Tocilizumab: The Interleukin-6 Blocker

Tocilizumab is a prescription antibody medicine that blocks the action of interleukin-6 (IL-6), one of the body’s main inflammation signals. It is given as a drip into a vein or as an injection under the skin. It was first developed for rheumatoid arthritis, and its uses have since spread to blood-vessel inflammation in older adults, a scarring lung disease, two forms of childhood arthritis, a dangerous reaction to a modern cancer cell therapy, and severe COVID-19 in hospital.

This page explains what interleukin-6 does, how tocilizumab blocks it, exactly which uses the current United States label lists, what the main trials for each use found, the boxed warning and the other hazards the label describes, what biosimilar versions are, and what is still not known. The Giant Cell Arteritis page reports the first-year results of the main giant cell arteritis trial; this page covers the earlier pilot trial and the three-year follow-up instead. The rheumatoid arthritis medicines page compares tocilizumab with the other drug families.

Table of Contents

  1. What Tocilizumab Is
  2. What Interleukin-6 Does
  3. How Tocilizumab Blocks the Signal
  4. The Uses the Label Lists
  5. Rheumatoid Arthritis Trials
  6. Giant Cell Arteritis Beyond the First Year
  7. Systemic Sclerosis Lung Disease
  8. Juvenile Idiopathic Arthritis
  9. Cytokine Release Syndrome After Cell Therapy
  10. COVID-19 in Hospital
  11. The Boxed Warning: Serious Infections
  12. Other Warnings on the Label
  13. How It Is Given
  14. Biosimilar Versions
  15. What Is Not Known
  16. Key Research Papers
  17. Connections
  18. Featured Videos

What Tocilizumab Is

Tocilizumab is a monoclonal antibody: a single, precisely shaped immune protein made in living cells in a factory and then purified. It is described in trial reports as a “humanised” antibody, meaning it was first made in mice and then rebuilt so that most of it matches human antibody structure, which makes it less likely to be attacked by the patient’s own immune system. The label calls it an “interleukin-6 (IL-6) receptor antagonist,” meaning it blocks the docking site that interleukin-6 uses rather than the signal molecule itself.

Because it is a large protein, it cannot be taken as a tablet; stomach acid and digestive enzymes would break it down. It is given as a one-hour drip into a vein (intravenous infusion) or as an injection under the skin (subcutaneous injection), depending on the condition. A 2014 review by the research group that developed it describes it as created specifically because uncontrolled, continuous production of interleukin-6 drives chronic inflammation and autoimmune disease.

A closely related medicine, sarilumab, blocks the same receptor. It appears on this page only where trials tested the two side by side.

What Interleukin-6 Does

Interleukin-6 is a cytokine, one of the small proteins cells use to send messages to one another. The 2014 review describes it as “promptly and transiently produced in response to infections and tissue injuries,” and as part of normal defence through three effects: the acute phase response, the making of new blood cells, and immune reactions. A 2019 review in Immunity adds roles in tissue repair and metabolism.

The label lists the cells that make it (T cells, B cells, monocytes and fibroblasts, along with the lining cells of joints and blood vessels) and what it does:

In a short infection, interleukin-6 rises and falls again. The 2014 review explains that the problem in disease is “dysregulated continual synthesis”: production that does not switch off. That ongoing signal is linked to fever, tiredness, anaemia and high inflammation markers, and in rheumatoid arthritis to joint damage. The 2019 review also notes a limit of the idea: “some inflammatory diseases do not seem to respond to IL-6 blockade.”

How Tocilizumab Blocks the Signal

Interleukin-6 works only after it locks onto its receptor. The receptor exists in two forms, and the label states that tocilizumab binds both:

By sitting in the docking site, tocilizumab stops interleukin-6 from passing on its message through either route. The label reports how quickly this shows up in blood tests: in rheumatoid arthritis trials, C-reactive protein fell to the normal range as early as week 2, with falls in rheumatoid factor, erythrocyte sedimentation rate, serum amyloid A and fibrinogen, and a rise in haemoglobin, the oxygen-carrying protein in red blood cells.

That fast drop in C-reactive protein is also the source of one of the drug’s main hazards. Because the liver stops making the protein on command, a normal C-reactive protein no longer means there is no inflammation or infection. This is described under Other Warnings on the Label.

The Uses the Label Lists

The current label of the original (reference) product on DailyMed, revised August 2025, lists seven uses. They are given here in the label’s own terms:

  1. Rheumatoid arthritis: adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), the group of medicines that includes methotrexate.
  2. Giant cell arteritis: adults with giant cell arteritis, the inflammation of large arteries that can cause blindness.
  3. Systemic sclerosis-associated interstitial lung disease: “slowing the rate of decline in pulmonary function” in adults whose systemic sclerosis (scleroderma) has caused scarring inflammation of the lungs.
  4. Polyarticular juvenile idiopathic arthritis: patients 2 years of age and older with the active form of childhood arthritis that affects many joints.
  5. Systemic juvenile idiopathic arthritis: patients 2 years of age and older with the active form of childhood arthritis that also causes fever and rash.
  6. Cytokine release syndrome: adults and children 2 years of age and older with severe or life-threatening cytokine release syndrome caused by chimeric antigen receptor (CAR) T-cell therapy.
  7. COVID-19: hospitalised adults and children aged 2 years and older with COVID-19 who are receiving corticosteroid medicines by mouth or vein and who need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), a machine that oxygenates the blood outside the body. The extension to children was added to the label in August 2025.

Polymyalgia rheumatica and Takayasu arteritis, two other inflammatory diseases where tocilizumab is studied, are not on this list.

Rheumatoid Arthritis Trials

The main measure in these trials was a 20% improvement on the American College of Rheumatology scale (ACR20), which counts swollen and tender joints, pain, disability, overall wellbeing and inflammation markers.

OPTION: added to methotrexate

The OPTION trial, published in 2008, gave 623 adults with moderate to severe rheumatoid arthritis tocilizumab 8 mg per kilogram, 4 mg per kilogram or placebo into a vein every 4 weeks, on top of their usual methotrexate. At 24 weeks, a 20% improvement was seen in 59% of the 8 mg group, 48% of the 4 mg group and 26% of the placebo group. Adverse events were reported by 69%, 71% and 63% respectively. Serious infections were the most common serious adverse events: six patients in the 8 mg group, three in the 4 mg group and two on placebo.

TOWARD: added to other standard medicines

The TOWARD trial gave 1,220 patients who were still active despite standard disease-modifying medicines either tocilizumab 8 mg per kilogram or placebo every 4 weeks for 24 weeks. A 20% improvement was seen in 61% versus 25%. Serious infections occurred in 2.7% versus 1.9%. The liver enzyme alanine aminotransferase rose above three times the upper limit of normal in 4% versus 1%. Total cholesterol rose in 23% versus 6%, and 16 patients started cholesterol-lowering medicine during the study. Severe (grade 3) neutropenia, a fall in the white cells that fight bacteria, occurred in 3.7% of tocilizumab patients and none on placebo.

ADACTA: on its own, against a TNF blocker

For people who cannot take methotrexate, the ADACTA trial compared tocilizumab alone (8 mg per kilogram every 4 weeks) with adalimumab alone, a widely used blocker of tumour necrosis factor, another inflammation signal. In 325 patients over 24 weeks, the disease activity score across 28 joints fell by 3.3 points with tocilizumab and 1.8 points with adalimumab, a difference the authors called superior. Serious adverse events occurred in 12% and 10%. Raised LDL cholesterol, raised alanine aminotransferase and lower platelet and neutrophil counts were more common with tocilizumab.

Cholesterol and the heart

Because tocilizumab raises blood fats, a large trial asked whether it raises heart attacks and strokes. The trial randomly assigned 3,080 people with rheumatoid arthritis and at least one heart risk factor to tocilizumab or etanercept, another tumour necrosis factor blocker, and followed them for an average of 3.2 years. By week 4, LDL cholesterol was a median 11.1% higher, HDL cholesterol 5.7% higher and triglycerides 13.6% higher on tocilizumab. Yet major heart and stroke events were similar: 83 on tocilizumab and 78 on etanercept (hazard ratio 1.05, 95% confidence interval 0.77 to 1.43). The authors wrote that the trial ruled out a risk of 1.43 or higher. Serious infection and gastrointestinal perforation were more frequent with tocilizumab.

Giant Cell Arteritis Beyond the First Year

The Giant Cell Arteritis page reports the first-year results of GiACTA, the trial that led to approval. Two other parts of the evidence add to it.

The first randomised trial

The first randomised trial in giant cell arteritis was a small, single-hospital study in Bern, Switzerland, published in 2016. Thirty patients aged 50 and over were assigned 2 to 1 to tocilizumab 8 mg per kilogram into a vein every 4 weeks for a year, or placebo, with both groups on prednisolone tapered to zero. By week 12, 17 of 20 (85%) on tocilizumab and 4 of 10 (40%) on placebo were in complete remission. By week 52, 85% and 20% had stayed free of relapse. The total prednisolone dose over the year was 43 mg per kilogram with tocilizumab and 110 mg per kilogram with placebo. Serious adverse events occurred in 35% and 50%.

Three years of follow-up

After the one-year GiACTA trial ended, 215 patients entered a two-year open phase in which their doctors chose any treatment. The question was what happens after tocilizumab is stopped. Of the 59 patients from the weekly tocilizumab group who were in remission and started this phase on no treatment, 25 (42%) stayed in remission for the full two years without tocilizumab or steroids. Over three years, the median total glucocorticoid dose was 2,647 mg in the weekly tocilizumab group against 5,277 mg and 5,323 mg in the two placebo groups. When patients relapsed and were treated, the median time back to remission was 15 days with tocilizumab alone, 16 days with tocilizumab plus steroids and 54 days with steroids alone. The authors concluded that indefinite treatment is “not required for all patients,” and noted that because of the risk of vision loss they still regard adding prednisone for a relapse as prudent.

A further analysis split the patients by whether their disease was new or had come back. With weekly tocilizumab, the median time to a first flare was 577 days in new disease and 575 days in relapsing disease, against 179 and 224 days on placebo.

Systemic Sclerosis Lung Disease

Systemic sclerosis is the autoimmune disease that thickens and scars the skin and, in many people, the lungs. The tocilizumab trials set out to treat the skin and found something else. The Systemic Sclerosis page covers the disease as a whole.

Lung function in these trials was measured as forced vital capacity: the total amount of air a person can blow out after a full breath, expressed as a percentage of what is expected for their age, sex and height.

The label reflects this history: its approved use is not for the skin but for “slowing the rate of decline in pulmonary function,” and it states that neither trial showed a significant effect on the skin score.

Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis is arthritis that starts before age 16 without a known cause. The Juvenile Idiopathic Arthritis page describes the subtypes.

Systemic juvenile idiopathic arthritis

This subtype brings daily spiking fevers, rash and inflamed organs along with the arthritis, and the trial report names interleukin-6 as playing a part in causing it. A 2012 trial randomly assigned 112 children aged 2 to 17, whose disease had not responded to anti-inflammatory painkillers and steroids, to tocilizumab into a vein every 2 weeks (8 mg per kilogram at 30 kg or more, 12 mg per kilogram below 30 kg) or placebo. At week 12, 85% of the tocilizumab group and 24% of the placebo group had no fever and at least a 30% improvement. By week 52, 80% of children on tocilizumab had at least a 70% improvement with no fever, 48% had no joints with active arthritis, and 52% had stopped steroid tablets. Across the trial and its extension there were 18 serious infections (0.11 per patient-year). Neutropenia developed in 19 children, and 21 had liver enzymes above 2.5 times the upper limit of normal.

Polyarticular juvenile idiopathic arthritis

A 2015 trial used a withdrawal design: all 188 children with many affected joints, who had not done well on methotrexate, first received tocilizumab for 16 weeks; those who improved were then randomly assigned to keep taking it or switch to placebo. Over the next 24 weeks the arthritis flared in 48.1% of the children switched to placebo and 25.6% of those who continued. Serious infections were the most common serious adverse event, at 4.9 per 100 patient-years.

Cytokine Release Syndrome After Cell Therapy

Chimeric antigen receptor T-cell therapy is a cancer treatment in which a patient’s own T cells are collected, engineered in a laboratory to recognise a marker on cancer cells, and given back. As the engineered cells multiply and kill cancer cells, they can release a flood of immune signals. This is cytokine release syndrome (CRS): high fever, falling blood pressure and, in severe cases, failing organs.

A 2014 review in Blood reported that the syndrome is associated with high levels of several cytokines including interleukin-6 and interferon gamma, and that “uncontrolled studies” showed tocilizumab, with or without steroids, can reverse it. The same review raised a concern: early, heavy immune suppression could weaken the cancer treatment itself, so its authors described limiting it to patients at risk of life-threatening disease.

The United States Food and Drug Administration approved this use on August 30, 2017. Its approval summary states the evidence was a retrospective analysis, not a randomised trial. Of 45 evaluable patients (median age 12) treated for severe or life-threatening syndrome, 31 (69%) responded, meaning the syndrome resolved within 14 days with no more than two doses and no other drugs besides steroids. In a second, independent group of 15 patients, 53% responded. The summary states that further study is needed to find the best dose.

How common this is shows in the 2018 global trial of tisagenlecleucel, a cell therapy for childhood leukaemia: cytokine release syndrome occurred in 77% of the 75 patients, and 48% of those received tocilizumab. A 2021 prospective study then tested giving one dose of tocilizumab early, as soon as high, persistent fevers began, to children with a large leukaemia burden. Grade 4 (life-threatening) syndrome occurred in 27% of this group, against 50% in an earlier comparable group, a difference that could have been chance (p = 0.18); the authors reported that cancer response was not harmed. In 2019 a consensus panel published shared grading rules for the syndrome so that results from different centres can be compared.

COVID-19 in Hospital

Severe COVID-19 pneumonia can turn into an overwhelming inflammatory reaction with high interleukin-6 levels, which is why tocilizumab was tested early in the pandemic. The trials disagreed at first, and the reasons help explain the narrow wording of the label.

The steroid point is central. The label’s summary of RECOVERY shows that among patients already on corticosteroids, 29.0% died with tocilizumab and 34.9% without it. Among patients not on corticosteroids, 39.0% died with tocilizumab and 34.6% without it, a result that could have been chance but showed no benefit. The label use is limited accordingly to patients receiving systemic corticosteroids.

The Boxed Warning: Serious Infections

A boxed warning is the strongest warning the Food and Drug Administration places on a label. Tocilizumab’s is titled “Risk of Serious Infections.” It states that patients treated with the drug are at increased risk of serious infections “that may lead to hospitalization or death,” and that most patients who developed them were also taking other immune-suppressing medicines such as methotrexate or corticosteroids.

The infections the box names are:

In the full warnings, the label lists the most common serious infections as pneumonia, urinary tract infection, cellulitis, shingles (herpes zoster), gastroenteritis, diverticulitis, sepsis and bacterial arthritis. It states that the drug is not given during an active infection, including a localised one, and that it is paused if a serious infection develops until the infection is controlled.

Other Warnings on the Label

Hidden infection: the C-reactive protein problem

The label states that signs and symptoms of acute inflammation “may be lessened due to suppression of the acute phase reactants.” In practice, a person on tocilizumab can have a serious infection with little fever and a normal C-reactive protein. The same applies to the next hazard.

Bowel perforation, especially with diverticulitis

The label reports tears in the wall of the gut (gastrointestinal perforation) in clinical trials, “primarily as complications of diverticulitis,” the inflammation of small pouches in the large bowel. In the 24-week controlled trials the rate was 0.26 events per 100 patient-years, and most patients affected were also taking anti-inflammatory painkillers, corticosteroids or methotrexate. The label describes prompt assessment of fever, new abdominal symptoms or a change in bowel habits.

A German national register of 13,310 people with rheumatoid arthritis found 37 lower intestinal perforations, 32 of them in the colon. The rate was 2.7 per 1,000 patient-years on tocilizumab against 0.2 to 0.6 on other treatments, an adjusted hazard ratio of 4.48. Only two of the 37 patients had a known history of diverticulitis. Four of the 11 tocilizumab patients did not have the typical signs of severe pain and a rigid abdomen, and the authors reported that only one patient had a highly raised C-reactive protein. A quarter of all patients died within 30 days of the perforation, including 5 of the 11 on tocilizumab.

Liver injury

The label reports serious liver injury, “some of these cases have resulted in liver transplant or death,” appearing months to years after starting. Raised liver enzymes were more common in trials, and more so with methotrexate. For rheumatoid arthritis, giant cell arteritis and the lung disease, the label lists a liver panel before starting, every 4 to 8 weeks for the first 6 months and every 3 months after; it advises against starting when liver enzymes are above 1.5 times the upper limit of normal and describes stopping the drug if they rise above 5 times. It is not used in active liver disease.

Blood counts

Tocilizumab lowers neutrophils and platelets. The label advises against starting it in these conditions when the neutrophil count is below 2,000 per cubic millimetre or platelets are below 100,000, and against continuing it when neutrophils fall below 500 or platelets below 50,000. It states that the fall in platelets was not linked to serious bleeding in trials. Counts are checked 4 to 8 weeks after starting and every 3 months after. For COVID-19 the starting limits are lower (neutrophils 1,000, platelets 50,000, liver enzymes 10 times normal).

Blood fats

The label reports rises in total cholesterol, triglycerides, LDL and HDL cholesterol. In the six-month trials of the injection under the skin, a sustained total cholesterol above 240 mg/dL occurred in 19% of patients dosed weekly, 19.6% dosed every other week and 10.2% on placebo. Lipids are checked 4 to 8 weeks after starting.

Allergic and skin reactions

Anaphylaxis has been reported, including deaths with the infusion. Reactions serious enough to stop treatment occurred in 0.1% (3 of 2,644) of patients in the six-month infusion trials and 0.7% (8 of 1,068) in the six-month injection trials. The label also lists a severe drug rash with internal-organ involvement known as DRESS (drug reaction with eosinophilia and systemic symptoms).

Nerves, cancer and vaccines

Multiple sclerosis and chronic inflammatory demyelinating polyneuropathy, conditions that strip the insulation from nerves, were reported rarely in rheumatoid arthritis trials. The label states that the effect on cancer risk “is not known but malignancies were observed in clinical studies.” Live vaccines are not given at the same time, because their safety has not been established, and the label describes bringing vaccinations up to date before starting.

Interactions with other medicines

Inflammation slows the liver enzymes (the cytochrome P450 system) that break down many drugs. By removing the interleukin-6 signal, tocilizumab can speed them back up. The label reports that one week after a single dose, exposure to simvastatin fell by up to 57% and to omeprazole by up to 28%. It names warfarin, cyclosporine and theophylline as medicines whose levels or effect are monitored when tocilizumab is started or stopped, and oral contraceptives, lovastatin and atorvastatin as medicines whose effect could fall. It is not combined with other biologic arthritis medicines, which were not studied together with it.

Pregnancy

The label states that the available human data are insufficient to draw conclusions about birth defects or miscarriage. Antibodies such as tocilizumab cross the placenta in the third trimester and may affect the infant’s immune response. In monkeys, the drug given during early pregnancy caused abortion or fetal death at 1.25 times the maximum human dose.

How It Is Given

Doses are set by condition and body weight. The label states:

For rheumatoid arthritis and both forms of childhood arthritis, the label states it may be given alone or with methotrexate. The trials gave the doses described in each section above.

Biosimilar Versions

A biosimilar is a copy of a biologic medicine made by a different manufacturer. Because antibodies are made in living cells, a copy cannot be chemically identical the way a generic tablet is; instead, regulators require it to show no clinically meaningful difference from the original. In the United States, biosimilars carry the name tocilizumab followed by a four-letter suffix, and DailyMed lists labels for several tocilizumab biosimilars alongside the original product.

One phase 3 trial in 471 adults with rheumatoid arthritis compared a biosimilar with the reference product for 24 weeks, and then switched half of the reference group to the biosimilar. The difference in disease activity score at week 12 was minus 0.01 points, inside the pre-set equivalence limits, and safety was comparable, including after the switch. A 2026 meta-analysis of three phase 3 trials (1,696 patients with rheumatoid arthritis) and five phase 1 trials in healthy volunteers found no significant differences in effect, side effects or blood levels. Antibodies against the drug itself were reported at a risk ratio of 1.28 (95% confidence interval 0.99 to 1.65), a result that could be chance.

What Is Not Known

Decisions about starting, continuing or stopping a biologic medicine belong with the clinician who prescribes it.

Key Research Papers

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  2. Kang S, Tanaka T, Narazaki M, Kishimoto T. Targeting Interleukin-6 Signaling in Clinic. Immunity. 2019;50(4):1007-1023. PubMed PMID: 30995492
  3. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371(9617):987-97. PubMed PMID: 18358926
  4. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, et al. 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. Arthritis Rheum. 2008;58(10):2968-80. PubMed PMID: 18821691
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  15. Brunner HI, Ruperto N, Zuber Z, Keane C, Harari O, Kenwright A, et al. Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann Rheum Dis. 2015;74(6):1110-7. PubMed PMID: 24834925
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  17. Le RQ, Li L, Yuan W, Shord SS, Nie L, Habtemariam BA, et al. FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome. Oncologist. 2018;23(8):943-947. PubMed PMID: 29622697
  18. Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, et al. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439-448. PubMed PMID: 29385370
  19. Kadauke S, Myers RM, Li Y, Aplenc R, Baniewicz D, Barrett DM, et al. Risk-Adapted Preemptive Tocilizumab to Prevent Severe Cytokine Release Syndrome After CTL019 for Pediatric B-Cell Acute Lymphoblastic Leukemia: A Prospective Clinical Trial. J Clin Oncol. 2021;39(8):920-930. PubMed PMID: 33417474
  20. Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, et al. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019;25(4):625-638. PubMed PMID: 30592986
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  23. REMAP-CAP Investigators; Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, et al. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med. 2021;384(16):1491-1502. PubMed PMID: 33631065
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Other Sources

  1. DailyMed, National Library of Medicine. Tocilizumab injection, reference product: prescribing information, including the boxed warning, indications, dosage, warnings and precautions, drug interactions, pregnancy and clinical studies (revised August 2025). DailyMed label

PubMed Topic Searches

  1. tocilizumab rheumatoid arthritis randomized
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  7. tocilizumab biosimilar

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