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 [F] Diseases Research  / PubMed Research Articles  /
Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: 52-Week Phase 3 Randomized Study Results.




Arthritis & rheumatology (Hoboken, N.J.) Feb ; ()


Weinblatt ME1; Baranauskaite A2; Dokoupilova E3; Zielinska A4; Jaworski J5; Racewicz A6; Pileckyte M7; Jedrychowicz-Rosiak K8; Baek I9; Ghil J10;

Author Information
  • 1Brigham and Women's Hospital, Boston, MA, USA.
  • 2Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • 3MEDICAL PLUS s.r.o, Uherske Hradiste, University of Veterinary and Pharmaceutical Sciences, Faculty of Pharmacy, Brno, Czech Republic.
  • 4Medica pro Familia Sp z o.o. S.K.A, Warszawa, Poland.
  • 5Reumatika - Centrum Reumatologii, Warszawa, Poland.
  • 6Zdrowie Osteo- Medic s.c, Białystok, Poland.
  • 7Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • 8Mazowieckie Centrum Badań Klinicznych, Grodzisk Mazowiecki, Poland.
  • 9Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.
  • 10Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.


OBJECTIVES: The 24-week equivalent efficacy and comparable safety results of SB5 and reference adalimumab (ADA) from the phase 3 randomized study in patients with moderate to severe rheumatoid arthritis (RA) have been reported previously. This transition study evaluated patients who switched from ADA to SB5 or continued on SB5 or ADA up to 52 weeks.

METHODS: In this phase 3 study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were re-randomized 1:1 to continue with ADA (ADA/ADA) or to switch to SB5 (ADA/SB5) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks.

RESULTS: The full analysis set comprised 542 patients: SB5 (n=269), ADA overall (n=273), ADA/SB5 (n=125), ADA/ADA (n=129). The American College of Rheumatology (ACR) responses seen at week 24 were maintained after transition from ADA to SB5, and the ACR response rates were comparable across treatment groups throughout the study; ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of anti-drug antibodies were comparable across treatment groups after transition.

CONCLUSION: SB5 was well tolerated over 1 year in patients with RA with comparable efficacy, safety, and immunogenicity to ADA. Switching from ADA to SB5 had no treatment-emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.




Publication Type: Journal Article

This article is licensed under the the National Library of Medicine License. It uses material from the PubMed National Library of Medicine Data.

Last Modified:   2016-03-27

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