ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0224

Efficacy of Long-term Treatment with Baricitinib 2 Mg in Patients with Active Rheumatoid Arthritis

Alvin Wells1, Bochao Jia2, Li Xie2, Guillermo Valenzuela3, Edward C Keystone4, Zhanguo Li5, Amanda Quebe2, Kirstin Griffing2, Susan Otawa2 and Boulos Haraoui6, 1Aurora Rheumatology and Immunotherapy Center, Franklin, 2Eli Lilly and Company, Indianapolis, IN, 3Integral Rheumatology & Immunology Specialists, Plantation, FL, 4Mount Sinai Hospital, Toronto, ON, Canada, 5Peking University People’s Hospital, Xicheng, Beijing, China (People's Republic), 6Institut de Rhumatologie de Montréal, Montreal, QC, Canada

Meeting: ACR Convergence 2020

Keywords: ,

Session Information

Date: Friday, November 6, 2020

Title: RA – Treatments Poster I: RA Treatments & Their Safety

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: The short-term efficacy of baricitinib was demonstrated previously.1,2 The objectives of this post-hoc analysis were to evaluate long-term efficacy of once-daily baricitinib 2 mg in patients with active rheumatoid arthritis (RA) who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD).

Methods: Data from patients in two 24-week, phase III studies, RA-BUILD (NCT01721057, csDMARD-IR) and RA-BEACON (NCT01721044, bDMARD-IR), and one long-term extension (LTE) study (RA-BEYOND, NCT01885078) were analyzed (120 total weeks); all patients had a diagnosis of adult-onset RA as defined by the American College of Rheumatology/European League Against Rheumatism 2010 Criteria for the Classification of RA.3 The main outcomes of this analysis were achievement of low-disease activity (LDA; Simple Disease Activity Index [SDAI] ≤11), clinical remission (SDAI ≤3.3), Health Assessment Questionnaire Disability Index ≤0.5, and safety. Non-responder imputation (NRI) and completer analyses were conducted on the modified intention-to-treat (mITT) population, which included patients who were randomized to baricitinib 2 mg in the RA-BUILD and RA-BEACON studies and who had received ≥1 dose of the study drug after randomization.

Results: A total of 684 patients in RA-BUILD and 527 patients in RA-BEACON were randomized. In RA-BUILD, 229 patients were randomized to baricitinib 2 mg; 180 of whom completed the study and entered RA-BEYOND. In RA-BEACON, 174 patients were randomized to baricitinib 2 mg; 117 of whom completed the study and entered RA-BEYOND. At week 120, based on the mITT population with data up to rescue, 27.5% of csDMARD-IR and 18.4% of bDMARD-IR patients treated with baricitinib 2 mg were in SDAI LDA; 13.1% of csDMARD-IR and 5.2% of bDMARD-IR patients were in SDAI remission (NRI). At week 120, 20.1% of csDMARD-IR and 10.9% of bDMARD-IR patients treated with baricitinib 2 mg met or exceeded the population normative value for physical function (NRI). The completer analysis results are not shown. Rates of adverse events of special interest were consistent with previous reports.

Conclusion: This analysis supports the long-term treatment sustained efficacy and safety of baricitinib 2 mg for up to 120 weeks.

Disclosure: A. Wells, Abbvie, 1, 2, Eli Lilly & Co., 1, 2; B. Jia, Eli Lilly and Company, 1, 3; L. Xie, Eli Lilly and Company, 1, 3; G. Valenzuela, Mallinckrodt, 2, 8, Merck, 5, Lilly, 5, 8, Amgen, 5, 8, Esaote, 5, Sanofi, 5, 8, UCB, 5, 8, Janssen, 5, 8, Horizon, 5, 8, Image Analysis Group, 5, Novartis, 5, 8, Alexion, 5, Celgene, 5, 8, Regeneron, 5, 8, AbbVie, 5, 8, Boehringer Ingelheim, 5, 8, Sandoz, 5, Gilead, 5, Exagen and Global Health Living, 5, Pfizer, 5, 8, Genentech, 5, 8, BMS, 8, Takeda, 8, Centocor, 8, Pharmacia, 8, Radius, 8; E. Keystone, AbbVie, 2, 5, 8, Celltrion, 2, 5, 8, Eli Lilly, 2, 5, 8, Pfizer Inc, 2, 5, 8, Merck, 2, 5, 8, Sandoz, 2, 5, 8, Samsung Bioepsis, 2, 5, 8, Myriad Autoimmune, 2, 5, 8, Purapharm, 2, 5, 8, Janssen, 2, 5, 8, Sanofi-Genzyme, 2, 5, 8, Amgen, 2, 5, 8, AstraZeneca, 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8, F. Hoffman-La Roche Ltd., 2, 5, 8, Genentech, 2, 5, 8, Gilead, 2, 5, 8, UCB, 2, 5, 8; Z. Li, None; A. Quebe, Eli Lilly & Co., 1, 2; K. Griffing, Eli Lilly and Company, 1, 3; S. Otawa, Eli Lilly and Company, 1, 3; B. Haraoui, AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb, 2, 5, Janssen, 2, 5, Pfizer, 2, 5, Roche, 2, 5, UCB, 2, 5.

To cite this abstract in AMA style:

Wells A, Jia B, Xie L, Valenzuela G, Keystone E, Li Z, Quebe A, Griffing K, Otawa S, Haraoui B. Efficacy of Long-term Treatment with Baricitinib 2 Mg in Patients with Active Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-long-term-treatment-with-baricitinib-2-mg-in-patients-with-active-rheumatoid-arthritis/. Accessed .

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