POS0684 IS UPADACITINIB CAPABLE OF IMPROVING PATIENT-REPORTED OUTCOMES OF RHEUMATOID ARTHRITIS IN A REAL-WORLD SETTING? RESULTS FROM THE POST-MARKETING OBSERVATIONAL UPwArds STUDY

Abstract

BackgroundThe efficacy of Upadacitinib (UPA), a selective Janus kinase inhibitor, has been evaluated in the SELECT clinical program 1-6. In addition, recent results from the non-interventional UPwArds study further confirmed UPAs clinical effectiveness regarding standard disease activity scores for rheumatoid arthritis (RA) in a real-world setting 7. However, patient-reported outcomes (PROs) as another cornerstone of clinical decision making yet remain to be addressed in the context of a post-marketing setting. This interim analysis, conducted after 250 patients had completed the 6-month follow-up visit, aims to fill this gap.ObjectivesTo evaluate the change of selected PROs over 6 months in patients treated with UPA in a real-world data environment.MethodsUPwArds is a prospective, open-label, multicenter, non-interventional, post-marketing study including adult patients with moderate-to-severe RA (swollen joint count [SJC28] ≥ 3 and inadequate response or intolerance to at least one previous disease-modifying antirheumatic drug). According to the German label, patients were treated with UPA 15 mg once daily, as monotherapy or in combination with methotrexate. For this analysis, the following PROs were included: 0-10 numerical rating scales (NRS) for pain and fatigue, the Health Assessment Questionnaire Disability Index (HAQ-DI), the duration and severity of morning stiffness, the Patient Health Questionnaire 9 (PHQ-9), and the Rheumatoid Arthritis Impact of Disease Questionnaire (RAID). Changes from baseline were evaluated for follow-up periods of 1 month, 3 months, and 6 months. Results are presented for the total sample using descriptive measures reflecting sample size (N), average values (standard deviation) for each assessment and average change scores (standard deviation) for follow-up visits. All data were analyzed as observed, with no imputation of missing data.Results483 patients (369 female, 114 male) were included in the study, with available baseline PRO information for 481 patients. 6-months follow-up data were yet available from 279 patients The baseline average age and disease duration were 58.0 (12.3) years and 9.0 (8.0) years, respectively, whereas the mean initial DAS28-CRP was 4.6 (1.0). At baseline, 60.8% of enrolled patients had previously been treated with biologic or targeted synthetic disease-modifying antirheumatic drugs. Overall, PRO scores improved from baseline throughout month 6 with a considerable amelioration at month 3, which was maintained at month 6. Responses were rapid, with improvement already evident at month 1 (Table 1). The NRS pain as a crucial PRO in RA confirmed the previously described pattern of results seen for most of the other PROs (Figure 1).Table 1.Baseline scores and average changes from baseline scoresNBaseline scores (SD)NChange from baseline - month 1 (SD)NChange from baseline - month 3 (SD)NChange from baseline - month 6(SD)Pain (NRS)4816.2 (2.2)393-2.2 (2.3)392-2.5 (2.5)258-2.4 (2.4)Fatigue (NRS)4815.5 (2.6)393-1.4 (2.3)393-1.6 (2.4)259-1.5 (2.3)HAQ-DI4711.3 (0.6)380-0.2 (0.3)376-0.2 (0.4)253-0.2 (0.4)Morning stiffness (duration, minutes)43968.9 (63.9)313-25.0 (55.3)296-29.6 (54.9)179-31.6 (51.7)Morning stiffness (severity)4785.2 (2.7)386-1.8 (2.3)393-2.2 (2.6)258-2.2 (2.9)PHQ-94778.7 (5.2)383-1.9 (3.9)381-2.3 (4.0)255-2.2 (3.8)RAID4815.6 (2.0)393-1.7 (1.8)392-2.0 (2.0)258-1.9 (1.9)ConclusionThis interim analysis confirmed a meaningful improvement regarding included PROs that cover various RA-related symptoms, depressiveness and the impact of symptoms of RA on daily life.