Rates of Serious Infections and Malignancies Among Patients with Rheumatoid Arthritis Receiving Either Tumor Necrosis Factor Inhibitor or Rituximab Therapy

Aaltonen, Kalle; Joensuu, Jussi; Virkki, Liisa; Sokka, Tuulikki; Aronen, Pasi; Relas, Heikki; Valleala, Heikki; Rantalaiho, Vappu; Pirilä, Laura; Puolakka, Kari; Uusitalo, Tea; Blom, Marja; Konttinen, Yrjö T.; Nordström, Dan

doi:10.3899/jrheum.140853

Cited by 70 publications

(44 citation statements)

References 23 publications

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“…In total, and considering the previous evidence from 2013,6 15 studies, 7 at low risk of bias, compared the risk of serious infections between bDMARDs and csDMARDs and overall found a significantly increased risk with adjusted HRs (aHR) between 1.0 and 1.8 per study 10–15 35–43. More recent studies at low risk of bias did not show an increased risk 10 14. One study comparing bDMARDs with the general population reported standardised incidence rates of 16–20 for tumour necrosis factor-α inhibitor (TNFi) and even higher for RTX (table 1).…”

Section: Resultsmentioning

confidence: 98%

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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

et al. 2017

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ObjectivesTo assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool.ResultsTwenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)—without differences across bDMARDs—a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5).ConclusionsThese findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.

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Section: Resultsmentioning

confidence: 98%

“…9 10 14 25 51–55 Both in comparison to the general population and to patients on csDMARDs, patients on bDMARDs did not show an increased risk for malignancies. In a few more recent studies, patients on non-TNFi were also included 9 10.…”

Section: Resultsmentioning

confidence: 99%

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

et al. 2017

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“…In a German study, the crude incidence rates per 1,000 person-years were reported to be 5.1 for TNF inhibitors as a class and 7.2 for anakinra (47). In a cohort of Finnish RA patients, the crude rates (95% CI) for malignancy per 1,000 person-years were 5.9 (2.8-11) for infliximab, 7.4 (4.6-11) for etanercept, 6.1 (3.5-9.9) for adalimumab, and 8.4 (3.1-18) for rituximab (35). Strength of evidence for malignancies was low.…”

Section: Resultsmentioning

confidence: 99%

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

Desai

Thaler

Mahlknecht

et al. 2016

Arthritis Care & Research

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ObjectiveTo systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA).MethodsWe searched electronic databases through July 2015 to retrieve randomized controlled trials (RCTs) and observational studies comparing AEs between 2 or more TIMs head‐to‐head. We reported on the following outcomes: number of AEs, discontinuation due to AEs, serious AEs, mortality, serious infections, tuberculosis, herpes zoster, and malignancies. We qualitatively synthesized the literature and conducted random‐effects meta‐analyses if 3 or more studies provided data for an outcome.ResultsTen head‐to‐head RCTs and 51 observational studies were included in this systematic review. A majority of the studies (70%) were conducted in RA patients. Risk of treatment discontinuation due to AEs was higher with infliximab than with adalimumab or etanercept in RA, PsA, and AS. A higher risk for serious infections was noted with infliximab than with abatacept, adalimumab, or etanercept in RA. Risk for treatment discontinuation due to AEs, serious infections, and tuberculosis was lower with etanercept than with adalimumab in RA. Limited evidence suggested no comparative differences in risk for mortality, malignancies, and herpes zoster for adalimumab, etanercept, and infliximab in RA.ConclusionImportant differences were noted in the safety profile of TIMs in RA, generally favoring abatacept, adalimumab, and etanercept over infliximab. Head‐to‐head comparative evidence for other TIMs and non‐RA populations was insufficient to draw conclusions for most of the safety outcomes.

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“…В рамках финского национального регистра (National Register for Biologic Treatment in Finland и Central Finland Central Hospital) [29] были проанализированы материалы применения БПВП (n=1400), ИНФ (n=642), ЭТЦ (n=1245), АДА (n=1207) и РТМ (n=438), касающиеся час-тоты серьезных инфекций, требующих госпитализации на фоне лечения ГИБП и БПВП. Риск инфекций составил 1,2 (95% ДИ 0,63-2,3) для ИНФ, 0,84 (95% ДИ 0,53-1,3) для ЭТЦ, 0,98 (95% ДИ 0,60-1,6) для АДА и 1,1 (95% ДИ 0,59-1,9) для РТМ.…”

Section: регистр Gerinisunclassified

The Efficacy and Safety of Rituximab in Rheumatoid Arthritis: New Evidence

Kusevich¹,

Авдеева²

2017

Naučno-praktičeskaâ revmatologiâ

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Rheumatoid arthritis (RA) is an autoimmune rheumatic disease characterized by chronic erosive arthritis (synovitis) and a systemic inflammatory lesion of the internal organs, which results in early disability and worse quality of life in patients. The accumulated data on the efficacy, safety, and cost-effectiveness of anti-B cell therapy allow identification of rituximab (RTM) as an extremely important drug of first- or second-line therapy with biological agents after ineffective treatment with tumor necrosis factor-α (TNF-α) inhibitors. In this connection, the choice of a personalized treatment regimen remains relevant in each specific case as before. Clinical experience with RTM suggests that the drug is highly effective in improving both clinical manifestations and quality of life in patients with active RA that is characterized by resistance to disease-modifying antirheumatic drugs and TNF-α inhibitors, as well as in those with early RA. The current literature presents a large amount of data on the role of prior therapy and the impact of the stage of RA when using different RTM doses on its efficiency, some of which will be discussed in this review.

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Rates of Serious Infections and Malignancies Among Patients with Rheumatoid Arthritis Receiving Either Tumor Necrosis Factor Inhibitor or Rituximab Therapy

Abstract: Our results provide some reassurance of the safety of biologic treatments in the treatment of RA.

Cited by 70 publications

References 23 publications

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

The Efficacy and Safety of Rituximab in Rheumatoid Arthritis: New Evidence

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