POS0435 CHARACTERISTICS AND 6-MONTH OUTCOMES AMONG REAL-WORLD PATIENTS WITH RHEUMATOID ARTHRITIS INITIATING UPADACITINIB: ANALYSIS FROM THE CORRONA REGISTRY

Abstract

Background:Upadacitinib (UPA) has demonstrated efficacy in randomized controlled trials1-3; 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<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 >=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.