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Phase 2 trial results: Tocilizumab may be effective for patients with GCA
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A phase 2, randomized, double-blind, placebo-controlled trial of tocilizumab conducted in Bern, Switzerland, resulted in remission in most patients with giant cell arteritis in the treatment group. In addition, prednisolone was tapered to 0 mg in 80% of these patients after a mean of 38 weeks, according to the results of a recently published study.
Researchers randomly assigned 30 patients with giant cell arteritis 2:1 to tocilizumab or placebo with 13 infusions every 4 weeks through week 52. Initiation with prednisolone at 1 mg/kg began at baseline and was tapered weekly. Other concomitant therapies included 100-mg aspirin per day, 40-mg pantoprazole per day, 1,000-mg calcium per day, 800-U cholecalciferol per day and 3-mg IV ibandronate every 3 months.
Seventeen of 20 patients (85%) in the tocilizumab group and four patients (40%) in the placebo group were in complete remission after 12 weeks. No variables such as age, sex, baseline erythrocyte sedimentation rate or C-reactive protein were associated with response to treatment.
“Currently, glucocorticoids are the gold-standard for the treatment of GCA, but they are associated with substantial side effects,” Sabine Adler, MD, a study investigator from the Department of Rheumatology, Immunology and Allergology at University Hospital, University of Bern, Bern, Switzerland, said. “In this study, Actemra showed significant improvement in relapse-free survival over placebo, reinforcing its association with rapid induction and maintenance of remission in patients with giant cell arteritis.”
One patient in the tocilizumab group relapsed and two withdrew from the study. Among the placebo group, three patients relapsed before week 12 and two additional patients relapsed after week 12. Three patients in the placebo group withdrew from the study and two asked to received treatment and switch groups.
Fifteen patients in the tocilizumab group had a total of 26 adverse reactions compared with 23 adverse reactions in seven patients in the placebo group. No infusion-related reactions occurred. In the tocilizumab group, a total of seven serious adverse events occurred in seven patients compared with 10 events in five of the patients who received placebo. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
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