Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

Daniel Aletaha; Andreas Kerschbaumer; Kastriot Kastrati; Christian Dejaco; Maxime Dougados; Iain B McInnes; Naveed Sattar; Tanja A Stamm; Tsutomu Takeuchi; Michael Trauner; Désirée van der Heijde; Marieke Voshaar; Kevin L Winthrop; Angelo Ravelli; Neil Betteridge; Gerd-Rüdiger R Burmester; Johannes Wj Bijlsma; Vivian Bykerk; Roberto Caporali; Ernest H Choy; Catalin Codreanu; Bernard Combe; Mary K Crow; Maarten de Wit; Paul Emery; Roy M Fleischmann; Cem Gabay; Merete Lund Hetland; Kimme L Hyrich; Annamaria Iagnocco; John D Isaacs; Joel M Kremer; Xavier Mariette; Peter A Merkel; Eduardo F Mysler; Peter Nash; Michael T Nurmohamed; Karel Pavelka; Gyula Poor; Andrea Rubbert-Roth; Hendrik Schulze-Koops; Anja Strangfeld; Yoshiya Tanaka; Josef S Smolen

doi:10.1136/ard-2022-222784

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

Daniel Aletaha^*, Andreas Kerschbaumer, Kastriot Kastrati, Christian Dejaco, Maxime Dougados, Iain B McInnes, Naveed Sattar, Tanja A Stamm, Tsutomu Takeuchi, Michael Trauner, Désirée van der Heijde, Marieke Voshaar, Kevin L Winthrop, Angelo Ravelli, Neil Betteridge, Gerd-Rüdiger R Burmester, Johannes Wj Bijlsma, Vivian Bykerk, Roberto Caporali, Ernest H ChoyCatalin Codreanu, Bernard Combe, Mary K Crow, Maarten de Wit, Paul Emery, Roy M Fleischmann, Cem Gabay, Merete Lund Hetland, Kimme L Hyrich, Annamaria Iagnocco, John D Isaacs, Joel M Kremer, Xavier Mariette, Peter A Merkel, Eduardo F Mysler, Peter Nash, Michael T Nurmohamed, Karel Pavelka, Gyula Poor, Andrea Rubbert-Roth, Hendrik Schulze-Koops, Anja Strangfeld, Yoshiya Tanaka, Josef S Smolen

^*Corresponding author for this work

Department for Rheumatology and Spine Diseases

25 Citations (Scopus)

Abstract

BACKGROUND: Targeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the specific receptor using anti-IL-6Rα antibodies or by directly inhibiting the IL-6 cytokine. This paper is an update of a previous consensus document, based on most recent evidence and expert opinion, that aims to inform on the medical use of interfering with the IL-6 pathway.

METHODS: A systematic literature research was performed that focused on IL-6-pathway inhibitors in inflammatory diseases. Evidence was put in context by a large group of international experts and patients in a subsequent consensus process. All were involved in formulating the consensus statements, and in the preparation of this document.

RESULTS: The consensus process covered relevant aspects of dosing and populations for different indications of IL-6 pathway inhibitors that are approved across the world, including rheumatoid arthritis, polyarticular-course and systemic juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, Castleman's disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19. Also addressed were other clinical aspects of the use of IL-6 pathway inhibitors, including pretreatment screening, safety, contraindications and monitoring.

CONCLUSIONS: The document provides a comprehensive consensus on the use of IL-6 inhibition to treat inflammatory disorders to inform healthcare professionals (including researchers), patients, administrators and payers.

Original language	English
Journal	Annals of the Rheumatic Diseases
Volume	82
Issue number	6
Pages (from-to)	773-787
Number of pages	15
ISSN	0003-4967
DOIs	https://doi.org/10.1136/ard-2022-222784
Publication status	Published - Jun 2023

Keywords

Autoimmune diseases
Biological therapy
Rheumatoid arthritis
autoimmune diseases
biological therapy
rheumatoid arthritis

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10.1136/ard-2022-222784

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Aletaha, D., Kerschbaumer, A., Kastrati, K., Dejaco, C., Dougados, M., McInnes, I. B., Sattar, N., Stamm, T. A., Takeuchi, T., Trauner, M., van der Heijde, D., Voshaar, M., Winthrop, K. L., Ravelli, A., Betteridge, N., Burmester, G.-R. R., Bijlsma, J. W., Bykerk, V., Caporali, R., ... Smolen, J. S. (2023). Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update. Annals of the Rheumatic Diseases, 82(6), 773-787. https://doi.org/10.1136/ard-2022-222784

Aletaha, D, Kerschbaumer, A, Kastrati, K, Dejaco, C, Dougados, M, McInnes, IB, Sattar, N, Stamm, TA, Takeuchi, T, Trauner, M, van der Heijde, D, Voshaar, M, Winthrop, KL, Ravelli, A, Betteridge, N, Burmester, G-RR, Bijlsma, JW, Bykerk, V, Caporali, R, Choy, EH, Codreanu, C, Combe, B, Crow, MK, de Wit, M, Emery, P, Fleischmann, RM, Gabay, C, Hetland, ML, Hyrich, KL, Iagnocco, A, Isaacs, JD, Kremer, JM, Mariette, X, Merkel, PA, Mysler, EF, Nash, P, Nurmohamed, MT, Pavelka, K, Poor, G, Rubbert-Roth, A, Schulze-Koops, H, Strangfeld, A, Tanaka, Y & Smolen, JS 2023, 'Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update', Annals of the Rheumatic Diseases, vol. 82, no. 6, pp. 773-787. https://doi.org/10.1136/ard-2022-222784

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title = "Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update",

abstract = "BACKGROUND: Targeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the specific receptor using anti-IL-6Rα antibodies or by directly inhibiting the IL-6 cytokine. This paper is an update of a previous consensus document, based on most recent evidence and expert opinion, that aims to inform on the medical use of interfering with the IL-6 pathway.METHODS: A systematic literature research was performed that focused on IL-6-pathway inhibitors in inflammatory diseases. Evidence was put in context by a large group of international experts and patients in a subsequent consensus process. All were involved in formulating the consensus statements, and in the preparation of this document.RESULTS: The consensus process covered relevant aspects of dosing and populations for different indications of IL-6 pathway inhibitors that are approved across the world, including rheumatoid arthritis, polyarticular-course and systemic juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, Castleman's disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19. Also addressed were other clinical aspects of the use of IL-6 pathway inhibitors, including pretreatment screening, safety, contraindications and monitoring.CONCLUSIONS: The document provides a comprehensive consensus on the use of IL-6 inhibition to treat inflammatory disorders to inform healthcare professionals (including researchers), patients, administrators and payers.",

keywords = "Autoimmune diseases, Biological therapy, Rheumatoid arthritis, autoimmune diseases, biological therapy, rheumatoid arthritis",

author = "Daniel Aletaha and Andreas Kerschbaumer and Kastriot Kastrati and Christian Dejaco and Maxime Dougados and McInnes, {Iain B} and Naveed Sattar and Stamm, {Tanja A} and Tsutomu Takeuchi and Michael Trauner and {van der Heijde}, D{\'e}sir{\'e}e and Marieke Voshaar and Winthrop, {Kevin L} and Angelo Ravelli and Neil Betteridge and Burmester, {Gerd-R{\"u}diger R} and Bijlsma, {Johannes Wj} and Vivian Bykerk and Roberto Caporali and Choy, {Ernest H} and Catalin Codreanu and Bernard Combe and Crow, {Mary K} and {de Wit}, Maarten and Paul Emery and Fleischmann, {Roy M} and Cem Gabay and Hetland, {Merete Lund} and Hyrich, {Kimme L} and Annamaria Iagnocco and Isaacs, {John D} and Kremer, {Joel M} and Xavier Mariette and Merkel, {Peter A} and Mysler, {Eduardo F} and Peter Nash and Nurmohamed, {Michael T} and Karel Pavelka and Gyula Poor and Andrea Rubbert-Roth and Hendrik Schulze-Koops and Anja Strangfeld and Yoshiya Tanaka and Smolen, {Josef S}",

note = "COPECARE {\textcopyright} Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2023",

month = jun,

doi = "10.1136/ard-2022-222784",

language = "English",

volume = "82",

pages = "773--787",

journal = "Annals of the Rheumatic Diseases",

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number = "6",

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TY - JOUR

T1 - Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions

T2 - an update

AU - Aletaha, Daniel

AU - Kerschbaumer, Andreas

AU - Kastrati, Kastriot

AU - Dejaco, Christian

AU - Dougados, Maxime

AU - McInnes, Iain B

AU - Sattar, Naveed

AU - Stamm, Tanja A

AU - Takeuchi, Tsutomu

AU - Trauner, Michael

AU - van der Heijde, Désirée

AU - Voshaar, Marieke

AU - Winthrop, Kevin L

AU - Ravelli, Angelo

AU - Betteridge, Neil

AU - Burmester, Gerd-Rüdiger R

AU - Bijlsma, Johannes Wj

AU - Bykerk, Vivian

AU - Caporali, Roberto

AU - Choy, Ernest H

AU - Codreanu, Catalin

AU - Combe, Bernard

AU - Crow, Mary K

AU - de Wit, Maarten

AU - Emery, Paul

AU - Fleischmann, Roy M

AU - Gabay, Cem

AU - Hetland, Merete Lund

AU - Hyrich, Kimme L

AU - Iagnocco, Annamaria

AU - Isaacs, John D

AU - Kremer, Joel M

AU - Mariette, Xavier

AU - Merkel, Peter A

AU - Mysler, Eduardo F

AU - Nash, Peter

AU - Nurmohamed, Michael T

AU - Pavelka, Karel

AU - Poor, Gyula

AU - Rubbert-Roth, Andrea

AU - Schulze-Koops, Hendrik

AU - Strangfeld, Anja

AU - Tanaka, Yoshiya

AU - Smolen, Josef S

PY - 2023/6

Y1 - 2023/6

N2 - BACKGROUND: Targeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the specific receptor using anti-IL-6Rα antibodies or by directly inhibiting the IL-6 cytokine. This paper is an update of a previous consensus document, based on most recent evidence and expert opinion, that aims to inform on the medical use of interfering with the IL-6 pathway.METHODS: A systematic literature research was performed that focused on IL-6-pathway inhibitors in inflammatory diseases. Evidence was put in context by a large group of international experts and patients in a subsequent consensus process. All were involved in formulating the consensus statements, and in the preparation of this document.RESULTS: The consensus process covered relevant aspects of dosing and populations for different indications of IL-6 pathway inhibitors that are approved across the world, including rheumatoid arthritis, polyarticular-course and systemic juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, Castleman's disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19. Also addressed were other clinical aspects of the use of IL-6 pathway inhibitors, including pretreatment screening, safety, contraindications and monitoring.CONCLUSIONS: The document provides a comprehensive consensus on the use of IL-6 inhibition to treat inflammatory disorders to inform healthcare professionals (including researchers), patients, administrators and payers.

AB - BACKGROUND: Targeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the specific receptor using anti-IL-6Rα antibodies or by directly inhibiting the IL-6 cytokine. This paper is an update of a previous consensus document, based on most recent evidence and expert opinion, that aims to inform on the medical use of interfering with the IL-6 pathway.METHODS: A systematic literature research was performed that focused on IL-6-pathway inhibitors in inflammatory diseases. Evidence was put in context by a large group of international experts and patients in a subsequent consensus process. All were involved in formulating the consensus statements, and in the preparation of this document.RESULTS: The consensus process covered relevant aspects of dosing and populations for different indications of IL-6 pathway inhibitors that are approved across the world, including rheumatoid arthritis, polyarticular-course and systemic juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, Castleman's disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19. Also addressed were other clinical aspects of the use of IL-6 pathway inhibitors, including pretreatment screening, safety, contraindications and monitoring.CONCLUSIONS: The document provides a comprehensive consensus on the use of IL-6 inhibition to treat inflammatory disorders to inform healthcare professionals (including researchers), patients, administrators and payers.

KW - Autoimmune diseases

KW - Biological therapy

KW - Rheumatoid arthritis

KW - autoimmune diseases

KW - biological therapy

KW - rheumatoid arthritis

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U2 - 10.1136/ard-2022-222784

DO - 10.1136/ard-2022-222784

M3 - Journal article

C2 - 35953263

SN - 0003-4967

VL - 82

SP - 773

EP - 787

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 6

ER -

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

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