Actemra (tocilizumab)
An approved treatment for Systemic Juvenile Idiopathic Arthritis and Giant Cell Arteritis.
The same compound appears under different names depending on the context. Here is how to identify Tocilizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Tocilizumab
- Brand name
- Actemra
- Drug class
- Anti-IL-6 receptor antibody
- Manufacturer
- Genentech / Roche
- How it's taken
- Given as an intravenous (IV) infusion over approximately 1 hour, or as a subcutaneous injection.
The first FDA-approved drug specifically for systemic JIA. Tocilizumab blocks the IL-6 receptor to suppress the inflammatory cascade that drives fevers, rash, and joint destruction. In the TENDER trial, 85% of children responded within 12 weeks. It is also FDA approved for giant cell arteritis in adults, since May 2017, as a steroid-sparing treatment used alongside a steroid taper.
Where Tocilizumab fits
First FDA-approved drug specifically for systemic JIA and a cornerstone biologic option. IL-6 blockade is particularly effective for patients with prominent arthritis in addition to systemic features. Used alongside or as an alternative to IL-1 inhibitors (canakinumab, anakinra). Choice between IL-6 and IL-1 pathways depends on the clinical phenotype and individual response.
How Tocilizumab works
In systemic JIA, cells produce excessive amounts of IL-6, an inflammatory signaling protein that amplifies the immune attack throughout the body. IL-6 is responsible for the spiking fevers, elevated inflammatory markers, growth failure, and progressive joint damage that characterize the disease. Tocilizumab blocks the receptor where IL-6 attaches to cells, preventing the signal from being delivered.
Tocilizumab blocks both forms of the IL-6 receptor: the version attached to cell surfaces (classical signaling) and the version floating freely in the blood (trans-signaling). By blocking both, tocilizumab provides comprehensive IL-6 suppression. This leads to rapid normalization of inflammatory markers, resolution of systemic symptoms, and protection of joints from further damage.
In the TENDER trial, 85% of children with active sJIA responded within 12 weeks. By 2 years, 88% achieved JIA ACR70 responses and 40% were able to discontinue corticosteroids entirely.
Mechanism: Humanized monoclonal antibody that blocks both soluble and membrane-bound IL-6 receptors, suppressing the IL-6-driven inflammatory cascade in systemic JIA
Side effects and safety
Common side effects include upper respiratory infections, headache, elevated blood pressure, and infusion reactions (when given IV) such as rash, flushing, and nausea. Tocilizumab can cause liver enzyme elevations (particularly ALT/AST), especially when combined with methotrexate, requiring regular liver function monitoring. Lipid levels may increase and should be checked periodically. Actemra carries a boxed warning for serious infections, including tuberculosis and fungal infections, that can lead to hospitalization or death; TB testing is required before starting treatment. Rare gastrointestinal perforations have been reported. Serious liver injury has occurred, in some cases leading to a liver transplant or death, and Actemra can lower neutrophil (a type of white blood cell) and platelet counts; in systemic JIA, liver tests and blood counts are checked at the second dose and then every 2 to 4 weeks. Severe allergic reactions, including anaphylaxis that has been fatal, can happen as early as the first infusion, and serious skin reactions such as DRESS have been reported; get emergency care right away if these occur. The label also warns about a possible higher cancer risk from immune suppression, nerve disorders that damage myelin such as multiple sclerosis, and use in people with liver disease, and says live vaccines should be avoided during treatment.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Tocilizumab
Given as an intravenous (IV) infusion over approximately 1 hour, or as a subcutaneous injection. For systemic JIA, the standard IV dose is weight-based: 12 mg/kg every 2 weeks for patients under 30 kg, or 8 mg/kg every 2 weeks for patients 30 kg and above. Subcutaneous formulations are also available for some patients.
Availability and cost
Approved biosimilars: Tyenne, Tofidence, Avtozma
Help paying for Actemra
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 per treatment; up to $15,000 per calendar year for drug costs.
For: private insurance · source - Free medicine program
Genentech Patient Foundation gives free ACTEMRA to eligible patients, e.g. uninsured or not covered with household income under $150,000 (more for households over 4).
For: no insurance, underinsured · source - Insurance and case manager help
Case Managers explain insurance coverage, find financial help, help with copay program enrollment and coordinate with your doctor and pharmacy.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Copay program excludes Medicare, Medicare Advantage, Medigap, Medicaid, VA, DoD and TRICARE. Patients under 18 need a caregiver or legal representative to manage copay help. The free-drug program is run by the separate Genentech Patient Foundation. Case Manager line: 1-800-ACTEMRA (1-800-228-3672), 6AM-5PM PT, Mon-Fri.
- From a charity · The Assistance FundJuvenile Arthritis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
The Phase 3 TENDER trial was the pivotal study for sJIA approval. At week 12, 85.3% of tocilizumab-treated patients achieved JIA ACR30 with absence of fever, compared to 24.3% on placebo. JIA ACR70 was reached by 70% versus 8% on placebo. By week 104 (2 years), 88% achieved ACR70 and 71% reached ACR90. Corticosteroid reduction was significant: 40% of patients discontinued steroids entirely by week 44.
Development history
Tocilizumab was originally developed through a collaboration between Osaka University and Chugai Pharmaceutical. Roche/Genentech brought it to global markets. After success in rheumatoid arthritis (approved 2010), the TENDER trial in systemic JIA demonstrated remarkable efficacy. FDA approved tocilizumab for sJIA in April 2011, making it the first drug specifically approved for this condition. It also has indications for rheumatoid arthritis, giant cell arteritis, polyarticular JIA, systemic sclerosis-associated ILD, cytokine release syndrome, and COVID-19 in certain hospitalized adults and children 2 years and older.
Explore Systemic Juvenile Idiopathic Arthritis and Giant Cell Arteritis trials
Other Systemic Juvenile Idiopathic Arthritis & Giant Cell Arteritis treatments
Common questions about Tocilizumab
▸What is Tocilizumab (Actemra)?
The first FDA-approved drug specifically for systemic JIA. Tocilizumab blocks the IL-6 receptor to suppress the inflammatory cascade that drives fevers, rash, and joint destruction. In the TENDER trial, 85% of children responded within 12 weeks. It is also FDA approved for giant cell arteritis in adults, since May 2017, as a steroid-sparing treatment used alongside a steroid taper.
▸How does Tocilizumab work?
In systemic JIA, cells produce excessive amounts of IL-6, an inflammatory signaling protein that amplifies the immune attack throughout the body. IL-6 is responsible for the spiking fevers, elevated inflammatory markers, growth failure, and progressive joint damage that characterize the disease. Tocilizumab blocks the receptor where IL-6 attaches to cells, preventing the signal from being delivered.
Tocilizumab blocks both forms of the IL-6 receptor: the version attached to cell surfaces (classical signaling) and the version floating freely in the blood (trans-signaling). By blocking both, tocilizumab provides comprehensive IL-6 suppression. This leads to rapid normalization of inflammatory markers, resolution of systemic symptoms, and protection of joints from further damage.
In the TENDER trial, 85% of children with active sJIA responded within 12 weeks. By 2 years, 88% achieved JIA ACR70 responses and 40% were able to discontinue corticosteroids entirely.
▸What are the side effects of Tocilizumab?
Common side effects include upper respiratory infections, headache, elevated blood pressure, and infusion reactions (when given IV) such as rash, flushing, and nausea. Tocilizumab can cause liver enzyme elevations (particularly ALT/AST), especially when combined with methotrexate, requiring regular liver function monitoring. Lipid levels may increase and should be checked periodically. Actemra carries a boxed warning for serious infections, including tuberculosis and fungal infections, that can lead to hospitalization or death; TB testing is required before starting treatment. Rare gastrointestinal perforations have been reported. Serious liver injury has occurred, in some cases leading to a liver transplant or death, and Actemra can lower neutrophil (a type of white blood cell) and platelet counts; in systemic JIA, liver tests and blood counts are checked at the second dose and then every 2 to 4 weeks. Severe allergic reactions, including anaphylaxis that has been fatal, can happen as early as the first infusion, and serious skin reactions such as DRESS have been reported; get emergency care right away if these occur. The label also warns about a possible higher cancer risk from immune suppression, nerve disorders that damage myelin such as multiple sclerosis, and use in people with liver disease, and says live vaccines should be avoided during treatment.
▸How is Tocilizumab taken?
Given as an intravenous (IV) infusion over approximately 1 hour, or as a subcutaneous injection. For systemic JIA, the standard IV dose is weight-based: 12 mg/kg every 2 weeks for patients under 30 kg, or 8 mg/kg every 2 weeks for patients 30 kg and above. Subcutaneous formulations are also available for some patients.
▸Is Tocilizumab FDA approved?
Yes, Tocilizumab (Actemra) is FDA approved (2010) for the treatment of Systemic Juvenile Idiopathic Arthritis and Giant Cell Arteritis.
▸Is Actemra approved for systemic JIA?
Yes. Actemra (tocilizumab) was the first FDA-approved drug specifically for systemic JIA, approved in April 2011 for children aged 2 and older. It blocks the IL-6 receptor to control fevers, inflammation, and joint damage.
▸What is the difference between tocilizumab and canakinumab for sJIA?
Tocilizumab blocks IL-6, while canakinumab blocks IL-1 beta. Both are effective first-line biologics. IL-6 blockade may be preferred when arthritis is prominent, while IL-1 blockade is often favored when systemic features like fevers dominate.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- New England Journal of Medicine · 2012. Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis. https://www.nejm.org/doi/full/10.1056/NEJMoa1112802
- U.S. Food and Drug Administration. ACTEMRA (tocilizumab) Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125276s148lbl.pdf
- Genentech / Roche. Actemra for Systemic JIA — Clinical Trial Results. https://www.actemra.com/sjia/proven-results/clinical-trial.html