PMID- 30451655
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2147-9720 (Print)
IS  - 2148-4279 (Electronic)
IS  - 2147-9720 (Linking)
VI  - 6
IP  - 1
DP  - 2019 Jan
TI  - A single-arm, open-label study to assess the immunogenicity, safety, and efficacy 
      of etanercept manufactured using the serum-free, high-capacity manufacturing 
      process administered to patients with rheumatoid arthritis.
PG  - 23-28
LID - 10.5152/eurjrheum.2018.18078 [doi]
AB  - OBJECTIVE: To evaluate the immunogenicity, safety, and efficacy of etanercept 
      (ETN) manufactured using the serum-free, high-capacity manufacturing (SFHCM) 
      process in patients with rheumatoid arthritis (RA). METHODS: In this global, 
      multicenter, open-label, single-arm study (NCT02378506), 187 adult patients with 
      moderate to severe RA received ETN 50 mg once weekly for 24 weeks manufactured 
      using the SFHCM process. Immunogenicity (presence of antidrug antibodies (ADAs) 
      and neutralizing antibodies (NAbs)) was assessed at 12 and 24 weeks. Safety and 
      efficacy were evaluated at 4, 12, and 24 weeks. RESULTS: Eight (4.5%) patients 
      tested positive for ADA, and there were no NAbs detected at any time throughout 
      the study. Ninety (48.1%) patients reported treatment-emergent adverse events 
      (AEs), of which 27 (14.4%) reported injection-site reactions, and 43 (23.0%) 
      reported infections. The majority of AEs were mild or moderate in severity, and 
      the drug was well tolerated. Throughout the duration of the study (week 4 to week 
      24), there was a progressive increase in the American College of Rheumatology 
      (ACR)-defined responses (ACR20: 55.9%-82.0%, ACR50: 16.1%-57.8%, and ACR70: 
      3.2%-26.7%) from baseline and the proportion of patients achieving low disease 
      activity and remission, with a corresponding decrease in measures of disease 
      activity. CONCLUSION: The immunogenicity, safety, and efficacy of ETN 
      manufactured using the SFHCM process were similar to the current approved ETN 
      formulation. ClinicalTrials.gov registration: NCT02378506.
FAU - Polak, Pavol
AU  - Polak P
AD  - Out-patient Rheumatology Clinic, Zilina, Slovakia.
FAU - Peric, Porin
AU  - Peric P
AD  - Clinical Hospital Center Zagreb, University of Zagreb School of Medicine, Zagreb, 
      Croatia.
FAU - Louw, Ingrid
AU  - Louw I
AD  - Panorama Medical Centre, Panorama, South Africa.
FAU - Gaylord, Stefanie M
AU  - Gaylord SM
AD  - Pfizer, Collegeville, PA, USA.
FAU - Williams, Theresa
AU  - Williams T
AD  - Pfizer, Collegeville, PA, USA.
FAU - Becker, Jean-Claude
AU  - Becker JC
AD  - Pfizer, New York, NY, USA.
FAU - Pedersen, Ron
AU  - Pedersen R
AD  - Pfizer, Collegeville, PA, USA.
FAU - Korth-Bradley, Joan
AU  - Korth-Bradley J
AD  - Pfizer, Collegeville, PA, USA.
FAU - Vlahos, Bonnie
AU  - Vlahos B
AD  - Pfizer, Collegeville, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02378506
PT  - Journal Article
PL  - Turkey
TA  - Eur J Rheumatol
JT  - European journal of rheumatology
JID - 101656068
PMC - PMC6459335
COIS- Conflict of Interest: P. Polak is the primary external reviewer and a consultant 
      for Pfizer on this study and principal investigator. P. Peric is a principal 
      investigator and a consultant for Pfizer on this study. I.L. is an advisor in 
      rheumatology for Bristol-Myers Squibb, Novartis, Pfizer, and Roche, and a 
      principal investigator on clinical studies sponsored by Amgen, AstraZeneca, 
      Baxalta, Bristol-Myers Squibb, Celgene, Coherus, Eli Lilly, Janssen, and Pfizer. 
      J.C.B. is an employee of Becker Clinical Research Consulting LLC, who was a paid 
      consultant to Pfizer in connection with the development of this manuscript and 
      owns stock in Pfizer. S.M.G., T.W., R.P., J.K.B., B.V. are employees of Pfizer 
      and own stock in Pfizer.
EDAT- 2018/11/20 06:00
MHDA- 2018/11/20 06:01
PMCR- 2019/01/01
CRDT- 2018/11/20 06:00
PHST- 2018/05/11 00:00 [received]
PHST- 2018/10/03 00:00 [accepted]
PHST- 2018/11/20 06:00 [pubmed]
PHST- 2018/11/20 06:01 [medline]
PHST- 2018/11/20 06:00 [entrez]
PHST- 2019/01/01 00:00 [pmc-release]
AID - eurjrheum.2018.18078 [pii]
AID - ejr-6-1-23 [pii]
AID - 10.5152/eurjrheum.2018.18078 [doi]
PST - ppublish
SO  - Eur J Rheumatol. 2019 Jan;6(1):23-28. doi: 10.5152/eurjrheum.2018.18078.