PMID- 28584187
OWN - NLM
STAT- MEDLINE
DCOM- 20171003
LR  - 20240327
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 76
IP  - 10
DP  - 2017 Oct
TI  - Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in 
      patients with moderate to severe rheumatoid arthritis: a randomised, 
      double-blind, phase III equivalence study.
PG  - 1679-1687
LID - 10.1136/annrheumdis-2016-210459 [doi]
AB  - OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to 
      adalimumab; structural, functional and pharmacokinetic evaluations have shown 
      that the two are highly similar. We report results from a phase III study 
      comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. 
      METHODS: In this randomised, double-blind, active comparator-controlled, 26-week 
      equivalence study, patients with moderate to severe active rheumatoid arthritis 
      (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) 
      every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at 
      week 24. Primary hypothesis that the treatments were equivalent would be 
      confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, 
      demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included 
      Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was 
      assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies 
      were assessed to determine immunogenicity. RESULTS: A total of 526 patients were 
      randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 
      response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the 
      RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the 
      primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were 
      similar. There were no clinically meaningful differences in AEs and laboratory 
      abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients 
      tested positive for binding antidrug antibodies. CONCLUSIONS: Results from this 
      study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, 
      safety and immunogenicity in patients with moderate to severe RA. TRIAL 
      REGISTRATION NUMBER: NCT01970475; Results.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of 
      the article) 2017. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Cohen, Stanley
AU  - Cohen S
AD  - Metroplex Clinical Research Center, Dallas, Texas, USA.
FAU - Genovese, Mark C
AU  - Genovese MC
AD  - Stanford University School of Medicine, Palo Alto, California, USA.
FAU - Choy, Ernest
AU  - Choy E
AD  - CREATE Centre, Section of Rheumatology, Institute of Infection and Immunity, 
      Cardiff University, Cardiff, UK.
FAU - Perez-Ruiz, Fernando
AU  - Perez-Ruiz F
AD  - Rheumatology Division, Cruces University Hospital, OSI EE-Cruces and Biocruces 
      Health Research Institute, Vizcaya, Spain.
FAU - Matsumoto, Alan
AU  - Matsumoto A
AD  - Arthritis and Rheumatism Associates, Wheaton, Maryland, USA.
FAU - Pavelka, Karel
AU  - Pavelka K
AD  - Na Slupi 4 Praha 2, Praha, Czech Republic.
FAU - Pablos, Jose L
AU  - Pablos JL
AD  - Instituto de Investigacion Hospital 12 de Octubre, Universidad Complutense de 
      Madrid, Madrid, Spain.
FAU - Rizzo, Warren
AU  - Rizzo W
AD  - Advanced Arthritis Care & Research, Scottsdale, Arizona, USA.
FAU - Hrycaj, Pawel
AU  - Hrycaj P
AD  - Department of Rheumatology and Clinical Immunology, Poznan University of Medical 
      Sciences, Poznan, Poland.
FAU - Zhang, Nan
AU  - Zhang N
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Shergy, William
AU  - Shergy W
AD  - RANA Clinical Research Center, Huntsville, Alabama, USA.
FAU - Kaur, Primal
AU  - Kaur P
AD  - Amgen Inc., Thousand Oaks, California, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01970475
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170605
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/adverse effects/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies/blood
MH  - Antirheumatic Agents/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Arthritis, Rheumatoid/blood/*drug therapy
MH  - Biosimilar Pharmaceuticals/adverse effects/*pharmacokinetics/*therapeutic use
MH  - C-Reactive Protein/metabolism
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Therapeutic Equivalency
MH  - Young Adult
PMC - PMC5629940
OTO - NOTNLM
OT  - DMARDs (biologic)
OT  - TNF-alpha
OT  - anti-TNF
OT  - inflammation
OT  - rheumatoid arthritis
COIS- Competing interests: SC reports grants and personal fees from Amgen, during the 
      conduct of the study; grants and personal fees from Abbvie, Boehringer Ingelheim, 
      Pfizer and Sandoz, outside the submitted work. MCG reports grants and personal 
      fees from Amgen, AbbVie and Pfizer, and personal fees from Sandoz, FKb, Samsung 
      BioEpis, Merck, Celltrion and Boehringer, during the conduct of the study. EC 
      reports grants and personal fees from Amgen, during the conduct of the study; 
      personal fees from Boehringer Ingelheim, Chelsea Therapeutics, Daiichi Sankyo, 
      Eli Lilly, GlaxoSmithKline, Hospita, ISIS, Jazz Pharmaceuticals, Janssen, 
      MedImmune, Merrimack Pharmaceutical, Merck, Napp, Novartis, Regeneron, 
      Sanofi-Aventis, Schering Plough, Synovate and Tonix and grants and personal fees 
      from Chugai Pharma, Ferring Pharmaceuticals, Novimmune, Pfizer, Pierre Fabre, 
      Roche and UCB, outside the submitted work. FP-R reports grants from Amgen, during 
      the conduct of the study; and personal fees from Amgen, outside the submitted 
      work. AM reports grants and personal fees from Amgen, during the conduct of the 
      study; grants and personal fees from AbbVie, Pfizer and Bristol-Myers Squibb, 
      grants from Takeda, Janssen, Gilead and UCB and personal fees from 
      GlaxoSmithKline, outside the submitted work. JLP reports lecturing and 
      consultancy fees from Roche, Novartis, Pfizer and Lilly, outside the submitted 
      work. NZ and PK are employees of Amgen Inc.
EDAT- 2017/06/07 06:00
MHDA- 2017/10/04 06:00
PMCR- 2017/10/06
CRDT- 2017/06/07 06:00
PHST- 2016/09/02 00:00 [received]
PHST- 2017/05/02 00:00 [revised]
PHST- 2017/05/04 00:00 [accepted]
PHST- 2017/06/07 06:00 [pubmed]
PHST- 2017/10/04 06:00 [medline]
PHST- 2017/06/07 06:00 [entrez]
PHST- 2017/10/06 00:00 [pmc-release]
AID - annrheumdis-2016-210459 [pii]
AID - 10.1136/annrheumdis-2016-210459 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459. 
      Epub 2017 Jun 5.