Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions

Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions

21 November 2012 | Josef S Smolen, Monika M Schoels, Norihiro Nishimoto, Ferdinand C Breedveld, Gerd R Burmester, Maxime Dougados, Paul Emery, Gianfranco Ferraccioli, Cem Gabay, Allan Gibofsky, Juan Jesus Gomez-Reino, Graeme Jones, Tore K Kvien, Miho Murakami, Neil Betteridge, Clifton O Bingham III, Vivian Bykerk, Ernest H Choy, Bernard Combe, Maurizio Cutolo, Winfried Graninger, Angel Lanas, Emilio Martin-Mola, Carlomaurizio Montecucco, Mikkel Ostergaard, Karel Pavelka, Andrea Rubbert-Roth, Naveed Sattar, Marieke Scholte-Voshaar, Yoshiya Tanaka, Michael Trauner, Gabriele Valentini, Kevin L Winthrop, Maarten de Wit, Désirée van der Heijde
This consensus statement provides recommendations for the use of tocilizumab (TCZ), an interleukin-6 (IL-6) receptor inhibitor, in the treatment of rheumatoid arthritis (RA) and other inflammatory conditions. TCZ is currently the only IL-6 pathway inhibitor approved for RA in Europe. The statement is based on evidence from clinical trials and expert opinion, and covers various aspects of TCZ use, including indications, contraindications, dose, co-medication, response evaluation, and safety. TCZ is indicated for adult RA patients with active disease who have not responded adequately to or are intolerant of at least one synthetic disease-modifying antirheumatic drug (sDMARD) or tumor necrosis factor (TNF) inhibitor. It can be used as monotherapy or in combination with MTX or other sDMARDs. The recommended initial dose is 8 mg/kg every 4 weeks, administered intravenously. TCZ has shown efficacy in reducing disease activity, improving functional and structural outcomes, and improving patient-reported outcomes such as pain and quality of life. Safety concerns include infusion reactions, serious infections, hepatic transaminase elevations, gastrointestinal perforations, and neutropenia. TCZ should be used with caution in patients with a history of gastrointestinal perforations, active infections, or chronic hepatitis B or C. Patients should be screened for tuberculosis before starting TCZ, and chemoprophylaxis should be given if they have latent tuberculosis infection. The statement also addresses other indications for TCZ, including systemic juvenile idiopathic arthritis (sJIA), polyarticular JIA, and Castleman's disease. TCZ has also been used in other inflammatory conditions such as secondary amyloidosis, polymyalgia rheumatica, adult-onset Still's disease, and systemic sclerosis, although these are not licensed indications. The consensus statement emphasizes the importance of individualized treatment decisions, considering patient-specific factors and the need for regular monitoring. It also highlights the need for further research to address open questions regarding the efficacy, safety, and optimal use of IL-6 pathway inhibitors in various patient populations. The recommendations aim to support clinicians, patients, payers, and other stakeholders in making informed decisions about the use of IL-6 pathway inhibitors in the treatment of RA and other inflammatory diseases.This consensus statement provides recommendations for the use of tocilizumab (TCZ), an interleukin-6 (IL-6) receptor inhibitor, in the treatment of rheumatoid arthritis (RA) and other inflammatory conditions. TCZ is currently the only IL-6 pathway inhibitor approved for RA in Europe. The statement is based on evidence from clinical trials and expert opinion, and covers various aspects of TCZ use, including indications, contraindications, dose, co-medication, response evaluation, and safety. TCZ is indicated for adult RA patients with active disease who have not responded adequately to or are intolerant of at least one synthetic disease-modifying antirheumatic drug (sDMARD) or tumor necrosis factor (TNF) inhibitor. It can be used as monotherapy or in combination with MTX or other sDMARDs. The recommended initial dose is 8 mg/kg every 4 weeks, administered intravenously. TCZ has shown efficacy in reducing disease activity, improving functional and structural outcomes, and improving patient-reported outcomes such as pain and quality of life. Safety concerns include infusion reactions, serious infections, hepatic transaminase elevations, gastrointestinal perforations, and neutropenia. TCZ should be used with caution in patients with a history of gastrointestinal perforations, active infections, or chronic hepatitis B or C. Patients should be screened for tuberculosis before starting TCZ, and chemoprophylaxis should be given if they have latent tuberculosis infection. The statement also addresses other indications for TCZ, including systemic juvenile idiopathic arthritis (sJIA), polyarticular JIA, and Castleman's disease. TCZ has also been used in other inflammatory conditions such as secondary amyloidosis, polymyalgia rheumatica, adult-onset Still's disease, and systemic sclerosis, although these are not licensed indications. The consensus statement emphasizes the importance of individualized treatment decisions, considering patient-specific factors and the need for regular monitoring. It also highlights the need for further research to address open questions regarding the efficacy, safety, and optimal use of IL-6 pathway inhibitors in various patient populations. The recommendations aim to support clinicians, patients, payers, and other stakeholders in making informed decisions about the use of IL-6 pathway inhibitors in the treatment of RA and other inflammatory diseases.
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