Published in:
01-12-2020 | Vasculitis | Research article
Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial
Authors:
Arsene Mekinian, David Saadoun, Eric Vicaut, Sara Thietart, Bertrand Lioger, Patrick Jego, Alexandre Bleibtreu, Nicolas Limal, Jerome Connault, Jacques-Eric Gottenberg, Pauline Lhorte, Jean Pierre Bertola, Juliette Delforge, Nicole Ferreira-Maldent, Antoinette Perlat, Zohra Talib, Matthieu Vautier, Léa Savey, Isabelle Quiere, Patrice Cacoub, Olivier Fain, for the French Takayasu network
Published in:
Arthritis Research & Therapy
|
Issue 1/2020
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Abstract
Objectives
To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).
Methods
Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up.
Results
Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p < 0.001), ITAS-2010 score (5 [2–7] versus 3 [0–8]; p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.
Conclusion
Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary.
Trial registration
ClinicalTrials.gov
NCT02101333. Registered on 02 April 2014.