26rhk074 10.3205/26rhk074 urn:nbn:de:0183-26rhk0748 Meeting Abstract Buttgereit Buttgereit Frank F

Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Corporate Member of Freie Universität Berlin and Humboldt Universität zu Berlin, and Deutsches Rheumaforschungszentrum, Berlin, Deutschland

author Witte Witte Julian J

Vandage GmbH, Bielefeld, Deutschland

author Brehler Brehler Randolf R

University Clinik Münster, Department of Dermatology, Münster, Deutschland

author Lenzen Lenzen Henrike H

Municipal Hospital Braunschweig, Department of Gastroenterology, Hepatology, Interventional Endoscopy & Diabetology, Braunschweig, Deutschland

author Terkamp Terkamp Christoph C

Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover, Deutschland

author Loth Loth Andreas A

University Clinic Frankfurt, Department of Otorhinolaryngology, Frankfurt am Main, Deutschland

author Surmann Surmann Bastian B

Vandage GmbH, Bielefeld, Deutschland

author Batram Batram Manuel M

Vandage GmbH, Bielefeld, Deutschland

author Gladbach Gladbach Tobias T

GlaxoSmithKline GmbH & Co. KG (GSK), München, Deutschland

author Özkul Özkul Dogukan D

GlaxoSmithKline GmbH & Co. KG (GSK), München, Deutschland

author Schröter Schröter Friederike F

GlaxoSmithKline GmbH & Co. KG (GSK), München, Deutschland

author Metz Metz Martin M

Charité – Universitätsmedizin Berlin, Institute of Allergology, Berlin, Deutschland

author Trinkmann Trinkmann Frederik F

University of Heidelberg, Thoraxklinik, Department of Pneumology and Critical Care Medicine, Translational Lung Research Center Heidelberg (TLRC), German Center for Lung Research (DZL), Heidelberg, Deutschland

author Laudien Laudien Martin M

University Clinic Kiel, University Medical Centre Schleswig-Holstein, Department of Otorhinolaryngology, Head and Neck Surgery, Kiel, Deutschland

author Müller-Diesing Müller-Diesing Flurin F

University Hospital Würzburg, Department of Otorhinolaryngology, Head and Neck Surgery, Würzburg, Deutschland

author Kötter Kötter Ina I

Auenlandklinik Bad Bramstedt/University Medical Center Hamburg-Eppendorf, Clinic for Rheumatology and Immunology/Division of Rheumatology and Systemic Inflammatory Diseases, Bad Bramstedt, Deutschland

author Schneider Schneider Udo U

Immanuel Krankenhaus Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Deutschland

author Dreher Dreher Michael M

University Clinic RWTH Aachen, Klinik für Pneumologie und Internistische Intensivmedizin (Medizinische Klinik V), Aachen, Deutschland

author German Medical Science GMS Publishing House

Düsseldorf

610 20260909 engl This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). M0656 074 Deutsche Gesellschaft für Rheumatologie Deutsche Gesellschaft für Orthopädische Rheumatologie Gesellschaft für Kinder- und Jugendrheumatologie 54. Kongress der Deutschen Gesellschaft für Rheumatologie und Klinische Immunologie (DGRh), 36. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR), 40. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh) Deutscher Rheumatologiekongress 2026 Epidemiologie & Versorgungsforschung Leipzig 20260909 20260912 EV.26 GSK TextIntroduction: Systemic glucocorticoids (GCs) remain integral to rheumatoid arthritis (RA) management; however, their long-term safety thresholds remain controversial. Clinically meaningful toxicity is generally assumed at doses exceeding 5 mg/day (prednisone equivalent), whereas the safety profile of very low-dose exposure remains uncertain. Moreover, the combined influence of dose intensity and treatment duration on adverse event (AE) risk has not been comprehensively quantified. We therefore examined dose–response relationships and temporal exposure dynamics of GC-associated AEs in RA using nationwide real-world data.Methods: German statutory health insurance claims data (2007–2022) were analyzed. Adults with confirmed RA initiating systemic GCs were matched 1:1 to GC-free controls based on age, sex, comorbidity burden, region, and index quarter. Incident AEs comprised cardiovascular, metabolic, infectious, neuropsychiatric, and musculoskeletal outcomes. Incidence rate ratios (IRRs) were estimated across predefined average daily dose strata using Poisson regression. To disentangle dose–time interactions, piecewise exponential additive mixed models (PAMMs) jointly modeled mean daily dose and time since initiation, enabling classification of exposure–response patterns as dose-driven, time-driven, or balanced.Results: Among 47,693 RA patients, 8,011 initiated systemic GCs; 5,531 were matched to controls. Composite AE risk increased progressively at doses >5 mg/day, with marked escalation at ≥7.5 mg/day. Cardiovascular events rose from an IRR of 1.83 at 5–<7.5 mg/day to 6.88 at ≥7.5 mg/day. Acute mental disorders increased from 0.95 at 2.5–<5 mg/day to 6.80 at ≥7.5 mg/day. In contrast, very low-dose exposure (>0–<2.5 mg/day) was associated with a lower composite AE incidence compared with controls (IRR 0.59 [0.54–0.63]). Within the 2.5–<5 mg/day range, risks were largely neutral during shorter treatment durations. PAMM analyses indicated pneumonia risk as predominantly dose-driven, whereas cardiovascular and psychiatric outcomes demonstrated balanced dose–time dynamics.Conclusion: In RA, GC-associated harm is strongly dose-dependent, with substantial risk escalation beyond 5 mg/day. Very low-dose exposure (≤2.5 mg/day) was not associated with measurable excess risk and was linked to lower composite AE incidence, suggesting a favorable net clinical balance between inflammation control and GC-related toxicity. These findings support minimizing cumulative exposure and avoiding higher-dose regimens while recognizing distinct safety profiles at very low doses.Disclosures: The study was funded by GSK (ID 222292) and is registered as clinical trial (ID: NCT06488703). 0 0 0 0