Contents lists available at ScienceDirect European Journal of Internal Medicine journal homepage: www.elsevier.com/locate/ejim Original Article Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study Maxime Samson a,b, ⁎ , Hervé Devilliers c , Kim Heang Ly d , François Maurier e , Boris Bienvenu f , Benjamin Terrier g , Pierre Charles h , Loïc Guillevin g,m , Jean-François Besancenot i , Eric Liozon d , Anne Laure Fauchais d , Romaric Loffroy j , Christine Binquet k , Sylvain Audia a,b , Raphaèle Seror l , Xavier Mariette l , Bernard Bonnotte a,b a Department of Internal Medicine and Clinical Immunology, CHU Dijon Bourgogne, Dijon, France b University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-21000 Dijon, France c Department of Internal Medicine and Systemic Diseases, CHU Dijon Bourgogne, INSERM, CIC 1432, Clinical Epidemiology Unit, Dijon, France d Department of Internal Medicine, CHU de Limoges, Limoges, France e Department of Internal Medicine, Hôpital Belle Isle, Metz, France f Department of Internal Medicine, Hôpital Côte de Nacre, CHU de Caen, Caen, France g Department of Internal Medicine, National Referral Center for Systemic and Rare Autoimmune Diseases, Hôpital Cochin, APHP, Paris, France h Department of Internal Medicine, Institut Mutualiste Montsouris, Paris, France i Department of Internal Medicine and Systemic Diseases, CHU Dijon Bourgogne, Dijon, France j Department of Radiology, CHU Dijon Bourgogne, Dijon, France k INSERM, CIC 1432, Clinical Epidemiology Unit, Dijon, France l Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP; Université Paris-Sud; INSERM U1184; Le Kremlin Bicêtre, France m Paris Descartes University, Paris 5, Paris, France ARTICLE INFO Keywords: Giant cell arteritis Clinical trial Tocilizumab Aortitis Relapse 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 diag- nosis. Trial registration: ClinicalTrials.gov (NCT01910038). https://doi.org/10.1016/j.ejim.2018.06.008 Received 12 December 2017; Received in revised form 24 March 2018; Accepted 6 June 2018 ⁎ Corresponding author at: Service de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, 2 boulevard Mal de Lattre de Tassigny, 21000 Dijon, France. E-mail address: maxime.samson@chu-dijon.fr (M. Samson). European Journal of Internal Medicine xxx (xxxx) xxx–xxx 0953-6205/ © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved. Please cite this article as: Samson, M., European Journal of Internal Medicine (2018), https://doi.org/10.1016/j.ejim.2018.06.008