Trial reportArthritis research & therapy2025
Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial.
Trial report in Arthritis research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02902731 (Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis
Who cites it
2 citing papers in PubMed.
- A systematic literature review to inform the 2025 EULAR recommendations for the management of polymyalgia rheumatica and primary large vessel vasculitis: management of disease including relapse and complications.EULAR rheumatology open · 2026Review
- Treatment strategies in giant cell arteritis and polymyalgia rheumatica: beyond glucocorticoids.Nature reviews. Rheumatology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEfficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed.
methodsThis phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients were randomized 1:1. From inclusion to week 16 (W16), patients in the anakinra (ANK) group received a daily subcutaneous injection of 100 mg of anakinra, whereas patients in the other group received placebo (PBO). In both arms, glucocorticoid (GC) discontinuation was planned at week 52 (W52). The endpoints were the relapse rates at W16, W26, and W52 and the completion of GC tapering. Given the emergence of the SARS-CoV-2 pandemic, the study was stopped prematurely.
resultsThirty patients with new GCA diagnoses from 5 centers were randomized as follows: 17 in the ANK group and 13 in the PBO group. During the first 16 weeks, the relapse rates were 12% (n = 2) and 23% (n = 3) in the ANK and PBO groups, respectively (p = 0.63). At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p = 0.47). At W52, the relapse rate (overall, 50%) did not differ between the ANK group (53%; 9/17 patients) and the PBO group (46%; 6/13 patients) (p = 1). Two patients in each group discontinued GCs (p = 0.87). Seven serious AEs were reported in five patients, including 4 in patients receiving ANK.
conclusionsAlthough prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure.
trial registrationClinicalTrials.gov NCT02902731.
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