POS0435 CHARACTERISTICS AND 6-MONTH OUTCOMES AMONG REAL-WORLD PATIENTS WITH RHEUMATOID ARTHRITIS INITIATING UPADACITINIB: ANALYSIS FROM THE CORRONA REGISTRY
Authors: J. M. Kremer, N. Tundia, R. McLean, T. Blachley, A. Maniccia, D. A. Pappas
Journal: Annals of the Rheumatic Diseases (2021)

Background: Upadacitinib (UPA) has demonstrated efficacy in randomized controlled trials 1-3 ; however, few data are available from patients with rheumatoid arthritis (RA) who have been treated with UPA in real-world clinical practice. Objectives: Describe the characteristics and 6-month outcomes in patients with RA initiating UPA in a real-world setting. Methods: We identified adults with RA enrolled in the Corrona RA Registry through October 31, 2020 who initiated UPA during or after August 2019 and had a follow-up visit 6 (±3) months after initiation of UPA. Descriptive statistics were used to summarize characteristics in all patients initiating UPA who had a 6-month follow-up visit. Outcomes (CDAI, modified HAQ-DI, pain, and fatigue) were described at the 6-month visit for all UPA initiators regardless of UPA use at 6 months and for the subset of patients who continued UPA through the 6-month visit. Patients who discontinued UPA before the 6-month visit were considered non-responders for dichotomous variables and were assigned the value at the time of discontinuation for continuous variables. Mean change from baseline in continuous variables was analyzed with one-sample t tests or one-sample Wilcoxon rank sum tests. Minimum clinically important difference (MCID) in HAQ-DI is defined as an improvement of 0.22 units or more. MCID in CDAI is an improvement of at least 2, 7, and 13 units for patients in low, moderate and severe disease at initiation, respectively. MCID for 100-point VAS is an improvement of ≥10 points. Percentages of patients achieving MCID thresholds were calculated. Results: We identified 181 patients who initiated UPA and had a 6-month follow-up visit. Mean±SD age was 58.6±12.1 years, 81% were female. Patients had RA for a mean of 11.5±9.8 years. At UPA initiation, 45% of patients were on monotherapy. Prior use of one or more TNFi and JAKi was 79% and 52%, respectively. Seventy-two percent of patients (n=130) initiated UPA as the third or higher line of therapy. Mean CDAI was 18.7±11.6 and mean HAQ-DI was 1.1±0.8 at initiation. Based on CDAI (n=155), 29%, 52%, and 15% of patients had high, moderate, and low disease activity, respectively; 4.5% were in remission at initiation. At 6 months (n=158), 22%, 39%, and 28% had high, moderate, and low disease activity, respectively; 11% were in remission. Among 138 initiators with valid CDAI measures at initiation and 6 months, mean change in CDAI was –4.8±11.8, P &lt;0.01. At 6 months, 46% (63/138) maintained and 39% (54/138) achieved improvement in any CDAI category. Improvements in other outcomes were significantly different from zero. Improvements &gt;=MCID in CDAI, HAQ-DI, pain, and fatigue were achieved in 36–44% of UPA initiators. Improvements were similar, but larger in the subset of patients (n=122) who continued UPA through the 6-month visit (Table 1). Conclusion: Among patients in the Corrona RA Registry, UPA is frequently started in those who failed multiple previous therapies. UPA initiators responded to therapy in the first 6 months with improvements in several disease activity measures including CDAI and HAQ-DI, as well as patient-reported pain and fatigue. References: [1]Fleischmann R. Arthritis Rheumatol . 2019;71:1788–800. [2]Smolen JS. Lancet . 2019;393:2303–11. [3]Burmester GR. Lancet. 2018;382:2505–12. Outcomes at 6-month follow-up All initiators (n=181 ) Subset remaining on UPA (n=122 ) n Value a n Value a Remission (CDAI &lt;2.8) 158 18 (11) 105 12 (11) Low (CDAI &gt;=2.8 and &lt;10) 158 44 (28) 105 38 (36) Moderate (CDAI &gt;=10 and &lt;22) 158 62 (39) 105 36 (34) High (CDAI &gt;=22) 158 34 (22) 105 19 (18) Improvement in any CDAI category 138 54 (39) 89 40 (45) Maintenance of CDAI category 138 63 (46) 105 39 (44) Mean change in CDAI 138 –4.8±11.8* 89 –7.1±12.0* HAQ-DI 154 –0.1±0.5* 101 –0.2±0.5* Pain 154 –9.3±25.1* 101 –13.5±25.8* Fatigue 153 –7.6±27.3* 100 –12.5±27.5* MCID achievement in CDAI 138 57 (41) 89 43 (48) HAQ-DI 154 55 (36) 101 39 (39) Pain 154 68 (44) 101 53 (52) Fatigue 153 65 (42) 100 49 (49) a Mean±SD or n (%). * P &lt;0.01 for improvement significantly different from zero. Acknowledgements: This study was sponsored by Corrona, LLC. Corrona has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Crescendo, Eli Lilly and Company, Genentech, Gilead, GSK, Janssen, Merck, Momenta Pharmaceuticals, Novartis, Pfizer, Regeneron, Roche, Sun, UCB, and Valeant. The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing services were provided by Joann Hettasch of Fishawack Facilitate Ltd., part of Fishawack Health, and funded by AbbVie. Disclosure of Interests: Joel M Kremer Shareholder of: Corrona, Consultant of: AbbVie, Grant/research support from: AbbVie, Employee of: Corrona, Namita Tundia Shareholder of: AbbVie, Employee of: AbbVie, Robert McLean Employee of: Corrona, Taylor Blachley Employee of: Corrona, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Dimitrios A Pappas Shareholder of: Corrona, Consultant of: AbbVie, Genentech, Novartis, Regeneron, and Roche Hellas, Employee of: Corrona