The results of a 2-year planned analysis of a Phase III trial of tocilizumab in patients with moderate to severe rheumatoid arthritis (RA) have been presented at the American College of Rheumatology annual meeting. 

Patients with RA who had an inadequate response to methotrexate (MTX) alone were randomised to receive MTX plus tocilizumab (4 mg/kg [n=399] or 8 mg/kg [n=398]) or placebo (control; n=393) every four weeks.  Stepwise rescue therapy was allowed from week 16 onwards if patients did not respond (<20% improvement in swollen joint count [SJC] and tender joint count [TJC]).  At week 52, all patients initiated open-label tocilizumab (8mg/kg) for the second year, unless they had achieved ≥ 70% improvement in SJC and TJC, in which case they could continue their blinded therapy.  The primary endpoints for the second year (week 104) were change from baseline in Genant-modified Total Sharp Score (GmTSS) and physical function (AUC of change from baseline in HAQ-DI).

• The mean change in GmTSS was 1.96 in the control group, 0.58 in the tocilizumab 4mg/kg group and 0.37 in the 8mg/kg group (both p≤0.0025)
• No radiographic progression was seen in 66% of the placebo group, 75% of the tocilizumab 4mg/kg group and 83% of the 8mg/kg group (both p≤0.0025)
• AUC of change from baseline in HAQ-DI showed significant improvement in physical function for both doses of tocilizumab versus control

Results for those initially randomised to 8mg/kg tocilizumab are presented separately (See Table 2 at the link below) – these show that DAS28 remission (DAS28<2.6) was achieved in around half of these patients at week 52, and this continued to increase to week 104.