This was a 12-month noninterventional, observational study in adult patients with RA who initiated
tocilizumab in routine practice in Canada according to the local product monograph. The primary end point was the proportion of patients receiving
tocilizumab at 6 months. Secondary end points were treatment patterns, effectiveness, and safety of
tocilizumab over 12 months.
RESULTS: Of 200 patients who initiated
tocilizumab (91.0% at 8 mg/kg), 67 (33.5%) received
tocilizumab monotherapy and 133 (66.5%) received
tocilizumab combined with conventional synthetic
disease-modifying antirheumatic drugs (csDMARDs). Kaplan-Meier analysis estimated that 85% (95% CI 74-92%) of monotherapy and 89% (95% CI 82-93%) of combination
therapy patients continued to receive
tocilizumab at 6 months (log-rank p = 0.0888). During the observation period, 12 (17.9%) monotherapy and 27 (20.3%) combination
therapy patients withdrew from the study. At month 12, 58.5% in the monotherapy group and 59.3% in the combination therapy group achieved Disease Activity Score at 28 joints remission (≤ 2.6), 25.6% and 24.7% achieved Simplified Disease Activity Index remission (≤ 3.3), and 18.2% and 22.3% achieved Clinical Disease Activity Index remission (≤ 2.8), respectively. Rates of serious adverse events and serious
infections were found in 29.6/100 patient-years (PY) and 3.1/100 PY, respectively, for monotherapy and 19.2/100 PY and 4.8/100 PY, respectively, for combination
therapy.
CONCLUSIONS: ClinicalTrials.gov identifier, NCT01613378 FUNDING: F. Hoffmann-La Roche (Roche) Canada.