Long-term outcome of patients with JIA treated with etanercept, results of the biologic register JuMBO

Minden, Kirsten; Niewerth, Martina; Zink, Angela; Seipelt, Eva; Foeldvari, Ivan; Girschick, Hermann; Ganser, Gerd; Horneff, Gerd

doi:10.1093/rheumatology/kes019

Cited by 99 publications

(71 citation statements)

References 30 publications

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“…One such study showed an incidence rate of serious infection of 2.1 per 100 person-years in patients treated with ETN, which is similar to the rate reported in JIA patients in the US study regardless of treatment (9).…”

supporting

confidence: 70%

287. Medically Significant Infections are Increased in Patients with Juvenile Idiopathic Arthritis Treated with Etanercept: Results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study

et al. 2014

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Objective. The association between anti-tumor necrosis factor therapy and increased rates of infection is widely documented in adults with rheumatoid arthritis. Findings in children with juvenile idiopathic arthritis (JIA) have been less well documented. The aims of this analysis were to compare the rates of medically significant infections (MSIs) in children with JIA treated with etanercept (ETN) versus methotrexate (MTX) and to compare the rates between combination therapy with ETN plus MTX and monotherapy with ETN. Methods.A total of 852 ETN-treated children and 260 MTX-treated children had been recruited to the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study (BSPAR-ETN). MSIs included infections that resulted in death or hospitalization or were deemed medically significant by the clinician. This on-drug analysis followed the patients until the first MSI, treatment discontinuation, the last followup, or death. Cox proportional hazards models, which were adjusted using propensity deciles, were used to compare rates of MSI between cohorts. Sensitivity analyses were conducted specifically with regard to serious infections (SIs), which were defined as those requiring hospitalization or treatment with intravenous antibiotics/antivirals.Results. The ETN-treated cohort was older and had a longer disease duration, but the disease activity was similar between the cohorts. A total of 133 first MSIs were reported (109 with ETN and 24 with MTX). Patients receiving ETN had higher rates of MSI than did the controls (propensity decile adjusted hazard ratio 2.13 [95% confidence interval 1.22-3.74]). The risk of MSI was higher whether patients were receiving combination or monotherapy. Sensitivity analysis showed no between-group difference in the rate of SIs, which were much less common.Conclusion. ETN therapy is associated with an increased risk of MSI; however, this increased risk disappears when considering only SIs, which suggests that either there were differences in the severity of infections and/or there was a possible reporting bias.Juvenile idiopathic arthritis (JIA) is the most common chronic inflammatory disease in children. The term describes a group of disorders characterized by joint The British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study (BSPAR-ETN) is supported by a research grant from BSPAR to the University of Manchester. BSPAR has received restricted income from Pfizer that finances an entirely separate contract between BSPAR and the University of Manchester to provide and oversee the data collection and analysis as well as the management of the study. The principal investigators and their team have full academic freedom and are able to work independently of pharmaceutical industry influence. All decisions concerning the analysis, interpretation, and publication of the study data are made autonomously of any industrial contribution.

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supporting

confidence: 70%

287. Medically Significant Infections are Increased in Patients with Juvenile Idiopathic Arthritis Treated with Etanercept: Results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study

et al. 2014

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“…The model has not considered the cost of this surgery and this assumption implies that biologic DMARDs have no impact on long-term disease progression in terms of joint damage. However, a prospective registry-based cohort study by Minden and colleagues 169 showed improved long-term prognosis for adult JIA patients who received etanercept during childhood. Furthermore, the AbbVie CS suggests that the reduction in orthopaedic surgery in JIA patients has been attributable to the increase in the use of immunomodulatory agents among children in recent decades and so DMARDs and biologic agents may have successfully prevented end-stage joint damage, based upon historical data that have shown a reduction.…”

Section: Clinical Effectivenessmentioning

confidence: 99%

The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation

Shepherd

Cooper²,

Harris³

et al. 2016

Health Technol Assess

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BackgroundJuvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel®, Pfizer), abatacept (Orencia®, Bristol-Myers Squibb), adalimumab (Humira®, AbbVie) and tocilizumab (RoActemra®, Roche) – with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded).Data sourcesElectronic bibliographic databases including MEDLINE, EMBASE, The Cochrane Library and the Database of Abstracts of Reviews of Effects were searched for published studies from inception to May 2015 for English-language articles. Bibliographies of related papers, systematic reviews and company submissions were screened and experts were contacted to identify additional evidence.Review methodsSystematic reviews of clinical effectiveness, health-related quality of life and cost-effectiveness were undertaken in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A cost–utility decision-analytic model was developed to compare the estimated cost-effectiveness of biologic DMARDs versus methotrexate. The base-case time horizon was 30 years and the model took a NHS perspective, with costs and benefits discounted at 3.5%.ResultsFour placebo-controlled randomised controlled trials (RCTs) met the inclusion criteria for the clinical effectiveness review (one RCT evaluating each biologic DMARD). Only one RCT included UK participants. Participants had to achieve an American College of Rheumatology Pediatric (ACR Pedi)-30 response to open-label lead-in treatment in order to be randomised. An exploratory adjusted indirect comparison suggests that the four biologic DMARDs are similar, with fewer disease flares and greater proportions of ACR Pedi-50 and -70 responses among participants randomised to continued biologic DMARDs. However, confidence intervals were wide, the number of trials was low and there was clinical heterogeneity between trials. Open-label extensions of the trials showed that, generally, ACR responses remained constant or even increased after the double-blind phase. The proportions of adverse events and serious adverse events were generally similar between the treatment and placebo groups. Four economic evaluations of biologic DMARDs for patients with JIA were identified but all had limitations. Two quality-of-life studies were included, one of which informed the cost–utility model. The incremental cost-effectiveness ratios (ICERs) for adalimumab, etanercept and tocilizumab versus methotrexate were £38,127, £32,526 and £38,656 per quality-adjusted life year (QALY), respectively. The ICER for abatacept versus methotrexate as a second-line biologic was £39,536 per QALY.LimitationsThe model does not incorporate the natural history of JIA in terms of long-term disease progression, as the current evidence is limited. There are no head-to-head trials of biologic DMARDs, and clinical evidence for specific JIA subtypes is limited.ConclusionsBiologic DMARDs are superior to placebo (with methotrexate where permitted) in children with (predominantly) polyarticular course JIA who have had an insufficient response to previous treatment. Randomised comparisons of biologic DMARDs with long-term efficacy and safety follow-up are needed to establish comparative effectiveness. RCTs for JIA subtypes for which evidence is lacking are also required.Study registrationThis study is registered as PROSPERO CRD42015016459.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Так, в 2007 г. было опубликовано 23 статьи, а спустя 10 лет, в 2017 г., -22 статьи в рецен-зируемых иностранных журналах в сети PubMed (ключе-вые слова: etanercept, JIA) [19]. Помимо крупных много-летних многоцентровых исследований, направленных на изучение отдаленной эффективности и безопасности [20,21], ежегодно детские ревматологи разных стран публикуют данные как локальных регистров, так и реги-стров, охватывающих пациентов целого государства [6,22]. Интерес ревматологов к результатам, полученным из реальной клинической практики, связан с тем, что в большие многоцентровые клинические исследования включаются далеко не все пациенты.…”

Section: обсуждение основного результата исследованияunclassified

Etanercept Treatment Results in Children With Non-Systemic Juvenile Idiopathic Arthritis: Remission, Recrudescence, and Adverse Events. Retrospective Cohort Study

Костик¹,

Чикова²,

Исупова³

et al. 2018

Vopr. sovr. pediatr.

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Background.Etanercept is a biological drug most commonly used in patients with juvenile idiopathic arthritis (JIA). The results of its use are showed in local studies.Objective.Our aim was to evaluate the efficacy and safety of the use of etanercept in children with non-systemic JIA, to determine the predictors of remission and the risk factors for the development of exacerbations.Methods.In a retrospective cohort study, the results of etanercept treatment (remission, exacerbations, adverse events) in children with non-systemic JIA were analyzed. The minimum follow-up period was 6 months.Results.The period of remission within 6–36 months occurred in 77/131 (58.8%), exacerbations developed in 18/129 (14.0%) patients. Predictors of achieving remission were the age of JIA onset < 8 years [relative risk (RR) 2.05; 95% confidence interval (CI) 1.27–3.23], the age of prescribing etanercept ≤ 10 years (RR 1.7, 95% CI 1.22–2.38), the time of the disease prior to etanercept prescription < 2.5 years (RR 2.4, 95% CI 1.4–4.4), the presence of HLA-B27 antigen (RR 2.15, 95% CI 0.98–4.75; p = 0.06). The risk of exacerbations was higher in children with polyarticular JIA (RR 2.7, 95% CI 0.9–8.2; p = 0.08), whereas methotrexate therapy reduced the risk of exacerbations (RR 0.32, 95% CI 0.1–1.15; p = 0.05). Etanercept was discontinued due to primary (improvement by the ACRpedi criteria after 3 months of therapy <30%) or secondary (loss of previously achieved ≥ 30% improvement) failure in 14/152 (9.2%) patients; de novo uveitis developed in 8/152 (5.3%) patients; reactions at the injection site — in 6/152 (4.0%) patients.Conclusion.Therapy involving etanercept is more likely to induce remission in younger patients with JIA onset at the age of 8 years and a history of less than 2.5 years. A high risk of exacerbations was noted in patients with polyarticular JIA, and low one — in those receiving methotrexate as a part of combined therapy.

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Long-term outcome of patients with JIA treated with etanercept, results of the biologic register JuMBO

Abstract: The first data from the JuMBO register indicate an improved long-term outcome of patients with severe JIA treated in the biologic era and an acceptable safety profile of ETA.

Cited by 99 publications

References 30 publications

287. Medically Significant Infections are Increased in Patients with Juvenile Idiopathic Arthritis Treated with Etanercept: Results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study

287. Medically Significant Infections are Increased in Patients with Juvenile Idiopathic Arthritis Treated with Etanercept: Results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study

The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation

Etanercept Treatment Results in Children With Non-Systemic Juvenile Idiopathic Arthritis: Remission, Recrudescence, and Adverse Events. Retrospective Cohort Study

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