Effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 Weeks in patients with active rheumatoid arthritis: The first phase IIIb real-life study (TAMARA)
Burmester GR, Feist E, Kellner H, Braun J, Iking-Konert C, Rubbert-Roth A.
Ann Rheum Dis Published online 27 December 2010. doi: 10.1136/ard.2010.139725
The TAMARA study was a multicentre open-label phase IIIb study designed to confirm the effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in a setting close to real-life medical care in Germany (N=286). RA patients with active disease and DAS28 >3.2 were treated with TCZ 8 mg/kg every 4 weeks.
Key study results are summarised below.
- At Week 24, 57% of patients achieved a DAS28 ≤3.2 and 48% achieved DAS28 remission
- More DMARD-IR patients (53%) than anti-TNF-IR patients (41%) achieved DAS28 remission
- Onset of action was rapid: after the first TCZ infusion the mean DAS28 decreased by 21.5±18.0% within 1 week and by 40.1±19.9% within 4 weeks (from a baseline of 6.0)
- Global satisfaction with the medication at Week 24 was reported by 78% of DMARD-IR patients and 72% of anti-TNF-IR patients
- 73% of DMARD-IR patients and 66% of anti-TNF-IR patients were satisfied with the effectiveness of the treatment, while 90% and 89%, respectively, were satisfied with the tolerability (Treatment Satisfaction Questionnaire for Medication)
- ACR20/50/70 response rates were 65%, 51% and 34% at Week 24, respectively
- Improvements were seen in all core set components
- Notably, there was a strong decrease in swollen and tender joint counts, and 33% and 42% of patients had 0 SJC and TJC, respectively
- The safety profile of TCZ was comparable to that observed in previous published randomised controlled trials (RCTs)
- Most adverse events were either mild or moderate and were resolved by the study end
In summary, the TAMARA study demonstrated that TCZ is efficacious in a setting close to real-life medical care, with a rapid and sustained improvement in signs and symptoms of RA and improvements in quality of life outcomes. Better efficacy results in TAMARA were observed than those for previous published RCTs with a comparable safety profile. These data confirm that TCZ is an important treatment option for RA patients in a real-life setting.