Detectable safety gestalt of rheumatoid arthritis treatments from pivotal clinical drug trials.
Objective To provide a meta-level comparison of standardized safety profiles ('gestalt') of currently licensed biologic and targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) in rheumatoid arthritis (RA) from pivotal clinical trials. Methods We systematically searched E...
| Publicado en: | Rheumatology Vol. 65; no. 7; pp. 1 - 11 |
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| Autores principales: | , , , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Jul2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=195931775&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 195931775 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14620324 DN9 jtl: Rheumatology issn: 14620324 maglogo: N pubinfo: dt: Jul2026 vid: 65 iid: 7 pid: 622 pub: Oxford University Press / USA artinfo: ui: 195931775 195931775 195931775 10.1093/rheumatology/keag263 195931775 ppf: 1 ppct: 10 formats: tig: atl: Detectable safety gestalt of rheumatoid arthritis treatments from pivotal clinical drug trials. aug: au: Konzett, Victoria Kerschbaumer, Andreas Willmann, Laurenz Aletaha, Daniel affil: Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria sug: subj: Arthritis, Rheumatoid Drug Therapy Antirheumatic Agents Therapeutic Use Antirheumatic Agents Adverse Effects Biological Products Therapeutic Use Biological Products Adverse Effects Drug Efficacy Patient Safety Human Male Female Adult Middle Age Aged Systematic Review Meta Analysis Embase Medline Cochrane Library Checklists Drug Tolerance Tumor Necrosis Factor Inhibitors Therapeutic Use Interleukins Antagonists and Inhibitors Janus Kinase Inhibitors Therapeutic Use Herpes Zoster Chemically Induced Anaphylaxis Chemically Induced Gastrointestinal Diseases Chemically Induced Biological Markers Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Objective To provide a meta-level comparison of standardized safety profiles ('gestalt') of currently licensed biologic and targeted synthetic disease-modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) in rheumatoid arthritis (RA) from pivotal clinical trials. Methods We systematically searched EMBASE, Medline and the Cochrane Library for randomized controlled RA drug approval trials of bDMARDs and tsDMARDs. The Medical Dictionary for Regulatory Activities (MedDRA) hierarchy system was applied to account for the heterogeneous safety reporting across trials, and random-effects meta-analyses of adverse events (AE) were performed at lower MedDRA levels as well as for major system organ classes. Serious AEs (SAE) and AEs of special interest (AESI) were studied descriptively. Forest plots and radar charts were used for visualization, to generate distinct safety profiles, referred to as 'safety gestalt', for each compound. Results Sixty-four randomized, placebo-controlled drug approval trials were considered, of which 25 studied TNF-α inhibitors, 10 studied IL-6 receptor inhibitors, 5 studied rituximab, 7 studied abatacept and 18 studied Janus kinase inhibitors. Meta-level comparisons of the total number of AEs and SAEs showed comparable overall safety and tolerability, while a more granular insight into distinct organ classes and AESIs disentailed differences between compounds and drug classes. Conclusion Standardized safety reporting and profiling of bDMARDs and tsDMARDs from pivotal clinical drug trials provides an overview of safety outcomes of commonly used RA therapies, supports safety-oriented treatment selection in individual patients, and provides essential context for safety evaluation of novel therapies during periods before long-term safety data become available. pubtype: Academic Journal doctype: meta analysis research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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