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.