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Tikhonova IA, Yang H, Bello S, et al. Enzyme-linked immunosorbent assays for monitoring TNF-alpha inhibitors and antibody levels in people with rheumatoid arthritis: a systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2021 Feb. (Health Technology Assessment, No. 25.8.)

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Enzyme-linked immunosorbent assays for monitoring TNF-alpha inhibitors and antibody levels in people with rheumatoid arthritis: a systematic review and economic evaluation.

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Appendix 11Rates of serious adverse events

TABLE 55

Serious adverse events in RA patients who were treated with TNF-α inhibitors

SourceType of serious infectionsPopulationEstimate rate of SAEs
Singh et al.79 (systematic review)Serious infection mostly included infections associated with death, hospitalisation or the use of intravenous antibiotics4788 TNF-α inhibitor-experienced people with RA who were recruited to 11 RCTs during 2005–13, with mean RA duration of 10.8 years19/1000
TA37523 (based on a systematic review by Singh et al.78)Serious infections included opportunistic infections as well as bacterial infections in most studiesAdults (aged ≥ 16 years) with any disease (except HIV/AIDS) included in studies of any of the nine biologics: abatacept (Orencia; Bristol-Myers Squibb Pharmaceuticals Limited, Uxbridge, UK), ADL (Humira), anakinra (Kineret®; Swedish Orphan Biovitrum Ltd, Great Abington, UK), CTZ (Cimzia), etanercept (Enbrel), golimumab (Simponi), IFX (Remicade), rituximab (Rituxan or MabThera®; Roche Products Limited, Welwyn Garden City, UK) and tocilizumab (Actemra®; F. Hoffman-La Roche Ltd, Basel, Switzerland)35/1000
Senabre Gallego et al.73Septic arthritis39 people in clinical remissionOne patient (out of 39) discontinued treatment owing to the AE (study follow-up: 12 months)
Dixon et al.76TuberculosisPeople with RA from the BSRBR-RA treated with ADL, ETN or IFX
  • ADL: 144/100,000 person-years
  • ETN: 39/100,000 person-years
  • IFX: 136/100,000 person-years
Bruce at al.75Pneumocystis jirovecii pneumoniaPeople with RA from the BSRBR-RA treated with TNF-α inhibitors2.0/10,000 person-years (95% CI 1.2 to 3.3 person-years)
Burmester et al.77SAE (defined as fatal or immediately life-threatening; required hospitalisation or prolonged hospitalisation; resulted in persistent or significant disability/incapacity, congenital anomaly or required medical or surgical intervention to prevent a serious outcome)15,132 people with RA exposed to ADL in 28 global clinical trials4.7 per 100 person-years
aJani et al.116In the high-level dose group: lower (34%) and upper (16%) respiratory tract infections, urinary tract infections (15%) and skin infections, including shingles (8%)People from the BSRBR-RA (safety data) and the Biologics in RA Genetics & Genomics Syndicate (serological samples)
  • Low/normal drug level: 54 (95% CI 30 to 98)b per 1000 person-years
  • High drug level: 76 (95% CI 55 to 104) per 1000 person-yearsc

AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus.

a

TNF-α drug levels were measured at 3, 6 and 12 months after biologic initiation and stratified as low/normal or high drug levels as per thresholds defined using concentration-effect curves for each drug. The risk of the first and total infections within the first year was analysed. Events occurring on drug dose or within 90 days of the last dose were included.

b

Crude rate in patients with low/normal drug level (n = 241).

c

Crude rate in patients with high drug level (n = 462).

Copyright © Queen’s Printer and Controller of HMSO 2021. This work was produced by Tikhonova et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK567303
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