Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

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, French Takayasu network, 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, French Takayasu network

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.

Keywords: Takayasu arteritis; Tocilizumab; Vasculitis treatment.

Conflict of interest statement

Coauthors declare no conflicts of interest for this study.

Figures

Fig. 1
Fig. 1
TOCITAKA trial data of steroids sparing effect and relapse rates after 6-month tocilizumab therapy. a Steroids amounts during the 18-month follow-up in TOCITAKA trial. b Frequencies of relapse after 6-month tocilizumab induction therapy, represented as cumulative proportion of patients in remission and with relapsing-persistent TAK disease at months 3, 6, 9, and 12 after the tocilizumab discontinuation

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