25rhk137 10.3205/25rhk137 urn:nbn:de:0183-25rhk1371 Meeting Abstract Feist Feist Eugen E

Helios Fachklinik Vogelsang-Gommern, Vogelsang-Gommern

author Bär Bär Sara S

MZ Ambulantes Rheumazentrum Erfurt, Erfurt

author Sieburg Sieburg Maren M

Rheumatologische Facharztpraxis, Magdeburg

author Detert Detert Jacqueline J

Rheumatologisch-Immunologische Arztpraxis Templin, Templin

author Resch-Passini Resch-Passini Johannes J

Rheuma-Zentrum Wien-Oberlaa, Vienna

author Prillwitz Prillwitz Heino H

Rheumatologisches Versorgungszentrum Weinfelden, Weinfelden

author Wiesemann Wiesemann Katharina K

AbbVie, Wiesbaden

author Gnuechtel Gnuechtel Sixten S

AbbVie, Wiesbaden

author Roulin Roulin Pascal P

AbbVie, Cham

author Rueben Rueben Alexandra A

AbbVie, Vienna

author Rubbert-Roth Rubbert-Roth Andrea A

Kantonsspital St.Gallen, St. Gallen

author German Medical Science GMS Publishing House

Düsseldorf

610 20250917 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). M0627 137 Deutsche Gesellschaft für Rheumatologie Deutsche Gesellschaft für Orthopädische Rheumatologie 53. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 39. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh) Deutscher Rheumatologiekongress 2025 Rheumatoide Arthritis Wiesbaden 20250917 20250920 RA.11 TextIntroduction: Upadacitinib (UPA), an oral reversible JAK inhibitor, has shown efficacy with an acceptable safety profile in patients with RA in the SELECT clinical trials . However, real-world (RW) data on long-term effectiveness and safety of UPA are limited. This sub-analysis of the UPHOLD study aims to evaluate long-term effectiveness and safety of UPA over 2 years in patients with RA in RW practice from Germany, Austria and Switzerland.Methods: UPHOLD (NCT04497597) is an international, observational cohort study of adults (≥ 18 years old) with moderate-to-severe RA in whom the treating physician decided to initiate treatment with UPA 15 mg once daily prior to study enrolment. Effectiveness endpoints included proportion of patients in each DAS28-CRP/SDAI/CDAI disease category by visit, proportion of patients maintaining DAS28-CRP remission/LDA by treatment strategy and prior therapy exposure, and change from baseline in patient-reported outcomes (PROs). All treatment-emergent adverse events (TEAEs) and selected TEAEs of interest are reported as exposure-adjusted event rates (events per 100 patient-years [E/100PY]).Results: Of the 268 patients enrolled, 262 received ≥ 1 UPA dose and 144 completed the study at 2 years. The most common primary reasons for discontinuation were lack of efficacy (n = 44 [16.4%]) and adverse events (n = 29 [10.8%]). The as-observed proportions of patients achieving DAS28-CRP, SDAI and CDAI remission at 2 years were 68.3%, 38.8% and 37.7%, respectively (Figure 1 ). Responses were generally similar whether patients were treated with UPA as monotherapy or in combination, and across prior treatment subgroups. Improvements were observed in all assessed PROs at 3 months, which were maintained or further improved through 2 years. A total of 435 TEAEs, including 50 serious TEAEs, were reported by the investigators. Due to small sample size and limited exposure, safety data should be interpreted with caution; however, the safety profile was generally consistent with previous phase 3 long-term clinical trials (Table 1 ) .Conclusion: UPA was effective for the treatment of RA in RW practice, of which two thirds achieved sustained DAS28-CRP remission over 2 years. The benefit–risk profile of UPA in this RW setting appears consistent with that demonstrated in phase 3 clinical trials , . Conaghan PG Pavelka K Hsieh SC Bonnington TL Kent TC Marchbank K Edwards CJ Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials 2023 Rheumatol Adv Pract rkad017 Conaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. DOI: 10.1093/rap/rkad017 http://dx.doi.org/10.1093/rap/rkad017 Burmester GR Cohen SB Winthrop KL Nash P Irvine AD Deodhar A Mysler E Tanaka Y Liu J Lacerda AP Palac H Shaw T Mease PJ Guttman-Yassky E Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis 2023 RMD Open e002735 Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. DOI: 10.1136/rmdopen-2022-002735 http://dx.doi.org/10.1136/rmdopen-2022-002735 11

Table 1: Summary of Safety

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1 1 Figure 1: Proportions of Patients with RA Achieving Remission Through 24 Months (AO)

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