The use of biologic response modifiers in polyarticular-course juvenile idiopathic arthritis: A systematic review

Ungar, Wendy J.; Costa, Vânia; Burnett, Heather; Feldman, Brian M.; Laxer, Ronald M.

doi:10.1016/j.semarthrit.2012.10.006

Cited by 45 publications

(39 citation statements)

References 63 publications

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“…There is, however, ample data from original studies and long term outcome studies to enable a historical comparison to the efficacy of high doses of biologics to standard doses or those on traditional DMARDs alone. None of the adverse events we report are inconsistent with the findings noted in prior published experience with these agents, and the nearly 70% response rate is convergent with prior reports as well [17][18][19][20][21]. Notably, Lovell et al demonstrated rates of SAEs to be 0.13 per patient-year, and rates of serious infections were 0.04 per patient-year, in a total etanercept exposure of 225 patientyears.…”

Section: Discussionsupporting

confidence: 74%

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

Sarkissian¹,

Birmingham²

2015

Rheumatology (Sunnyvale)

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Objectives: To review a cohort of patients receiving higher than standard or FDA approved dosing of TNF inhibitors to assess the safety and efficacy of these agents in the management of inflammatory joint and eye disease in a clinical pediatric rheumatology setting. Methods:A retrospective review was performed of patients 1-17 years of age with inflammatory diseases requiring TNF inhibitor therapy treated with at least six weeks of treatment of a higher than the standard FDA approved dose of TNF inhibitors, from 12/1/11-4/8/14. Entanercept (Enbrel) was given at doses greater than 0.8 mg/kg, Infliximab (Remicade) was infused in doses greater than 5 mg/kg or more frequently than every eight weeks, and Adalimumab (Humira) was given at either 20 mg/kg weekly for patients weighing less than 30 kg or 40 mg/kg weekly for patients weighing greater than 30 kg. Serious adverse events (SAE), infections, and infusion reactions were all documented. We also noted clinical improvement based on parent/patient's report of decreased symptoms and provider assessment, including exam findings and laboratory parameters. Results:Thirty-five patients were included (average 11.3 years). Of these, 24 (68%) were noted to have improvement of either symptoms or exam. There was one SAE noted in the group and one infusion reaction, and 10 patients with illnesses that may have been exacerbated by immune suppression. Conclusion:Higher than standard-dose or FDA approved dosing of TNF inhibitors appear safe and efficacious in the management of pediatric inflammatory diseases, however, caution must be taken with interpretation of the results due to the retrospective chart review study design. Larger, prospective, controlled studies will be necessary to more fully evaluate safety and efficacy of this treatment approach.

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Section: Discussionsupporting

confidence: 74%

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

Sarkissian¹,

Birmingham²

2015

Rheumatology (Sunnyvale)

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“…167,168 Both of these included a range of biologic DMARDs, including the four relevant to the scope of this assessment. However, none of these reviews identified any additional RCT evidence to this assessment report.…”

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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“…Наибольшее число пациентов с ЮИА, получающих этанерцепт в настоящее время, включены в немецкий регистр BIKER («Биопрепараты в педиатрической рев-матологии») [18,21]. В регистре представлена терапев-тическая эффективность этанерцепта с 1-го мес его применения [33,34].…”

Section: Discussionunclassified

“…В последние годы возможности эффективного лече-ния ЮИА значительно расширились в связи с внедрени-ем в клиническую практику генно-инженерных биологи-ческих препаратов [18,19]. Первыми биологическими агентами, которые стали широко применять в клиниче-ской практике, стали ингибиторы ФНО ␣ [20].…”

Section: вопросы современной педиатрииunclassified

Long Term Follow-up on Effectiveness and Safety of Etanercept in Juvenile Idiopathic Arthritis Without S ystemic Manifestations

Baranov¹,

Alexeeva²,

Bzarova³

et al. 2015

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The use of biologic response modifiers in polyarticular-course juvenile idiopathic arthritis: A systematic review

Cited by 45 publications

References 63 publications

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

Safety and Efficacy of High-dose Tumor Necrosis Factor (TNF) Inhibitors in the Management of Pediatric Inflammatory Diseases

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

Long Term Follow-up on Effectiveness and Safety of Etanercept in Juvenile Idiopathic Arthritis Without S ystemic Manifestations

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