ArticleRheumatology (Oxford, England)2020
Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years' follow-up.
Article in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 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
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Rational approach to the prescription of anti-rheumatic drugs in rheumatoid arthritis: a product leaflet-based strategy in Italy.Frontiers in immunology · 2024Pooled it
- Pooled it
- Mesenchymal stem cells combined with IFN-γ treatment versus mesenchymal stem cells monotherapy: safety and efficacy over five years extension follow-up.Stem cell research & therapy · 2025Trial
- Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.Annals of the rheumatic diseases · 2024Trial
- Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Pharmacokinetics and Pharmacodynamics of Subcutaneous Sarilumab and Intravenous Tocilizumab Following Single-Dose Administration in Patients With Active Rheumatoid Arthritis on Stable Methotrexate.Journal of clinical pharmacology · 2021Trial
- Trial
- Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies.Arthritis research & therapy · 2020Trial
- Clinical characteristics of bloodstream infections in the patients receiving anti-IL-6 receptor antibody.Infection · 2026Article
- Heart Failure in Rheumatoid Arthritis: Epidemiology, Pathogenesis, Diagnosis, Treatment, and Emerging Insights-A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2026Review
- IL6 genetic perturbation mimicking IL-6 inhibition is associated with lower cardiometabolic risk.Nature cardiovascular research · 2025Article
- Human Genetics Informing Drug Development in Cardiovascular Disease: Interleukin-6 Signaling as a Case Study.Circulation. Genomic and precision medicine · 2025Review
- Abatacept, Golimumab, and Sarilumab as Selected Bio-Originator Disease-Modifying Antirheumatic Drugs with Diverse Mechanisms of Action in Their Current Use in Treatment.Journal of clinical medicine · 2025Review
- Patient-Centric Approach for the Treatment of Rheumatoid Arthritis-Associated Interstitial Lung Disease in Older People.Drugs & aging · 2025Review
- IL-6R Inhibitors and Gastrointestinal Perforations: A Pharmacovigilance Study and a Predicting Nomogram.Biomedicines · 2024Article
- Navigating the Neuroimmunomodulation Frontier: Pioneering Approaches and Promising Horizons-A Comprehensive Review.International journal of molecular sciences · 2024Review
- Effectiveness and safety of sarilumab in patients with rheumatoid arthritis: A multicenter, retrospective, inverse probability of treatment-weighted analysis based on the FRAB-registry.Clinical rheumatology · 2024Article
- Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Cardiovascular Risk Assessment in Rheumatoid Arthritis: Accelerated Atherosclerosis, New Biomarkers, and the Effects of Biological Therapy.Life (Basel, Switzerland) · 2023Review
- UGT1A1 genetic variants are associated with increases in bilirubin levels in rheumatoid arthritis patients treated with sarilumab.The pharmacogenomics journal · 2022Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSarilumab is a human monoclonal antibody that blocks IL-6 from binding to membrane-bound and soluble IL-6 receptor-α. We assessed the long-term safety of sarilumab in patients from eight clinical trials and their open-label extensions.
methodsData were pooled from patients with rheumatoid arthritis who received at least one dose of sarilumab in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; combination group) or as monotherapy (monotherapy group). Treatment-emergent adverse events (AEs) and AEs and laboratory values of special interest were assessed.
results2887 patients received sarilumab in combination with csDMARDs and 471 patients received sarilumab monotherapy, with mean exposure of 2.8 years and 1.7 years, maximum exposure 7.3 and 3.5 years, and cumulative AE observation period of 8188 and 812 patient-years, respectively. Incidence rates per 100 patient-years in the combination and monotherapy groups, respectively, were 9.4 and 6.7 for serious AEs, 3.7 and 1.0 for serious infections, 0.6 and 0.5 for herpes zoster (no cases were disseminated), 0.1 and 0 for gastrointestinal perforations, 0.5 and 0.2 for major adverse cardiovascular events, and 0.7 and 0.6 for malignancy. Absolute neutrophil counts <1000 cells/mm3 were recorded in 13% and 15% of patients, respectively. Neutropenia was not associated with increased risk of infection or serious infection. Analysis by 6-month interval showed no signal for increased rate of any AE over time.
conclusionThe long-term safety profile of sarilumab, either in combination with csDMARDs or as monotherapy, remained stable and consistent with the anticipated profile of a molecule that inhibits IL6 signalling.
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