Maxime Samson1, Hervé Devilliers2, Kim Heang Ly3, François Maurier4, Boris Bienvenu5, Benjamin Terrier6, Pierre Charles7, Loïc Guillevin8, Jean-François Besancenot9, Eric Liozon3, Anne Laure Fauchais3, Romaric Loffroy10, Christine Binquet11, Sylvain Audia12, Raphaèle Seror13, Xavier Mariette13, Bernard Bonnotte12. 1. Department of Internal Medicine and Clinical Immunology, CHU Dijon Bourgogne, Dijon, France; University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-21000 Dijon, France. Electronic address: maxime.samson@chu-dijon.fr. 2. Department of Internal Medicine and Systemic Diseases, CHU Dijon Bourgogne, INSERM, CIC 1432, Clinical Epidemiology Unit, Dijon, France. 3. Department of Internal Medicine, CHU de Limoges, Limoges, France. 4. Department of Internal Medicine, Hôpital Belle Isle, Metz, France. 5. Department of Internal Medicine, Hôpital Côte de Nacre, CHU de Caen, Caen, France. 6. Department of Internal Medicine, National Referral Center for Systemic and Rare Autoimmune Diseases, Hôpital Cochin, APHP, Paris, France. 7. Department of Internal Medicine, Institut Mutualiste Montsouris, Paris, France. 8. Department of Internal Medicine, National Referral Center for Systemic and Rare Autoimmune Diseases, Hôpital Cochin, APHP, Paris, France; Paris Descartes University, Paris 5, Paris, France. 9. Department of Internal Medicine and Systemic Diseases, CHU Dijon Bourgogne, Dijon, France. 10. Department of Radiology, CHU Dijon Bourgogne, Dijon, France. 11. INSERM, CIC 1432, Clinical Epidemiology Unit, Dijon, France. 12. Department of Internal Medicine and Clinical Immunology, CHU Dijon Bourgogne, Dijon, France; University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-21000 Dijon, France. 13. Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP; Université Paris-Sud; INSERM U1184; Le Kremlin Bicêtre, France.
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).
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).
Authors: Maxime Samson; Hélène Greigert; Marion Ciudad; Claire Gerard; Thibault Ghesquière; Malika Trad; Marc Corbera-Bellalta; Coraline Genet; Sethi Ouandji; Claudie Cladière; Marine Thebault; Kim Heang Ly; Eric Liozon; François Maurier; Boris Bienvenu; Benjamin Terrier; Loïc Guillevin; Pierre Charles; Valérie Quipourt; Hervé Devilliers; Pierre-Henry Gabrielle; Catherine Creuzot-Garcher; Georges Tarris; Laurent Martin; Philippe Saas; Sylvain Audia; Maria Cinta Cid; Bernard Bonnotte Journal: Clin Transl Immunology Date: 2021-09-12
Authors: Ji Zongfei; Zhang Lijuan; Sun Ying; Liu Dongmei; Wu Sifan; Kong Xiufang; Ma Lingying; Liu Yun; Ma Lili; Chen Huiyong; Jiang Lindi Journal: Ther Adv Chronic Dis Date: 2021-06-30 Impact factor: 5.091
Authors: Ji Zongfei; Chen Rongyi; Cui Xiaomeng; Ma Lili; Ma Lingying; Kong Xiufang; Dai Xiaomin; Zhang Zhuojun; Chen Huiyong; Sun Ying; Jiang Lindi Journal: Front Immunol Date: 2020-07-08 Impact factor: 7.561
Authors: Wolfgang A Schmidt; Bhaskar Dasgupta; Raashid Luqmani; Sebastian H Unizony; Daniel Blockmans; Zhihong Lai; Regina H Kurrasch; Ivana Lazic; Kurt Brown; Ravi Rao Journal: Rheumatol Ther Date: 2020-08-25