Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Treatment with upadacitinib (UPA) monotherapy, a selective Janus kinase-1 (JAK-1) inhibitor, resulted in significant and clinically meaningful improvements in patient-reported outcomes (PROs) at Week 12 or 14 in patients with RA with no prior use of MTX (MTX-naïve) and an inadequate response to MTX (MTX-IR).1,2 The current analysis evaluated the potential long-term benefits of UPA monotherapy on PROs in these patients.
Methods: SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are ongoing Phase 3, randomized controlled trials where MTX-naïve or MTX-IR patients (respectively) with active RA received UPA monotherapy (15 mg or 30 mg once daily [QD]) or weekly MTX. Here we report on PROs in SELECT-EARLY and SELECT-MONOTHERAPY patients who continued UPA for 24 or 26 weeks, respectively. PROs included: Patient Global Assessment of Disease Activity (PtGA), pain by visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; SELECT-EARLY only), and duration and severity of morning (AM) stiffness. Mean changes from baseline and 95% confidence intervals (CIs) were calculated for each PRO at Week 24/26. The percentages of patients who continued to report improvements ≥minimum clinically important differences (MCIDs) at Week 24/26 were calculated among those who reported clinically meaningful changes in a given PRO at Week 12/14 (SELECT-EARLY and SELECT-MONOTHERAPY, respectively).
Results: MTX-naïve patients reported improvements from baseline in all PROs at Week 24 (Table 1). Of MTX-naïve patients reporting improvements ≥MCIDs at Week 12, 83% to 90% treated with UPA 15 mg and 84% to 90% with UPA 30 mg maintained clinically meaningful responses ≥MCIDs at Week 24. MTX-IR patients also reported improvements from baseline across all PROs at Week 26 (Table 2). Of MTX-IR patients reporting improvements ≥MCIDs at Week 14, 84% to 90% treated with UPA 15 mg and 85% to 94% with UPA 30 mg maintained clinically meaningful responses ≥MCIDs at Week 26.
Conclusion: A substantial proportion of MTX-naïve and MTX-IR patients with active RA treated with UPA 15 mg or 30 mg QD monotherapy continued to report clinically meaningful improvements in disease activity, physical function, pain, fatigue, and AM stiffness through Week 24/26.
References: 1. Strand V, et al. Poster THU0192 presented at EULAR 2019; Madrid, Spain; 2. Strand V, et al. Arthritis Rheumatol. 2018;70(Suppl 10):abstract 2547.
Medical writing services provided by Emily Mercadante of JK Associates, Inc. (Fishawack Group) and funded by AbbVie.
To cite this abstract in AMA style:Strand V, Tundia N, Friedman A, Camp H, Suboticki J, Goldschmidt D, Fernan C, Bergman M. Impact of 24- or 26-Week Upadacitinib Monotherapy on Patient-Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis and No Prior Use of or an Inadequate Response to Methotrexate: Results from Two Phase 3 Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/impact-of-24-or-26-week-upadacitinib-monotherapy-on-patient-reported-outcomes-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis-and-no-prior-use-of-or-an-inadequate-response-to-meth/. Accessed July 8, 2020.
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