AB0255 BASELINE CHARACTERISTICS OF PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH UPADACITINIB IN GERMAN REAL-WORLD PRACTICE: RESULTS FROM THE POST-MARKETING OBSERVATIONAL UPwArds STUDY
Authors: T. Witte, U. Kiltz, F. Haas, E. Riechers, U. Prothmann, D. Adolf, C. Holland, R. Hecht, A. Roessler, K. Famulla, K. Krueger
Journal: Annals of the Rheumatic Diseases (2021)

Background: The efficacy and safety of upadacitinib (UPA), a selective Janus kinase inhibitor, has been evaluated in the SELECT rheumatoid arthritis (RA) clinical program, 1–6 but its real-world effectiveness remains to be investigated. The UPwArds study will assess the association of C-reactive protein (CRP) level with remission and other efficacy outcomes in patients with RA treated with UPA in German real-world practice. Objectives: To describe the baseline characteristics of patients enrolled in the UPwArds study. Methods: The prospective, open-label, multicenter, non-interventional, post-marketing UPwArds study included adult patients with moderate-to-severe RA (swollen joint count [SJC28] ≥3 and inadequate response or intolerance to ≥1 disease-modifying antirheumatic drug [DMARD]). Patients were treated with UPA 15 mg once daily, as monotherapy or in combination with methotrexate (MTX; 50:50 mono:combo enrollment planned), according to the German label. Variables assessed included medical history (disease duration, previous RA therapy, and vaccination status), CRP level, and disease activity (disease activity score [DAS28(CRP)], tender joint count [TJC28], and SJC28). There was no recruitment restriction regarding CRP level. This descriptive interim analysis reports patient baseline characteristics after enrollment was complete. All data were analyzed as observed, with no imputation of missing data. Results: 533 patients (UPA monotherapy: 257 [48%]; UPA plus MTX: 276 [52%]) were included. Mean patient age was 58 years; mean disease duration was 9 years (Table 1). Despite having active RA, almost half the population (44%; n=237) did not have elevated CRP at the start of UPA treatment. Mean DAS28(CRP) was 4.6; mean TJC28 and SJC28 were 7.7 and 5.6, respectively. Overall, 39% of patients had not been treated with any biologic (b) DMARD or targeted synthetic (ts) DMARD before enrollment; 25% and 36% had previously been treated with 1 or ≥2 bDMARDs or tsDMARDs, respectively (Figure 1). 8.7% of patients had previously received a herpes zoster vaccination (8.1% Shingrix; 0.6% Zostavax). Conclusion: In German clinical practice, the population of patients with RA in the UPwArds study was predominantly treatment-refractory. Half of these patients had no elevated CRP despite active disease; future analyses will assess the impact of CRP on efficacy outcomes. References: [1]Smolen JS, et al. Lancet 2019;393:2303–11; [2]Burmester GR, et al. Lancet 2018;391:2503–12; [3]Genovese MC, et al. Lancet 2018;391:2513–24; [4]van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20; [5]Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800; [6]Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21. Table 1. Baseline characteristics Age, years UPA UPA + MTX Total 57.7 (13.2) n=257 58.1 (11.4) n=276 57.9 (12.3) n=533 Disease duration, years 9.4 (8.3) 8.5 (7.7) 9.0 (8.0) n=253 n=272 n=525 CRP, mg/dL 1.3 (1.9) 1.1 (1.7) 1.2 (1.8) n=257 n=276 n=533 CRP &gt;ULN, n (%) 137 (53.3) 159 (57.6) 296 (55.5) n=257 n=276 n=533 TJC28 7.4 (6.0) 7.9 (6.4) 7.7 (6.2) n=257 n=276 n=533 SJC28 5.5 (3.7) 5.6 (4.1) 5.6 (3.9) n=257 n=276 n=533 Patient’s Global Assessment 6.2 (1.9) 6.3 (1.8) 6.3 (1.8) n=257 n=276 n=533 Physician’s Global Assessment 5.8 (1.5) 5.9 (1.6) 5.9 (1.6) n=257 n=276 n=533 DAS28(CRP) 4.6 (1.0) 4.6 (1.0) 4.6 (1.0) n=257 n=276 n=533 DAS28(ESR) 4.8 (1.1) 4.9 (1.2) 4.9 (1.1) n=224 n=239 n=463 CDAI 24.9 (10.2) 25.7 (10.8) 25.4 (10.5) n=257 n=276 n=533 SDAI 26.2 (10.5) 26.9 (11.3) 26.6 (10.9) n=257 n=276 n=533 RAID 5.7 (2.0) 5.7 (2.0) 5.7 (2.0) n=255 n=275 n=530 Pain (RAID-1) 6.2 (2.2) 6.1 (2.3) 6.2 (2.2) n=255 n=275 n=530 SF-12 Physical Component Summary 32.6 (8.5) 33.9 (8.6) 33.3 (8.6) n=245 n=262 n=507 SF-12 Mental Component Summary 42.4 (11.6) 42.6 (11.3) 42.5 (11.5) n=245 n=262 n=507 HAQ-DI 1.3 (0.7) 1.3 (0.6) 1.3 (0.6) n=250 n=270 n=520 PHQ-9 8.9 (5.3) 8.6 (5.3) 8.7 (5.3) n=252 n=272 n=524 Erosions, n (%) 87 (33.9) 95 (34.4) 182 (34.1) n=257 n=276 n=533 Data are mean (SD), n unless otherwise stated Acknowledgements: AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and in the writing, review, and approval of the abstract. AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study. No honoraria or payments were made for authorship. Medical writing support was provided by Grant Thomas Kirkpatrick, MSc, of 2 the Nth (Cheshire, UK), and was funded by AbbVie. Disclosure of Interests: 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, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer, Florian Haas Consultant of: AbbVie, Celgene, Novartis, and Pfizer, Grant/research support from: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, Roche, and Sanofi Genzyme, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, and UCB, Grant/research support from: AbbVie, Chugai, Lilly, Janssen, 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: Employee of StatConsult and may own stock or options, Carsten Holland Employee of: Employee of AbbVie and may own stock or options, Rouven Hecht Employee of: Employee of AbbVie and may own stock or options, Alexander Roessler Employee of: Employee of AbbVie and may own stock or options, Kirsten Famulla Employee of: Employee of AbbVie and may own stock or options, Klaus Krueger Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Gilead, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, and UCB.