SAT0638 Clinical activity, ultrasound assessment and drug monitoring in rheumatoid arthritis patients receiving ANTI-TNF-α therapy with extended interval of administration

Gallego, JM Senabre; Mingot, M Marco; Naranjo, Antonio; Llinares-Tello, Francisca; Pons, A.; Barber-Vallés, Xavier; Santos-Soler, G.; Salas-Heredia, Esteban; Cano, C.; Lorente, Macarena; Garcia, J.; Molina, Juan

doi:10.1136/annrheumdis-2017-eular.3066

Cited by 1 publication

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“…One study from the clinical effectiveness systematic review, Senabre Gallego et al, 73 reported the rate of AEs experienced by patients who were treated with TNF-α inhibitor therapies. This study recruited 39 participants with RA who had achieved remission.…”

Section: Rate Of Serious Adverse Eventsmentioning

confidence: 99%

“…In this study, the modelled AE rate for people who were receiving a full dose of biologics, three events per 100 patient-years, was adopted from Senabre Gallego et al 73 The AE rate in tapered patients was estimated using an odds ratio (OR) for serious infections in people who were treated with low-dose biologics compared with people who were receiving the standard dose 79 (see Appendix 12). The resulting AE rate in tapered patients was two events per 100 patient-years.…”

Section: Rate Of Serious Adverse Eventsmentioning

confidence: 99%

“…(qaly* or qald* or qale* or qtime* or life year or life years).ti,ab,kf. 73. disability adjusted life.ti,ab,kf.…”

Section: Search Strategymentioning

confidence: 99%

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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

Tikhonova

Yang

Bello

et al. 2021

Health Technol Assess

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Background Rheumatoid arthritis is a chronic autoimmune disease that primarily causes inflammation, pain and stiffness in the joints. People with severe disease may be treated with biological disease-modifying anti-rheumatic drugs, including tumour necrosis factor-α inhibitors, but the efficacy of these drugs is hampered by the presence of anti-drug antibodies. Monitoring the response to these treatments typically involves clinical assessment using response criteria, such as Disease Activity Score in 28 joints or European League Against Rheumatism. Enzyme-linked immunosorbent assays can also be used to measure drug and antibody levels in the blood. These tests may inform whether or not adjustments to treatment are required or help clinicians to understand the reasons for treatment non-response or a loss of response. Methods Systematic reviews were conducted to identify studies reporting on the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assays to measure drug and anti-drug antibody levels to monitor the response to tumour necrosis factor-α inhibitors [adalimumab (Humira®; AbbVie, Inc., North Chicago, IL, USA), etanercept (Enbrel®; Pfizer, Inc., New York, NY, USA), infliximab (Remicade®, Merck Sharp & Dohme Limited, Hoddesdon, UK), certolizumab pegol (Cimzia®; UCB Pharma Limited, Slough, UK) and golimumab (Simponi®; Merck Sharp & Dohme Limited)] in people with rheumatoid arthritis who had either achieved treatment target (remission or low disease activity) or shown primary or secondary non-response to treatment. A range of bibliographic databases, including MEDLINE, EMBASE and CENTRAL (Cochrane Central Register of Controlled Trials), were searched from inception to November 2018. The risk of bias was assessed using the Cochrane ROBINS-1 (Risk Of Bias In Non-randomised Studies – of Interventions) tool for non-randomised studies, with adaptations as appropriate. Threshold and cost–utility analyses that were based on a decision tree model were conducted to estimate the economic outcomes of adding therapeutic drug monitoring to standard care. The costs and resource use were considered from the perspective of the NHS and Personal Social Services. No discounting was applied to the costs and effects owing to the short-term time horizon of 18 months that was adopted in the economic analysis. The impact on the results of variations in testing and treatment strategies was explored in numerous clinically plausible sensitivity analyses. Results Two studies were identified: (1) a non-randomised controlled trial, INGEBIO, that compared standard care with therapeutic drug monitoring using Promonitor® assays [Progenika Biopharma SA (a Grifols–Progenika company), Derio, Spain] in Spanish patients receiving adalimumab who had achieved remission or low disease activity; and (2) a historical control study. The economic analyses were informed by INGEBIO. Different outcomes from INGEBIO produced inconsistent results in both threshold and cost–utility analyses. The cost-effectiveness of therapeutic drug monitoring varied, from the intervention being dominant to the incremental cost-effectiveness ratio of £164,009 per quality-adjusted life-year gained. However, when the frequency of testing was assumed to be once per year and the cost of phlebotomy appointments was excluded, therapeutic drug monitoring dominated standard care. Limitations There is limited relevant research evidence and much uncertainty about the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assay-based testing for therapeutic drug monitoring in rheumatoid arthritis patients. INGEBIO had serious limitations in relation to the National Institute for Health and Care Excellence scope: only one-third of participants had rheumatoid arthritis, the analyses were mostly not by intention to treat and the follow-up was 18 months only. Moreover, the outcomes might not be generalisable to the NHS. Conclusions Based on the available evidence, no firm conclusions could be made about the cost-effectiveness of therapeutic drug monitoring in England and Wales. Future work Further controlled trials are required to assess the impact of using enzyme-linked immunosorbent assays for monitoring the anti-tumour necrosis factors in people with rheumatoid arthritis. Study registration This study is registered as PROSPERO CRD42018105195. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 8. See the NIHR Journals Library website for further project information.

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Section: Rate Of Serious Adverse Eventsmentioning

confidence: 99%

Section: Rate Of Serious Adverse Eventsmentioning

confidence: 99%