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ACR 2019 | Daily Highlights
Ustekinumab for GA
USTEKINUMAB FOR THE TREATMENT OF GIANT CELL ARTERITIS
Abstract: 1837
Authors: Mark Matza et al.
Key content:
Interleukins (IL)-12 and 23 are thought to play a pathogenic role in Giant Cell Arteritis (GCA). This study evaluated the efficacy of the IL-12/23 antagonist ustekinumab (UST) in GCA patients. This prospective, single center, open-label pilot study evaluated the efficacy and safety of UST in combination with prednisone for new onset and relapsing GCA patients with active disease. (The definitions of diagnosis and disease activity were adopted from the GIACTA trial.) UST 90 mg was administered subcutaneously at baseline and weeks 4, 12, 20, 28, 36 and 44. All patients received a pre-specified 6-month prednisone taper starting at 60 mg, 40 mg, or 20 mg based on investigators’ clinical judgment. The primary endpoint, prednisone-free remission, was defined as the absence of disease flare from induction of remission up to week 52 and the concurrent normalization of ESR (< 40 mm/hour) and CRP (< 10 mg/L), while adhering to the protocol prednisone.
A sample of 20 consecutive patients was planned for the study. However, the study was prematurely terminated due to inefficacy. Thus, the outcomes of the first 11 patients that completed 52 weeks of treatment are reported. 27% had new-onset disease, and 91% had a positive temporal artery biopsy. The initial prednisone dose was 60 mg in 2 patients, 40 mg in 8 patients and 20 mg in 1 patient. All patients achieved disease remission within 4 weeks of baseline. Only 2 patients (18%) achieved the primary outcome. Of the 9 patients (82%) who failed to achieve the primary outcome, 7 patients had a flare after a mean period of 23 weeks and 3-6 UST injections. The mean (SD) prednisone dose at the time of flare was 3 (3) mg/day. The other 2 patients who failed to achieve the primary outcome did not have a disease flare, but their inflammatory markers were elevated at week 52.
Relevance:
In conclusion UST in combination with 6 months of prednisone was not associated with clinically significant rates of sustained disease remission in this cohort of GCA patients. Based on the current understanding of pathogenesis the negative results may surprise. Thus, the negative data are of importance.
Zusammenfassung und Kommentar von:
Prof. Dr. Peter Villiger
Bern
