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ACR 2020 | Daily Highlights
GCA: initial treatment
A PROOF OF CONCEPT STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN COMBINATION WITH ULTRA-SHORT GLUCOCORTICOID ADMINISTRATION TO TREAT NEWLY DIAGNOSED GIANT CELL ARTERITIS – A 24 WEEK ANALYSIS
Abstract: 0515
Authors: Lisa Christ et al.
Key content:
The GUSTO (GCA treatment with Ultra-Short GC and TCZ) trial was set up to unravel the efficacy of TCZ-monotherapy after ultra-short GC treatment in new-onset GCA. In this investigator-initiated, single-arm, single-center, open-label clinical trial with Simon’s two stage design, 18 patients with newly diagnosed GCA were enrolled. Patients received 500mg methylprednisolone intravenously for three consecutive days. Thereafter, GC treatment was discontinued and TCZ (8mg/kg body-weight) was administered intravenously, followed by weekly subcutaneous TCZ injections (162mg) from day 10 until week 52. The primary endpoints included the proportion of patients (i) achieving remission within 31 days and (ii) without relapse at week 24.
Results: Baseline characteristics include 12/18 female patients with a median age of 72 (range 64–78) years; 11/18 with median 1 (range 1–7) day of prior GC-treatment; 15/18 with cranial symptoms (10/18 with jaw claudication, 6/18 with visual involvement), 10/18 with PMR-symptoms, 16/18 with positive cranial ultrasound, 14/18 with aortitis on MRI, 14/18 with vasculitis on cranial MRI and 13/18 with GCA-findings in temporal biopsy.
At interim analysis, only 3/12 patients had achieved remission at 31 days. Thus, the primary end point was missed. However, 14/18 patients achieved remission after a mean of 78 days (95% CI 58–97) and 13 stayed relapse-free up to 24 weeks (72%; 95% CI 47–90%). 3/18 patients (17%) were non-responders and started on rescue GC-treatment (2/3; 2/18 (11%) discontinued the study due to an adverse event (hepatopathy and diverticulitis, respectively, one patient 1/2 after induction of remission).
Relevance:
Although the primary end-point was not met (as remission was induced after 78 instead of 31 days), our data show that GC treatment can be reduced to a 3-day pulse in a high proportion of GCA patients treated with TCZ. The study adds a further piece of evidence regarding the therapeutic potency of IL-6 blockade in GCA.
Zusammenfassung und Kommentar von:
Prof. Dr. Peter Villiger
Bern
