prikaz prve stranice dokumenta 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
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Scientific paper - Original scientific paper
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
European Journal of Rheumatology, 6 (2019), 1; 23-28. https://doi.org/10.5152/eurjrheum.2018.18078
Polak, Pavol; Perić, Porin; Louw, Ingrid; Gaylord, Stefanie M.; Williams, Theresa; Becker, Jean-Claude; Pedersen, Ron; Korth-Bradley, Joan; Vlahos, Bonnie

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Polak, P., Perić, P., Louw, I., Gaylord, S. M., Williams, T., Becker, J. C. ... Vlahos, B. (2019). 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. European Journal of Rheumatology, 6. (1), 23-28. doi: 10.5152/eurjrheum.2018.18078

Polak, Pavol, et al. "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." European Journal of Rheumatology, vol. 6, no. 1, 2019, pp. 23-28. https://doi.org/10.5152/eurjrheum.2018.18078

Polak, Pavol, Porin Perić, Ingrid Louw, Stefanie M. Gaylord, Theresa Williams, Jean Claude Becker, Ron Pedersen, Joan Korth Bradley and Bonnie Vlahos. "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." European Journal of Rheumatology 6, no. 1 (2019): 23-28. https://doi.org/10.5152/eurjrheum.2018.18078

Polak, P., et al. (2019) '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', European Journal of Rheumatology, 6(1), pp. 23-28. doi: 10.5152/eurjrheum.2018.18078

Polak P, Perić P, Louw I, Gaylord SM, Williams T, Becker JC, and sur.. 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. European Journal of Rheumatology [Internet]. 2019 January [cited 2024 November 04];6(1):23-28. doi: 10.5152/eurjrheum.2018.18078

P. Polak, et al., "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", European Journal of Rheumatology, vol. 6, no. 1, pp. 23-28, January 2019. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:030476. [Accessed: 04 November 2024]

Metadata
Title (english)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
AuthorPavol Polak
AuthorPorin Perić
AuthorIngrid Louw
AuthorStefanie M. Gaylord
AuthorTheresa Williams
AuthorJean-Claude Becker
AuthorRon Pedersen
AuthorJoan Korth-Bradley
AuthorBonnie Vlahos
Author's institutionUniversity of Zagreb
School of Medicine
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Abstract (english)
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.
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review
Publication versionAccepted version
Journal titleEuropean Journal of Rheumatology
Numberingvol. 6, no. 1, pp. 23-28
p-ISSN2147-9720
DOIhttps://doi.org/10.5152/eurjrheum.2018.18078
URN:NBNurn:nbn:hr:105:030476
Publication2019-01
Document URLhttp://doi.org/10.5152/eurjrheum.2018.18078
Type of resourceText
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2024-03-28 10:33:25