The effects of the spleen tyrosine kinase inhibitor fostamatinib on ambulatory blood pressure in patients with active rheumatoid arthritis: results of.

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The effects of the spleen tyrosine kinase inhibitor fostamatinib on ambulatory blood pressure in patients with active rheumatoid arthritis: results of the OSKIRA-ABPM (ambulatory blood pressure monitoring) randomized trial George D. Kitas, MD, PhD, FRCP, Gabriel Abreu, PhD, Krystyna Jedrychowicz-Rosiak, MD, Jeffrey L. Miller, MD, Roumen Nakov, MD, PhD, Seva Panfilov, MD, PhD, Jiri Vencovsky, MD, PhD, Millie Wang, MD, Michael E. Weinblatt, MD, William B. White, MD Journal of the American Society of Hypertension Volume 8, Issue 11, Pages 780-790 (November 2014) DOI: 10.1016/j.jash.2014.08.013 Copyright © 2014 American Society of Hypertension Terms and Conditions

Figure 1 (A) Flow chart of study design. Randomized treatment given on background of disease-modifying anti–rheumatic drug (DMARD). (B) Patient disposition. Percentages are calculated based on the number of patients randomized. ABPM, ambulatory blood pressure monitoring; BP, blood pressure; NSAID, nonsteroidal anti–inflammatory drug. Journal of the American Society of Hypertension 2014 8, 780-790DOI: (10.1016/j.jash.2014.08.013) Copyright © 2014 American Society of Hypertension Terms and Conditions

Figure 2 Ambulatory blood pressure (mm Hg): 24–hour profile plots of hourly group means. Systolic blood pressure (top) and diastolic blood pressure (bottom) were measured by ABPM over a 24–hour period at baseline and day 28 following treatment with fostamatinib or placebo. For patients who withdrew prematurely, ABPM was measured at the early discontinuation visit and used in place of day 28 data. ABPM, ambulatory blood pressure monitoring. Journal of the American Society of Hypertension 2014 8, 780-790DOI: (10.1016/j.jash.2014.08.013) Copyright © 2014 American Society of Hypertension Terms and Conditions

Figure 3 Clinic blood pressure actual values over time. (A) Systolic blood pressure and (B) diastolic blood pressure were measured in the clinic at baseline and at days 8, 15, 29, and 36 following treatment with fostamatinib or placebo. Dotted lines represent vital sign reference ranges. The mean is plotted and the median is represented by the line within the box. The boxes extend to the limits of the interquartile range. The whiskers extend to the most extreme observations within 1.5 times the interquartile range from the nearest quartile. Journal of the American Society of Hypertension 2014 8, 780-790DOI: (10.1016/j.jash.2014.08.013) Copyright © 2014 American Society of Hypertension Terms and Conditions

Figure 4 Disease Activity Score C-reactive protein (CRP) based on a 28–joint count (DAS28) (A) and European League Against Rheumatism (EULAR) (B) responses. DAS28 EULAR response is based on a combination of DAS28 score and DAS28 improvement. Non–responder imputation (baseline observation carried forward) has been applied following premature withdrawal, or any dose of background disease–modifying anti–rheumatic drug (DMARD) increased (all subsequent visits) or any other rheumatoid arthritis (RA) treatment initiated, including DMARDs, anti–tumor necrosis factors (TNFs), or other biologics (all subsequent visits), or receiving any parenteral steroids, or for patients with no post–baseline data. GH, patients’ global assessment on visual analog scale of 100 mm; Ln(CRP), natural logarithm of CRP (mg/L); SJC, 28–joint count for swelling; TJC, 28–joint count for tenderness. Journal of the American Society of Hypertension 2014 8, 780-790DOI: (10.1016/j.jash.2014.08.013) Copyright © 2014 American Society of Hypertension Terms and Conditions