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THU0201 A pooled analysis of three tnf-Α inhibitor biosimilar studies in patients with rheumatoid arthritis comparing radiographic progression by disease activity states
  1. J.S. Smolen1,
  2. M. Weinblatt2,
  3. P. Emery3,
  4. E. Keystone4,
  5. M. Genovese5,
  6. G. Myung6,
  7. E. Hong6,
  8. I. Baek6,
  9. S. Lee6,
  10. J. Ghil6
  1. 1Medical University of Vienna, Vienna, Australia
  2. 2Brigham and Women’s Hospital, Boston, USA
  3. 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK
  4. 4Mount Sinai Hospital, Toronto, Canada
  5. 5Stanford University Medical Center, Stanford, USA
  6. 6Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of Ireland


Background SB4, SB2, and SB5 are biosimilars of the reference etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. Radiographic progression using the modified Total Sharp Score (mTSS) at week 0 and final week (week 52 for etanercept and adalimumab and week 54 for infliximab) was measured in phase III randomised, double-blind studies comparing efficacy and safety of biosimilar to its reference product.

Objectives Assess and compare radiographic progression by disease activity states at week 24 (for etanercept and adalimumab) or week 30 (for infliximab) in terms of DAS28 from a pooled analysis of three biosimilar studies.1–3

Methods Patients with radiographic data from each phase III study were pooled and grouped based on their disease activity state (remission, low disease activity [LDA], moderate disease activity [MDA], and high disease activity [HDA]) at week 24 or 30 in terms of DAS28. The mean change in mTSS and the proportion of radiographic non-progressors of higher disease activity groups (LDA, MDA, and HDA) in reference to remission were summarised descriptively and odds ratios (OR) were compared using 95% confidence interval (CI) obtained from logistic model with baseline DAS28.

Results A total of 1263 patients from phase III studies had radiographic assessment available and the results are summarised in table 1.

Across all treatment groups, radiographic progression was the highest in HDA followed by MDA, LDA, and remission. In all treatments combined, the mean change in mTSS was 0.03, 0.38, 0.27, and 1.27 and the proportion of non-progressors was 79.7% (181/227), 78.1% (125/160), 74.1% (473/638), 58.4% (139/238) in remission, LDA, MDA, and HDA groups, respectively.

In all treatments combined, compared to remission group, the estimated difference in mTSS was greater in HDA (1.15, 95% CI: 0.63–1.66) than MDA (0.20, 95% CI: −0.22–0.62) and LDA (0.36, 95% CI: −0.20–0.91) groups and the OR of the proportion of the non-progressors was the smallest in HDA (OR 0.40, 95% CI: 0.26–0.61) followed by MDA (OR 0.76, 95% CI: 0.52–1.10) and LDA (OR 0.90, 95% CI: 0.55–1.49) (figure 1). This trend was similarly observed in other treatment groups.

Abstract THU0201 – Table 1

Summary of Change in Mean mTSS and a Proportion of Non-progressors

Abstract THU0201 – Figure 1

Odds Ratios of Non-progressors in Reference to Remission (vs. Remission)

Conclusions A pooled radiographic assessment data from three different biosimilar studies showed that radiographic progression was greater as disease activity worsened.

References [1] Emery, et al. Rheumatology2017Dec;56(12):2093–2101.

[2] Smolen, et al. Ann Rheum Dis2018Feb;77(2):234–240.

[3] Weinblatt, et al. Arthritis Rheumatol2018Jan;70(1):40–48.

Disclosure of Interest J. Smolen Grant/research support from: AbbVie, Janssen, MSD, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, AstraZeneca, Astro-Pharma, Celgene, GSK, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Novo Nordisk, Pfizer, Roche, Samsung Bioepis, Sanofi and UCB, M. Weinblatt Grant/research support from: Amgen, Bristol-Myers Squibb, Crescendo Bioscience, and Sanofi, Consultant for: AbbVie, Amgen, Novartis, Roche, GlaxoSmithKline, Merck, Samsung, Crescendo Bioscience, and AstraZeneca, and Bristol-Myers Squibb, Lilly, and Pfizer, P. Emery Consultant for: Pfizer, MSD, AbbVie, Bristol-Myers Squibb, UCB, Roche, Novartis, Samsung, Sandoz and Lilly, E. Keystone Consultant for: Abbott, AstraZeneca, Bristol-Myers Squibb, Crescendo Bioscience, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Pfizer, UCB, Samsung Bioepis, M. Genovese Consultant for: Samsung, Merck, Abbvie, Amgen, BI, J. Vencovsky Consultant for: Samsung Bioepis, Biogen, G. Myung Employee of: Samsung Bioepis, E. Hong: None declared, I. Baek Employee of: Samsung Bioepis, S. Lee Employee of: Samsung Bioepis, J. Ghil Employee of: Samsung Bioepis

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