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Observational Study
. 2025 Dec:75:152869.
doi: 10.1016/j.semarthrit.2025.152869. Epub 2025 Nov 6.

Tocilizumab monotherapy versus combined in aortitis associated with giant cell arteritis: Factors associated with imaging remission in a multicenter open-label study of 196 patients

Adrián Martín-Gutiérrez  1 , Javier Loricera  1 , Diana Prieto-Peña  1 , Vicente Aldasoro  2 , Olga Maiz  3 , Eugenio de Miguel  4 , Eva Galíndez-Agirregoikoa  5 , Iván Ferraz-Amaro  6 , Santos Castañeda  7 , Ricardo Blanco  8 ; Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group
Collaborators, Affiliations
Observational Study

Tocilizumab monotherapy versus combined in aortitis associated with giant cell arteritis: Factors associated with imaging remission in a multicenter open-label study of 196 patients

Adrián Martín-Gutiérrez et al. Semin Arthritis Rheum. 2025 Dec.

Abstract

Background: Aortitis is a frequent and potentially serious complication of giant cell arteritis (GCA). The phenotype associated with aortitis (GCA-aortitis) can present greater therapeutic challenges than the cranial-dominant phenotype. Tocilizumab (TCZ) is approved for GCA, although its efficacy in GCA-aortitis has not been specifically assessed in randomized controlled trials.

Objective: To assess the effectiveness and safety of TCZ monotherapy (TCZmono) compared with TCZ plus conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (TCZcombo) in patients with GCA-aortitis in real-world practice, and to identify variables associated with imaging remission.

Methods: A multicenter observational study comparing TCZcombo versus TCZmono. Outcomes at 12 and 24 months included clinical remission, EULAR-defined remission, imaging remission, prednisone-sparing effect, and safety. Multivariable logistic regression identified factors linked to imaging remission at 24 months.

Results: A total of 196 patients (148 female, 48 male) with GCA-aortitis received TCZ (136 TCZmono, 60 TCZcombo). At 24 months, imaging remission was higher in the TCZcombo group (50.0%¦vs. 15.8%; p=0.026). No significant differences were found in clinical or EULAR-defined remission. TCZcombo demonstrated a prednisone-sparing effect. The serious adverse event (SAE) rate was numerically lower with TCZcombo (8.7 vs. 13.2 per 100 patient-years; p=0.21). TCZcombo increased the odds of imaging remission 5.26-fold (odds ratio [OR] 5.26; 95% confidence interval [CI]: 1.03-26.85; p=0.046).

Conclusion: In patients with GCA-aortitis, TCZcombo may be more effective than TCZmono in achieving imaging remission and promoting glucocorticoid tapering, but without definitive evidence regarding a reduction of serious adverse events.

Keywords: Aortitis; Biological therapy; Conventional synthetic DMARDs; Giant cell arteritis; Immunosuppressive agents; Tocilizumab.

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Conflict of interest statement

Declaration of competing interest Disclosures that might be interpreted as constituting possible conflict(s) of interest for the study: Javier Loricera had consultation fees/participation in company-sponsored speaker´s bureau from Roche, Galápagos, Novartis, UCB Pharma, MSD, Celgene, Astra Zeneca, and Grünenthal and received support for attending meetings and/or travel from Janssen, Abbvie, Roche, Novartis, MSD, UCB Pharma, Celgene, Galápagos Lilly, Pfizer. Eugenio De Miguel has received research funding/consulting and conferences fees from Abbvie, Novartis, Pfizer, Roche, Janssen, Lilly, MSD, BMS, UCB, Grünenthal and Sanofi. Iván Ferraz-Amaro has received grants/research supports from Abbvie, MSD, Janssen, and Roche, as well as consultation fees from company sponsored speakers’ bureaus associated with Abbvie, Pfizer, Roche, Sanofi, Celgene, and MSD. Santos Castañeda has received research support from MSD, Pfizer and UCB, and had consultation fees/participation in company-sponsored speaker’s bureau from BMS, Eli-Lilly, Janssen, Roche, Gedeon-Richter, Grünenthal Pharma and UCB. Ricardo Blanco received grants/research support from AbbVie, MSD, and Roche, and had consultation fees/participation in a company-sponsored speaker’s bureau from AbbVie, Pfizer, Roche, GSK, Lilly, UCB, BMS, Novartis, Janssen, UCB and MSD. The following authors did not declare financial disclosures: Adrián Martín-Gutiérrez, Diana Prieto-Peña, Vicente Aldasoro, Olga Maiz, Eva Galíndez-Agirregoikoa.

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