Tocilizumab Infections Less in ACPA+ Patients Save

Tocilizumab is in the spotlight at this year’s ACR 2016 meeting but there is still much to learn, including more about its safety profile. In an abstract presented at today’s poster session (Abstract 2618), Morel, et al. analyzed the French REGistry – RoAcTEmra (REGATE) for the incidence rate of severe infections with tocilizumab in RA and also to determine independent risk factors for SI using a multivariate model.

Out of 2,606 person-years, they observed 125 serious infections in 122 patients for an incidence rate of 4.7/100 PYs. Lung and skin/soft tissue infections were most frequent (28% and 26%). There were 3 deaths – 1 septic shock, 1 PJP and 1 H. influenza. Interestingly there were 4 “opportunistic infections” including the 1 PJP case, the H. influzenza, 1 tuberculosis, and 1 Klebsiella pneumoniae infection. There was no observed increase in infection rate over the first 3 years of follow up.

The multivariate analysis found ACPA positivity to be negatively associated with risk of infection (HR 0.55 CI95% 0.35-0.86) and a baseline PMN level > 4.5g/L to be predictive of serious infection (HR 1.62 CI95% 1.06-2.5, p=0.02). This may help identify patient populations who should be monitored more closely for infections.