A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.
Adult
Aged
Antineoplastic Agents, Immunological
/ administration & dosage
Antirheumatic Agents
/ administration & dosage
Area Under Curve
Arthritis, Rheumatoid
/ drug therapy
Biosimilar Pharmaceuticals
/ administration & dosage
Carbon-Sulfur Lyases
/ administration & dosage
Double-Blind Method
Female
Humans
Infusions, Intravenous
Male
Middle Aged
Rituximab
/ administration & dosage
Safety
Severity of Illness Index
Therapeutic Equivalency
Treatment Outcome
ABP 798
biosimilar
pharmacokinetics
rheumatoid arthritis
rituximab
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
11
12
2019
accepted:
01
06
2020
pubmed:
7
7
2020
medline:
28
9
2021
entrez:
7
7
2020
Statut:
ppublish
Résumé
ABP 798 is a proposed biosimilar to rituximab reference product (RP), an anti-CD20 monoclonal antibody. Pharmacokinetics (PK), pharmacodynamics (PD), and safety results from the comparative clinical study that evaluated the PK, PD, safety, efficacy, and immunogenicity of ABP 798 versus rituximab RP are presented here. Subjects with moderate to severe rheumatoid arthritis (RA) received 2 doses of ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU), each consisting of two 1000-mg infusions 2 weeks apart. For the second dose (week 24), ABP 798- and rituximab EU-treated subjects received the same treatment; rituximab US-treated subjects transitioned to ABP 798. End points included area under the serum concentration-time curve from time 0 extrapolated to infinity and maximum observed serum concentration following the second infusion of the first dose (PK) and percentage of subjects with complete CD19+ cell depletion days 1-33 (PD). Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25. Complete CD19+ B-cell depletion on day 3 among groups confirmed PD similarity. These findings demonstrated PK/PD similarity between ABP 798 and rituximab RP in subjects with moderate to severe RA.
Substances chimiques
Antineoplastic Agents, Immunological
0
Antirheumatic Agents
0
Biosimilar Pharmaceuticals
0
rituximab-alliinase conjugate
0
Rituximab
4F4X42SYQ6
Carbon-Sulfur Lyases
EC 4.4.-
Banques de données
ClinicalTrials.gov
['NCT02792699']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1003-1014Informations de copyright
© 2020 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.
Références
Uhlig T, Goll G. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology. 2017;56(suppl 4):iv49-iv62.
Salles G, Barrett M, Foà R, et al. Rituximab in B-cell hematologic malignancies: a review of 20 years of clinical experience. Adv Ther. 2017;34(10):2232-2273.
Scher J. B-cell therapies for rheumatoid arthritis. Bull NYU Hosp Jt Dis. 2012;70(3):200-203.
Frampton JE. Rituximab: a review in pemphigus vulgaris. Am J Clin Dermatol. 2020;21(1):149-156.
Weiner GJ. Rituximab: mechanism of action. Semin Hematol. 2010;47(2):115-123.
Volkov M, van Schie KA, van der Woude D. Autoantibodies and B cells: the ABC of rheumatoid arthritis pathophysiology. Immunol Rev. 2020;294(1):148-163.
Edwards JC, Cambridge G. Sustained improvement in rheumatoid arthritis following a protocol designed to deplete B lymphocytes. Rheumatology (Oxford). 2001;40(2):205-211.
Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350(25):2572-2581.
Keystone E, Fleischmann R, Emergy P, et al. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: An open-label extension analysis. Arthritis Rheum. 2007;56(12):3896-3909.
Smolen JS, Goncalves J, Quinn M, Benedetti F, Lee JY. Era of biosimilars in rheumatology: reshaping the healthcare environment. RMD Open. 2019;5(1):e000900.
Goel N, Chance K. Biosimilars in rheumatology: understanding the rigor of their development. Rheumatology. 2017;56(2):187-197.
Markus R, Liu J, Ramchandani M, Landa D, Born T, Kaur P. Developing the totality of evidence for biosimilars: regulatory considerations and building confidence for the healthcare community. BioDrugs. 2017;31(3):175-187.
Deeks ED. CP-P10 (TruximaTM): a rituximab biosimilar. BioDrugs. 2017; 31(3):275-278.
Zelenetz AD. The era of therapeutic biosimilars has arrived: what you need to know. J Natl Compr Canc Netw. 2019;17(11.5):1424-1426.
Konstantinidou S, Papaspiliou A, Kokkotou E. Current and future roles of biosimilars in oncology practice. Oncol Lett. 2020;19(1):45-51.
Seo N, McBride H, Huang A, et al. Analytical and functional similarity of Amgen proposed biosimilar ABP 798 to rituximab. Poster P-123-T. Presented at: WCBP 2018.
Breedveld F, Agarwal S, Yin M, et al. Rituximab pharmacokinetics in patients with rheumatoid arthritis: B-cell levels do not correlate with clinical response. J Clin Pharmacol. 2007;47(9):1119-1128.
Burmester G-R, Drescher E, Hrycaj P, et al. Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis. Clin Rheumatol. In press.