A systematic literature review informing the consensus statement on efficacy and safety of pharmacological treatment with interleukin-6 pathway inhibition with biological DMARDs in immune-mediated inflammatory diseases
RMD Open, vol. 8, pp. e002359
Abstract
OBJECTIVES: Informing an international task force updating the consensus statement on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) selectively targeting interleukin-6 (IL-6) pathway in the context of immune-mediated inflammatory diseases. METHODS: A systematic literature research of all publications on IL-6 axis inhibition with bDMARDs published between January 2012 and December 2020 was performed using MEDLINE, EMBASE and Cochrane CENTRAL databases. Efficacy and safety outcomes were assessed in clinical trials including their long-term extensions and observational studies. Meeting abstracts from ACR, EULAR conferences and results on clinicaltrials.gov were taken into consideration. RESULTS: 187 articles fulfilled the inclusion criteria. Evidence for positive effect of IL-6 inhibition was available in various inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still's disease, cytokine release syndrome due to chimeric antigen receptor T cell therapy and systemic sclerosis-associated interstitial lung disease. Newcomers like satralizumab and anti-IL-6 ligand antibody siltuximab have expanded therapeutic approaches for Castleman's disease and neuromyelitis optica, respectively. IL-6 inhibition did not provide therapeutic benefits in psoriatic arthritis, ankylosing spondylitis and certain connective tissue diseases. In COVID-19, tocilizumab (TCZ) has proven to be therapeutic in advanced disease. Safety outcomes did not differ from other bDMARDs, except higher risks of diverticulitis and lower gastrointestinal perforations. Inconsistent results were observed in several studies investigating the risk for infections when comparing TCZ to TNF-inhibitors. CONCLUSION: IL-6 inhibition is effective for treatment of several inflammatory diseases with a safety profile that is widely comparable to other bDMARDs.
Authors 17
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Affiliation as printed
Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Wien, Austria
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Daniel Aletaha corresponding
Affiliation as printed
Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Wien, Austria
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Charité - Universitätsmedizin Berlin
Affiliation as printed
Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany
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Affiliation as printed
University Library, Medical University of Vienna, Wien, Austria
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Medical University of Graz · Krankenhaus Bruneck
Affiliation as printed
Rheumatology, Hospital of Bruneck, Bruneck, Italy
Rheumatology, Medical University of Graz, Graz, Austria
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Hôpital Cochin · Université Paris Descartes
Affiliation as printed
Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France
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Affiliation as printed
Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK
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Affiliation as printed
UO Pediatria II—Reumatologia, Istituto Giannina Gaslini, Genova, Italy
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Affiliation as printed
Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, UK
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Affiliation as printed
Section for Outcomes Research, Medical University of Vienna, Vienna, Austria
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Affiliation as printed
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Japan
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Affiliation as printed
Division of Gastroenterology and Hepatology, Medical University of Vienna Department of Medicine III, Wien, Austria
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Leiden University Medical Center
Affiliation as printed
Rheumatology, LUMC, Leiden, The Netherlands
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Radboud University Medical Center · Sint Maartenskliniek · Sint Maartenskliniek
Affiliation as printed
Department of Pharmacy and Department of Research & Innovation, Sint Maartenskliniek, Ubbergen, The Netherlands
Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands
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Oregon Health & Science University
Affiliation as printed
Schools of Medicine and Public Health, Oregon Health and Science University, Portland, Oregon, USA
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Affiliation as printed
Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Wien, Austria
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Affiliation as printed
Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Wien, Austria
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