TY - JOUR
T1 - Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions
AU - Smolen, Josef S.
AU - Schoels, Monika M.
AU - Nishimoto, Norihiro
AU - Breedveld, Ferdinand C.
AU - Burmester, Gerd R.
AU - Dougados, Maxime
AU - Emery, Paul
AU - Ferraccioli, Gianfranco
AU - Gabay, Cem
AU - Gibofsky, Allan
AU - Gomez-Reino, Juan Jesus
AU - Jones, Graeme
AU - Kvien, Tore K.
AU - Murakami, Miho
AU - Betteridge, Neil
AU - Bingham, Clifton O.
AU - Bykerk, Vivian
AU - Choy, Ernest H.
AU - Combe, Bernard
AU - Cutolo, Maurizio
AU - Graninger, Winfried
AU - Lanas, Angel
AU - Martin-Mola, Emilio
AU - Montecucco, Carlomaurizio
AU - Ostergaard, Mikkel
AU - Pavelka, Karel
AU - Rubbert-Roth, Andrea
AU - Sattar, Naveed
AU - Scholte-Voshaar, Marieke
AU - Tanaka, Yoshiya
AU - Trauner, Michael
AU - Valentini, Gabriele
AU - Winthrop, Kevin L.
AU - De Wit, Maarten
AU - Van Der Heijde, Désirée
PY - 2013/4
Y1 - 2013/4
N2 - 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.
AB - 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.
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U2 - 10.1136/annrheumdis-2012-202469
DO - 10.1136/annrheumdis-2012-202469
M3 - Article
C2 - 23172750
AN - SCOPUS:84874426304
SN - 0003-4967
VL - 72
SP - 482
EP - 492
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 4
ER -