Is tocilizumab (Actemra) effective in the treatment of giant cell arteritis (GCA) (temporal arteritis)?

Updated: Sep 03, 2020
  • Author: Mythili Seetharaman, MD; Chief Editor: Herbert S Diamond, MD  more...
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Answer

Tocilizumab (Actemra) was approved by the FDA in May 2017 for giant cell arteritis (GCA). [150] Approval was based on the phase 3 GiACTA trial (n=251), in which subcutaneous tocilizumab or placebo was added to standardized prednisone regimens. [149]

The primary efficacy endpoint was the proportion of patients achieving sustained remission from week 12 through week 52. Sustained remission (resolution of GCA symptoms, normalization of inflammatory laboratory test results, and tapering of prednisone) occurred in a greater proportion of patients receiving tocilizumab compared with those receiving placebo (P ≤0.0002). The cumulative prednisone dose in patients treated with tocilizumab was less than half of that in patients who received placebo. [149]

In a phase 2 trial in 30 patients with GCA (new onset in 23, relapsing in seven) who were randomized to receive steroids plus either tocilizumab or placebo, 85% of patients given tocilizumab reached complete remission by week 12, compared with 40% of patients given placebo. By week 52, 85% of patients in the tocilizumab group achieved relapse-free survival versus 20% in the placebo group. Due to earlier discontinuation of steroids, the cumulative prednisolone dose after 52 weeks was 43 mg/kg in the tocilizumab group versus 110 mg/kg in the placebo group. [148]

In an open-label study, treatment with  tocilizumab led to rapid and maintained improvement in 19 of 22 patients whose GCA was refractory to corticosteroid treatment, or who had experienced unacceptable corticosteroid side effects. However, serious infection-related complications--including a fatal stroke associated with infective endocarditis--occurred in three patients. [151] Tocilizumab carries a boxed warning for serious infections. [150]


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