title: Effects of fostamatinib (R788), an oral spleen tyrosine kinase inhibitor, on health-related quality of life in patients with active rheumatoid arthritis: analyses of patient-reported outcomes from a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To assess the influence of fostamatinib on patient-reported outcomes (PRO) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).
  
  
  METHODS
  Patients taking background MTX (N = 457) were enrolled in a phase II clinical trial (NCT00665925) and randomized equally to placebo, fostamatinib 100 mg twice daily (bid), or fostamatinib 150 mg once daily (qd) for 24 weeks. Self-administered PRO measures included pain, patient's global assessment (PtGA) of disease activity, physical function, health-related quality of life (HRQOL), and fatigue. Mean change from baseline and a responder analysis of the proportion of patients achieving a minimal clinically important difference were determined.
  
  
  RESULTS
  At Week 24, there were statistically significant improvements in pain, PtGA, physical function, fatigue, and the physical component summary of the Medical Outcomes Study Short Form-36 (SF-36) for fostamatinib 100 mg bid compared with placebo. Mean (standard error) changes from baseline in the fostamatinib 100 mg bid group versus the placebo group were -31.3 (2.45) versus -17.8 (2.45), p < 0.001 for pain; -29.1 (2.26) versus -16.7 (2.42), p < 0.001 for PtGA; -0.647 (0.064) versus -0.343 (0.062), p < 0.001 for physical function; 7.40 (1.00) versus 4.50 (0.94), p < 0.05 for fatigue; 8.52 (0.77) versus 4.90 (0.78), p < 0.01 for SF-36 physical component score; and 3.99 (0.93) versus 3.71 (0.99), p = 0.83 for SF-36 mental component score. Patients receiving fostamatinib 150 mg qd showed improvements in some PRO, including physical function.
  
  
  CONCLUSIONS
  Patients treated with fostamatinib 100 mg bid showed significant improvements in HRQOL outcomes.
authors: Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA 02115, USA. MWEINBLATT@PARTNERS.ORG
authors: Michael E
authors: ME
authors: Weinblatt
authors: Arthur
authors: A
authors: Kavanaugh
authors: Mark C
authors: MC
authors: Genovese
authors: David A
authors: DA
authors: Jones
authors: Theresa K
authors: TK
authors: Musser
authors: Elliott B
authors: EB
authors: Grossbard
authors: Daniel B
authors: DB
authors: Magilavy
mesh_terms: D000328:Adult; D000368:Aged; D000631:Aminopyridines; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D006801:Humans; D047908:Intracellular Signaling Peptides and Proteins / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D009025:Morpholines; D009043:Motor Activity; D010078:Oxazines / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D011725:Pyridines / Q000627:therapeutic use*; D011743:Pyrimidines; D011788:Quality of Life; D012720:Severity of Illness Index; D000072377:Syk Kinase; D016896:Treatment Outcome
chemical_list: D000631:Aminopyridines; D018501:Antirheumatic Agents; D047908:Intracellular Signaling Peptides and Proteins; D009025:Morpholines; D010078:Oxazines; D011725:Pyridines; D011743:Pyrimidines; D011505:Protein-Tyrosine Kinases; C000606896:SYK protein, human; D000072377:Syk Kinase; C523665:fostamatinib