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Tocilizumab Combination Therapy or Monotherapy or Methotrexate Monotherapy in Methotrexate-naïve Patients with Early Rheumatoid Arthritis: 2-year Clinical and Radiographic Results from the Randomized, Placebo-controlled FUNCTION Trial

Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A and Dimonaco S. - Ann Rheum Dis Published Online First: 7 April 2017. Doi 10.1136/annrheumdis-20160210561

Burmester et al. present data showing that 52-week efficacy and safety of intravenous tocilizumab plus methotrexate, or tocilizumab monotherapy are maintained through to Week 104 in patients with early rheumatoid arthritis.

Patients were assigned to four treatment groups: 4 mg/kg TCZ + MTX, 8 mg/kg TCZ + MTX, 8 mg/kg TCZ + placebo or placebo + MTX. Patients not achieving DAS28 ≤3.2 at Week 52 and who were not receiving 8 mg/kg TCZ were rescued to 8 mg/kg TCZ + MTX. Of the 1162 randomly assigned patients, 1157 were included in the intent-to-treat population; 1153 to the safety population.

DAS28-ESR remission rates were maintained from Week 52 through to Week 104: in the 8mg/kg TCZ + MTX group, DAS28-ESR remission rates were 49.3% at Week 52, and 47.6% at Week 104. For
post-escape patients receiving placebo + MTX and 4 mg/kg TCZ + MTX, response rates were 51.4% and 30.5%, respectively at Week 104. Inhibition of radiographic progression was also maintained through to Week 104 for both the TCZ 8 mg/kg treatment groups.

Infections were the most commonly reported adverse events ranging from 89.4/100 PY (8 mg/kg TCZ + MTX) to 113.3/100 PY (4 mg/kg TCZ + MTX). However, most were mild to moderate in intensity.

To conclude, patients with early rheumatoid arthritis treated either with TCZ monotherapy or TCZ in combination with MTX, maintained clinical benefits through to Week 104 with no new safety signals.