LAUSR

Background: Upadacitinib (UPA), a selective JAK-1 inhibitor, has demonstrated efficacy in active RA among patients with an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD-IR).1 To understand treatment effectiveness from the patients’ perspective we examined the impact of UPA on patient-reported outcomes (PROs). Objectives: To evaluate the effect of UPA vs placebo (PBO) on PROs in SELECT-NEXT (NCT02675426), a randomized controlled trial assessing the efficacy and safety of UPA in csDMARD-IR RA patients. Methods: Patients in SELECT-NEXT received UPA 15 mg or 30 mg daily or PBO for 12 weeks followed by a 5-year extension phase. PROs included physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]), Patient’s Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), pain by VAS, fatigue by FACIT-F, duration and severity of morning (AM) stiffness, quality of life (QoL) by Short Form 36 Health Survey [SF-36], and Work Instability Scale for RA (RA-WIS). Changes in least square means (LSMs) from baseline (BL) to week 12 were based on mixed effect repeated measures models. Percentages of patients reporting changes in PRO scores from BL to week 12 ≥minimum clinically important differences (MCIDs) or scores ≥normative values (age- and gender-matched for SF-36 only) were determined for UPA and PBO arms; comparisons between groups used chi-square tests. For each PRO, the incremental number needed to treat (NNT) to achieve clinically meaningful improvement from BL (≥MCID) was calculated. Results: Data from 661 patients (221 in UPA 15 mg; 219 in UPA 30 mg; 221 in PBO) were analysed. Mean age was 56 years, 79% were female; 45% had RA for ≥5 years. Statistically significant LSM changes from BL to week 12 were reported with both UPA doses vs PBO for HAQ-DI, PtGA, pain, FACIT–F, duration and severity of AM stiffness, SF-36 (PCS; 6 or 7/8 domains), and RA-WIS (Table). Compared with PBO at week 12, significantly more UPA-treated (both doses) patients reported improvement ≥MCID in HAQ-DI, PtGA, pain, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS; 4 or 7/8 domains), and RA-WIS as well as scores ≥normative values in HAQ-DI, PtGA, FACIT-F, SF-36 (PCS; 4 or 5/8 domains). For most PROs, NNTs with UPA ranged from 4 to 8 patients.Table 1 LSM changes from baseline and percentage of responders at week 12 after UPA initiation Conclusions: Treatment with UPA 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in physical function, pain, fatigue, AM stiffness, QoL, and less work instability among csDMARD-IR RA patients. The NNTs to achieve these improvements were favourable. Reference [1]Burmester, et al. Arthritis Rheumatol2017:69(suppl 10), abstract 1904. Acknowledgements: Financial support for the study was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Medical writing services were provided by Joann Hettasch of Fishawack Communications and funded by AbbVie. Disclosure of Interest: V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB, J. Pope Consultant for: AbbVie, Amgen, BMS, Celltrion, GSK, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Sandoz, UCB, N. Tundia Shareholder of: AbbVie, Employee of: AbbVie, A. Friedman Shareholder of: AbbVie, Employee of: AbbVie, H. Camp Shareholder of: AbbVie, Employee of: AbbVie, A. Pangan Shareholder of: AbbVie, Employee of: AbbVie, A. Ganguli Shareholder of: AbbVie, Employee of: AbbVie, M. Fuldeore Shareholder of: AbbVie, Employee of: AbbVie, D. Goldschmidt Employee of: Analysis Group, Inc., which received consulting fees from AbbVie for this study, M. Schiff Consultant for: Abbvie, BMS, Eli Lilly, JNJ, UCB, Speakers bureau: AbbVie, BMS