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

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; Vivian Bykerk; Ernest H Choy; Bernard Combe; Maurizio Cutolo; Winfried Graninger; Angel Lanas; Emilio Martin-Mola; Carlomaurizio Montecucco; Mikkel Østergaard; 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

doi:10.1136/annrheumdis-2012-202469

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

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, Vivian Bykerk, Ernest H Choy, Bernard Combe, Maurizio CutoloWinfried Graninger, Angel Lanas, Emilio Martin-Mola, Carlomaurizio Montecucco, Mikkel Østergaard, 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

88 Citations (Scopus)

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.

Original language	English
Journal	Annals of the Rheumatic Diseases
ISSN	0003-4967
DOIs	https://doi.org/10.1136/annrheumdis-2012-202469
Publication status	Published - Apr 2013

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Smolen, J. S., Schoels, M. M., Nishimoto, N., Breedveld, F. C., Burmester, G. R., Dougados, M., Emery, P., Ferraccioli, G., Gabay, C., Gibofsky, A., Gomez-Reino, J. J., Jones, G., Kvien, T. K., Murakami, M., Betteridge, N., Bingham, C. O., Bykerk, V., Choy, E. H., Combe, B., ... van der Heijde, D. (2013). Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2012-202469

Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. / Smolen, Josef S; Schoels, Monika M; Nishimoto, Norihiro et al.

In: Annals of the Rheumatic Diseases, 04.2013.

Research output: Contribution to journal › Journal article › Research › peer-review

Smolen, JS, Schoels, MM, Nishimoto, N, Breedveld, FC, Burmester, GR, Dougados, M, Emery, P, Ferraccioli, G, Gabay, C, Gibofsky, A, Gomez-Reino, JJ, Jones, G, Kvien, TK, Murakami, M, Betteridge, N, Bingham, CO, Bykerk, V, Choy, EH, Combe, B, Cutolo, M, Graninger, W, Lanas, A, Martin-Mola, E, Montecucco, C, Østergaard, M, Pavelka, K, Rubbert-Roth, A, Sattar, N, Scholte-Voshaar, M, Tanaka, Y, Trauner, M, Valentini, G, Winthrop, KL, de Wit, M & van der Heijde, D 2013, 'Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions', Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2012-202469

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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.",

author = "Smolen, {Josef S} and Schoels, {Monika M} and Norihiro Nishimoto and Breedveld, {Ferdinand C} and Burmester, {Gerd R} and Maxime Dougados and Paul Emery and Gianfranco Ferraccioli and Cem Gabay and Allan Gibofsky and Gomez-Reino, {Juan Jesus} and Graeme Jones and Kvien, {Tore K} and Miho Murakami and Neil Betteridge and Bingham, {Clifton O} and Vivian Bykerk and Choy, {Ernest H} and Bernard Combe and Maurizio Cutolo and Winfried Graninger and Angel Lanas and Emilio Martin-Mola and Carlomaurizio Montecucco and Mikkel {\O}stergaard and Karel Pavelka and Andrea Rubbert-Roth and Naveed Sattar and Marieke Scholte-Voshaar and Yoshiya Tanaka and Michael Trauner and Gabriele Valentini and Winthrop, {Kevin L} and {de Wit}, Maarten and {van der Heijde}, D{\'e}sir{\'e}e",

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doi = "10.1136/annrheumdis-2012-202469",

language = "English",

journal = "Annals of the Rheumatic Diseases",

issn = "0003-4967",

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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 - Østergaard, 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.

U2 - 10.1136/annrheumdis-2012-202469

DO - 10.1136/annrheumdis-2012-202469

M3 - Journal article

C2 - 23172750

SN - 0003-4967

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

ER -

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

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