Background Takayasu’s arteritis (TAK) is a rare large-vessel vasculitis characterized by granulomatous inflammation in the aorta and its major branches.[1] The affected arteries may become narrowed or even occluded, resulting in ischemia of the corresponding tissue or organs and threatening patient survival.[2] However, effective treatment strategies for TAK are lacking.

Although TCZ and TNF-α inhibitors are commonly applied in the treatment of refractory TAK, a formal head-to-head study evaluating their efficacy is lacking. According to retrospective studies,[3, 4] the complete response rate associated with TCZ was slightly better than those associated with TNF-α inhibitors at 6 months (70% vs. 66%; 70% vs. 61%). However, another study indicated a better 3-month complete remission rate associated with TNF-α inhibitors than with TCZ (30% vs. 18%) [5]. Thus, the data are inconclusive regarding which medication is more effective. Furthermore, the 6-month nonresponse and 12-month relapse rates associated with these treatments were approximately 25% and 19%, respectively.[3] Thus, given the inconsistent results obtained thus far in this context, we conducted this randomized, open-label, head-to-head study to compare the efficacy and safety of the TNF-α antibody adalimumab (ADA) and TCZ combined with GCs and MTX in patients with active and severe TAK.

Objectives This study was aimed at investigating the efficacy and safety of adalimumab (ADA) and tocilizumab (TCZ) in patients with active and severe Takayasu arteritis (TAK) concomitantly treated with glucocorticoids (GCs) and methotrexate (MTX).

Methods Forty patients were randomized into ADA and TCZ groups (n = 21 and 19, respectively). They were treated with ADA or TCZ combined with GCs and MTX, respectively. The planned follow-up duration was 12 months. The primary end point was the efficacy rate (ER) at 6 months.

Results The intention to treat (ITT) population included 21 and 19 patients from the ADA and TCZ groups, respectively. In this population, the ERs at 6 months were higher in the ADA group (85.71% vs. 52.63%, P = 0.02). Similar tendencies were also noted in per-protocol set (89.47% vs. 62.50%, P = 0.06). At the 6-month time point, the percentages of patients receiving a GC dose of ≤10 mg/day and the cumulative GC dose were similar between the ADA and TCZ groups (47.37% vs. 43.75%, P = 0.83; 4200 mg vs. 4100 mg, P = 0.15, respectively). Imaging improvement or stabilization was observed in most patients in both groups (ADA vs. TCZ: 19/19 vs. 15/16, P = 0.27). Adverse event incidence was comparable between the two groups (ADA vs. TCZ: 38.10% vs. 47.37%, P = 0.55).

Conclusion ADA probably was more effective than TCZ in combined treatment with GCs and MTX among patients with active and severe TAK.

References

1. Group JCSJW. Guideline for management of vasculitis syndrome (JCS 2008). Japanese Circulation Society. Circ J 2011, 75(2):474-503.
2. Zaldivar Villon MLF, de la Rocha JAL, Espinoza LR. Takayasu Arteritis: Recent Developments. Curr Rheumatol Rep 2019, 21(9):45.
3. Mekinian A, Comarmond C, Resche-Rigon M et al. Efficacy of Biological-Targeted Treatments in Takayasu Arteritis: Multicenter, Retrospective Study of 49 Patients. Circulation 2015, 132(18):1693-1700.
4. Novikov PI, Smitienko IO, Moiseev SV. Tumor necrosis factor alpha inhibitors in patients with Takayasu’s arteritis refractory to standard immunosuppressive treatment: cases series and review of the literature. Clin Rheumatol 2013, 32(12):1827-1832.
5. Mekinian A, Resche-Rigon M, Comarmond C et al. Efficacy of tocilizumab in Takayasu arteritis: Multicenter retrospective study of 46 patients. J Autoimmun 2018, 91:55-60.

Acknowledgements: NIL.

Disclosure of Interests None Declared.

Keywords: Clinical trials, Vasculitis, Treat to target

DOI: 10.1136/annrheumdis-2023-eular.4610