RESUMO
Introduction. Studies have shown that tocilizumab (TCZ) is effective in the treatment of rheumatoid arthritis. This study examined the efficacy and safety of TCZ in Filipino patients with moderate to severe rheumatoid arthritis (RA). Methods. This was an open-label, one-arm clinical trial approved by the Philippine Council Health Research Development-National Ethics Committee (PCHRD-NEC), among moderate-severe active RA Filipino patients in 4 RA clinics. The study consisted of a 28-day screening-baseline period; a 24-week treatment period, with once every-4-weeks TCZ 8mg/kg intravenous infusion (IV) and an efficacy-safety evaluation. Patients already receiving methotrexate (MTX) at study entry went on with MTX plus TCZ per medical discretion. Descriptive statistics computed for physician's and patient's global assessment of disease activity, patient's global assessment of pain, ACR20, ACR50 and ACR70. Analysis of variance (ANOVA) determined significant changes over time for DAS-28 ESR, FACIT and HAQ-DI fatigue scores. Twenty-nine of thirty patients were included in efficacy and safety analysis. Results. After 24 weeks of TCZ: 86%, 66%, and 48% of 29 Filipino RA patients achieved ACR20, ACR50, ACR70, respectively, with 34% achieving remission according to DAS28-ESR. Median times to first achieving ACR20, ACR50 and ACR70 were 4, 12, and 24 weeks, respectively. There were also significant rapid reductions in physician's and patient's global assessment of disease activity, patient's global assessment of pain, HAQ-DI and FACIT scores noted over time. Tolerability profile was similar to published literature on TCZ. Conclusions. TCZ has been shown to be effective in the treatment of Filipino patients with moderate to severe rheumatoid arthritis. TCZ can be given in an out-patient RA clinic setting.
