A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

Autor: Roy M. Fleischmann, Rieke Alten, Margarita Pileckyte, Kasia Lobello, Steven Y. Hua, Carol Cronenberger, Daniel Alvarez, Amy E. Bock, K. Lea Sewell

Publikováno v: Arthritis Research & Therapy, Vol 20, Iss 1, Pp 1-12 (2018)

Abstract Background This double-blind, randomized, 78-week study evaluated the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-06410293, a candidate adalimumab biosimilar, versus adalimumab reference product (Humira®)

Externí odkaz: https://doaj.org/article/1d4bd355220e4ba2b38cbe7e573f3370

Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis

Autor: Roy M. Fleischmann, Amy E. Bock, Wuyan Zhang, Charles M. Godfrey, Ivana Vranic, Carol Cronenberger, Eva Dokoupilová

Publikováno v: Rheumatology and Therapy. 9:839-850

The aim of this sub-study was to evaluate injection success of patients with rheumatoid arthritis (RA) and their caregivers administering the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF: adalimumab-afzb; AbriladaThis sub-study included adult pat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c58f54ca73100780cd84f9a908a6a456
https://doi.org/10.1007/s40744-022-00439-8

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions

Autor: Daniel Aletaha, Andreas Kerschbaumer, Kastriot Kastrati, Christian Dejaco, Maxime Dougados, Iain B McInnes, Naveed Sattar, Tanja A Stamm, Tsutomu Takeuchi, Michael Trauner, Désirée van der Heijde, Marieke Voshaar, Kevin L Winthrop, Angelo Ravelli, Neil Betteridge, Gerd-Rüdiger R Burmester, Johannes WJ Bijlsma, Vivian Bykerk, Roberto Caporali, Ernest H Choy, Catalin Codreanu, Bernard Combe, Mary K Crow, Maarten de Wit, Paul Emery, Roy M Fleischmann, Cem Gabay, Merete Lund Hetland, Kimme L Hyrich, Annamaria Iagnocco, John D Isaacs, Joel M Kremer, Xavier Mariette, Peter A Merkel, Eduardo F Mysler, Peter Nash, Michael T Nurmohamed, Karel Pavelka, Gyula Poor, Andrea Rubbert-Roth, Hendrik Schulze-Koops, Anja Strangfeld, Yoshiya Tanaka, Josef S Smolen

Publikováno v: Annals of the rheumatic diseases. BMJ
Aletaha, D, Kerschbaumer, A, Kastrati, K, Dejaco, C, Dougados, M, McInnes, I B, Sattar, N, Stamm, T A, Takeuchi, T, Trauner, M, van der Heijde, D S, Voshaar, M, Winthrop, K L, Ravelli, A, Betteridge, N, Burmester, G-R D R, Bijlsma, J W J, Bykerk, V, Caporali, R, Choy, E H, Codreanu, C, Combe, B, Crow, M K, de Wit, M, Emery, P, Fleischmann, R M, Gabay, C, Hetland, M L, Hyrich, K L, Iagnocco, A, Isaacs, J D, Kremer, J M, Mariette, X, Merkel, P, Mysler, E F, Nash, P, Nurmohamed, M T, Pavelka, K, Poor, G, Rubbert-Roth, A, Schulze-Koops, H, Strangfeld, A, Tanaka, Y & Smolen, J S 2022, ' Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions : an update ', Annals of the Rheumatic Diseases . https://doi.org/10.1136/ard-2022-222784
Annals of the Rheumatic Diseases. BMJ PUBLISHING GROUP
Annals of the Rheumatic Diseases
Aletaha, D, Kerschbaumer, A, Kastrati, K, Dejaco, C, Dougados, M, McInnes, I B, Sattar, N, Stamm, T A, Takeuchi, T, Trauner, M, Van Der Heijde, D, Voshaar, M, Winthrop, K L, Ravelli, A, Betteridge, N, Burmester, G R R, Bijlsma, J W J, Bykerk, V, Caporali, R, Choy, E H, Codreanu, C, Combe, B, Crow, M K, De Wit, M, Emery, P, Fleischmann, R M, Gabay, C, Hetland, M L, Hyrich, K L, Iagnocco, A, Isaacs, J D, Kremer, J M, Mariette, X, Merkel, P, Mysler, E F, Nash, P, Nurmohamed, M T, Pavelka, K, Poor, G, Rubbert-Roth, A, Schulze-Koops, H, Strangfeld, A, Tanaka, Y & Smolen, J S 2023, ' Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions : an update ', Annals of the Rheumatic Diseases, vol. 82, no. 6, pp. 773–787 . https://doi.org/10.1136/ard-2022-222784
Annals of the Rheumatic Diseases. BMJ Publishing Group

BackgroundTargeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the specific receptor using anti-IL-6Rα antibodies or by d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a5450f45d4f38f87158cb07200a3b129
https://doi.org/10.1136/ard-2022-222784

Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial

Autor: Joel M, Kremer, Ricardo, Blanco, Anne-Marie, Halland, Marek, Brzosko, Ruben, Burgos-Vargas, Christopher M, Mela, Lucy, Rowell, Roy M, Fleischmann

Publikováno v: Clinical and experimental rheumatology. 34(4)

To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab.LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8a60b71c02ed2509ec5b1a7e568628b6
https://pubmed.ncbi.nlm.nih.gov/27087059

Blocking the effect of interleukin-1 and tumor necrosis factor in rheumatoid arthritis is well tolerated and effective

Autor: Roy M Fleischmann

Publikováno v: Therapy. 1:255-266

Interleukin (IL)-1 is a primary mediator in the pathophysiology of rheumatoid arthritis. Elevated IL-1 levels have been detected in the synovium of patients with rheumatoid arthritis and such elevated levels have been correlated with disease severity

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1c2574851e1cce21257acb27b2c336da
https://doi.org/10.2217/14750708.1.2.255