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

J Am Soc Hypertens. 2014 Nov;8(11):780-90. doi: 10.1016/j.jash.2014.08.013. Epub 2014 Sep 4.

Abstract

Clinical trials of fostamatinib in patients with rheumatoid arthritis showed blood pressure (BP) elevation using clinic measurements. The OSKIRA-ambulatory BP monitoring trial assessed the effect of fostamatinib on 24-hour ambulatory systolic BP (SBP) in patients with active rheumatoid arthritis. One hundred thirty-five patients were randomized to fostamatinib 100 mg twice daily (bid; n = 68) or placebo bid (n = 67) for 28 days. Ambulatory, clinic, and home BPs were measured at baseline and after 28 days of therapy. Primary end point was change from baseline in 24-hour mean SBP. Fostamatinib increased 24-hour mean SBP by 2.9 mm Hg (P = .023) and diastolic BP (DBP) by 3.5 mm Hg (P < .001) versus placebo. Clinic/home-measured BPs were similar to those observed with ambulatory BP monitoring. After treatment discontinuation (1 week), clinic BP values returned to baseline levels. Fostamatinib induced elevations in 24-hour mean ambulatory SBP and DBP. BP elevations resolved with fostamatinib discontinuation.

Keywords: Hypertension; spleen tyrosine kinase inhibitor; systolic blood pressure.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aminopyridines
  • Antirheumatic Agents / therapeutic use
  • Arthritis, Rheumatoid / complications
  • Arthritis, Rheumatoid / diagnosis
  • Arthritis, Rheumatoid / drug therapy*
  • Blood Pressure Monitoring, Ambulatory
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Hypertension / complications
  • Hypertension / diagnosis
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Morpholines
  • Multivariate Analysis
  • Oxazines / therapeutic use*
  • Protein-Tyrosine Kinases / antagonists & inhibitors*
  • Protein-Tyrosine Kinases / therapeutic use
  • Pyridines / therapeutic use*
  • Pyrimidines
  • Reference Values
  • Risk Assessment
  • Sex Factors
  • Treatment Outcome

Substances

  • Aminopyridines
  • Antirheumatic Agents
  • Morpholines
  • Oxazines
  • Pyridines
  • Pyrimidines
  • Protein-Tyrosine Kinases
  • fostamatinib