Abstract
BackgroundPlacebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA). However, limited data exist on the effectiveness and safety of TCZ for GCA in real-world clinical practice.MethodsThis was a retrospective, single-center analysis of patients with GCA treated with intravenous or subcutaneous TCZ (2010–2018). Outcomes evaluated before and after TCZ initiation included occurrence of flare, time to flare, annualized flare rate, flare characteristics (i.e., polymyalgia rheumatica [PMR] symptoms, cranial manifestations), prednisone use, and safety. Flare was defined as the recurrence of unequivocal GCA manifestations requiring treatment intensification. Subgroup analyses of patients with PMR or visual manifestations at GCA diagnosis were performed.ResultsSixty patients with GCA were included. The median (IQR) disease duration before and after the start of TCZ was 0.6 (0.2–1.6) and 0.5 (0.3–1.4) years, respectively. At least 1 flare was observed in 43 patients (71.7%) before and in 18 (30.0%) after TCZ initiation. Median (IQR) time to flare was 0.5 (0.3–0.7) years before TCZ treatment and 2.1 (0.6–2.6) years after TCZ initiation (HR 0.22; 95% CI 0.10–0.50; p = 0.0003). The annualized flare rate significantly decreased following TCZ use (before TCZ 1.4 [95% CI 1.0–2.1]; after TCZ 0.6 [95% CI 0.3–1.0] events/year; p < 0.001). Similar improvements were observed in patients with visual manifestations or PMR symptoms at GCA diagnosis. TCZ reduced the incidence of new visual manifestations, and no flares associated with permanent vision loss occurred while patients were receiving TCZ. Mean (SD) prednisone dose at TCZ onset and at the end of follow-up was 30 (18.3) and 5 (6.9) mg/day, respectively (p < 0.0001). After TCZ initiation, 46.6% of patients successfully discontinued prednisone. The incidence of adverse events, primarily attributed to glucocorticoids, was similar before and after TCZ initiation.ConclusionsIn this real-world setting, TCZ improved GCA clinical outcomes significantly and demonstrated effectiveness in the subgroups of patients with PMR symptoms and GCA-related visual manifestations at GCA diagnosis. No new cases of blindness occurred after TCZ initiation. Adverse events, many attributable to glucocorticoids, were comparable before and after TCZ treatment.
Highlights
Placebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA)
A new treatment option is available after randomized clinical trials demonstrated that interleukin 6 (IL-6) receptor blockade with tocilizumab (TCZ) in combination with shorter glucocorticoid courses is efficacious for maintaining disease remission and sparing the use of glucocorticoids in patients with new-onset or relapsing GCA [5, 9]
Some evidence suggests that TCZ is effective in controlling polymyalgia rheumatica (PMR), a comorbid condition observed in nearly half of patients with GCA [13, 14]
Summary
Placebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA). A new treatment option is available after randomized clinical trials demonstrated that interleukin 6 (IL-6) receptor blockade with tocilizumab (TCZ) in combination with shorter glucocorticoid courses is efficacious for maintaining disease remission and sparing the use of glucocorticoids in patients with new-onset or relapsing GCA [5, 9]. Some evidence suggests that TCZ is effective in controlling polymyalgia rheumatica (PMR), a comorbid condition observed in nearly half of patients with GCA [13, 14] It is unknown, whether GCA patients with PMR symptoms at diagnosis respond differently to TCZ compared with those without such symptoms and whether IL-6 blockade reduces the incidence of PMR during subsequent disease relapses. Anterior ischemic optic neuropathy (AION) has been reported in a patient receiving TCZ [5], but the incidence of GCA-related visual manifestations during disease flare in patients receiving IL-6 blockade therapy is unknown
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