

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Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials

Cohen

Tanaka

Mariette

et al. 2017

Annals of the Rheumatic Diseases

340

272

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ObjectivesTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We report an integrated safety summary of tofacitinib from two phase I, nine phase II, six phase III and two long-term extension studies in adult patients with active RA.MethodsData were pooled for all tofacitinib-treated patients (data cut-off: 31 March 2015). Incidence rates (IRs; patients with event/100 patient-years) and 95% CIs are reported for adverse events (AEs) of interest.Results6194 patients received tofacitinib for a total 19 406 patient-years' exposure; median exposure was 3.4 patient-years. IR (95% CI) for serious AEs was 9.4 (9.0 to 9.9); IR for serious infections was 2.7 (2.5 to 3.0). IR for (all) herpes zoster was 3.9 (3.6 to 4.2); IR for disseminated or multidermatomal herpes zoster was 0.3 (0.2 to 0.4). IR for opportunistic infections (excluding tuberculosis) was 0.3 (0.2 to 0.4) and was 0.2 (0.1 to 0.3) for tuberculosis. IR for malignancies (excluding non-melanoma skin cancer (NMSC)) was 0.9 (0.8 to 1.0); NMSC IR was 0.6 (0.5 to 0.7). IR for gastrointestinal perforations was 0.1 (0.1 to 0.2). Analysis of IR for serious infections, herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in IR with longer-duration tofacitinib exposure.ConclusionThis analysis of tofacitinib exposure up to 8.5 years allowed estimation of safety events with improved precision versus previous tofacitinib reports. AEs were generally stable over time; no new safety signals were observed compared with previous tofacitinib reports.Trial registration numbers NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT00413699, NCT00661661; Results.

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Section: Discussionmentioning

confidence: 58%

Section: Discussionmentioning

confidence: 58%

Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials

Cohen

Tanaka

Mariette

et al. 2017

Annals of the Rheumatic Diseases

340

272

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“…However, corticosteroids are potent immunosuppressive drugs, and their potential to increase patient susceptibility to major infections has been noted in patients with RA [18,30,35,[39][40][41][42][43] in a dose-dependent manner [18,19,37,44]. Methotrexate (MTX) is one of the most commonly used drugs in the treatment of RA.…”

Section: Therapeutic Drugs: Corticosteroids and Methotrexatementioning

confidence: 99%

Biological agents and respiratory infections: Causative mechanisms and practice management

Takayanagi

2015

Respiratory Investigation

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“…However, these studies have focused on individuals with specific high-risk comorbidities in autoimmune diseases such as rheumatoid arthritis and targeted individual infections such as pneumonia [11–18]. Further, some of these studies determined steroid use retrospectively [19–21].…”

Section: Introductionmentioning

confidence: 99%

Association of baseline steroid use with long-term rates of infection and sepsis in the REGARDS cohort

et al. 2017

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BackgroundPrior studies associate steroid use with infection risk but were limited to select populations and short follow-up periods. The association of steroid use with long-term risk of community-acquired infections is unknown. We sought to determine the association of steroid risk with long-term risks of community- acquired infections and sepsis.MethodsWe used data on 30,239 adults aged ≥ 45 years old from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) cohort. The primary exposure was oral or injectable steroid use, determined from medication inventory obtained at baseline in-home visit. The primary outcome was time to first infection event during 2003–2012, determined through adjudicated review of hospital records. We determined associations between baseline steroid use and first infection hospitalization events using Cox proportional hazards models, adjusting for demographics, health behaviors, chronic medical conditions, and medication adherence. Among the first infection hospitalization events, we also determined the association between baseline steroid use and sepsis.ResultsSteroid use was reported in 2.24% (n = 677) of the study population. There were 2593 incident infection events during the 10-year follow-up period. Infection incidence rates were higher for steroid than non-steroid users (37.99 vs. 13.79 per 1000 person-years). Steroid use was independently associated with increased risk of infection (adjusted HR 2.10, 95% CI: 1.73–2.56). Among first-infection events, steroid use was associated with increased odds of sepsis (adjusted OR 2.11, 95% CI: 1.33–3.36). The associations persisted in propensity matched analyses as well as models stratified by propensity score and medication adherence.ConclusionsIn this population-based cohort study, baseline steroid use was associated with increased long-term risks of community-acquired infections and sepsis.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-017-1767-1) contains supplementary material, which is available to authorized users.

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Predictors for the 5-year risk of serious infections in patients with rheumatoid arthritis treated with anti-tumour necrosis factor therapy: a cohort study in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry

Abstract: Age, corticosteroid use, VAS pain, HAQ, TJC28 and the presence of comorbidities all at baseline were significant predictors for developing a serious infection during TNF inhibiting therapy in RA patients.

Cited by 40 publications

References 18 publications

Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials

Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials

Biological agents and respiratory infections: Causative mechanisms and practice management

Association of baseline steroid use with long-term rates of infection and sepsis in the REGARDS cohort

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