Trial reportArthritis research & therapy2016
Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study.
Trial report in Arthritis research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00106535 (A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis), which is not on this map. Cited by 22 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.
A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
Who cites it
22 citing papers in PubMed, 57 citations in OpenAlex.
- Serum biomarkers in prednisolone-treated hand osteoarthritis patients.Rheumatology (Oxford, England) · 2023Trial
- In Contrast to Anti-CCP, MMP-Degraded and Citrullinated Vimentin (VICM) Is Both a Diagnostic and a Treatment Response Biomarker.International journal of molecular sciences · 2022Trial
- Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study.Arthritis research & therapy · 2021Trial
- The Janus kinase 1/2 inhibitor baricitinib reduces biomarkers of joint destruction in moderate to severe rheumatoid arthritis.Arthritis research & therapy · 2020Trial
- Identification of heterogenous treatment response trajectories to anti-IL6 receptor treatment in rheumatoid arthritis.Scientific reports · 2020Trial
- Trial
- Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA).Osteoarthritis and cartilage · 2017Trial
- Advances in Extracellular Matrix-Associated Diagnostics and Therapeutics.Journal of clinical medicine · 2025Review
- Association between type III collagen degradation and local tissue damage of a single joint.Osteoarthritis and cartilage open · 2024Article
- The fibroid phenotype of biological naïve patients with rheumatoid arthritis are less likely to respond to anti-IL-6R treatment.Scientific reports · 2024Article
- Association of biochemical markers with bone marrow lesion changes on imaging-data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium.Arthritis research & therapy · 2024Article
- Changes in type VI collagen degradation reflect clinical response to treatment in rheumatoid arthritis patients treated with tocilizumab.Arthritis research & therapy · 2024Article
- Tailored therapeutic decision of rheumatoid arthritis using proteomic strategies: how to start and when to stop?Clinical proteomics · 2023Review
- Clinical monitoring in osteoarthritis: Biomarkers.Osteoarthritis and cartilage · 2022Article
- Title Current Status of the Search for Biomarkers for Optimal Therapeutic Drug Selection for Patients with Rheumatoid Arthritis.International journal of molecular sciences · 2021Review
- Bone phenotypes in rheumatology - there is more to bone than just bone.BMC musculoskeletal disorders · 2020Review
- Aptamers for Proteins Associated with Rheumatic Diseases: Progress, Challenges, and Prospects of Diagnostic and Therapeutic Applications.Biomedicines · 2020Review
- GPDPLQScientific reports · 2019Article
- Combining naproxen and a dual amylin and calcitonin receptor agonist improves pain and structural outcomes in the collagen-induced arthritis rat model.Arthritis research & therapy · 2019Article
- Tissue metabolite of type I collagen, C1M, and CRP predicts structural progression of rheumatoid arthritis.BMC rheumatology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRheumatoid arthritis (RA) is characterized by gradual joint destruction. Tocilizumab (TCZ) significantly suppresses symptoms, however not all patients are protected from joint damage. We investigated whether early measurement of specific biomarkers could predict early joint protection response to tocilizumab.
methodSerum biomarkers (CRPM, VICM, C1M, C2M, C3M (MMP-degraded CRP, vimentin type I, II and III collagen), CTX-I/OC (bone turnover), and CRP) were measured in 740 RA patients (the LITHE study) treated with Placebo, or 4 or 8 mg/kg TCZ. Early responders were those with ≥20 % improvement in SJC or TJC by week 16. The biomarkers' predictability of response was investigated by AUROC and classification regression tree analysis.
resultsThe best biomarker predictability for identification of TCZ responders were; baseline CTX-I/OC (AUC 0.66, p = 0.0005) and changes in C1M (AUC 0.67, p = 0.0072), C2M (AUC 0.72, p = 0.0002), C3M (AUC 0.63, p = 0.018) and the combination of biomarkers (AUC 0.81, p = 0.0025). Patients with high bone turnover (CTX-I/OC) and low C2M were 6.8-fold (p = 0.003) more likely to have an early response to TCZ.
conclusionThis enhanced pharmacodynamic (PD) response enabled identification of early responders with a superior TCZ clinical benefit. This biomarker model may assist in the identification of TCZ responsive RA patients and thus potentially benefit individual patients.
trial registrationClinicaltrials.gov: NCT00106535 . JAN 2005.
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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.