Actemra

 Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor
The Samurai Trial evaluated 306 patients with active RA who had an inadequate clinical response to DMARDs or immunosuppressant. It evaluated the ability of tocilizumab monotherapy in inhibiting the progression of structural joint damage.  Doses of Actemra 8 mg/kg intravenously every 4 weeks or conventional DMARDs were given for 52 weeks.

Summary of Results: 

At week 52, the tocilizumab group showed statistically significantly less radiographic change in Total Modified Sharp Score (TSS) (mean 2.3 range 1.5 to 3.2) than the DMARD group (mean 6.1 range 4.2 to 8.0). Tocilizumab monotherapy also improved signs and symptoms. At week 52, proportions of the patients achieving ACR20, ACR50, and ACR70 response were 78%, 64%, and 44% in the tocilizumab group and 34%, 13%, and 6% in the DMARD group, respectively. At week 52, clinical remission (defined as DAS28 < 2.6) was achieved in 59% of patients receiving tocilizumab, but only in 3% of patients receiving DMARDs. Significant improvement in Physical function and health-related quality of life (MHAQ scores) was seen.

ACTEMRA monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.

  

Reference:

Norihiro Nishimoto et al. Ann Rheum Dis 2007; 66:1162–1167.