Tocilizumab

(Actemra®)

Tocilizumab

Drug updated on 12/11/2024

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 (IL-6) receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
  • Indicated for the treatment of adult patients with giant cell arteritis (GCA)
  • Indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
  • Indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)
  • Indicated for the treatment of patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)
  • Indicated for adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threateningcytokine release syndrome
  • Indicate for 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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  • This summary is based on the review of 34 systematic review(s)/meta-analysis(es). [1-33]
  • Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA): Tocilizumab was approved as a corticosteroid-sparing therapy for GCA, and Sarilumab was approved for PMR, showing effectiveness in managing these conditions.
  • Systemic Juvenile Idiopathic Arthritis (JIA): Canakinumab demonstrated greater effectiveness than placebo (odds ratio (OR) = 55.0) in managing JIA, with Tocilizumab also included in efficacy analyses though ranking lower than Canakinumab.
  • Rheumatoid Arthritis (RA): Tocilizumab showed effective symptom control in RA, particularly for patients with the AA genotype for the Interleukin 6 receptor (IL-6R) gene, achieving better American College of Rheumatology (ACR) 20 and ACR 50 response rates compared to Adalimumab in monotherapy.
  • Sustained Remission in GCA: Tocilizumab maintained higher remission rates than placebo and standard corticosteroid tapering regimens, with weekly dosing being more effective than bi-weekly or placebo.
  • General Safety: No significant differences in adverse events, including serious infections, were noted between Tocilizumab and other biologics or placebo, though infection was the most common adverse event in GCA treatments with Tocilizumab.
  • Specific Risks: Tocilizumab in RA patients showed a significant risk of hepatitis B virus (HBV) reactivation, particularly in positive hepatitis B surface antigen (HBsAg(+)) patients without antiviral prophylaxis, with a reactivation rate of 69.4%. Increased cholesterol levels and a higher risk of lower gastrointestinal perforations were also associated with its use.
  • Safety Profile in Comparative Studies: Tocilizumab demonstrated a comparable safety profile to other biologic disease-modifying anti-rheumatic drugs (bDMARDs) but with a higher risk of diverticulitis and gastrointestinal perforations compared to other treatments.
  • Tocilizumab was primarily studied in RA and GCA patients, with specific subgroup considerations for patients with HBV infection in RA, IL-6R gene polymorphisms, and those aged 50 years or older with GCA, as well as JIA patients and RA patients intolerant to or inadequately responding to Methotrexate (MTX).

Product Monograph / Prescribing Information

Document TitleYearSource
Actemra (tocilizumab) Prescribing Information.2024Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The pipeline of immunomodulatory therapies in polymyalgia rheumatica and giant cell arteritis: A systematic review of clinical trials2024Autoimmunity Reviews
Comparative efficacy and safety of different drugs in patients with systemic juvenile idiopathic arthritis: A systematic review and network meta-analysis2024Medicine
The Risk of Hepatitis B Virus Reactivation in Rheumatoid Arthritis Patients Receiving Tocilizumab: A Systematic Review and Meta-Analysis2024Viruses
Updates on the Prognosis of Giant Cell Arteritis: A Systematic Review2023Cureus
Randomized Clinical Trials on the Efficacy and Safety of Tocilizumab in Subjects with Rheumatoid Arthritis: A Systematic Review2023Int J Mol Sci. 2020 Aug 31;21(17):6290. doi: 10.3390/ijms21176290.
Norwegian society of rheumatology recommendations on diagnosis and treatment of patients with giant cell arteritis2022J Rheumatol. 2023 Jan;50(1):36-47. doi: 10.3899/jrheum.220152. Epub 2022 Aug 15.
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 diseases2022Autoimmun Rev. 2022 Jan;21(1):102927. doi: 10.1016/j.autrev.2021.102927. Epub 2021 Aug 30.
Genetic Biomarkers as Predictors of Response to Tocilizumab in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis2022Eur J Intern Med. 2021 Jun;88:96-103. doi: 10.1016/j.ejim.2021.03.040. Epub 2021 Apr 18.
Tocilizumab for giant cell arteritis2022Autoimmun Rev. 2021 Jun;20(6):102829. doi: 10.1016/j.autrev.2021.102829. Epub 2021 Apr 16.
Comparison of Adalimumab to Other Targeted Therapies in Rheumatoid Arthritis: Results from Systematic Literature Review and Meta-Analysis2022BioDrugs. 2021 Mar;35(2):175-186. doi: 10.1007/s40259-021-00467-w. Epub 2021 Feb 17.
Natural and iatrogenic ocular manifestations of rheumatoid arthritis: a systematic review2022Rheumatology (Oxford). 2020 Sep 1;59(9):2226-2236. doi: 10.1093/rheumatology/keaa170.
Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and meta-analysis of clinical trial studies2021Orphanet J Rare Dis. 2020 Feb 4;15(1):41. doi: 10.1186/s13023-020-1324-x.
Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: A network meta-analysis2021Medicine
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 trials2021Rheumatology (Oxford)
Efficacy and safety of steroid-sparing treatments in giant cell arteritis according to the glucocorticoids tapering regimen: A systematic review and meta-analysis2021European Journal of Internal Medicine
Comparative efficacy and safety of Janus kinase inhibitors and biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and network meta-analysis2021Therapeutic Advances in Musculoskeletal Disease
Giant Cell Arteritis: A Systematic Review and Meta-Analysis of Test Accuracy and Benefits and Harms of Common Treatments2021American College of Rheumatology Open Rheumatology
Comparative effectiveness and safety of non-tumour necrosis factor biologics and Janus kinase inhibitors in patients with active rheumatoid arthritis showing insufficient response to tumour necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trials2021Journal of Clinical Pharmacy and Therapeutics
Biologics and Targeted Synthetic Drugs Can Induce Immune-Mediated Glomerular Disorders in Patients with Rheumatic Diseases: An Updated Systematic Literature Review2021BioDrugs
Response to interleukin-6 receptor antagonists in patients with rheumatoid arthritis is independent of the number of prior used TNF inhibitors: A systematic review and metaanalysis2021Joint Bone Spine
Model-Based Meta-Analysis Compares DAS28 Rheumatoid Arthritis Treatment Effects and Suggests an Expedited Trial Design for Early Clinical Development2021⁠Clinical Pharmacology & Therapeutics
Therapeutic options for patients with rare rheumatic diseases: a systematic review and meta-analysis2020Orphanet Journal of Rare Diseases
Cost-Effectiveness of Tofacitinib for Patients with Moderate-to-Severe Rheumatoid Arthritis in China2020Pharmacoeconomics
Risk of malignancy with non-TNFi biologic or tofacitinib therapy in rheumatoid arthritis: A meta-analysis of observational studies2020Seminars in Arthritis and Rheumatism
The benefit-risk balance for biological agents in juvenile idiopathic arthritis: a meta-analysis of randomized clinical trials2020Rheumatology
Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naive to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison2020Rheumatic & Musculoskeletal Diseases Open
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis2020Rheumatoid Arthritis
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Rheumatoid Arthritis
Epidemiological and advanced therapeutic approaches to treatment of uveitis in pediatric rheumatic diseases: a systematic review and meta-analysis2020Orphanet Journal of Rare Diseases
Comparative Risk of Cardiovascular Events With Biologic and Synthetic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis: A Systematic Review and Meta-Analysis2020Arthritis Care and Research
The Efficacy and Evidence-Based Use of Biologics in Children and Adolescents: Using Monoclonal Antibodies and Fusion Proteins as Treatments2019Medicine
Systematic literature review informing the 2018 update of the EULAR recommendation for the management of large vessel vasculitis: focus on giant cell arteritis2019Rheumatic & Musculoskeletal Diseases Open
Immunogenicity of biologic agents in juvenile idiopathic arthritis: a systematic review and meta-analysis2019Rheumatology

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