SAT0255 Patient reported outcomes of upadacitinib: results from biologic inadequate responders (SELECT BEYOND PHASE III TRIAL)
Authors: V. Strand, M. Schiff, N. Tundia, A. Friedman, S. Meerwein, A. Pangan, A. Ganguli, M. Fuldeore, Y. Song, J. Pope
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Patient reported outcomes (PROs) were studied in patients with active rheumatoid arthritis (RA) who had an inadequate response to biologic disease modifying anti-rheumatic drugs (bDMARD-IR) in a trial of upadacitinib (UPA), a selective JAK-1 inhibitor. Improvements in PROs are important when evaluating comprehensive efficacy of treatments for RA. <h3>Objectives</h3> The objective of this post-hoc analysis was to compare PRO responses and numbers needed to treat (NNT) in order to assess clinically meaningful improvements in bDMARD-IR patients with RA receiving UPA. <h3>Methods</h3> Data from the SELECT BEYOND randomised controlled trial (RCT) (NCT02706847) were used to compare PRO responses between UPA (15 mg QD and 30 mg QD) and PBO. PROs included physical function by Health Assessment Questionnaire Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA) by visual analogue scale (VAS), pain by VAS, duration and severity of morning (AM) stiffness, health-related quality of life by Short Form 36 Health Survey (SF-36), and severity of insomnia by Insomnia Severity Index (ISI). Changes in least squares means (LSM) from baseline to week 12 were based on mixed effect repeated measures models. Percentages of patients reporting changes in PRO scores from baseline to week 12≥minimum clinically important difference (MCID) values or scores≥normative values (age- and gender-matched for SF-36 only) were determined; comparisons between groups used chi-square tests. For each PRO measure, the incremental NNT to achieve clinically meaningful improvements from baseline (≥MCID) was calculated. <h3>Results</h3> Data from 498 patients (169 in PBO, 164 in UPA 15 mg, 165 in 30 mg UPA) were analysed. Mean age was 57 years, 84% were females, and 55% had RA for ≥10 years. Both UPA doses resulted in statistically significant LSM changes from baseline vs PBO in HAQ-DI, PtGA, pain, duration and severity of AM stiffness, SF-36 Physical Component Summary (PCS), 7/8 domains (15 mg), and 6/8 domains (30 mg) (Table). Compared with PBO at week 12, UPA-treated patients reported higher responses that were statistically significant and clinically meaningful for HAQ-DI, PtGA, pain, duration and severity of AM stiffness, SF-36 PCS, 7/8 domains (15 mg), 5/8 domains (30 mg), and ISI (30 mg). The Table presents the proportion of patients reporting scores that were ≥normative values at week 12. Across most PROs, the NNTs with UPA ranged from 4 to 7 patients. <h3>Conclusions</h3> This RCT demonstrated that even in difficult-to-treat bDMARD-IR patients with active RA, treatment with UPA resulted in significantly more patients with clinically meaningful improvements in PROs or responses that approached normative values. The NNT to achieve a meaningful response was favourable. <h3>Acknowledgements</h3> 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 Lourdes Yun of Fishawack Communications and funded by AbbVie. <h3>Disclosure of Interest</h3> V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB, M. Schiff Consultant for: Abbvie, BMS, Eli Lilly, JNJ, UCB, Speakers bureau: AbbVie and BMS, N. Tundia Shareholder of: AbbVie, Employee of: AbbVie, A. Friedman Shareholder of: AbbVie, Employee of: AbbVie, S. Meerwein 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, Y. Song Employee of: Analysis Group, Inc., which received consulting fees from AbbVie for this study, J. Pope Consultant for: AbbVie, Amgen, BMS, Celltrion, GSK, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Sandoz, UCB