Efficacy of tocilizumab in patients with moderate to severe active rheumatoid
arthritis and a previous inadequate response to disease-modifying antirheumatic
drugs: the ROSE study.
Author(s): Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A.
Affiliation(s): New York University Hospital for Joint Diseases, New York, USA.
Publication date & source: 2012, Ann Rheum Dis. , 71(2):198-205
OBJECTIVE: To evaluate efficacy of tocilizumab in US patients with moderate to
severe active rheumatoid arthritis (RA) and inadequate clinical response to
disease-modifying antirheumatic drugs (DMARD). Safety-related outcomes were also
METHODS: The rapid onset and systemic efficacy study was a 24-week, randomised,
double-blind trial. Patients were randomly assigned 2:1 to tocilizumab 8 mg/kg
(n=412) or placebo (n=207) every 4 weeks while continuing background DMARD in
RESULTS: The primary efficacy endpoint, percentage of patients achieving ACR50
response at week 24, was higher with tocilizumab versus placebo (30.1% vs 11.2%;
p<0.0001). Percentages of ACR20 and ACR50 responders were significantly higher
with tocilizumab versus placebo as early as week 4 and continued to week 24; more
patients in the tocilizumab versus placebo group also achieved ACR70 responses
beginning at week 8 (p<0.01). Significant improvements associated with
tocilizumab versus placebo were seen in routine assessment of patient index data
responses, EULAR good response, DAS28 and percentages of patients achieving low
disease activity and clinical remission (based on DAS28). A substudy examining
early response to therapy showed improved patient global assessment of disease
activity (p=0.005) and pain (p=0.01) and DAS28 (p=0.007) with tocilizumab versus
placebo at day 7. Safety findings were consistent with the known tocilizumab
safety profile; rates of serious infections (per 100 patient-years) were 7.87
(95% CI 4.30 to 13.2) and 1.20 (95% CI 0.03 to 6.66) in the tocilizumab and
placebo groups, respectively.
CONCLUSIONS: This study demonstrated the efficacy of tocilizumab in improving
measures of disease activity in patients with RA who failed to respond adequately
to DMARD therapy. Rapid improvement in clinical outcomes was demonstrated in a
substudy as early as week 1 as shown by DAS28 scores, patient measures and
C-reactive protein. TRIAL REGISTRY NO: NCT00531817.