Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab.
Acute-Phase Proteins
/ analysis
Antibodies, Monoclonal, Humanized
/ administration & dosage
Blood Sedimentation
C-Reactive Protein
/ analysis
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Giant Cell Arteritis
/ blood
Glucocorticoids
/ administration & dosage
Humans
Induction Chemotherapy
Male
Middle Aged
Prednisone
/ administration & dosage
Symptom Flare Up
Journal
Arthritis & rheumatology (Hoboken, N.J.)
ISSN: 2326-5205
Titre abrégé: Arthritis Rheumatol
Pays: United States
ID NLM: 101623795
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
08
11
2018
accepted:
28
02
2019
pubmed:
6
3
2019
medline:
31
1
2020
entrez:
6
3
2019
Statut:
ppublish
Résumé
This study was undertaken to evaluate glucocorticoid dosages and serologic findings in patients with giant cell arteritis (GCA) flares. Patients with GCA were randomly assigned to receive double-blind dosing with either subcutaneous tocilizumab (TCZ) 162 mg weekly plus 26-week prednisone taper (TCZ-QW + Pred-26), every-other-week TCZ plus 26-week prednisone taper (TCZ-Q2W + Pred-26), placebo plus 26-week prednisone taper (PBO + Pred-26), or placebo plus 52-week prednisone taper (PBO + Pred-52). Outcome measures were prednisone dosage, C-reactive protein (CRP) level, and erythrocyte sedimentation rate (ESR) at the time of flare. One hundred patients received TCZ-QW + Pred-26, 49 received TCZ-Q2W + Pred-26, 50 received PBO + Pred-26, and 51 received PBO + Pred-52. Of the 149 TCZ-treated patients, 36 (24%) experienced flare, 23 (64%) of whom were still receiving prednisone (median dosage 2.0 mg/day). Among 101 PBO + Pred-treated patients, 59 (58%) experienced flare, 45 (76%) of whom were receiving prednisone (median dosage 5.0 mg/day). Many flares occurred while patients were taking >10 mg/day prednisone: 9 (25%) in the TCZ groups and 13 (22%) in the placebo groups. Thirty-three flares (92%) in TCZ-treated groups and 20 (34%) in PBO + Pred-treated groups occurred with normal CRP levels. More than half of the PBO + Pred-treated patients had elevated CRP levels without flares. Benefits of the TCZ and prednisone combination over prednisone alone for remission induction were apparent by 8 weeks. Most GCA flares occurred while patients were still receiving prednisone. Acute-phase reactant levels were not reliable indicators of flare in patients treated with TCZ plus prednisone or with prednisone alone. The addition of TCZ to prednisone facilitates earlier GCA control.
Identifiants
pubmed: 30835950
doi: 10.1002/art.40876
pmc: PMC6772126
doi:
Substances chimiques
Acute-Phase Proteins
0
Antibodies, Monoclonal, Humanized
0
Glucocorticoids
0
C-Reactive Protein
9007-41-4
tocilizumab
I031V2H011
Prednisone
VB0R961HZT
Banques de données
ClinicalTrials.gov
['NCT01791153']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1329-1338Subventions
Organisme : F. Hoffmann-La Roche
Pays : International
Informations de copyright
© 2019 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.
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