ArticleRheumatology and therapy2020
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.
Article in Rheumatology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02531633 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.
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.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Biologic therapies for the treatment of large vessel vasculitis: A systematic review and meta-analysis.PloS one · 2025Pooled it
- Evidence on treat to target strategies in polymyalgia rheumatica and giant cell arteritis: a systematic literature review.Rheumatology (Oxford, England) · 2024Pooled it
- Pooled it
- Pooled it
- A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis.Arthritis research & therapy · 2023Trial
- 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
- [News on the treatment of large vessel vasculitis].Zeitschrift fur Rheumatologie · 2024Review
- Diagnosing vasculitis with ultrasound: findings and pitfalls.Therapeutic advances in musculoskeletal disease · 2024Review
- Observational
- Identification of periductal mastitis and granulomatous lobular mastitis: a literature review.Annals of translational medicine · 2023Review
- Advances in the Treatment of Giant Cell Arteritis.Journal of clinical medicine · 2022Review
- Review
- Large-vessel vasculitis.Nature reviews. Disease primers · 2022Review
- Looking ahead: giant-cell arteritis in 10 years time.Therapeutic advances in musculoskeletal disease · 2022Review
- The Th17 Pathway in Vascular Inflammation: Culprit or Consort?Frontiers in immunology · 2022Review
- Towards Drug Repurposing in Cancer Cachexia: Potential Targets and Candidates.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Serum C-Reactive Protein and Interleukin-6 Levels as Biomarkers for Disease Severity and Clinical Outcomes in Patients with Idiopathic Granulomatous Mastitis.Journal of clinical medicine · 2021Article
- Biologic Therapies for Giant Cell Arteritis.Biologics : targets & therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 3 countries.
Funding
Abstract
introductionTo evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).
methodsIn this multicentre, randomised, double-blind, placebo-controlled, two-part phase 3 trial (NCT02531633; Part A [52-week double-blind treatment]; Part B [104-week follow-up]), patients with GCA were randomised (3:3:2:2:2) to sirukumab 100 mg every 2 weeks plus 6-month or 3-month prednisone taper, sirukumab 50 mg every 4 weeks plus 6-month prednisone taper, or placebo every 2 weeks plus 6-month or 12-month prednisone taper. The primary endpoint was the proportion of patients in sustained remission at week 52. Secondary endpoints included disease flare and safety. The study was terminated early (October 2017; sponsor decision).
resultsOf 161 patients randomised (sirukumab: n = 107; placebo: n = 54), 28 (17.4%) completed week 52 (median treatment duration: 24-30 weeks). In a revised intent-to-treat (ITT) subgroup (completed week 52 or discontinued before study termination [n = 55]); six patients (all receiving sirukumab) achieved the primary endpoint. In the ITT population (n = 161), the proportion of patients with flares (week 2-52) was lower with sirukumab (18.4-30.8%) than placebo (37.0-40.0%). The proportion of patients with flares (week 2-12) was highest with sirukumab 100 mg every 2 weeks plus 3-month prednisone taper (23.1%). In Part A, 94.4% of patients reported ≥ 1 treatment-emergent adverse event (TEAE); 19.3% reported serious TEAEs. The proportions of patients with TEAEs were generally similar across treatment arms. No deaths occurred.
conclusionsAlthough data were limited due to early termination and shortened treatment duration, sirukumab treatment resulted in numerically lower proportions of patients with flare by week 52 versus placebo, with no unexpected safety findings.
trial registrationClinicaltrials.gov: NCT02531633.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.