NDLI: Pharmacokinetics and Tolerability of a Dual Variable Domain Immunoglobulin ABT-981 Against IL-1 and IL-1ß in Healthy Subjects and Patients With Osteoarthritis of the Knee.

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Pharmacokinetics and Tolerability of a Dual Variable Domain Immunoglobulin ABT-981 Against IL-1 and IL-1ß in Healthy Subjects and Patients With Osteoarthritis of the Knee.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kosloski, Matthew P. Goss, Sandra Wang, Susanne X. Liu, Jia Loebbert, Ralf Medema, Jeroen K. Liu, Wei Dutta, Sandeep
Description	Country affiliation: United States Author Affiliation: Kosloski MP ( AbbVie Inc, North Chicago, IL, USA.); Goss S ( AbbVie Inc, North Chicago, IL, USA.); Wang SX ( AbbVie Inc, North Chicago, IL, USA.); Liu J ( AbbVie Inc, North Chicago, IL, USA.); Loebbert R ( AbbVie Deutschland GmbH and Co KG, Wiesbaden, Hesse, Germany.); Medema JK ( AbbVie Inc, North Chicago, IL, USA.); Liu W ( AbbVie Inc, North Chicago, IL, USA.); Dutta S ( AbbVie Inc, North Chicago, IL, USA.)
Abstract	The interleukin (IL)-1 family of proinflammatory cytokines are thought to play a significant role in the structural progression of osteoarthritis and its associated symptoms. IL-1 and IL-1ß are 2 distinct cytokines found in the cartilage, synovial membrane, and synovial fluid of patients with osteoarthritis. The aim of these studies was to evaluate the pharmacokinetics of ABT-981, a dual variable domain immunoglobulin (DVD-Ig) capable of simultaneously binding IL-1 and IL-1ß, in healthy subjects and patients with osteoarthritis of the knee. Fifty-six healthy adult subjects were randomized to receive single doses of ABT-981 intravenously (0.3, 1, 3, or 10 mg/kg), subcutaneously (0.3, 1, 3 mg/kg), or matching placebo in a 3:1 ratio. Thirty-six patients with osteoarthritis of the knee were randomized to receive 4 subcutaneous ABT-981 doses of 0.3, 1, or 3 mg/kg administered every 2 weeks, 3 subcutaneous doses of ABT-981 3 mg/kg every 4 weeks, or matching placebo in a 7:2 active:placebo ratio. ABT-981 behaved similarly to conventional monoclonal antibodies following single or multiple doses with mean maximum serum concentrations 2 to 9 days after subcutaneous doses, mean terminal half-lives of 10 to 14 days, and an absolute subcutaneous bioavailability of 46%. Exposure of ABT-981 was approximately linear following single or multiple doses every 2 weeks with monoexponential decline of terminal-phase concentrations. The most common adverse events associated with ABT-981 were diarrhea and headache in healthy subjects and injection site erythema in subjects with osteoarthritis of the knee. Decreased absolute neutrophil counts were observed in response to ABT-981 administration.
File Format	HTM / HTML
ISSN	00912700
Issue Number	12
Journal	The Journal of Clinical Pharmacology
Volume Number	56
e-ISSN	15524604
Language	English
Publisher	Wiley
Publisher Date	2016-12-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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