ArticleArthritis care & research2018
Long-Term Safety of Rituximab in Rheumatoid Arthritis: Analysis From the SUNSTONE Registry.
Article in Arthritis care & research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- The risk of venous thromboembolism in RA.Rheumatology (Oxford, England) · 2026Review
- Heart Failure in Rheumatoid Arthritis: Epidemiology, Pathogenesis, Diagnosis, Treatment, and Emerging Insights-A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2026Review
- Frontiers in Rheumatoid Arthritis: Emerging Research and Unmet Needs in Pharmacologic Management.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Rheumatoid Arthritis and Osteoporosis as Prototypes of Immunosenescence in Osteoimmunology: Molecular Pathways of Inflammaging and Targeted Therapies.International journal of molecular sciences · 2025Review
- Managing Rheumatoid Arthritis in Older Adults with Cancer.Drugs & aging · 2025Review
- Real-world evidence of biological treatments in rheumatoid arthritis and spondyloarthritis in Morocco: results of the RBSMR registry.BMC rheumatology · 2025Article
- Comment on: Longitudinal risk of serious infections in patients with inflammatory arthritis on immunomodulating therapy compared to controls: Reply.Rheumatology advances in practice · 2025Article
- Comment on: Longitudinal risk of serious infections in patients with inflammatory arthritis on immunomodulating therapy compared to controls.Rheumatology advances in practice · 2025Article
- Hypogammaglobulinemia, late-onset neutropenia, and infections following rituximab.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2023Review
- Effectiveness of Different Rituximab Doses Combined with Leflunomide in the Treatment or Retreatment of Rheumatoid Arthritis: Part 2 of a Randomized, Placebo-Controlled, Investigator-Initiated Clinical Trial (AMARA).Journal of clinical medicine · 2022Article
- Anti-viral efficacy of a next-generation CD4-binding site bNAb in SHIV-infected animals in the absence of anti-drug antibody responses.iScience · 2022Article
- Long-Term Safety of Rituximab in Granulomatosis With Polyangiitis and in Microscopic Polyangiitis.Arthritis care & research · 2021Observational
- Long-Term Safety of Rituximab (Risks of Viral and Opportunistic Infections).Current rheumatology reports · 2021Review
- Cardiovascular effects of approved drugs for rheumatoid arthritis.Nature reviews. Rheumatology · 2021Review
- Navigating immunosuppression in a pandemic: A guide for the dermatologist from the COVID Task Force of the Medical Dermatology Society and Society of Dermatology Hospitalists.Journal of the American Academy of Dermatology · 2020Review
- Risk of Malignancies in Patients with Rheumatoid Arthritis Treated with Rituximab: Analyses of Global Postmarketing Safety Data and Long-Term Clinical Trial Data.Rheumatology and therapy · 2020Article
- A comprehensive review of rituximab therapy in rheumatoid arthritis patients.Clinical rheumatology · 2019Review
- Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting.Frontiers in pharmacology · 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
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the long-term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥ 1 antitumor necrosis factor therapies in the United States (SUNSTONE Registry).
methodsIn this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard-of-care follow-up visits at least every 6 months. The primary outcome was the incidence of protocol-defined significant infections. Secondary outcomes included serious adverse events potentially associated with rituximab, cardiovascular or thrombotic (CVT) events, seizures, deaths and pregnancies. Posthoc analyses assessed outcomes by concomitant medication use.
resultsOverall, 989 patients (safety-evaluable population) received ≥ 1 dose of rituximab, with a total follow-up of 3844 patient-years (PYs; mean duration, 3.9 years). In total, 341 significant infections occurred in 197 patients (19.9%). The incidence rates (95% CI) for significant infections, CVT events, and seizures were 8.87 (7.98, 9.86), 1.95 (1.56, 2.45), and 0.18 (0.09, 0.38) per 100 PYs, respectively. The incidence of significant infections did not increase with time or with cumulative rituximab exposure. During the study, 64 patients died (crude mortality [95% CI]: 1.66 per 100 PYs [1.30, 2.13]). The most common causes of death were infections (19 patients), malignancy (14), and cardiovascular events (13). Eight pregnancies were reported in 7 patients.
conclusionIn patients with RA treated with rituximab for up to 5 years, the rates of significant infections were stable over time and higher in patients who received long-term systemic steroid treatment. This article is protected by copyright. All rights reserved.
Identifiers
What OpenQuestion holds
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.