Dr. Maria Cid of the University of Barcelona, Spain, coauthor of a related editorial, comments in an email to Reuters Health, “Although the primary endpoint—remission at 31 days—was not achieved, the GUSTO has demonstrated, indeed, that 78% of patients achieve remission within 24 weeks with tocilizumab monotherapy following three IV methyl-prednisolone pulses. Moreover in 72% of patients, remission was sustained through the trial duration.”4
“However,” she notes, “remission was substantially slower than in the standard of care and one patient suffered GCA-related permanent visual loss.”
“Results of the GUSTO trial are preliminary and this treatment regimen cannot be recommended,” she says. “However, the trial provides proof of concept that glucocorticoid exposure can be further reduced in some patients receiving tocilizumab. The extent of reduction, its efficacy and safety in the short and in the long-term need to be explored in larger clinical trials with extended follow-up.”
The study was funded by Bern University Hospital, University of Bern and F. Hoffmann-LaRoche. Dr. Villiger and another coauthor have received fees from Hoffmann-LaRoche and one coauthor is an employee and shareholder.
References
- Christ L, Sietz L, Scholz G, et al. Tocilizumab monotherapy after ultra-short glucocorticoid administration in giant cell arteritis: A single-arm, open-label, proof-of-concept study. Lancet Rheumatol. 2021 Jul 2. Online first.
- Seitz M, Reichenbach S, Bonel HM, et al. Rapid induction of remission in large vessel vasculitis by IL-6 blockade. A case series. Swiss Med Wkly. 2011 Jan 17;141:w13156. eCollection 2011.
- Villiger PM, Adler S, Kuchen S, et al. Tocilizumab for induction and maintenance of remission in giant cell arteritis: A phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2016 May 7;387(10031):1921–1927. Epub 2016 Mar 4.
- Cid MC, Espígol-Frigolé G. Risks and benefits of tocilizumab monotherapy in giant cell arteritis. Lancet Rheumatol. 2021 Jul 2. Online first.