title: Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious.
abstract: OBJECTIVE
  To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).
  
  
  METHODS
  We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.
  
  
  RESULTS
  A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.
  
  
  CONCLUSIONS
  In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.
authors.affiliation: a Department of Rheumatology , Odense University Hospital , Odense , Denmark.
authors.forename: H M
authors.initials: HM
authors.lastname: Lindegaard
authors.affiliation: b Holbaek Hospital , Holbaek , Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Johansen
authors.affiliation: c Landspitali University Hospital , Reykjavik , Iceland.
authors.forename: G
authors.initials: G
authors.lastname: Gröndal
authors.affiliation: d Frederiksberg Hospital , Frederiksberg , Denmark.
authors.forename: E C
authors.initials: EC
authors.lastname: Jensen
authors.affiliation: e Gentofte Hospital , Gentofte , Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Juul
authors.affiliation: f Aalborg University Hospital , Aalborg , Denmark.
authors.forename: A M
authors.initials: AM
authors.lastname: Schlemmer
authors.affiliation: g Roche A/S , Hvidovre , Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Agular
authors.affiliation: h Svendborg Hospital , Svendborg , Denmark.
authors.forename: Imj
authors.initials: I
authors.lastname: Hansen
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D002097:C-Reactive Protein / Q000276:immunology; D004342:Drug Hypersensitivity / Q000209:etiology; D004487:Edema / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005483:Flushing / Q000139:chemically induced; D005938:Glucocorticoids / Q000627:therapeutic use; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced; D007262:Infusions, Intravenous; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D005938:Glucocorticoids; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; C502936:tocilizumab; D008727:Methotrexate