POS0666 TREATMENT EFFECTIVENESS OF UPADACITINIB AT 3 MONTHS IN US PATIENTS WITH RHEUMATOID ARTHRITIS FROM THE UNITED RHEUMATOLOGY NORMALIZED INTEGRATED COMMUNITY EVIDENCE (NICE[TM]) REAL-WORLD DATA
Authors: A. Gibofsky, B. Dhillon, M. E. Pearson, N. Tundia, Y. Song, K. Dunlap, G. Wright
Journal: Annals of the Rheumatic Diseases (2021)

Background: Upadacitinib (UPA), an oral Janus kinase inhibitor (JAKi), has demonstrated efficacy in the phase 3 SELECT clinical program, conducted across a range of patients (pts) with rheumatoid arthritis (RA). 1–6 Real-world data for UPA, including in pts previously treated with a JAKi, have not yet been reported since global approvals beginning in 2019. Objectives: To assess the characteristics of US-based pts receiving UPA and its effectiveness in clinical practice at 3 months. Methods: This observational study included US-based pts from the United Rheumatology Normalized Integrated Community Evidence (UR-NICE) database who initiated UPA 15 mg once daily from FDA approval (August 2019) to July 31, 2020 and had ≥6-month pre-baseline data available. Effectiveness was assessed in pts with a reported Clinical Disease Activity Index (CDAI) score at 3 months after UPA initiation and included proportions of pts achieving CDAI remission (≤2.8), CDAI low disease activity (≤10), other disease activity measures, and pt-reported outcomes. A subgroup analysis assessed UPA effectiveness in pts with or without prior tofacitinib (TOFA) treatment. Results: This analysis included 252 pts treated with UPA 15 mg, of whom 98 (38.9%) received UPA monotherapy and 154 (61.1%) received UPA combined with conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs). 64.3% of pts were from the Southern region of the USA. 86.1%, 72.2%, and 47.6% of pts had been previously treated with csDMARDs, biologic DMARDs, and JAKis, respectively. Baseline characteristics were largely similar between UPA monotherapy and combination therapy groups and those with or without prior TOFA treatment (Table 1). Pts with prior TOFA treatment had a longer duration of RA since diagnosis and higher steroid use versus those without. UPA 15 mg improved disease activity scores (including CDAI) and pt-reported outcomes (including physical function and pain) after 3 months of treatment (Figure 1). Similar effectiveness was observed with UPA 15 mg in pts with or without prior TOFA treatment. Conclusion: In the UR-NICE real-world database of US-based pts, improvements in clinical and pt-reported outcomes were observed at 3 months in UPA-treated pts with RA, including those with or without prior TOFA treatment, despite the treatment-refractory population included in this dataset. References: [1]Burmester GR, et al. Lancet 2018;391:2503–12. [2]Smolen JS, et al. Lancet 2019;393:2303–11. [3]Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800. [4]Genovese MC, et al. Lancet 2018;391:2513–24. [5]van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20. [6]Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21. Table 1. Baseline characteristics n (%), unless otherwise stated Full analysis set (n=252 ) Pts with prior TOFA treatment (n=113 ) Pts without prior TOFA treatment (n=139 ) Mean (SD) exposure, days 219.7 (112.1) 215.7 (116.7) 222.9 (108.5) Female 199 (79.0) 85 (75.2) 114 (82.0) Age ≥65 years 75 (29.8) 34 (30.1) 41 (29.5) Oral steroid use 140 (55.6) 70 (61.9) 70 (50.4) Prior csDMARDs 217 (86.1) 102 (90.3) 115 (82.7) Prior TOFA 113 (44.8) 113 (100.0) 0 Prior biologic DMARDs 182 (72.2) 86 (76.1) 96 (69.1) Tumor necrosis factor inhibitor 147 (58.3) 66 (58.4) 81 (58.3) Interleukin-6 receptor inhibitor 87 (34.5) 47 (41.6) 40 (28.8) n Mean (SD ) n Mean (SD ) n Mean (SD ) Duration of RA diagnosis, years 188 4.0 (3.0) 89 5.1 (2.9) 99 3.1 (2.8) Methotrexate dose, mg/week 88 17.0 (5.1) 28 17.8 (5.0) 60 16.6 (5.2) SJC28 239 4.8 (5.7) 108 4.5 (5.0) 131 5.0 (6.2) TJC28 237 6.5 (6.7) 107 6.5 (6.8) 130 6.5 (6.6) CDAI 225 20.4 (13.4) 105 20.2 (13.5) 120 20.6 (13.3) Routine assessment of patient index data 3 165 4.2 (2.3) 72 4.2 (2.4) 93 4.3 (2.2) Disease Activity Score in 28 joints based on C-reactive protein 167 3.9 (1.5) 83 3.9 (1.5) 84 3.9 (1.5) Health Assessment Questionnaire-Disability Index 170 2.5 (2.1) 74 2.4 (2.2) 96 2.5 (2.1) Pain (0–10) 229 56.5 (28.5) 104 56.9 (29.3) 125 56.1 (28.0) SD, standard deviation; S/TJC, swollen/tender joint count Acknowledgements: AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Hilary Wong, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie. Disclosure of Interests: Allan Gibofsky Shareholder of: AbbVie, Amgen, Johnson &amp; Johnson, and Pfizer, Consultant of: AbbVie, Celgene, Eli Lilly, Flexion, Pfizer, Relburn Pharma, and Samumed. Paid consultant with investment analysts on behalf of the Gerson Lehrman Group, Bhavna Dhillon Shareholder of: May own stock or options in United Rheumatology, Employee of: United Rheumatology, Mark E. Pearson Shareholder of: May own AbbVie stock or options, Namita Tundia Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Yanna Song Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Kendall Dunlap Shareholder of: May own stocks or shares in AbbVie, Employee of: AbbVie, Grace Wright Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Exagen, Myriad Autoimmune, Novartis, Sanofi/Regeneron, UCB, and Vindico, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Exagen, Gilead, Janssen, Myriad Autoimmune, Novartis, Pfizer, Sanofi/Regeneron, and UCB, Employee of: President and Founder of the Association of Women in Rheumatology