Trial of tocilizumab in giant-cell arteritis
Open accessAbstract
BACKGROUND: Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis. METHODS: In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed. RESULTS: Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week. CONCLUSIONS: Tocilizumab, received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153 .).
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Two randomized controlled trials showed efficacy of tocilizumab for induction and maintenance of remission in patients with new-onset and relapsing giant cell arteritis.
“Two RCTs recently showed the efficacy of TCZ for the induction and maintenance of remission in patients with new-onset and relapsing GCA.97,98”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [97]
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- Authors
- Stone, J. H., Tuckwell, K., Dimonaco, S., Klearman, M., Aringer, M., Blockmans, D., Brouwer, E., Cid, M. C., Dasgupta, B., Rech, J., Salvarani, C., Schett, G., Schulze-Koops, H., Spiera, R., Unizony, S. H., & Collinson, N.
- Affiliations
- Harvard University (US)
- University Medical Center Groningen (NL)
- University of Modena and Reggio Emilia (IT)
- Hospital for Special Surgery (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-07-27
- Volume
- 377
- Issue
- 4
- Pages
- 317-328
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2737436316
- Cited by
- 1,386
- References
- 27
- Citations by year
- 2026: 108 · 2025: 120 · 2024: 146 · 2023: 152 · 2022: 167 · 2021: 210 · 2020: 181 · 2019: 152 · 2018: 108 · 2017: 37 · 2016: 1
- FWCI
- 108.11
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
- Lirias (KU Leuven) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Keywords
- giant cell arteritis, tocilizumab, glucocorticoid tapering, prednisone, relapse prevention, glucocorticoid-free remission, steroid-sparing therapy, adverse events, treatment duration, remission duration, vasculitis, anti-TNF therapy
- MeSH terms
- Aged, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Glucocorticoids, Humans, Injections, Subcutaneous, Male, Middle Aged, Prednisone, Remission Induction, Giant Cell Arteritis, Receptors, Interleukin-6, Antibodies, Monoclonal, Humanized
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