by Melani Hirschi
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May 2025

Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis: an open-label study

Summary

The management of Takayasu arteritis (TAK) remains challenging due to its relapsing nature, often requiring long-term therapy over years. Given the risks of refractory disease and glucocorticoid-related (GC) toxicity, safe and sustained GC-sparing strategies are essential. The 2021 ACR/VF guidelines currently favor tumor necrosis factor inhibitors (TNFi) over tocilizumab (TCZ) as initial therapy, based on greater clinical experience and supporting data [1]. However, direct comparative studies are lacking. By providing head-to-head efficacy and safety data on adalimumab (ADA) versus TCZ, the study aims to clarify which biologic agent may offer superior short-term and long-term benefits in patients with active and severe TAK [2].

This randomized, controlled, open-label study enrolled 40 patients who were treated with either ADA (n=21) or TCZ (n=19), both combined with GCs and methotrexate. The primary endpoint was the efficacy rate (ER) at 6 months, with secondary endpoints including ER at 9 and 12 months, relapse rate, GC tapering, adverse effects, and quality of life changes during treatment.

The results demonstrated that the ER at 6 months was significantly higher in the ADA group compared to TCZ in the intention-to-treat population (P=0.02), with a similar trend observed in the per-protocol analysis (P=0.06). By 9 and 12 months, efficacy rates were comparable between groups. The proportion of patients achieving glucocorticoid tapering to ≤10 mg/day at 6 months did not differ significantly (P=0.83). Relapse rates and adverse event frequencies over the 12-month follow-up were also similar (P=0.96 and P=0.55, respectively). For detailed statistics, see the following table.

Outcome

Adalimumab (ADA)

Tocilizumab (TCZ)

P-value

Patients enrolled

21

19

 

ER at 6 months (ITT)

85.71% (18/21)

52.63% (10/19)

0.02

ER at 6 months (Per-protocol)

89.47%

62.50%

0.06

ER at 9 months

61.90% (13/21)

42.11% (8/19)

0.21

CR rate at 9 months (ITT)

47.62% (10/21)

42.11% (8/19)

0.73

CR & ER at 12 months

57.14% (12/21)

26.32% (5/19)

0.05

Patients completing 12-month treatment

12

8

 

GC dose ≤10 mg/day at 6 months

47.37%

43.75%

0.83

Relapse Rate (12 months)

9.52%

10.53%

0.96

Adverse Events (12 months)

38.10%

47.37%

0.55

Impact on Patient Treatment and Future Perspectives

This study suggests that ADA, in combination with glucocorticoids and methotrexate, may offer superior short-term efficacy compared to TCZ in patients with active and severe TAK. These findings support the 2021 ACR/VF guideline recommendation favoring TNFi over TCZ as initial biologic to facilitate GC-sparing, reinforcing ADA’s role as a preferred first-line agent for remission induction. Nonetheless, the comparable long-term efficacy and safety profiles observed between ADA and TCZ indicate that TCZ remains a valid alternative, particularly for patients with intolerance or contraindications to TNFi.

References:

1. Maz M, Chung SA, Abril A, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Care & Research. 2021;73(8):1071-1087. doi:10.1002/acr.24632.

2. Wang J, Kong X, Ma L, et al. Treatment Efficacy and Safety of Adalimumab Versus Tocilizumab in Patients With Active and Severe Takayasu Arteritis: An Open-Label Study. Rheumatology (Oxford, England). 2024;63(5):1359-1367. doi:10.1093/rheumatology/kead387.

Composed by

Dr. med. Andrea Gloor

Assistenzärztin, Universitätsklinik für Notfallmedizin
Inselspital, Universitätsspital Bern

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