Biologics: Targets & Therapy (Dec 2023)

Tocilizumab Vs Methotrexate in a Cohort of Patients Affected by Active GCA: A Comparative Clinical and Ultrasonographic Study

  • Grazzini S,
  • Conticini E,
  • Falsetti P,
  • D'Alessandro M,
  • Sota J,
  • Terribili R,
  • Baldi C,
  • Fabiani C,
  • Bargagli E,
  • Cantarini L,
  • Frediani B

Journal volume & issue
Vol. Volume 17
pp. 151 – 160

Abstract

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Silvia Grazzini,1,* Edoardo Conticini,1,* Paolo Falsetti,1 Miriana D’Alessandro,2 Jurgen Sota,1 Riccardo Terribili,1 Caterina Baldi,1 Claudia Fabiani,3 Elena Bargagli,2 Luca Cantarini,1 Bruno Frediani1 1Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy; 2Respiratory Diseases and Lung Transplant Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy; 3Ophthalmology Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy*These authors contributed equally to this workCorrespondence: Edoardo Conticini, Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, AOUS Le Scotte, viale Mario Bracci 14, Siena, 53100, Italy, Email [email protected]: No head-to-head study has assessed the superiority of tocilizumab versus methotrexate in giant cell arteritis (GCA), and few studies have demonstrated its effectiveness in terms of ultrasonographic findings, but without a control group. The primary endpoint was to assess whether tocilizumab was superior to methotrexate in inducing normalization of US findings, whereas the secondary endpoint was to assess the effectiveness of precocious withdrawal of glucocorticoids.Methods: We prospectively enrolled all the patients with active GCA at our clinic. The inclusion criteria were clinical diagnosis of GCA; active disease; and clinical, laboratory, and US data, evaluated using the halo count (HC) and OMERACT GCA Ultrasonography Score (OGUS). Evaluations were repeated at 3, 6, and 12 months.Results: Twenty patients were treated with Tocilizumab and 9 with Methotrexate. All but three tocilizumab-treated patients achieved remission at six months, whereas at 12 months, all patients were in glucocorticoid-free remission. Up to three of the nine methotrexate patients experienced a lack of efficacy or minor relapses. Tocilizumab-treated patients showed a statistically significant difference between baseline and all follow-ups in terms of OGUS and HC, whereas the difference in the Methotrexate group was significant after 1 year. The mean glucocorticoid dosage significantly decreased in both groups. No severe adverse events or major relapses were reported.Conclusion: Our study demonstrates the superiority in terms of rapidity of a tocilizumab-based scheme over a methotrexate-based scheme in inducing clinical and US remission. Precocious withdrawal of glucocorticoids did not increase the risk of relapse.Keywords: GCA, giant cell arteritis, methotrexate, tocilizumab, ultrasonography, vasculitis

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