Actualités
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
Dans la rubrique Actualités, vous ne trouverez qu'une petite sélection d'informations. En tant que membre, vous bénéficiez d'un accès exclusif à notre espace membres privé, qui propose des articles détaillés, des informations approfondies et des contenus supplémentaires précieux. Devenez membre dès maintenant et restez parfaitement informé !