Time‐dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis

Sakai, Ryoko; Komano, Yukiko; Tanaka, Michi; Nanki, Toshihiro; Koike, Ryuji; Nagasawa, Hayato; Amano, Koichi; Nakajima, Ayako; Atsumi, Tatsuya; Koike, Takao; Ihata, Atsushi; Ishigatubo, Yoshiaki; Saito, Kazuyoshi; Tanaka, Yoshiya; Ito, Satoshi; Sumida, Takayuki; Tohma, Shigeto; Tamura, Naoto; Fujii, Tomoyuki; Sugihara, Takahiko; Kawakami, Atsushi; Hagino, Noboru; Ueki, Yukitaka; Hashiramoto, Akira; Nagasaka, Kenji; Miyasaka, Nobuyuki; Harigai, Masayoshi

doi:10.1002/acr.21666

Cited by 80 publications

(60 citation statements)

References 41 publications

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“…Recent publications from the first Asian biologics register in Japan revealed SI rates with infliximab and etanercept to be very similar to those reported in Western cohorts [17,18]. Sites and predictors of infection were also similar, though a large proportion of SI in both the anti-TNF and sDMARD arms were OIs.…”

Section: All-site Serious Infectionsmentioning

confidence: 53%

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Lahiri¹,

Dixon²

2015

Best Practice & Research Clinical Rheumatology

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Section: All-site Serious Infectionsmentioning

confidence: 53%

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Lahiri¹,

Dixon²

2015

Best Practice & Research Clinical Rheumatology

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“…These included seven studies on infections (4 serious infections,12 14 16 18 2 skin infections21 24 and 1 tuberculosis62), 2 on cancer,43 63 1 on cardiovascular events,53 1 on neurological events51 and 1 on gastrointestinal perforation 56. Again, due to heterogeneity, a meta-analysis could not be performed.…”

Section: Resultsmentioning

confidence: 99%

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis

et al. 2014

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ObjectivesTo update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism (EULAR) recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies (including registries). Interventions were any bDMARD (anakinra, infliximab, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab or certolizumab pegol) or sDMARD (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, gold/auranofin, azathioprine, chlorambucil, chloroquine, cyclosporin, cyclophosphamide, mycophenolate, minocycline, penicillamine, tacrolimus or tofacitinib) and a comparator was required. Information on GCs was collected from the included studies. All safety outcomes were included.ResultsForty-nine observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria. Substantial heterogeneity precluded meta-analysis of any of the outcomes. Patients on tumour necrosis factor inhibitors (TNFi) compared to patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1–1.8), a higher risk of tuberculosis, and an increased risk of infection by herpes zoster cannot be excluded. Patients on TNFi did not have an increased risk for malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). From the studies identified on conventional sDMARDs, no new safety signals were found.ConclusionsThe findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.

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“…The reported risk of HZs in biologic disease-modifying antirheumatic drug (bDMARD) users varies. For example, the reported odds ratio of HZs ranged from 0.95 (95% confidence interval [CI], 0.75∼1.21) to 2.61 (95% CI, 0.86∼7.91) for tumor necrosis factor (TNF) blockers compared with conventional DMARDs (cDMARDs) [13,14]. The risk of HZ in Asian RA patients seems to be higher, considering higher incidence of HZ in Asian RA patients in recent tofacitinib trials [15].…”

Section: Introductionmentioning

confidence: 99%

Risk of Herpes Zoster in Patients with Rheumatoid Arthritis Undergoing Biologic Disease-Modifying Therapy

et al. 2017

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Objective. Rheumatoid arthritis (RA) patients suffer from an increased risk of herpes zoster (HZ) partially due to immunosuppressant medications. This study investigated HZ in RA patients treated with biologic disease-modifying antirheumatic drugs (bDMARDs), as compared with conventional DMARDs (cDMARDs). Methods. This retrospective case series study assembled record information of 277 RA patients who received bDMARDs after failure of at least one cDMARDs at Seoul National University Hospital between August 2003 and February 2015. Following capture of baseline information and identification of HZ episodes, crude HZ incidence rates per 100 patient-years (95% confidence intervals) were calculated. Results. For 718 treatment courses, 277 (38.6%) comprised cDMARDs, 66 (9.2%) infliximab, 175 (24.4%) etanercept, 95 (13.2%) adalimumab, 9 (1.3%) golimumab, 41 (5.7%) rituximab, 31 (4.3%) abatacept, and 24 (3.3%) tocilizumab. There were 37 HZ episodes, 16 during cDMARD treatment courses, and 21 accompanying bDMARDs, two with infliximab, eight with etanercept, five with adalimumab, and three each with rituximab and abatacept. The crude HZ incidence rate per 100 patient-years was 2.4 (1.4∼3.9) for cDMARDs, 2.2 (0.3∼7.9) for infliximab, 1.8 (0.8∼3.6) for etanercept, 3.7 (1.2∼8.4) for adalimumab, 3.9 (0.8∼11.0) for rituximab, and 8.5 (1.8∼23.1) for abatacept. Conclusion. We conclude that bDMARDs do not always increase the risk of HZs in RA patients, although HZ rates vary for different bDMARDs. (J Rheum Dis 2017;24:220-226)

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Time‐dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis

Abstract: Objective. To investigate associations between continuous treatments with tumor necrosis factor (TNF) antagonists and risk for developing serious infections (SIs

Cited by 80 publications

References 41 publications

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis

Risk of Herpes Zoster in Patients with Rheumatoid Arthritis Undergoing Biologic Disease-Modifying Therapy

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