Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

• Published in: Health technology assessment (Winchester, England) England), 2016-05, Vol.20 (39), p.1-326
• Main Authors: Archer, Rachel, Tappenden, Paul, Ren, Shijie, Martyn-St James, Marrissa, Harvey, Rebecca, Basarir, Hasan, Stevens, John, Carroll, Christopher, Cantrell, Anna, Lobo, Alan, Hoque, Sami
• Format: Article
• Language: English
• Subjects: adalimumab; Adalimumab - economics; Adalimumab - therapeutic use; Antibodies, Monoclonal - economics; Antibodies, Monoclonal - therapeutic use; Biosimilar Pharmaceuticals - economics; Biosimilar Pharmaceuticals - therapeutic use; clinical effectiveness systematic review; Colitis, Ulcerative - drug therapy; Cost-Benefit Analysis; economic model; Gastrointestinal Agents - administration & dosage; Gastrointestinal Agents - adverse effects; Gastrointestinal Agents - economics; Gastrointestinal Agents - therapeutic use; golimumab; Hospitalization; Humans; infliximab; Infliximab - economics; Infliximab - therapeutic use; Models, Econometric; Quality of Life; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; State Medicine; ulcerative colitis
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta20390

Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities. Peer-reviewed publications, European Public Assessment Reports and manufacturers' submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals. A systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model. Ten randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade(®), Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira(®), AbbVie) or golimumab (GOL) (Simponi(®), MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, i