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Clinical efficacy of tocilizumab shown in patients with early RA
Patients with early, progressive rheumatoid arthritis who took tocilizumab showed clinical improvement in the signs and symptoms of the disease at 24 weeks, according to the results of a recently published study.
“These results add to the body of evidence showing the efficacy of [tocilizumab] TCZ as therapy for patients with [rheumatoid arthritis] RA across several populations, including patients who respond inadequately to [disease-modifying antirheumatic drugs] DMARDs or to [anti-tumor necrosis factor] anti-TNF agents and patients who receive TCZ monotherapy because [methotrexate] MTX is contraindicated or cannot be tolerated,” Gerd R. Burmester, MD, from the Department of Rheumatology and Clinical Immunology at Charité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin in Berlin, Germany, and colleagues wrote in their study.
Gerd R. Burmester
Burmester and colleagues evaluated 1,157 patients from the FUNCTION study with early progressive RA who were MTX-naïve and underwent treatment with tocilizumab and MTX combination therapy, according to the abstract. Patients were randomly assigned to one of the following groups and followed to week 52: 4 mg/kg TCZ and MTX; 8 mg/kg TCZ and MTX; 8 mg/kg TCZ and placebo; or placebo with MTX. The primary outcome for patients at 24 weeks was a DAS28-erythrocyte sedimentation rate (ESR) of less than 2.6.
Investigators found significantly more patients in the 8-mg/kg TCZ/MTX and 8-mg/kg TCZ/placebo groups reached DAS28-ESR remission at 24 weeks compared with patients in the placebo/MTX group (45%, 39% and 15%, respectively), according to the abstract. Improvement of radiographic progression was also seen in the 8-mg/kg TCZ/MTX group (mean change from baseline van der Heijde–modified total Sharp score = 0.08) compared with the placebo and MTX (1.14) group, as well as a mean reduction in health disability index in the 8-mg/kg TCZ/MTX group (−0.81) compared with the placebo and MTX group (−0.64).
The researchers noted both 8-mg/kg TCZ/MTX and 4-mg/kg TCZ/MTX groups showed improvement in the signs and symptoms of RA compared with the methotrexate groups and found similar levels of adverse treatments among all groups, according to the abstract. – by Jeff Craven
Disclosures: Burmester reports grants from Roche and is on the speakers bureau for AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer and UCB Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.