Rapid and sustained improvement in bone and cartilage turnover markers with the anti–interleukin‐6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: Results from a substudy of the multicenter double‐blind, placebo‐controlled trial of tocilizumab in inadequate responders to methotrexate alone

Garnero, Patrick; Thompson, Elizabeth J.; Woodworth, Thasia; Smolen, Josef S.

doi:10.1002/art.25053

Cited by 192 publications

(120 citation statements)

References 47 publications

(75 reference statements)

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“…Our literature search found 2 RCTs that examined the effects of tocilizumab, an IL-6 receptor inhibitor, on bone turnover markers in RA (29,30). Both studies found that tocilizumab administered at 4 mg/kg and 8 mg/kg for 24 weeks was associated with significant reduction in bone resorption markers, C-terminal crosslinking telopeptide of type I collagen generated by matrix metalloproteinases, and C-terminal crosslinking telopeptide of type I collagen compared with placebo.…”

mentioning

confidence: 99%

Meta‐Analysis of Tumor Necrosis Factor Inhibitors and Glucocorticoids on Bone Density in Rheumatoid Arthritis and Ankylosing Spondylitis Trials

Siu

Haraoui

Bissonnette

et al. 2015

Arthritis Care & Research

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Objective. To examine the impact of antirheumatic drugs on bone mineral density (BMD) in rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis using a systematic review. Methods. Electronic databases were systematically searched for randomized controlled trials. Studies were grouped based on disease, treatment, and site of BMD measurement. Change in BMD (DBMD) from baseline to end of study was recorded. Standardized mean difference (SMD) of DBMD between treatment and controls was standardized for meta-analyses and 95% confidence intervals (95% CIs) were calculated. Results. Treatment effects on BMD were not the primary outcomes of the trials. Thirteen studies were eligible (11 RA, 2 AS, 0 PsA, and 0 psoriasis). For RA, significantly less hand bone loss was seen with tumor necrosis factor inhibitors (TNFi; SMD DBMD 0.33 [95% CI 0.13, 0.53], P 5 0.001, I 2 5 0%) and glucocorticoids (SMD DBMD 0.51 [95% CI 0.20, 0.81], P 5 0.001, I 2 5 0%). TNFi had no significant effect on lumbar spine and hip BMD. Glucocorticoids were associated with a negative effect on lumbar spine (SMD DBMD 20.30 [95% CI 20.55,20.04], P 5 0.02, I 2 5 52%), but not hip BMD. For AS, a significant increase in BMD was seen with TNFi at the lumbar spine (SMD DBMD 0.96 [95% CI 0.64, 1.27], P < 0.001, I 2 5 16%) and hip (SMD DBMD 0.38 [95% CI 0.13, 0.62], P 5 0.003, I 2 5 0%). Data were insufficient to perform meta-analyses in PsA and psoriasis or for other antirheumatic drugs. Conclusion. In RA, TNFi and glucocorticoids appeared to attenuate hand bone loss. TNFi did not impact lumbar spine and hip BMD and glucocorticoids had negative effects on lumbar spine and no effect on hip BMD. In AS, TNFi was associated with improved lumbar spine and hip BMD.

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confidence: 99%

Meta‐Analysis of Tumor Necrosis Factor Inhibitors and Glucocorticoids on Bone Density in Rheumatoid Arthritis and Ankylosing Spondylitis Trials

Siu

Haraoui

Bissonnette

et al. 2015

Arthritis Care & Research

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“…These findings suggest a slight but significant positive effect of a mixture of methotrexate, placebo, and disease progression on the bone biomarker changes over a long‐term period. In a clinical trial of patients with RA receiving tocilizumab or placebo with methotrexate, median P1NP, and OC, CFB in the placebo group seemed to increase at 24 weeks, although it was reported as nonsignificant 27. In another study, urinary excretion levels of N‐telopeptide of type I collagen (bone resorption marker) significantly decreased in patients with RA treated with methotrexate 28…”

Section: Discussionmentioning

confidence: 99%

Dissociated Agonist of Glucocorticoid Receptor or Prednisone for Active Rheumatoid Arthritis: Effects on P1NP and Osteocalcin Pharmacodynamics

Shoji

Suzuki

Conrado

et al. 2017

CPT Pharmacom & Syst Pharma

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Fosdagrocorat (PF‐04171327), a dissociated agonist of the glucocorticoid receptor, has potent anti‐inflammatory activity in patients with rheumatoid arthritis with reduced adverse effects on bone health. To identify fosdagrocorat doses with bone formation marker changes similar to prednisone 5 mg, we characterized treatment‐related changes in amino‐terminal propeptide of type I collagen (P1NP) and osteocalcin (OC) with fosdagrocorat (1, 5, 10, or 15 mg) and prednisone (5 or 10 mg) in a phase II randomized trial (N = 323). The time course of markers utilized a mixed‐effects longitudinal kinetic‐pharmacodynamic model. Median predicted changes from baseline at week 8 with fosdagrocorat 5, 10, and 15 mg were −18, −22, and −22% (P1NP), and −7, −13, and −17% (OC), respectively. Changes with prednisone 5 and 10 mg were −15% and −18% (P1NP) and −10% and −17% (OC). The probability of fosdagrocorat doses up to 15 mg being noninferior to prednisone 5 mg for P1NP and OC changes was >90%.

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“…Также лече-ние ТЦЗ сопровождается падением концентрации маркеров костной деструкции CTXI и карбокситерминального тело-пептида коллагена I типа (ICTP). Следует отметить, что снижение уровня ICTP, HELIXII, MMП3 более выражено у ответивших на терапию ТЦЗ, чем в группе больных с отсут-ствием такого ответа [54].…”

Section: тоцилизумабunclassified

Role of laboratory biomarkers in monitoring and prediction of the effectiveness of treatment of rheumatic diseases using genetically engineered drugs

Александрова¹,

Новиков²,

Насонов³

2014

Modern Rheumatology Journal

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Значительный прогресс в лечении иммуновоспалительных ревматических заболеваний (РЗ) связан с разработкой нового класса ле-карственных средств -генно-инженерных биологических препаратов (ГИБП). В настоящее время в крови, синовиальной жидко-сти, моче и биоптатах пораженных тканей выявлены молекулярные и клеточные биомаркеры (антитела, показатели острой фа-зы воспаления, цитокины, хемокины, факторы роста, маркеры активации эндотелия, иммуноглобулины, криоглобулины, субпопу-ляции Т-и В-лимфоцитов, продукты Significant progress in treating immunoinflammatory rheumatic diseases (RD) is related to the design of a novel family of drugs, biologic drugs. Molecular and cellular biomarkers (antibodies, indicators of acute inflammation, cytokines, chemokines, growth factors, endothelial activation markers, immunoglobulins, cryoglobulins, T-and B-cell subpopulations, products of bone and cartilage metabolism, genetic and metabolic markers) that allow one to conduct immunological monitoring and prediction of the effectiveness of RD therapy using tumor necrosis factor α inhibitors (infliximab, adalimumab, golimumab, etanercept), anti-B-cell drugs (rituximab, belimumab), interleukin-6 receptor antagonist (tocilizumab), and T-cell costimulation blocker (abatacept) have been detected in blood

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Cited by 192 publications

References 47 publications

Meta‐Analysis of Tumor Necrosis Factor Inhibitors and Glucocorticoids on Bone Density in Rheumatoid Arthritis and Ankylosing Spondylitis Trials

Meta‐Analysis of Tumor Necrosis Factor Inhibitors and Glucocorticoids on Bone Density in Rheumatoid Arthritis and Ankylosing Spondylitis Trials

Dissociated Agonist of Glucocorticoid Receptor or Prednisone for Active Rheumatoid Arthritis: Effects on P1NP and Osteocalcin Pharmacodynamics

Role of laboratory biomarkers in monitoring and prediction of the effectiveness of treatment of rheumatic diseases using genetically engineered drugs

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