ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 559

Radiographic Progression Based on Baseline Demographics and Disease Characteristics from Three TNF-Alpha Inhibitor Biosimilar Studies in Patients with Rheumatoid Arthritis

Josef S. Smolen1, Young Mo Kang2, Wan-Hee Yoo3, Paul Emery4, Michael E Weinblatt5, Edward C. Keystone6, Mark C. Genovese7, Gihyun Myung8, Evelyn Hong8, Inyoung Baek8 and Jeehoon Ghil8, 1Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, 2Kyungpook National University School of Medicine, Daegu, Korea, Republic of (South), 3Chonbuk National University School of Medicine, Jeonju, Korea, Republic of (South), 4University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 5Brigham and Women's Hospital, Boston, MA, 6Mount Sinai Hospital, Toronto, ON, Canada, 7Stanford University Medical Center, Palo Alto, CA, 8Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Date: Sunday, October 21, 2018

Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology

Session Type: ACR Poster Session A

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

Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. Radiographic data were assessed using the modified Total Sharp Score (mTSS) at week 0 and final week (week 52 for etanercept and adalimumab and week 54 for infliximab) in phase III biosimilar studies.1-3 The purpose of this analysis is to identify baseline demographics and disease characteristics that are associated with radiographic progression (RP) and build a matrix model to show the proportion of patients with RP by the identified baseline factors.

Methods: Patients who had radiographic data were pooled. RP was defined as a change in mTSS >0 from week 0 to final week. The three baseline factors that had the strongest Pearson¡¯s correlation coefficient with the change in mTSS were selected, and univariate logistic regression analysis was performed to assess the association between each baseline factor and predicted probability of patients with RP. Then, multivariate logistic model was fitted to develop a matrix that shows the proportion of patients with RP in each tertile of baseline factors.

Results: A total of 1371 patients had radiographic assessments. The mean change in mTSS was 0.41 and the number of patients who had RP was 376 patients (27.4%). The swollen joint count 28 ([SJC28], p-value = 0.0041), C-reactive protein ([CRP], p-value = 0.033), and Physician Global Assessment ([PhGA], p-value = 0.048) had the strongest correlation with RP (Table 1). Predicted probability of patients with RP as a function of SJC28, CRP, and PhGA is displayed in Figure 1. The proportion of patients with RP increased as baseline levels of each factor worsened (Figure 2). The proportion of patients with RP was greatest (37%, 95% CI: 32, 43) in the highest tertile of each category (SJC28 >17, CRP >30, and PhGA >80) and least (12%, 95% CI: 8, 20) in the lowest tertile of each category (SJC28< 10, CRP <5, and PhGA <50).  

Conclusion: A pooled radiographic assessment data showed that baseline SJC28, CRP, and PhGA are associated with RP, and the proportion of patients with RP increases as each baseline factor worsened.  

 References

  1. Smolen JS et al. Rheumatology. 2017 Oct 1;56(10):1771-1779
  2. Weinblatt ME et al. Arthritis Rheumatol. 2018; Jan;70(1):40-48
  3. Weinblatt ME et al. Arthritis Rheumatol. doi: 10.1002/art.40444

Disclosure: J. S. Smolen, AbbVie, Janssen, MSD, Pfizer, Roche, and UCB, 2,AbbVie, Amgen, AstraZeneca, Astro-Pharma, Celgene, GSK, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Novo Nordisk, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB, 5; Y. M. Kang, None; W. H. Yoo, None; P. Emery, Pfizer,MSD,Abbvie,BMS,UCB,Roche,Novartis,Samsung, Sandoz and Lilly, 2, 5, 8; M. E. Weinblatt, Amgen, Bristol-Myers Squibb, Crescendo Bioscience, and Sanofi/Regeneron, 2,AbbVie, Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Corrona, GSK, Gilead, Lilly, Lycera, Merck, Novartis, Pfizer, Roche, Samsung Bioepis, Set Point, and UCB, 5,Lycera, Canfite, Scipher, Vorso, and Inmedix, 1; E. C. Keystone, Abbott, AstraZeneca, Bristol-Myers Squibb, Crescendo Bioscience, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Pfizer, UCB, Samsung Bioepis, 5; M. C. Genovese, Samsung, Merck, Abbvie, Amgen, BI, 5; G. Myung, Samsung Bioepis, 3; E. Hong, Samsung Bioepis, 3; I. Baek, Samsung Bioepis, 3; J. Ghil, Samsung Bioepis, 3.

To cite this abstract in AMA style:

Smolen JS, Kang YM, Yoo WH, Emery P, Weinblatt ME, Keystone EC, Genovese MC, Myung G, Hong E, Baek I, Ghil J. Radiographic Progression Based on Baseline Demographics and Disease Characteristics from Three TNF-Alpha Inhibitor Biosimilar Studies in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/radiographic-progression-based-on-baseline-demographics-and-disease-characteristics-from-three-tnf-alpha-inhibitor-biosimilar-studies-in-patients-with-rheumatoid-arthritis/. Accessed .

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