Tocilizumab

(Actemra®)

Actemra®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 80 mg/4 mL [20 mg/mL], 200 mg/10 mL [20 mg/mL], 400 mg/20 mL [20 mg/mL]); Injection (subcutaneous; 162 mg/0.9 mL)
Drug ClassInterleukin-6 receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of rheumatoid arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
  • Indicated for treatment of giant cell arteritis (GCA): Adult patients with giant cell arteritis.
  • Indicated for treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD): Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
  • Indicated for treatment of polyarticular juvenile idiopathic arthritis (PJIA): Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
  • Indicated for treatment of systemic juvenile idiopathic arthritis (SJIA): Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
  • Indicated for treatment of cytokine release syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
  • Indicated for treatment of coronavirus disease 2019 (COVID-19): Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Latest News

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Summary
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  • Actemra (tocilizumab) is indicated for the treatment of rheumatoid arthritis (RA) in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs); the treatment of giant cell arteritis (GCA) in adult patients with giant cell arteritis; the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD); the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; the treatment of systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older with active systemic juvenile idiopathic arthritis; the treatment of cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
  • This summary is based on the review of 93 systematic review(s)/meta-analysis(es). [1-95]
  • Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Tocilizumab led to a reduction in disease progression, with a 66% lower risk of a >10% decrease in FVC% predicted compared to placebo.
  • Rheumatoid Arthritis (RA): Tocilizumab significantly reduced oral glucocorticoid use compared to TNF-inhibitors and abatacept and was particularly effective in genetic subgroups with the IL-6R rs12083537 AA genotype.
  • COVID-19: Tocilizumab was associated with reduced 28-day mortality, decreased need for mechanical ventilation, and higher hospital discharge rates compared to standard of care, with improved outcomes particularly in non-intubated severe cases.
  • Giant Cell Arteritis (GCA): Tocilizumab reduced the risk of relapse and serious adverse events compared to methotrexate and glucocorticoid use, effectively achieving sustained remission and lowering the need for escape therapy.
  • Rheumatoid Arthritis (RA): Tocilizumab resulted in increased lipid profiles but no significant difference in the incidence of serious adverse events compared to other treatments. Genetic markers indicated variability in safety outcomes.
  • COVID-19: Tocilizumab was associated with a higher incidence of adverse reactions, including secondary infections, thrombotic and bleeding events, and acute liver injury, compared to baricitinib. However, it did not significantly increase the risk of serious adverse events or infections compared to standard of care.
  • Giant Cell Arteritis (GCA): Tocilizumab had a safety profile comparable to other glucocorticoid-sparing agents, with no significant increase in serious adverse events.
  • Subgroups based on genetic polymorphisms, particularly IL-6R SNPs in Rheumatoid Arthritis (RA) patients, exhibited variable responses and safety profiles, with the IL-6R rs12083537 AA genotype showing a better treatment response to tocilizumab, suggesting personalized treatment considerations.
  • In COVID-19, tocilizumab was more effective in severe non-intubated cases and patients receiving corticosteroids, indicating the importance of patient selection for optimal outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Actemra (tocilizumab) Prescribing Information.2022Genentech Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Tocilizumab in patients with systemic sclerosis-associated interstitial lung disease: a systematic review and meta-analysis.2024Annals of the American Thoracic Society
Oral glucocorticoid use in patients with rheumatoid arthritis initiating TNF-inhibitors, tocilizumab or abatacept: results from the international TOCERRA and PANABA observational collaborative studies.2024Joint Bone Spine
Assessment of the available therapeutic approaches for severe COVID-19: a meta-analysis of randomized controlled trials.2023Scientific Reports
Efficacy and safety of tocilizumab and baricitinib among patients hospitalized for COVID-19: a systematic review and meta-analysis.2023Frontiers in Pharmacology
Effectiveness of tocilizumab in non-intubated cases with COVID-19: a systematic review and meta-analysis.2023Infection
Efficacy and safety of interleukin-6 receptor antagonists in adult patients admitted to intensive care unit with COVID-19: a systematic review and meta-analysis of randomized controlled trials.2023Preventive Medicine Reports
Interleukin-6 blocking agents for treating COVID-19: a living systematic review.2023Cochrane Database of Systematic Reviews
Effect of tocilizumab, sarilumab, and baricitinib on mortality among patients hospitalized for COVID-19 treated with corticosteroids: a systematic review and meta-analysis.2023Clinical Microbiology and Infection
Randomized clinical trials on the efficacy and safety of tocilizumab in subjects with rheumatoid arthritis: a systematic review.2023Current Reviews in Clinical and Experimental Pharmacology
Genetic biomarkers as predictors of response to tocilizumab in rheumatoid arthritis: a systematic review and meta-analysis.2022Genes
Effectiveness of tocilizumab in the treatment of hospitalized adults COVID-19: a systematic review and meta-analysis.2022Medicine Open
Efficacy and harms of tocilizumab for the treatment of COVID-19 patients: a systematic review and meta-analysis.2022PLoS One
Australian public assessment report for tocilizumab (RCH).2022Australian Government Department of Health
Clinical efficacy and safety of interleukin-6 receptor antagonists (tocilizumab and sarilumab) in patients with COVID-19: a systematic review and meta-analysis.2022Emerging Microbs and Infections
Associations between the interleukin-6 rs1800795 G/C and interleukin-6 receptor rs12083537 A/G polymorphisms and response to disease-modifying antirheumatic drugs in rheumatoid arthritis: a meta-analysis.2022International Immunopharmacology
Indirect comparison of glucocorticoid-sparing agents for remission maintenance in giant cell arteritis: a network meta-analysis.2022Mayo Clinic Proceedings
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.2022RMD Open
Efficacy of pharmacological interventions in COVID-19: a network meta-analysis.2022British Journal of Clinical Pharmacology
Efficacy and safety of baricitinib and tocilizumab in hospitalized patients with COVID-19: a comparison using systematic review and meta-analysis.2022Frontiers in Pharmacology
Association between tocilizumab, sarilumab and all-cause mortality at 28 days in hospitalised patients with COVID-19: a network meta-analysis.2022PLoS One
Efficacy of COVID-19 treatments among geriatric patients: a systematic review.2022Therapeutic Advances in Infectious Disease
Tocilizumab for giant cell arteritis.2022Cochrane Database of Systematic Reviews
Tocilizumab in addition to standard of care in the management of COVID-19: a meta-analysis of RCTs.2022Acta Biomedica
Efficacy and secondary infection risk of tocilizumab, sarilumab and anakinra in COVID-19 patients: a systematic review and meta-analysis.2022Reviews in Medical Virology
Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials.2022British Journal of Clinical Pharmacology
Mortality rates among hospitalized patients with COVID-19 infection treated with tocilizumab and corticosteroids: a Bayesian reanalysis of a previous meta-analysis.2022JAMA Network Open
Use of tocilizumab and sarilumab alone or in combination with corticosteroids for covid-19: systematic review and network meta-analysis.2022BMJ Medicine
Efficacy and safety of tocilizumab in the management of COVID-19: a systematic review and meta-analysis of observational studies.2022Clinical and Experimental Rheumatology
Efficacy and safety of immunomodulators in patients with COVID-19: a systematic review and network meta-analysis of randomized controlled trials.2022Infectious Diseases and Therapy
Specific interleukin-1 inhibitors, specific interleukin-6 inhibitors, and GM-CSF blockades for COVID-19 (at the edge of sepsis): a systematic review.2022Frontiers in Pharmacology
Association between tocilizumab treatment and clinical outcomes of COVID-19 patients: a systematic review and meta-analysis.2022Aging
Comparative efficacy and safety of biologic agents in patients with active rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitors: a Bayesian network meta-analysis of randomized controlled trials.2022International Journal of Clinical Pharmacology and Therapeutics
Tocilizumab in patients hospitalized with COVID-19 pneumonia: systematic review and meta-analysis of randomized controlled trials.2022Journal of Investigative Medicine
The use of tocilizumab in patients with COVID-19: a systematic review, meta-analysis and trial sequential analysis of randomized controlled studies.2021Journal of Clinical Medicine
Tocilizumab and systemic corticosteroids in the management of patients with COVID-19: a systematic review and meta-analysis.2021International Journal of Infectious Diseases
Efficacy and secondary infection risk of tocilizumab, sarilumab and anakinra in COVID-19 patients: a systematic review and meta-analysis.2021Reviews in Medical Virology
Tocilizumab administration for the treatment of hospitalized patients with COVID-19: a systematic review and meta-analysis.2021Respirology
Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and meta-analysis of clinical trial studies.2021Reumatologia
Tocilizumab in the treatment of COVID-19-A meta-analysis.2021International Journal of Medicine
Rationale and evidence on the use of tocilizumab in COVID-19: a systematic review.2021Pulmonology
Assessment report: RoActemra.2021European Medicines Agency
Systematic review on treatment trials of tocilizumab: a repurposing drug against COVID-19.2021Reviews on Recent Clinical Trials
A systematic review on treatment-related mucocutaneous reactions in COVID-19 patients.2021Dermatologic Therapy
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: a systematic review and network meta-analysis.2021PLoS Medicine
Tocilizumab for treating COVID-19: a systemic review and meta-analysis of retrospective studies.2021European Journal of Clinical Pharmacology
Efficacy of tocilizumab in COVID-19: a systematic review and meta-analysis.2021Journal of Medical Virology
Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis.2021Clinical Microbiology and Infection
Efficacy and safety of tocilizumab for coronavirus disease 2019 (COVID-19) patients: a systematic review and meta-analysis.2021Drug Research
Interleukin-6 blocking agents for treating COVID-19: a living systematic review.2021Cochrane Database of Systematic Reviews
Comparison of the efficacy and safety of biological agents in patients with systemic juvenile idiopathic arthritis: a Bayesian network meta-analysis of randomized controlled trials.2021International Journal of Clinical Pharmacology and Therapeutics
Interventions for treatment of COVID-19: second edition of a living systematic review with meta-analyses and trial sequential analyses (The LIVING Project).2021PLoS One
Decreased mortality in coronavirus disease 2019 patients treated with tocilizumab: a rapid systematic review and meta-analysis of observational studies.2021Clinical Infectious Diseases
Tocilizumab as treatment for COVID-19: a systematic review and meta-analysis.2021World Journal of Methodology
Efficacy and safety of tocilizumab in severe and critical COVID-19: a systematic review and meta-analysis.2021Expert Review of Clinical Immunology
IL-6 inhibition in the treatment of COVID-19: a meta-analysis and meta-regression.2021Journal of Infection
A complementary critical appraisal on systematic reviews regarding the most efficient therapeutic strategies for the current COVID-19 (SARS-CoV-2) pandemic.2021Journal of Medical Virology
Tocilizumab in hospitalized patients with COVID-19: a meta analysis of randomized controlled trials.2021Lung
Tocilizumab in COVID-19: a meta-analysis, trial sequential analysis, and meta-regression of randomized-controlled trials.2021Intensive Care Medicine
Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19).2021Leukemia
Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider.2021Annals of Rheumatic Diseases
Efficacy and safety of steroid-sparing treatments in giant cell arteritis according to the glucocorticoids tapering regimen: a systematic review and meta-analysis.2021European Journal of Internal Medicine
Giant cell arteritis: a systematic review and meta-analysis of test accuracy and benefits and harms of common treatments.2021ACR Open Rheumatology
The effect of tocilizumab on COVID-19 patient mortality: a systematic review and meta-analysis of randomized controlled trials.2021International Immunopharmacology
Effect of tocilizumab in reducing the mortality rate in COVID-19 patients: a systematic review with meta-analysis.2021Journal of Personalized Medicine
Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: a network meta-analysis.2021Medicine
The effect of tocilizumab on mortality in hospitalized patients with COVID-19: a meta-analysis of randomized controlled trials.2021European Journal of Clinical Pharmacology
Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis, first update.2021Clinical Microbiology and Infection
Tocilizumab treatment for COVID-19 patients: a systematic review and meta-analysis.2021Infectious Diseases of Poverty
Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials.2021International Journal of Clinical Pharmacology and Therapeutics
Tocilizumab and systemic corticosteroids in the management of patients with COVID-19: a systematic review and meta-analysis.2021International Journal of Infectious Diseases
Systematic review and subgroup meta-analysis of randomized trials to determine tocilizumab's place in COVID-19 pneumonia.2021Infectious Diseases and Therapy
Systematic review and meta-analysis of anakinra, sarilumab, siltuximab and tocilizumab for COVID-19.2021Thorax
Systematic review and meta-analysis of tocilizumab therapy versus standard of care in over 15,000 COVID-19 pneumonia patients during the first eight months of the pandemic.2021International Journal of Environmental Research and Public Health
Tocilizumab for giant cell arteritis.2021Cochrane Database of Systematic Reviews
Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: a meta-analysis.2021Journal of the American Medical Association
Tocilizumab for the treatment of immune-related adverse events: a systematic literature review and a multicentre case series.2021European Journal of Internal Medicine
The use of tocilizumab in patients with COVID-19: a systematic review, meta-analysis and trial sequential analysis of randomized controlled studies.2021Journal of Clinical Medicine
Immunomodulatory therapies for the treatment of SARS-CoV-2 infection: an update of the systematic literature review to inform EULAR points to consider.2021RMD Open
Efficacy of COVID-19 treatments: a Bayesian network meta-analysis of randomized controlled trials.2021Frontiers in Public Health
Beneficial and harmful outcomes of tocilizumab in severe COVID-19: a systematic review and meta-analysis.2021Pharmacotherapy
Tocilizumab administration for the treatment of hospitalized patients with COVID-19: a systematic review and meta-analysis.2021Respirology
Effectiveness of tocilizumab in Behcet's disease: a systematic literature review.2020Seminars in Arthritis and Rheumatism
Tocilizumab for the treatment of TAFRO syndrome: a systematic literature review.2020Annals of Hematology
Tocilizumab for severe COVID-19: a systematic review and meta-analysis.2020International Journal of Antimicrobial Agents
Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis.2020Clinical Microbiology and Infection
Efficacy of tocilizumab in COVID-19: a systematic review and meta-analysis.2020Journal of Medical Virology
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: a systematic review and network meta-analysis.2020PLoS Medicine
Addition of tocilizumab to the standard of care reduces mortality in severe COVID-19: a systematic review and meta-analysis.2020Frontiers in Medicine
Clinical outcomes in COVID-19 patients treated with tocilizumab: an individual patient data systematic review.2020Journal of Medical Virology
Efficacy of various treatment modalities for nCOV-2019: a systematic review and meta-analysis.2020European Journal of Investigation
Mortality in tocilizumab-treated patients with COVID-19: a systematic review and meta-analysis.2020Clinical and Experimental Rheumatology
Efficacy and safety of biological agents in patients with giant cell arteritis: a meta-analysis of randomized trials.2020International Journal of Clinical Pharmacology and Pharmaceutics
The benefit-risk balance for biological agents in juvenile idiopathic arthritis: a meta-analysis of randomized clinical trials.2020Rheumatology
A systematic review of trial registry entries for randomized clinical trials investigating COVID-19 medical prevention and treatment.2020PLoS One
Comparison of adverse events of biologicals for treatment of juvenile idiopathic arthritis: a systematic review.2019Expert Opinion on Drug Safety

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