Trial reportAnnals of the rheumatic diseases2019
Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis.
Trial report in Annals of the rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 95 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
95 citing papers in PubMed, 2 syntheses or guidelines pooled it, 167 citations in OpenAlex.
- Pooled it
- A systematic review, umbrella review, and quality assessment on clinical translation of stem cell therapy for knee osteoarthritis: Are we there yet?Stem cell research & therapy · 2023Pooled it
- RANKL blockade for erosive hand osteoarthritis: a randomized placebo-controlled phase 2a trial.Nature medicine · 2024Trial
- Serum biomarkers in prednisolone-treated hand osteoarthritis patients.Rheumatology (Oxford, England) · 2023Trial
- Advances in targeting IL-1 family cytokines for the treatment of inflammatory diseases.Nature reviews. Rheumatology · 2026Review
- Controlled release of CD200 inhibits inflammatory macrophages and chondrocyte catabolism.npj biomedical innovations · 2026Article
- The complexity of pain in osteoarthritis.Nature reviews. Rheumatology · 2026Review
- Cross-platform transcriptomic data integration identifies an overactive neuro-immune signature in human osteoarthritis synovium.Osteoarthritis and cartilage · 2026Article
- Harnessing bi-exosome combination alleviates osteoarthritis progression.Bioactive materials · 2026Article
- Osteoarthritis: molecular pathogenesis and potential therapeutic options.Signal transduction and targeted therapy · 2026Review
- Modular hydrogel niche orchestrates microenvironment detoxification and stem cell redirecting toward precision osteoarthritis therapy.Bioactive materials · 2026Article
- Osteoarthritis as a systemic disease.Nature reviews. Rheumatology · 2026Review
- Understanding the Inflammatory Aspect of Osteoarthritis: Lessons from Immune Checkpoint Inhibitors.Journal of clinical medicine · 2026Review
- Article
- Recent Developments in Osteoarthritis Research: Innovative Therapeutic Approaches and the Role of Polyphenols and Nanotechnology.International journal of molecular sciences · 2025Review
- Breaking Down Osteoarthritis: Exploring Inflammatory and Mechanical Signaling Pathways.Life (Basel, Switzerland) · 2025Review
- Neutralization of acyl CoA binding protein (ACBP) for the experimental treatment of osteoarthritis.Cell death and differentiation · 2025Article
- Antibody and aptamer-based therapies for osteoarthritis: Application of antibodies and promise of aptamers.Molecular therapy. Nucleic acids · 2025Review
- The inflammatory endotype in osteoarthritis: Reflections from the 2024 OARSI clinical trials symposium (CTS) with a special emphasis on feasibility for clinical development.Osteoarthritis and cartilage open · 2025Review
- Pyroptosis: A spoiler of peaceful coexistence between cells in degenerative bone and joint diseases.Journal of advanced research · 2025Review
35 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
18 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA).
methodsPatients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks. At baseline and week 26, subjects had bilateral hand radiographs and MRI of the hand with the greatest number of baseline tender and/or swollen joints. Continuous endpoints were assessed using analysis of covariance models, with treatment and country as main factors and baseline measurements as covariates.
resultsOf 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)). AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 (least squares mean difference, 1.5 (95% CI -1.9 to 5.0)). Other clinical and imaging endpoints were not different between lutikizumab and placebo. Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils. Lutikizumab pharmacokinetics were consistent with phase I studies and not affected by antidrug antibodies. Injection site reactions and neutropaenia were more common in the lutikizumab group; discontinuations because of adverse events occurred more frequently with lutikizumab (4/64) versus placebo (1/67).
conclusionDespite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo.
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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.