Cited by 855Rheumatoid Arthritis Research and TherapiesAutoimmune and Inflammatory Disorders ResearchNatural Compounds in Disease Treatment

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Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study

Genovese, Mark C., McKay, James D., Nasonov, Evgeny L., Mysler, Eduardo F., da Silva, Nilzio A., Alecock, Emma, Woodworth, Thasia, Gomez‐Reino, Juan J.·2008·Arthritis & Rheumatism

DOI 10.1002/art.23940

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Abstract

Objective To examine the efficacy and safety of the humanized anti-interleukin-6 receptor antibody tocilizumab combined with conventional disease-modifying antirheumatic drugs (DMARDs) in patients with active rheumatoid arthritis (RA). Methods A total of 1,220 patients were randomized (2:1 ratio) in the phase III, double-blind, placebo-controlled, multicenter TOWARD (Tocilizumab in Combination With Traditional DMARD Therapy) study. Patients remained on stable doses of DMARDs and received tocilizumab 8 mg/kg or placebo (control group) every 4 weeks for 24 weeks. Results At week 24, the proportion of patients achieving a response according to the American College of Rheumatology criteria for 20% improvement (ACR20) was significantly greater in the tocilizumab plus DMARD group than in the control group (61% versus 25%; P or=1 adverse event (AE), compared with 61% of patients in the control group. AEs leading to withdrawal from the study were infrequent (4% of patients in the tocilizumab group and 2% of those in the control group). Serious AEs occurred in 6.7% and 4.3% of patients in the tocilizumab and control groups, respectively, and serious infections occurred in 2.7% and 1.9%, respectively. Elevations in the alanine aminotransferase level, from normal at baseline to >3-fold the upper limit of normal, occurred in 4% of patients in the tocilizumab group and 1% of those in the control group, and elevated total cholesterol levels were observed in 23% and 6% of patients, respecti…

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Low Baseline Interleukin-17A Levels Are Associated with Better Treatment Response at 12 Weeks to Tocilizumab Therapy in Rheumatoid Arthritis Patients
Lee, S.-J., Park, W., Park, S. H., Shim, S., Baek, H., Yoo, D., Kim, H., Lee, S., Leee, Y. J., Park, Y., et al. (2015) · Journal of Immunological Research · doi:10.1155/2015/487230 · Cited by 13
Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.
Karsh, J., Keystone, E. C., Haraoui, B. P., Thorne, C., Pope, J. E., Bykerk, V. P., Maksymowych, W. P., Zummer, M., Bensen, W., & KRAISHI, M. M. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.110188 · Cited by 13
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Tocilizumab and missed personalized medicine opportunities for patients with rheumatoid arthritis?
Littman, B. (2009) · Arthritis & Rheumatism · doi:10.1002/art.24474 · Cited by 13
Role of Interleukin-6 in Rheumatoid Arthritis-Associated Interstitial Lung Disease: Focus on the JAK/STAT Pathway and Macrophage Polarization
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Extrapolation of Upadacitinib Efficacy in Juvenile Idiopathic Arthritis Leveraging Pharmacokinetics, Exposure–Response Models, and Real‐World Patient Data
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Louthrenoo, W., Kasitanon, N., Katchamart, W., Aiewruengsurat, D., Chevaisrakul, P., Chiowchanwisawakit, P., Dechanuwong, P., Hanvivadhanakul, P., Mahakkanukrauh, A., Manavathongchai, S., et al. (2017) · International Journal of Rheumatic Diseases · doi:10.1111/1756-185x.13130 · Cited by 12
Safety of biologics in rheumatoid arthritis
Horton, S., Nam, J., & Buch, M. (2012) · International Journal of Clinical Rheumatology · doi:10.2217/ijr.12.37 · Cited by 12
Inhibition of IL6 in rheumatoid arthritis and juvenile idiopathic arthritis.
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IL-6 blockade in chronic inflammatory diseases
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Cardiovascular safety of the class of JAK inhibitors or tocilizumab compared with TNF inhibitors in patients with rheumatoid arthritis: Systematic review and a traditional and Bayesian network meta-analysis of randomized clinical trials
Pugliesi, A., Oliveira, D., Filho, V. A. D. S., Machado, J. D. O., Pereira, A. G., Bichuette, J. D. C. S., Sachetto, Z., de Carvalho, L. S. F., & Bértolo, M. B. (2024) · Seminars in Arthritis and Rheumatism · doi:10.1016/j.semarthrit.2024.152563 · Cited by 14
Bayesian network meta-analysis methods for combining individual participant data and aggregate data from single arm trials and randomised controlled trials
Singh, J., Gsteiger, S., Wheaton, L., Riley, R., Abrams, K., Gillies, C., & Bujkiewicz, S. (2022) · BMC Medical Research Methodology · doi:10.1186/s12874-022-01657-y · Cited by 11
“IPD were available for two trials of tocilizumab [33, 34], whilst only AD were available for the remaining trials [35–49].”
Method
Comparison of individual and combination treatments with naproxen, prednisolone and hydroxychloroquine to treat Complete Freund’s Adjuvant induced arthritis
Akhtar, M., Zubair, S., Saleem, A., Alsharif, K., & Abdel-Daim, M. M. (2021) · InflammoPharmacology · doi:10.1007/s10787-021-00875-y · Cited by 11
Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study
Isaacs, J., Salih, A., Sheeran, T., Patel, Y., Douglas, K., McKay, N., Naisbett-Groet, B., & Choy, E. (2019) · Rheumatology Advances in Practice · doi:10.1093/rap/rkz010 · Cited by 11
Long-term safety and efficacy of weekly subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis who had an inadequate response to subcutaneous tocilizumab every other week: Results from the open-label extension of the SHINOBI study
Ogata, A., Tanaka, Y., Ishii, T., Kaneko, M., Miwa, H., Ohsawa, S., & Yamakawa, R. (2018) · Modern Rheumatology · doi:10.1080/14397595.2018.1533514 · Cited by 11
Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study
Haraoui, B., Jamal, S., Ahluwalia, V., Fung, D., Manchanda, T., & Khraishi, M. (2018) · Rheumatology and Therapy · doi:10.1007/s40744-018-0130-6 · Cited by 11
Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry
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Efficacy and Safety of Tabalumab, an Anti–B-Cell–Activating Factor Monoclonal Antibody, in a Heterogeneous Rheumatoid Arthritis Population: Results From a Randomized, Placebo-Controlled, Phase 3 Trial (FLEX-O)
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Self-citation
Tocilizumab unmasks a stage-dependent interleukin-6 component in statin-induced apoptosis of metastatic melanoma cells
Minichsdorfer, C., Wasinger, C., Sieczkowski, E., Atil, B., & Hohenegger, M. (2015) · Melanoma research · doi:10.1097/cmr.0000000000000172 · Cited by 11
IL-17RA in Intestinal Inflammation
Liu, S., Ren, J., & Li, J. (2014) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000217 · Cited by 13
IL-6 pathway-driven investigation of response to IL-6 receptor inhibition in rheumatoid arthritis
Wang, J., Platt, A., Upmanyu, R., Germer, S., Lei, G., Rabe, C., Benayed, R., Kenwright, A., Hemmings, A., Martin, M., et al. (2013) · BMJ Open · doi:10.1136/bmjopen-2013-003199 · Cited by 59
Tocilizumab: is there life beyond anti‐TNF blockade?
Alves, J., Marinho, A., & Serra, M. (2011) · International journal of clinical practice · doi:10.1111/j.1742-1241.2010.02612.x · Cited by 11
Targeting the Glycoprotein 130 Receptor Subunit to Control Pain and Inflammation
Jazayeri, J., Upadhyay, A., Vernallis, A., & Carroll, G. (2010) · Journal of Interferon and Cytokine Research · doi:10.1089/jir.2010.0035 · Cited by 11
[Current treatment of rheumatoid arthritis].
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The time has come to limit the placebo period in rheumatoid arthritis trials to 3 months: a systematic comparison of 3- and 6-month response rates in trials of biological agents
Boers, M. (2009) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2009.115832 · Cited by 11
“the literature was searched for trials of currently licensed and commonly used biological agents in patients with moderate to severe RA who had an incomplete response to DMARDs. To be eligible for the current review, trial treatment had to be constant over 6 months and data on ACR20, ACR50, ACR70 response at both 3 an…”
Integrated Bioinformatics and Experimental Analysis Revealed Crosstalk Between IL-6, Autophagy, Ubiquitination, and Key miRNAs in Female Infertility: Insights from Ovarian Endometriosis and Polycystic Ovary Syndrome
Nahdi, S., Arafah, M., & Harrath, A. H. (2025) · Cells · doi:10.3390/cells14211693 · Cited by 12
Tocilizumab Reduces Depression Risk in Rheumatoid Arthritis Patients: A Systematic Review and Meta-Analysis
Baghdadi, L. (2024) · Psychology Research and Behavior Management · doi:10.2147/prbm.s482409 · Cited by 10
Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis
Karateev, A., Lila, A., Panevin, T., Potapova, A., Semashko, A., Bobkova, A. O., Amirjanova, V. N., & Zotkin, E. (2022) · Rheumatology Science and Practice · doi:10.47360/1995-4484-2022-427-437 · Cited by 10
Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs
Daraghmeh, D. N., Hopkins, A., King, C., Abuhelwa, A., Wechalekar, M., Proudman, S., Sorich, M., & Wiese, M. (2022) · Rheumatology · doi:10.1093/rheumatology/keac357 · Cited by 10
Systems model identifies baseline cytokine concentrations as potential predictors of rheumatoid arthritis inflammatory response to biologics
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New Rheumatoid Arthritis Treatments for ‘Old’ Patients: Results of a Systematic Review
Caporali, R., Fakhouri, W., Nicolay, C., Longley, H. J., Losi, S., & Rogai, V. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01435-6 · Cited by 10
Cardiovascular Effects of Biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Drakopoulou, M. I., Σουλαϊδόπουλος, Σ., Oikonomou, G., Tousoulis, D. M., & Toutouzas, K. P. (2020) · Current Vascular Pharmacology · doi:10.2174/1570161118666200214115532 · Cited by 12
The multi-biomarker disease activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II trial
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“The response of CRP, which is a component of the MBDA score, can precede clinical response with biologics [30, 31].”
Background
Patient-reported outcomes in newly diagnosed early rheumatoid arthritis patients treated to target with a tocilizumab- or methotrexate-based strategy
Teitsma, X. M., Jacobs, J. W. G., Welsing, P. M. J., Pethö‐Schramm, A., Borm, M. E. A., Hendriks, L., Denissen, N. H. A. M., van Laar, J. M., Lafeber, F. P. J. G., & Bijlsma, J. W. J. (2017) · Rheumatology · doi:10.1093/rheumatology/kex319 · Cited by 12
RITUXIMAB AND TOCILIZUMAB FOR THE TREATMENT OF RHEUMATOID ARTHRITIS
González-Vacarezza, N., Aleman, A., González, G., & Pérez, A. (2014) · International Journal of Technology Assessment in Health Care · doi:10.1017/s0266462314000221 · Cited by 10
“References included in the metaanalysis: 25 (28-52).”
Clinical and ultrasound evaluation of the response to tocilizumab treatment in patients with rheumatoid arthritis: a case series
Epis, O., Filippucci, E., Sedie, A. D., de Matthaeis, A., & Bruschi, E. (2014) · Rheumatology International · doi:10.1007/s00296-012-2638-3 · Cited by 10
“This rapid and prolonged effect is in line with some previous larger clinical trials, which highlighted the efficacy of tocilizumab starting from the first weeks of therapy and lasting for the entire period of follow-up [2, 6, 8].”
Result

Authors: Genovese, M. C., McKay, J. D., Nasonov, E. L., Mysler, E. F., da Silva, N. A., Alecock, E., Woodworth, T., & Gomez‐Reino, J. J.
Affiliations: Stanford Medicine (US)
Oklahoma State University at Tulsa (US)
Association of Rheumatologists of Russia (RU)
Roche (United Kingdom) (GB)
ORCID: Genovese, Mark C.
McKay, James D.
Nasonov, Evgeny L.
Mysler, Eduardo F.
Woodworth, Thasia
Venue: Arthritis & Rheumatism
Publisher: Wiley
Published: 2008-09-29
Volume: 58
Issue: 10
Pages: 2968-2980
ISSN: 0004-3591 (ISSN-L)
1529-0131
DOI: 10.1002/art.23940
OpenAlex: W2063485775
Cited by: 855
References: 0
Citations by year: 2026: 13 · 2025: 19 · 2024: 17 · 2023: 22 · 2022: 28 · 2021: 31 · 2020: 42 · 2019: 32 · 2018: 48 · 2017: 49 · 2016: 57 · 2015: 63 · 2014: 61 · 2013: 82 · 2012: 67
FWCI: 51.32
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Arthritis & Rheumatism (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Health Sciences › Medicine › Hematology › Autoimmune and Inflammatory Disorders Research
Health Sciences › Medicine › Complementary and alternative medicine › Natural Compounds in Disease Treatment
Keywords: tocilizumab, IL-6 receptor inhibition, rheumatoid arthritis, disease-modifying antirheumatic drugs, combination therapy, inadequate response to DMARDs, ACR20 response, DAS28 remission, C-reactive protein, adverse events, serious infections, alanine aminotransferase elevation, total cholesterol, drug safety
MeSH terms: Adult, Aged, Antibodies, Monoclonal, Arthritis, Rheumatoid, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Severity of Illness Index, Antirheumatic Agents, Receptors, Interleukin-6, Antibodies, Monoclonal, Humanized

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Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study

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