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Safety, tolerability, and pharmacodynamics of an anti-interleukin-1α/β dual variable domain immunoglobulin in patients with osteoarthritis of the knee:

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Presentation on theme: "Safety, tolerability, and pharmacodynamics of an anti-interleukin-1α/β dual variable domain immunoglobulin in patients with osteoarthritis of the knee:"— Presentation transcript:

1 Safety, tolerability, and pharmacodynamics of an anti-interleukin-1α/β dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study  S.X. Wang, S.B. Abramson, M. Attur, M.A. Karsdal, R.A. Preston, C.J. Lozada, M.P. Kosloski, F. Hong, P. Jiang, M.J. Saltarelli, B.A. Hendrickson, J.K. Medema  Osteoarthritis and Cartilage  Volume 25, Issue 12, Pages (December 2017) DOI: /j.joca Copyright © 2017 The Authors Terms and Conditions

2 Fig. 1 Disposition of patients. Study enrolled 36 patients with OA of the knee. Four patients discontinued the study drug (after one or two doses of ABT-981 or three doses of placebo) but continued study visits; one patient discontinued the study after one dose of ABT-981. Osteoarthritis and Cartilage  , DOI: ( /j.joca ) Copyright © 2017 The Authors Terms and Conditions

3 Fig. 2 Mean percentage change from baseline in IL-1α (A) and IL-1β (B). Arrows indicate the days of ABT-981 injection; apatients received four injections of ABT-981 (0.3, 1, or 3 mg/kg) or placebo EOW on days 1, 15, 29, and 43 in cohorts 1–3, and bthree injections of ABT-981 (3 mg/kg) E4W on days 1, 29, and 57 in cohort 4. Patients who received placebo E4W (n = 2) were excluded from the analysis. Follow-up period was until day 113 (cohorts 1–3) or day 127 (cohort 4). Error bars represent standard error. Osteoarthritis and Cartilage  , DOI: ( /j.joca ) Copyright © 2017 The Authors Terms and Conditions

4 Fig. 3 Mean percentage change from baseline in ANC vs study day. Arrows indicate the days of ABT-981 injection, as described for Fig. 2. Error bars represent standard error. Osteoarthritis and Cartilage  , DOI: ( /j.joca ) Copyright © 2017 The Authors Terms and Conditions

5 Fig. 4 Mean percentage change from baseline in (A) hsCRP, (B) C1M, (C) C3M, and (D) CRPM. Arrows indicate the days of ABT-981 injection, as described for Fig. 2. Error bars represent standard error. Osteoarthritis and Cartilage  , DOI: ( /j.joca ) Copyright © 2017 The Authors Terms and Conditions

6 Fig. 5 Least-squares mean change from baseline in the VAS patient's assessment of pain. Arrows indicate the days of ABT-981 injection, as described for Fig. 2. Cohort 4 data (E4W dosing) are not shown due to the different assessment schedule. Osteoarthritis and Cartilage  , DOI: ( /j.joca ) Copyright © 2017 The Authors Terms and Conditions


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