Tocilizumab for Giant Cell Arteritis

Summary

A Cochrane review [Abstract] 1 included 2 studies with a total of 281 subjects (mean age 70 years) with new-onset or relapsing giant cell arteritis (GCA). One study (n=30) compared tocilizumab infusions 8 mg/kg administered every 4 weeks versus placebo for 52 weeks. Participants in both groups also received prednisolone, which was tapered, and all participants received 100 mg aspirin per day, pantoprazole, calcium, cholecalciferol, and ibandronate. The second study (n=251) randomized participants into 2 intervention and 2 comparator groups: tocilizumab s.c. 162 mg weekly plus a 26-week prednisone taper (n=100), tocilizumab s.c. 162 mg every other week plus a 26-week prednisone taper (n=50), placebo plus a 26-week prednisone taper (n = 50), placebo plus a 52-week prednisone taper (n = 51).

Tocilizumab every 4 weeks compared to placebo (1 study, n=30): Tocilizumab increased the proportion of participants with sustained remission at ≥ 12 months (RR 4.25, 95% CI 1.21 to 14.88). No difference in all-cause mortality was observed (RR 0.17, 95% CI 0.01 to 3.94). At 12 months, mean time to first relapse after induction of remission was 25 weeks in favor of participants receiving tocilizumab compared to placebo (MD 25, 95% CI 11.4 to 38.6). There was no difference in adverse events (RR 1.07, 95% CI 0.66 to 1.73). The study also reported that among participants whose prednisolone dose was successfully tapered to 0 mg per day, 16 (80%) participants receiving tocilizumab versus 2 (20%) participants receiving placebo experienced complete remission. Tocilizumab weekly compared to placebo + 52-week prednisone taper: Tocilizumab increased the proportion of participants with sustained remission (RR 3.17, 95% CI 1.71 to 5.89; n=151) and the proportion of participants who did not need escape therapy, defined by the study as the inability to keep to the protocol-defined prednisone taper (RR 1.71, 95% CI 1.24 to 2.35; n=151). There was no difference in adverse events (RR 1.06, 95% CI 0.98 to 1.16; n=151). Tocilizumab weekly compared to placebo + 26-week prednisone taper: Tocilizumab increased the proportion of participants with sustained remission (RR 4.00, 95% CI 1.97 to 8.12; n=150) and the proportion of participants who did not need escape therapy (RR 2.96, 95% CI 1.83 to 4.78; n=150). There was no difference in adverse events (RR 1.02, 95% CI 0.96 to 1.09; n=150). Tocilizumab every other week compared to placebo + 52-week prednisone taper: Tocilizumab increased the proportion of participants with sustained remission at ≥ 12 months (RR 3.01, 95% CI 1.57 to 5.75; n=100) and the proportion of participants who did not need escape therapy (RR 1.49, 95% CI 1.04 to 2.14; n=100). No difference in adverse events was observed (RR 1.04, 95% CI 0.94 to 1.15; n=100). Tocilizumab every other week compared to placebo + 26-week prednisone taper: Tocilizumab increased the proportion of participants with sustained remission at ≥ 12 months (RR 3.79, 95% CI 1.82 to 7.91; n=99). There was no statisticlly significant difference in the proportion of participants who did not need escape therapy (RR 0.65, 95% CI 0.27 to 1.54; n=99). No difference in adverse events was observed (RR 1.00, 95% CI 0.92 to 1.08; n=99).