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TCZ monotherapy or TCZ+MTX
initiated at 52 weeks showed significant clinical efficacy even at 104 weeks
with no new safety warning.
A recent study concludes that patients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals.
Rheumatoid arthritis (RA), a chronic, systemic disabling condition, affecting joints having unknown aetiology. The optimal management of RA requires a multidisciplinary approach, biologic disease-modifying antirheumatic drugs (DMARDs). The study has been conducted with an objective to analyze if the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) can be maintained to week 104.
The trial involved methotrexate (MTX)-naive patients with moderate to severe, active and early progressive RA. They were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo or placebo+MTX for 104 weeks. Patients who did not receive 8 mg/kg TCZ and not achieved Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) ≤3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory.
In the study, intent-to-treat populations included 1157 patients and safety
included 1153 patients. It was found that DAS28-ESR remission (<2.6) rates
were maintained from weeks 52 to 104 (eg, 8 mg/kg TCZ+MTX, 49.3% to 47.6%).
Placebo+MTX and 4 mg/kg TCZ+MTX escape patients' week 104 response rates were
51.4% and 30.5%, respectively. Inhibition of radiographic progression was found
maintained with 8 mg/kg TCZ (e.g., 8 mg/kg TCZ+MTX mean (SD) change from
baseline in the modified total Sharp score: 0.13 (1.28), week 52; 0.19 (2.08),
week 104). The safety profile of TCZ was consistent with that of previous
reports.
Annals of Rheumatic Diseases
Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial
Gerd R Burmester, William F Rigby et al.
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