ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0924

Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension

Désirée van der Heijde1, Atul Deodhar2, Walter Maksymowych3, Joachim Sieper4, Filip Van den Bosch5, Tae-Hwan Kim6, Mitsumasa Kishimoto7, Andrew Ostor8, Bernard Combe9, Yunxia Sui10, Yuanyuan Duan11, Alvina D. Chu11 and In-Ho Song12, 1Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, 2Oregon Health & Science University, Portland, OR, 3Department of Medicine, University of Alberta, Alberta, Canada, Edmonton, AB, Canada, 4Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, 5Dept. of Rheumatology - Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, 6Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 7Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, 8Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, 9Montpellier University, Montpellier, France, 10AbbVie, North Chicago, IL, 11AbbVie Inc, North Chicago, 12AbbVie Inc., North Chicago, IL

Meeting: ACR Convergence 2021

Keywords: , , ,

Session Information

Date: Sunday, November 7, 2021

Title: Spondyloarthritis Including PsA – Treatment Poster I: Axial Spondyloarthritis (0908–0939)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: The objective of this long-term analysis of the SELECT-AXIS 1 study was to report safety and efficacy of upadacitinib (UPA) in active AS through 2 years.

Methods: SELECT-AXIS 1 (NCT03178487) included a placebo-controlled, 14-week (wk) period followed by a 90-wk open-label extension.1 The study enrolled patients (pts) with active AS (fulfilling modified New York criteria) who had an inadequate response to NSAID therapy and were biologic DMARD naive. At baseline (BL), pts were randomized to UPA 15 mg once daily (QD) or PBO; at wk 14, pts continued to receive UPA 15 mg QD (continuous UPA) while PBO pts were switched to UPA. Efficacy assessments related to signs and symptoms included Assessment of SpondyloArthritis international Society (ASAS) 40 response, ASAS partial remission (PR) and AS Disease Activity Score (ASDAS) inactive disease (ID) and low disease activity (LDA). Imaging assessments included changes from BL in MRI Spondyloarthritis Research Consortium of Canada (SPARCC) spine and SI joint scores and in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) at wk 104. As observed (AO) and non-responder imputation (NRI) data for binary endpoints and mixed-effect model repeated measures for continuous efficacy endpoints are reported. UPA treatment-emergent adverse events (AEs) were monitored throughout the study.

Results: Of 187 pts randomized at BL, 178 pts (each n=89 for UPA and PBO) completed wk 14 on study drug and entered the open-label extension; 144 pts (77%) completed wk 104 (UPA, n=71; PBO to UPA, n=73). ASAS40 response was maintained through 2 years among pts receiving continuous UPA; similar results at wk 104 were observed among pts who switched from PBO to UPA at wk 14 (Figure). A similar pattern and maintenance of response was also observed for other efficacy endpoints (Figure). MRI SPARCC spine and SI joint scores decreased from BL to wk 14 and were maintained thereafter to wk 104 with continuous UPA; a similar magnitude of decrease was seen at wk 104 in pts who switched from PBO to UPA at wk 14 (Table 1). The mean (95% CI) change from BL to wk 104 in the mSASSS was 0.68 (0.27, 1.09) in the total group (Table 1). Overall UPA treatment-emergent AE rate was 242.7/100 patient-years (PY). Infections were the most common AEs; no serious infections, active tuberculosis, adjudicated major adverse cardiovascular events, lymphoma, non-melanoma skin cancer, renal dysfunction, or gastrointestinal perforations were observed. Five (1.6/100 PY) non-serious herpes zoster infections (limited to 1 dermatome), 1 event of colitis (0.3/100 PY), 16 (5.2/100 PY) non-serious uveitis events (mostly in HLA-B27 positive pts with a history of uveitis), and 35 (11.3/100 PY) mostly asymptomatic and transient events of creatine phosphokinase elevation were observed throughout the 2 years among pts receiving UPA (Table 2).

Conclusion: UPA 15 mg QD showed sustained and consistent efficacy over 2 years for ASAS40 (primary endpoint) and other clinically relevant endpoints (ASDAS ID, ASDAS LDA, and ASAS PR). A low rate of radiographic progression was observed based on spinal radiographs. No new safety findings were observed.

1. van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.

Clinical Efficacy Endpoints Over Time

Baseline Mean and Mean Change From Baseline in MRI SPARCC score and mSASSS

Treatment-emergent Adverse Events Throughout the Study

Disclosures: D. van der Heijde, AbbVie, 2, Amgen, 2, Astellas, 2, AstraZeneca, 2, Bayer, 2, BMS, 2, Boehringer Ingelheim, 2, Celgene, 2, Cyxone, 2, Daiichi, 2, Eisai, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Janssen, 2, Merck, 2, Novartis, 2, Pfizer, 2, Regeneron, 2, Roche, 2, Sanofi, 2, Takeda, 2, UCB Pharma, 2, Imaging and Rheumatology BV, 4; A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2; W. Maksymowych, AbbVie, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Boehringer Ingelheim, 2, Celgene, 2, 5, Eli Lilly, 2, 5, Galapagos, 2, 5, Janssen, 6, Novartis, 2, 5, 6, Pfizer Inc, 2, 5, 6, UCB, 2, 5, 6; J. Sieper, AbbVie, 2, 5, 6, Merck, 2, 5, 6, Pfizer, 2, 5, 6, Janssen, 2, 6, Lilly, 2, 6, Novartis, 2, 6, UCB, 2, 6, Roche, 2, 6; F. Van den Bosch, AbbVie, 2, 5, 6, Janssen, 2, 5, 6, UCB, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Galapagos, 2, 6, Gilead, 2, 6; T. Kim, AbbVie, 6, Celltrion, 6, Kirin, 6, Lilly, 6, Novartis, 6; M. Kishimoto, AbbVie, 2, 6, Amgen-Astellas BioPharma, 2, 6, Asahi-Kasei Pharma, 2, 6, Astellas, 2, 6, Ayumi Pharma, 2, 6, BMS, 2, 6, Celegene, 2, 6, Chugai, 2, 6, Daiichi-Sankyo, 2, 6, Eisai, 2, 6, Eli Lilly, 2, 6, Gilead, 2, 6, Janssen, 2, 6, Kyowa Kirin, 2, 6, Novartis, 2, 6, Ono Pharma, 2, 6, Pfizer, 2, 6, Tanabe-Mitsubishi, 2, 6, UCB, 2, 6; A. Ostor, AbbVie, 2, 6, Bristol-Myers Squibb, 2, 6, Eli Lilly, 2, 6, Gilead, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Janssen, 1, 2, UCB, 1, 2, Paradigm, 1, 2; B. Combe, AbbVie, 2, 4, 5, 6, Lilly, 2, 4, 5, 6, Gilead, 2, 4, Galapagos, 2, 4, Janssen, 2, 5, BMS, 2, Celltrion, 2, Novartis, 2, Roche-Chugai, 2, Sanofi, 2, Merck, 6; Y. Sui, AbbVie, 11; Y. Duan, AbbVie, 11; A. Chu, AbbVie, 11; I. Song, AbbVie, 3, 11.

To cite this abstract in AMA style:

van der Heijde D, Deodhar A, Maksymowych W, Sieper J, Van den Bosch F, Kim T, Kishimoto M, Ostor A, Combe B, Sui Y, Duan Y, Chu A, Song I. Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-upadacitinib-in-patients-with-active-ankylosing-spondylitis-2-year-results-from-a-randomized-double-blind-placebo-controlled-study-with-open-label-extension/. Accessed .

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