Clinical Medicine Insights: Therapeutics

Golimumab (GLM) is a fully human monoclonal antibody with amino acid sequences of the light and heavy chains identical to those of infliximab, that binds specifically to both the soluble and transmembrane bioactive forms of human TNF-, thereby inhibiting the biological activity of TNF. GLM was studied in an extensive program of RCTs that included one study in phase I and one in phase II, and studies in phase III including patients failing MTX (GO-FORWARD), failing other anti TNF (GO-AFTER), MTX naïve patients (GO-BEFORE), and one study with IV GLM in patients that remained active in spite of receiving MTX. These studies showed that GLM is effective and safe for the treatment of RA, with a efficacy and safety profile very similar to the other classic anti TNF biologics, and determined the approval by the FDA in April 2009 for use in moderately-to-severely active RA in combination with methotrexate (MTX) when given to adults. In comparison to other biologics for RA, GLM has some advantages: first, it's less frequent administration (every 4 weeks); and second, its subcutaneous route of administration, which allows patients to self administer the drug at home. Currently, GLM represents an option to RA active patients desiring less frequent injections and to patients in whom the previous treatment with other TNF- inhibitors failed.