0200: Severe infections and malignancies in patients with cranial and extracranial giant cell arteritis treated with tocilizumab. National multicenter study of 471 patients of clinical practice

Sunday, October 26, 2025

10:30 AM - 12:30 PM Central Time

Location: Hall F1

TABLE. Severe infections and malignancies documented in the 471 GCA patients treated with tocilizumab.

Abstract Poster Presenter(s)

AM

Adrián Martín-Gutiérrez, -None-

Hospital Universitario Marques de Valdecilla, IDIVAL
Renedo de Piélagos, Spain

Disclosure(s): No financial relationships with ineligible companies to disclose

Background/Purpose: Infections and malignancies are two of the most feared side effects of biologic therapies. Giant cell arteritis (GCA) is a vasculitis which affects older people in whom the risk of infection and malignancies is higher.

Our aim was to assess severe infections and malignancies that occurred during the follow-up of a series of patients with (GCA) treated with tocilizumab (TCZ).

Methods: Multicentre study of 471 patients diagnosed with GCA and treated with TCZ. The diagnosis of GCA was performed between 2014 and 2020 according to: a) 1990 ACR criteria, b) temporal artery biopsy, and/or c) imaging evaluation techniques. Rate of infections and malignancies are expressed as the exposure-adjusted incidence rate (EAIR) per 100 person years (PY).

Results: We studied 471 patients (342 women; mean age, 74±9 years) treated with TCZ. The phenotypic distribution was: cranial GCA (cGCA) (n=217; 46%), mixed GCA (mixGCA) (n=174; 37%), and extracranial GCA (ecGCA) (n=80; 17%).

After 25.3±21.7 months of follow-up, 63 (13.4%) patients had severe infections (6.4 EAIR/100 PYs), which were more frequent in cGCA (n=44; 20.3%) (Table). The most frequent infections were: urinary tract infection (n=14; 3%), bacteriemia/sepsis (n=9; 1.9%), varicella zoster virus infection (n=6; 1.3%), pneumonia (n=6; 1.3%), upper respiratory tract infection (n=5; 1.1%), cellulitis (n=5; 1.1%), abscess (n=4; 0.8%), septic arthritis (n=2; 0.4%), osteomyelitis (n=2; 0.4%), septic bursitis (n=1; 0.2%), meningitis (n=1; 0.2%), pyelonephritis (n=1; 0.2%), pericarditis due to Lysteria (n=1; 0.2%), candidiasis (n=1; 0.2%), and Cytomegalovirus infection (n=1; 0.2%).

Four (0.8%) patients developed a neoplasia (0.4 EAIR/100 PYs). The most frequent malignancies were: bladder cancer (n=1), colon cancer (n=1), lung cancer (n=1), and myelodysplastic syndrome (n=1).

Conclusion: In this wide series of TCZ in GCA of clinical practice, although TCZ is a relatively safe therapy in GCA, in our series, severe infections were observed in a non-negligible percentage rate of patients, being more frequent in cGCA. Neoplasms were rarer.