ASSOCIATION OF EARLY REMISSION ON CLINICAL AND PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS: POST-HOC ANALYSIS OF DATA FROM THE SELECT-COMPARE STUDY

Background: Rheumatoid arthritis (RA) has a negative impact on daily activities and is associated with high disease burden and impaired quality of life (QoL). Over time, the treatment target for RA has changed from symptomatic relief to clinical remission. Currently, there is evidence indicating that early remission is associated with clinical and functional benefits in early RA patients using csDMARDs; [1] however, the association between early attainment of remission after addition of targeted therapy to csDMARD and any clinical, functional, or QoL benefits in patients with RA remains unclear. Objectives: This study assessed the association of early remission (defined as DAS28-CRP <2.6 at week 12 following UPA or ADA initiation) with outcomes such as pain, physical function, fatigue, and QoL in patients with RA with inadequate response to methotrexate (MTX) who were treated with upadacitinib (UPA) or adalimumab (ADA). Methods: This post-hoc analysis used data collected from SELECT-COMPARE (NCT02629159), a phase 3 randomized clinical trial evaluating UPA vs ADA or placebo in patients with moderately to severely active RA who were on stable background MTX. Patients randomized to UPA or ADA were pooled for these analyses and patients on placebo were excluded. Mean change from baseline and the proportion of patients who reached minimum clinical important differences (MCID) and normative cut-off scores were evaluated for the following outcomes: pain on visual analog scale (VAS), physical function (measured using Health Assessment Questionnaire – Disability Index [HAQ-DI]), QoL (Short form–36 Physical and Mental Component Summary scores [SF-36 PCS and MCS]), fatigue (measured using Functional Assessment of Chronic illnesses Therapy-Fatigue [FACIT-Fatigue]), Patient’s Global Assessment (PtGA), Physician’s Global Assessment (PhGA), and swollen and tender joint counts. Outcomes for patients who achieved early remission vs those who did not were compared at weeks 26, 48 (~1 yr), 156 (3 yr) and 252 (~5 yr). Differences in mean change from baseline and adjusted odds ratios (aOR) were compared between groups using multivariable linear/logistic regression adjusting for baseline characteristics. Results: Of 885 patients, 28% (247/885) reached early remission at week 12. Significantly greater improvements from baseline were observed for all outcomes at week 26 in patients who achieved early remission compared with those who did not after linear/logistic regression adjustment for baseline characteristics (Table 1). Early remission was associated with significantly greater odds (aOR range: 2.9–5.1) of achieving meaningful improvements in HAQ-DI, fatigue, pain, PtGA, and physical QoL (SF-36 PCS) for at least 48 weeks (Figure 1). Patients in early remission also had significantly greater odds (2.4–3.5) of achieving meaningful improvements in HAQ-DI, pain and PtGA for a minimum of 252 weeks. There were no significant differences between patients who achieved early remission vs those who did not for improvement in mental QoL (SF-36 MCS). Regarding normative values, a higher percentage of patients who achieved early remission vs those who did not had scores comparable to the general population for physical and mental QoL, HAQ-DI, and fatigue for a minimum of 48 weeks; more patients in the early remission group had zero swollen and tender joint counts for up to 252 weeks. A reduction in the mean change difference between groups and odds ratios was observed over time, possibly because some patients in the non-remission group at week 12 achieved remission at later time points. Conclusion: This post-hoc analysis demonstrated that patients with moderately to severely active RA and an inadequate response to MTX, who were treated with either UPA or ADA and achieved early remission, had less subsequent pain, and fatigue, as well as better physical function and physical QoL for at least 1 year vs patients who did not reach early remission. Thus, achieving remission early was associated with better health outcomes in patients with RA using targeted therapies. REFERENCES: [1] ten Klooster PM, et al. Clin Rheum. 2019;38:2727–36. Acknowledgements: AbbVie funded this study and participated in the study design; study research; collection, analysis, and interpretation of data; and writing, reviewing, and approving of this publication. All authors had access to the data and participated in the development, review, and approval, and in the decision to submit this publication. No honoraria or payments were made for authorship. Medical writing services provided by Joann Hettasch, PhD, of Fishawack Facilitate Ltd, part of Avalere Health, and funded by AbbVie. Disclosure of Interests: Laure Gossec AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, AbbVie, Biogen, Lilly, Novartis, UCB, Jayesh Patel AbbVie, AbbVie, Aditi Kadakia AbbVie, AbbVie, Siran Fang AbbVie, AbbVie, Yi Peng AbbVie, AbbVie, Sander Strengholt AbbVie, AbbVie, Peter C. Taylor Data Safety Monitoring Board/Advisory Board for Immunovant, Sanofi and Kymab, Abbvie, Biogen, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Nordic Pharma, Pfizer, UCB, Acelyrin Inc., Galapagos to University of Oxford, Andrew Östör served on Advisory boards for AbbVie, Janssen, Lilly, Novartis, Pfizer & GSK, AbbVie, Janssen, Lilly, Novartis, Pfizer & GSK, undertaken clinical trials for AbbVie, Janssen, Lilly, Novartis, Pfizer & GSK. DOI: 10.1136/annrheumdis-2024-eular.1469 Keywords: Clinical Trial, Biological DMARD, Remission, Outcome measures, Quality of life Citation: , volume 83, supplement 1, year 2024, page 776Session: Rheumatoid arthritis (Poster View)

Clinical Trial, Biological DMARD, Remission, Outcome measures, Quality of life