CTU Bern (Clinical Trials Unit)

Tocilizumab effective for patients with giant cell arteritis

21.03.2016 - Giant cell arteritis is an immune-mediated disease of medium and large-sized arteries that affects mostly people older than 50 years of age. The study aimed to assess the efficacy and safety of tocilizumab in the first randomised clinical trial in patients with newly diagnosed or recurrent giant cell arteritis.

Overall, 30 patients were randomized, 20 to tocilizumab and 10 to placebo, to receive 13 infusions every 4 weeks. The primary outcome was the proportion of patients who achieved complete remission of disease at a prednisolone dose of 0·1 mg/kg per day at week 12. At week 12, 17 of 20 patients who had received tocilizumab achieved complete remission (85%) but only 4 of 10 patients who had received placebo (40%) – a risk difference of 65%, 95 confidence interval 36 to 94%). Seven (35%) patients in the tocilizumab group and five (50%) in the placebo group had serious adverse events.

The online version of the article can be found here:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00560-2/abstract