title: Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions.
abstract: BACKGROUND
  Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. This consensus document informs on interference with the IL-6 pathway based on evidence and expert opinion.
  
  
  METHODS
  Preparation of this document involved international experts in RA treatment and RA patients. A systematic literature search was performed that focused on TCZ and other IL6-pathway inhibitors in RA and other diseases. Subsequently, incorporating available published evidence and expert opinion, the steering committee and a broader expert committee (both including RA patients) formulated the current consensus statement.
  
  
  RESULTS
  The consensus statement covers use of TCZ as combination- or monotherapy in various RA populations and includes clinical, functional and structural aspects. The statement also addresses the second approved indication in Europe JIA and non-approved indications. Also early phase trials involving additional agents that target the IL-6 receptor or IL-6 were evaluated. Safety concerns, including haematological, hepatic and metabolic issues as well as infections, are addressed likewise.
  
  
  CONCLUSIONS
  The consensus statement identifies points to consider when using TCZ, regarding indications, contraindications, screening, dose, comedication, response evaluation and safety. The document is aimed at supporting clinicians and informing patients, administrators and payers on opportunities and limitations of IL-6 pathway inhibition.
authors.affiliation: Correspondence to Professor Josef S Smolen, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Waehringer Guertel 18-20, Vienna A-1090, Austria. josef.smolen@wienkav.at
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
authors.forename: Monika M
authors.initials: MM
authors.lastname: Schoels
authors.forename: Norihiro
authors.initials: N
authors.lastname: Nishimoto
authors.forename: Ferdinand C
authors.initials: FC
authors.lastname: Breedveld
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.forename: Cem
authors.initials: C
authors.lastname: Gabay
authors.forename: Allan
authors.initials: A
authors.lastname: Gibofsky
authors.forename: Juan Jesus
authors.initials: JJ
authors.lastname: Gomez-Reino
authors.forename: Graeme
authors.initials: G
authors.lastname: Jones
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.forename: Miho
authors.initials: M
authors.lastname: Murakami
authors.forename: Neil
authors.initials: N
authors.lastname: Betteridge
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.forename: Vivian
authors.initials: V
authors.lastname: Bykerk
authors.forename: Ernest H
authors.initials: EH
authors.lastname: Choy
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cutolo
authors.forename: Winfried
authors.initials: W
authors.lastname: Graninger
authors.forename: Angel
authors.initials: A
authors.lastname: Lanas
authors.forename: Emilio
authors.initials: E
authors.lastname: Martin-Mola
authors.forename: Carlomaurizio
authors.initials: C
authors.lastname: Montecucco
authors.forename: Mikkel
authors.initials: M
authors.lastname: Ostergaard
authors.forename: Karel
authors.initials: K
authors.lastname: Pavelka
authors.forename: Andrea
authors.initials: A
authors.lastname: Rubbert-Roth
authors.forename: Naveed
authors.initials: N
authors.lastname: Sattar
authors.forename: Marieke
authors.initials: M
authors.lastname: Scholte-Voshaar
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Michael
authors.initials: M
authors.lastname: Trauner
authors.forename: Gabriele
authors.initials: G
authors.lastname: Valentini
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Winthrop
authors.forename: Maarten
authors.initials: M
authors.lastname: de Wit
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
mesh_terms: 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; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D007249:Inflammation / Q000188:drug therapy* / Q000276:immunology; D019947:Receptors, Interleukin-6 / Q000037:antagonists & inhibitors*; D000093242:Interleukin-6 Inhibitors; D015850:Interleukin-6
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D019947:Receptors, Interleukin-6; D000093242:Interleukin-6 Inhibitors; C508600:IL6 protein, human; D015850:Interleukin-6; C502936:tocilizumab