Drug updated on 11/4/2024
Dosage Form | Injection (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 Class | Interleukin-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
Summary
- 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 (OR (odds ratio) = 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 IL-6R gene, achieving better ACR (American College of Rheumatology) 20 and ACR50 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 reactivation, particularly in 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 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 hepatitis B virus (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 Title | Year | Source |
---|---|---|
Actemra (tocilizumab) Prescribing Information. | 2024 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Norwegian society of rheumatology recommendations on diagnosis and treatment of patients with giant cell arteritis. | 2023 | Frontiers in Medicine |
The Italian Society of Rheumatology clinical practice guidelines for the management of large vessel vasculitis | 2022 | Semin Arthritis Rheum. 2020 Oct;50(5):930-937. doi: 10.1016/j.semarthrit.2020.08.007. Epub 2020 Aug 28. |
European Headache Federation recommendations for neurologists managing giant cell arteritis | 2020 | The Journal of Headache and Pain |