ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1423

Patient-Reported Outcomes of Abatacept in Combination with MTX in Early, MTX-Naïve, ACPA Positive Patients with RA: 1-Year Results from a Phase IIIb Study

Paul Emery1, Yoshiya Tanaka 2, Vivian Bykerk 3, Clifton Bingham 4, Thomas Huizinga 5, Gustavo Citera 6, Joe Zhuo 7, Kuan-Hsiang Gary Huang 8, Robert Wong 7, Sean Connolly 8, Yedid Elbez 9 and Roy Fleischmann 10, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, 2University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 3Hospital for Special Surgery, New York City, NY, 4Johns Hopkins University, Baltimore, MD, 5Leiden University Medical Center, Leiden, Netherlands, 6Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 7Bristol-Myers Squibb, Princeton, 8Bristol-Myers Squibb, Princeton, NJ, 9Excelya, Boulogne-Billancourt, France, 10Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , , ,

Session Information

Date: Monday, November 11, 2019

Title: RA – Treatments Poster II: Established Treatments

Session Type: Poster Session (Monday)

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

Background/Purpose: Early biologic use can improve long-term control of RA, and early use of abatacept (ABA) + MTX has demonstrated sustained improvements in selected patient-reported outcomes (PROs).1,2 AVERT-2 (NCT02504268) is an ongoing, large, Phase IIIb, randomized, double-blinded study evaluating efficacy and safety of SC ABA + MTX vs ABA placebo (PBO) + MTX in ACPA positive (+) patients (pts) with early RA (disease duration ≤6 months) for 56 weeks, followed by a 48-week de-escalation.3 Results of a post hoc analysis of PROs at 24 and 52 weeks in the AVERT-2 study are presented.

Methods: For the induction period, pts were randomized to SC ABA (125 mg weekly) + MTX or ABA PBO + MTX for 56 weeks. Key inclusion criteria: age ≥18 years; RA diagnosis ≤6 months (ACR/EULAR 2010 criteria); ACPA+; CRP >3 mg/L (upper limit of normal/ESR ≥28 mm/h); TJC ≥3 and SJC ≥3; DMARD naïve. PROs included pain (visual analog scale [VAS], 0–10 cm), pt assessment of disease activity (PtDA; VAS, 0–10 cm), physical function (HAQ-DI; 0–3), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), Work Productivity and Activity Impairment (WPAI) questionnaire and pt overall quality of life (Short-Form 36 [SF-36] physical component summary [PCS]/mental component summary version 2.0). Adjusted mean change from baseline (adMCFB) and the proportion of pts attaining a minimal clinically important difference (MCID; values defined in Table 2)4 at 24 and 52 weeks were calculated for each PRO in the intention-to-treat population. AdMCFB was estimated using a mixed effect model with repeated measures.

Results: Of the 752 randomized pts, 451 were treated with ABA + MTX and 301 with ABA PBO + MTX. Baseline characteristics were similar across treatment arms.3 The adMCFB showed improvements in all PROs at both timepoints for both treatment arms (Table 1), with ABA + MTX vs ABA PBO + MTX showing greater magnitude of improvement in pain PtDA, HAQ-DI and SF-36 PCS at both Weeks 24 and 52 (p≤0.0001). For all PROs except WPAI, more than half of pts achieved the MCID (Table 2). Compared with ABA PBO + MTX, a significantly greater proportion of ABA + MTX–treated pts attained the MCID in pain, PtDA and HAQ-DI at Weeks 24 and 52 (p< 0.05). Although there was no difference at Week 24, by Week 52 a greater proportion of pts attained the MCID in SF-36 PCS with ABA + MTX than with PBO + MTX.

Conclusion: In pts with early RA, treatment with abatacept + MTX and abatacept PBO + MTX were both associated with substantial improvements in PROs and quality of life by 24 weeks that were sustained over 1 year. Compared with abatacept PBO + MTX, a significantly greater proportion of abatacept + MTX–treated pts reported clinically meaningful improvements in pain, PtDA and function (HAQ-DI) by 24 weeks; this difference was sustained at 52 weeks. Further long-term follow-up analysis including impact of de-escalation of therapy is warranted.

References:

  1. Emery P, et al. Ann Rheum Dis 2015;74:19–26.
  2. Emery P, et al. RMD Open 2019;5:e000840.
  3. Emery P, et al. ACR Annual Meeting 2018; San Diego, CA, USA: Poster 563.
  4. Reilly MC, et al. Gut2007;56(Suppl 3):159.

 

Professional medical writing: Claire Line, PhD, funded by Bristol-Myers Squibb.

Disclosure: P. Emery, AbbVie, 2, 5, 9, BMS, 2, 5, Bristol-Myers Squibb, 2, 5, 9, Gilead, 5, Lilly, 2, 5, 9, MSD, 2, 5, 9, Novartis, 2, 5, 9, Pfizer, 2, 5, 9, Roche, 2, 5, 9, Samsung, 2, 5, 9, Samsung Bioepis Co., Ltd., 2, Sandoz, 2, 5, 9, UCB, 2, 5, 9; Y. Tanaka, Abbvie, 8, AbbVie, 5, 8, Asahi-kasei, 2, Asahi-Kasei, 2, Asahi-kasei, BMS, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Ono, Pfizer, Sanofi, Takeda, UCB, 2, Astellas, 8, Astellas Pharma, 9, Astellas Pharma, Inc., 2, 3, 5, 8, 9, Astellas, BMS, Chugai, Daiichi-Sankyo, Eli Lilly, Janssen, Mitsubishi-Tanabe, Pfizer, Sanofic, UCB, YL Biologics, 8, BMS, 2, 5, 8, Bristol-Myers, 2, 8, Bristol-Myers Squibb, 2, 8, Chugai, 2, 8, Daiichi-Sankyo, 2, 8, Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, Abbvie, Pfizer, YL Biologics, Bristol-Myers, 8, Eisai, 2, 8, Eli Lilly, 5, 8, Eli Lilly and Company, 8, Genzyme, 5, Glaxo-Smithkline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi-kasei, 8, Janssen, 8, Mitsubishi-Tanabe, 2, 8, Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, Abbvie, Astellas, Daiichi-Sankyo, Ono, MSD, Taisho-Toyama., 2, Mitsubishi-Tanabe, Takeda, Daiichi-Sankyo, Chugai, Bristol-Myers, MSD, Astellas, Abbvie, Eisai, 2, Novartis, 8, Ono, 2, Pfizer, 5, 8, Pfizer Inc, 8, Roche, 5, Sanofi, 2, Takeda, 2, 8, Teijin, 8, UCB, 2, YL Biologics, 8; V. Bykerk, AbbVie, 5, Amgen, 1, 2, 3, 5, 8, Brainstorm Therapeutics, 1, 2, 3, 5, 8, Bristol-Myers Squibb, 5, Genentech, 5, Gilead, 5, NIH, 2, Pfizer, 1, 2, 3, 5, 8, Regeneron, 5, Regeneron Pharmaceuticals, Inc, 5, Sanofi, 5, Sanofi/Genzyme-Regeneron, 5, Sanofi-Genzyme/Regeneron, 1, 2, 3, 5, 8, Scipher, 1, 2, 3, 5, 8, The Cedar Hill Foundation, 9, UCB, 1, 2, 3, 5, 8, UCB Pharma, 5; C. Bingham, Abbvie, 5, AbbVie, 5, BMS, 2, 5, Bristol Meyer Squibb, 2, 5, Bristol Myers-Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, Eli Lilly, 5, Eli/Lilly, 5, Genentech/Roche, 5, Janssen, 5, Janssen Research & Development, LLC, 2, Pfizer Inc, 5, Regeneron/Sanofi, 5, Sanofi/Regeneron, 5; T. Huizinga, Abblynx, 2, 5, 8, Abbott, 2, 5, 8, Biotest AG, 2, 5, 8, Boehringer Ingelheim, 2, 5, 8, Boeringher Ingelheim, 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8, Crescendo Bioscience, 2, 5, 8, Eli Lilly, 2, 5, 8, Epirus, 2, 5, 8, Galapagos, 2, 5, 8, Janssen, 2, 5, 8, Merck, 2, 5, 8, Novartis, 2, 5, 8, Nycomed, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, Sanofi-Aventis, 2, 5, 8, Takeda, 2, 5, 8, UCB, 2, 5, 8, Zydus, 2, 5, 8; G. Citera, AbbVie, 5, 8, Abbvie, 2, 5, 8, BMS, 5, BRISTOL MYERS SQUIBB ARGENTINA, 8, Bristol-Myers Squibb, 5, 8, Eli Lilly, 5, Gema Biotech, 2, 5, 8, Genzyme, 5, Janssen, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, Sanofi Genzyme, 5, 8; J. Zhuo, Bristol-Myers Squibb, 1, 3; K. Huang, Bristol-Myers Squibb, 1, 3, 4; R. Wong, Bristol-Myers Squibb, 3, 4; S. Connolly, Bristol-Myers Squibb, 1, 3, 4; Y. Elbez, None; R. Fleischmann, AbbVie, 2, 5, Acea, 2, 5, Akros, 5, Amgen, 2, 5, AstraZeneca, 2, 5, BMS, 2, 5, Bristol‐Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, Celgene, 2, 5, Celltrion, 5, Celtrion, 2, 5, Centrexion, 2, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck-Serono, 2, 5, EMD Serono, 2, EMD-Serano, 2, EMD-Serono, 2, Genentech, 2, 5, Genetech, 2, GlaxoSmithKline, 2, 5, GSK, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Merck, 2, Nektar, 2, Novartis, 2, 5, Pfizer, 2, 5, Pfizer Inc, 2, 5, Regeneron, 2, Resolve, 2, Roche, 2, Samsung, 5, Sandoz, 5, Sanofi Genzyme, 2, Sanofi‐Aventis, 2, 5, Sanofi-Aventis, 2, 5, Sanofi-Genzyme, 2, Selecta, 2, Tahio, 5, Taiho, 5, UCB, 2, 5.

To cite this abstract in AMA style:

Emery P, Tanaka Y, Bykerk V, Bingham C, Huizinga T, Citera G, Zhuo J, Huang K, Wong R, Connolly S, Elbez Y, Fleischmann R. Patient-Reported Outcomes of Abatacept in Combination with MTX in Early, MTX-Naïve, ACPA Positive Patients with RA: 1-Year Results from a Phase IIIb Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/patient-reported-outcomes-of-abatacept-in-combination-with-mtx-in-early-mtx-naive-acpa-positive-patients-with-ra-1-year-results-from-a-phase-iiib-study/. Accessed .

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