26rhk195 10.3205/26rhk195 urn:nbn:de:0183-26rhk1958 Meeting Abstract Witte Witte Torsten T

Hannover Medical School, Department of Rheumatology and Immunology, Hannover, Deutschland

author Kiltz Kiltz Uta U

Rheumazentrum Ruhrgebiet, Herne, Deutschland Ruhr-Universität Bochum, Bochum, Deutschland

author Riechers Riechers Elke E

Hannover Medical School, Department of Rheumatology and Immunology, Hannover, Deutschland

author Adolf Adolf Daniela D

StatConsult GmbH, Biometry and Data Management, Magdeburg, Deutschland

author Prothmann Prothmann Ulrich U

Knappschaftsklinikum Saar, Püttlingen, Deutschland

author Rössler Rössler Alexander A

AbbVie Germany GmbH & Co. KG, Wiesbaden, Deutschland

author Goetz Goetz Konrad K

AbbVie Germany GmbH & Co. KG, Wiesbaden, Deutschland

author Krüger Krüger Klaus K

Praxiszentrum St. Bonifatius, München, 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 195 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 Rheumatoide Arthritis Leipzig 20260909 20260912 RA.10 TextIntroduction: The SELECT clinical trial program demonstrated upadacitinib to be an effective treatment for RA with an acceptable safety profile , , , , , .Methods: UPwArds was a post-marketing observational study of adults with RA who had an inadequate response to at least one csDMARD. The Rheumatoid Arthritis Impact of Disease (RAID) questionnaire was used to measure the disease impact reported by patients. A RAID score ≤ 3 was determined as a patient acceptable symptom state (PASS) whereas a relative improvement of 50% was defined as minimal clinically important difference (MCID) . Two stepwise logistic regression analyses were performed to evaluate the potential association of age, disease duration, pre-treatment with b/tsDMARDs, RF/ACPA status, pain, fatigue and emotional well-being with RAID-PASS as well as with RAID-MCID at 6-month follow-up. The relation of the RAID to the CDAI was investigated by Spearman correlational analysis and receiver operating characteristic (ROC) curve modelling.Results: 516 patients were assessed in this post-hoc analysis. RAID scores improved remarkably, showing a continued symptom amelioration (Figure 1a ). A similar pattern of results was found for the total score and the symptom domains of pain, functional disability and fatigue (Figure 1b ). A comparison of the baseline findings with the 12-month results revealed improved mean values across all RAID domains (Figure 1c ). An MCID was achieved by 40.2% of patients after 12 months, while a RAID-PASS was achieved by 47.2%. RAID-PASS as well as RAID-MCID were significantly associated with positive RF/ACPA status, pre-treatment with b/tsDMARDs and emotional well-being. Additionally, pain was significantly related to RAID-PASS. Correlational analysis of the total RAID score and CDAI after six months revealed a positive correlation with a large effect size (rS = 0.60). A corresponding ROC curve showed that an area under the curve of 0.80 could be achieved when predictingCDAI-remission from the total RAID score at the same time point (Figure 2a ). Safety data for UPA during UPwArds have been previously reported .Conclusion: Patient-reported impact of RA on daily life decreased noticeably during the first 12 months after initiation of upadacitinib treatment. More than 40% of patients achieved MCID-/PASS-criteria by the end of the study.Disclosures: Torsten Witte Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Chugai, Gilead, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Roche, and UCB., Uta Kiltz Consultant of: AbbVie, Alfasigma, Eli Lilly and Company, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GBA, GSK, Hexal, Novartis, Pfizer and UCB, Elke Riechers Consultant of: AbbVie, Chugai, Janssen, Medac, Novartis, and UCB, Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Medac, Novartis, Pfizer, Roche, and UCB, Ulrich Prothmann Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Glaxo Smith Kline, Novartis, Pfizer, Roche, Sanofi, SOBI, and UCB, Daniela Adolf Employee of StatConsult and may own stock or options, Konrad Götz Employee of AbbVie and may own stock or options, Alexander Rössler Employee of AbbVie and may own stock or options, Klaus Krüger Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Gilead, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, and UCB.AbbVie funded this study, contributed to its design, participated in data collection, analysis and interpretation of data, and in writing, review, and approval of the abstract. AbbVie and the authors thank all study investigators for their contributions and all patients that participated in this study. No honoraria or payments were made for authorship. Medical writing support was provided by Dr. Matthias Englbrecht and was funded by AbbVie. Statistical analyses were provided by StatConsult, which was funded by AbbVie. Smolen JS Pangan AL Emery P Rigby W Tanaka Y Vargas JI Zhang Y Damjanov N Friedman A Othman AA Camp HS Cohen S Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study 2019 Lancet 2303-2311 Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, Zhang Y, Damjanov N, Friedman A, Othman AA, Camp HS, Cohen S. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 Jun 8;393(10188):2303-2311. DOI: 10.1016/S0140-6736(19)30419-2 http://dx.doi.org/10.1016/S0140-6736(19)30419-2 Burmester GR Kremer JM Van den Bosch F Kivitz A Bessette L Li Y Zhou Y Othman AA Pangan AL Camp HS Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial 2018 Lancet 2503-2512 Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. DOI: 10.1016/S0140-6736(18)31115-2 http://dx.doi.org/10.1016/S0140-6736(18)31115-2 Genovese MC Fleischmann R Combe B Hall S Rubbert-Roth A Zhang Y Zhou Y Mohamed MF Meerwein S Pangan AL Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial 2018 Lancet 2513-2524 Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. 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1 1 Figure 1: a-c) Total RAID score and individual symptom domain improvements

2 2 Figure 2: ROC curve modelling CDAI-remission by RAID total score at 6 months follow-up

2 0 0