Authors' objectives:

The aim of this report is to provide a clinical review and economic evaluation relating to the introduction of infliximab and etanercept to the sequence of disease-modifying anti-rheumatic drugs (DMARDs) used in the treatment of rheumatoid arthritis (RA) by answering two questions:

1. What is the evidence supporting the incremental benefit of infliximab and etanercept as additional therapies for the treatment of RA?

2. What is the cost-effectiveness of different sequences of DMARDs that may include infliximab or etanercept?

Authors' results and conclusions: Infliximab: Results were based on one-year data from trials. Three randomized controlled trials (RCTs), with a total of 529 participants, compared infliximab plus methotrexate MTX) with MTX alone. After 12 months of treatment, the percentage of patients showing improvement was greater among those treated with infliximab plus MTX compared with those who had injections of MTX alone. Etanercept: Three RCTs, with a total of 955 participants, compared etanercept with placebo. Analysis was restricted to the approved dose for use in Canada: 25 mg twice weekly of etanercept without MTX compared with placebo. After six months of treatment, patients receiving etanercept were more likely to have a response to therapy as measured by American College of Rheumatology ACR20, ACR50, or ACR70 criteria.

Authors' recommendations: Clinical Review: Infliximab plus MTX is efficacious compared with MTX alone for treating long-standing RA after both six and 12 months in patients who no longer respond to DMARD treatment. Although long-term studies are lacking, current data suggest that infliximab is well tolerated. Etanercept is efficacious compared with placebo after six months for treating long-standing RA in patients who no longer respond to DMARDs. Although long-term studies are lacking, current data suggest that etanercept is well tolerated by most patients in the short term. More long-term randomized trials are needed to corroborate these findings and to determine the benefit-to-harm ratio, including an evaluation of potentially rare or delayed adverse events, and the sustainability of treatment response to infliximab and etanercept in patients with longstanding RA. Ongoing post-marketing surveillance is required to establish effectiveness and to determine the incidence of adverse events and the sustainability of treatment response. The reports of disseminated or extra pulmonary tuberculosis, invasive fungal infections, and other opportunistic infections with an anti-TNF treatment require ongoing surveillance to determine the true incidence with infliximab and etanercept treatment, and to watch for rare adverse events. Economic Analysis: Neither etanercept nor infliximab seem to be cost-effective under commonly accepted criteria. This study is limited to patients with long-standing RA and may be inapplicable when comparing infliximab and etanercept with more conventional DMARDs in patients with early RA. Head-to-head comparator trials between biological agents are needed to evaluate the comparative benefits and harms.

Authors' methods: Overview

Project Status: Completed

URL for project: https://www.ccohta.ca/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Coordinating Office for Health Technology Assessment

Contact Address: 600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553, Fax: +1 613 226 5392;

Contact Name: requests@cadth.ca

Contact Email: requests@cadth.ca

Copyright: Canadian Coordinating Office for Health Technology Assessment (CCOHTA)