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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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

Citirajte ovaj rad

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, br. 1, 2019, str. 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 i 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, br. 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), str. 23-28. doi: 10.5152/eurjrheum.2018.18078

Polak P, Perić P, Louw I, Gaylord SM, Williams T, Becker JC, i 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]. 01.2019. [pristupljeno 03.05.2024.];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, br. 1, str. 23-28, Siječanj 2019. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:030476. [Citirano: 03.05.2024.]

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Podaci o radu
Naslov (engleski)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
AutorPavol Polak
AutorPorin Perić
AutorIngrid Louw
AutorStefanie M. Gaylord
AutorTheresa Williams
AutorJean-Claude Becker
AutorRon Pedersen
AutorJoan Korth-Bradley
AutorBonnie Vlahos
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Sažetak (engleski)
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.
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeZavršna verzija rukopisa prihvaćena za objavljivanje (postprint)
Naslov časopisaEuropean Journal of Rheumatology
Brojčani podacivol. 6, br. 1, str. 23-28
p-ISSN2147-9720
DOIhttps://doi.org/10.5152/eurjrheum.2018.18078
URN:NBNurn:nbn:hr:105:030476
Datum objave publikacije2019-01
URL dokumentahttp://doi.org/10.5152/eurjrheum.2018.18078
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
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Datum i vrijeme pohrane2024-03-28 10:33:25