What is the clinical effectiveness, cost effectiveness and implications for safety of assessing anti-tumour necrosis factor (TNF)α drug levels and antibodies in children with moderate to severe inflammatory bowel disease compared with existing tx?

Title 

What is the clinical effectiveness, cost effectiveness and implications for safety of assessing anti-tumour necrosis factor (TNF)α drug levels and antibodies in children with moderate to severe inflammatory bowel disease compared with existing clinical strategies in use in NHSScotland?

Agency 

HIS; Healthcare Improvement Scotland
Delta House, 50 West Nile Street, Glasgow G1 2NP, Scotland
Tel: +44 141 225 6998; e-mail: Doreen.Pedlar@nhs.net; website: http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg.aspx

Reference

Technologies scoping report 18; ISBN 1-84404-954-X; http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg_scoping_reports/technologies_scoping_report_18.aspx 

Aim

This work was undertaken in response to an enquiry from NHS Greater Glasgow and Clyde. It is intended to provide an overview of the evidence base, including gaps and uncertainties, and inform decisions on the feasibility of producing an evidence review product on the topic.

Conclusions and results

Data on the associations between clinical response, development of anti-TNFα antibodies and serum levels of anti-TNFα medications are complex and conflicting, and there is a lack of standardisation of assays or outcome measures. No prospective comparative studies were identified assessing the utility of the measures in directing clinical decision making in a paediatric population. Ten ongoing trials, of which
the majority are in adults, were identified.

Recommendations

Technologies scoping reports do not make recommendations for NHSScotland.
See SHTG Advice Statement 009/13.

Methods

A systematic search of the secondary literature was carried out between 4–19 March 2013 to identify systematic reviews, health technology assessments and other evidence-based reports. Medline, Medline in process, Embase and Web of Knowledge databases were searched for systematic reviews and meta-analyses. The primary literature was systematically searched between 11–19 March 2013 using the following databases: Medline, Medline in process, Embase, and Web of Knowledge. Results were limited to English language studies on paediatric populations published between 2003–2013.

Key websites were searched for guidelines, policy documents, clinical summaries, economic studies and ongoing trials (ongoing trials search 1–5 May 2013). Websites of organisations related to this topic, for example British Society for Gastroenterology, Academy for Paediatric Gastroenterology, British Society for Paediatric Gastroenterology Hepatology and Nutrition, were also searched.

Further research/reviews required

Given the large number of trials in progress, an evidence review of the primary literature should be considered in 2 years.

INAHTA Brief issue: 2012/092

Agency: HIS, Healthcare Improvement Scotland
(Formerly:

Written by

Doreen Pedlar)
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Reference:

Technologies scoping report 18; ISBN 1-84404-954-X; http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/shtg_scoping_reports/technologies_scoping_report_18.aspx   

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