A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis

Makhzoum JP, Cid MC, Samson M, Henes J, Schönau V, Espigol-Frigole G, Ross C, Ahlman MA, Hsu MC, Li S, Verdijk P, Okonkwo L, Grayson PC, Blockmans D (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Annals of the Rheumatic Diseases BMJ Publishing Group

DOI: 10.1016/j.ard.2026.01.009

Abstract

ObjectivesGuselkumab, a monoclonal antibody, selectively targets the p19 subunit of interleukin-23. This randomised, double-blind, placebo-controlled, phase 2 study evaluated guselkumab vs placebo for the treatment of giant cell arteritis (GCA).MethodsPatients ≥50 years of age with new-onset or relapsing GCA were randomised 2:1 to guselkumab or placebo. Both arms received background glucocorticoid (GC) therapy, with a protocol-defined taper through week 26. The primary endpoint was the proportion of patients achieving GC-free remission at week 28.ResultsThirty-five patients were randomised to receive guselkumab and 18 to receive placebo. All patients were White, 70% were female, and the mean age was 71.5 years; 60% had new-onset and 40% had relapsing GCA. At week 28, 40% (14/35) and 33% (6/18) of patients in the guselkumab and placebo groups, respectively, achieved GC-free remission (P = .64), whereas 31% (11/35) and 39% (7/18) had experienced a GCA flare or discontinued due to worsening GCA. Median time to first GCA flare through week 28 was not estimable (NE) in the guselkumab group (90% CI: 27.7-NE) and 29.7 weeks (90% CI: 20.1-NE) in the placebo group (P = .64). Through week 60, 97% (34/35) and 94% (17/18) of patients in the guselkumab and placebo groups, respectively, had adverse events (AEs); the most common AEs, aside from worsening of GCA (49% and 56%, respectively), were COVID-19 infection (23% and 28%) and headache (17% and 39%).ConclusionsThe study’s primary endpoint (GC-free remission) was not met; results do not support the use of guselkumab in the treatment of GCA.

Authors with CRIS profile

Verena Schönau Department of Medicine 3 – Rheumatology and Immunology

Involved external institutions

Université de Montréal CA Canada (CA) Universitat de Barcelona (UB) / University of Barcelona ES Spain (ES) Centre hospitalier universitaire (CHU) de Dijon Bourgogne FR France (FR) Universitätsklinikum Tübingen DE Germany (DE) Augusta University US United States (USA) (US) Johnson & Johnson Services, Inc. US United States (USA) (US) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) US United States (USA) (US) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven BE Belgium (BE)

How to cite

APA:

Makhzoum, J.P., Cid, M.C., Samson, M., Henes, J., Schönau, V., Espigol-Frigole, G.,... Blockmans, D. (2026). A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis. Annals of the Rheumatic Diseases. https://doi.org/10.1016/j.ard.2026.01.009

MLA:

Makhzoum, Jean Paul, et al. "A phase 2, randomised, placebo-controlled study of guselkumab in adults with new-onset or relapsing giant cell arteritis." Annals of the Rheumatic Diseases (2026).

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