Highlights
- •Short-term treatment with TCZ should be evaluated at GCA diagnosis to spare GC.
- •The safety profile of 3 months of treatment with TCZ is good in GCA patients.
- •Relapses frequently occur after TCZ discontinuation (~50% 9 months after TCZ withdrawal)
Abstract
Background
The aim of this study was to evaluate tocilizumab (TCZ) as an add-on therapy to glucocorticoids
(GC) during the first 3 months of treatment of giant cell arteritis (GCA).
Methods
GCA patients, as defined by ≥3/5 ACR criteria and positive temporal artery biopsy
(TAB) or angio-CT-scan or PET-scan-proven aortitis, were included in this prospective
open-label study. Prednisone was started at 0.7 mg/kg/day and then tapered according
to a standardized protocol. All patients received four infusions of TCZ (8 mg/kg/4 weeks)
after inclusion. The primary endpoint was the percentage of patients in remission
with ≤0.1 mg/kg/day of prednisone at week 26 (W26). Patients were followed for 52 weeks
and data prospectively recorded.
Results
Twenty patients with a median (IQR) age of 72 (69–78) years were included. TAB were
positive in 17/19 (90%) patients and 7/16 (44%) had aortitis. Remission was obtained
in all cases. At W26, 15 (75%) patients met the primary endpoint. Ten patients experienced
relapse during follow-up, mainly patients with aortitis (P = 0.048), or CRP >70 mg/L (P = 0.036) or hemoglobin ≤10 g/dL (P = 0.015) at diagnosis. Among 64 adverse events (AE) reported in 18 patients, three
were severe and 30, mostly non-severe infections (n = 15) and hypercholesterolemia (n = 8), were imputable to the study.
Conclusion
This study shows that an alternative strategy using a short-term treatment with TCZ
can be proposed to spare GC for the treatment of GCA. However, 50% of patients experienced
relapse during the 9 months following TCZ discontinuation, especially patients with
aortitis, or CRP > 70 mg/L or Hb ≤ 10 g/dL at diagnosis.
Trial registration: ClinicalTrials.gov (NCT01910038).
Keywords
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Article info
Publication history
Published online: July 24, 2018
Accepted:
June 6,
2018
Received in revised form:
March 24,
2018
Received:
December 12,
2017
Identification
Copyright
© 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
