Actemra (Tocilizumab) Description
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. Actemra is an Interleukin-6 (IL-6) receptor antagonist approved by the FDA in 2010.
The extensive Actemra RA IV, clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.
Additionally, to further support U.S. COVID-19 response efforts, Genentech announced it would provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services.
Actemra (Tocilizumab) Indication
Actemra is currently approved for indications in rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Actemra® (tocilizumab) 400 mg/20 mL vial for intravenous use.
Actemra is also in clinical studies to assess if Actemra is an effective treatment for adults with severe COVID-19 disease. However, in some patients with COVID-19, the immune response runs amok, overexpressing IL-6 and generating a “cytokine storm,” which can lead to potentially life-threatening damage to lungs and other organs.
Actemra is not currently FDA-approved for this use.
Actemra (Tocilizumab) News
January 9, 2021 - U.K. finds Japanese arthritis drug is effective for COVID-19 treatment. Tocilizumab was developed jointly by Osaka University and Japanese firm Chugai Pharmaceutical Co. In clinical trials funded by the government, the risk of death dropped by 24% for COVID-19 patients treated with the two drugs — tocilizumab and sarilumab — within 24 hours of being taken to intensive care units, it said, adding that the drugs can also shorten the period of hospitalization of patients by seven to 10 days.
January 7, 2021 - Arthritis drugs could help save the lives of Covid patients, research finds. Early results from an international trial previously suggested tocilizumab might improve outcomes for those with life-threatening coronavirus infections. Both tocilizumab and sarilumab are known as IL-6 receptor antagonists, which dampen down the effect of proteins that can cause an overreaction of the immune system. Severe Covid has previously been linked to dangerous levels of inflammation in the body.
August 1, 2020 - A retrospective cohort study published in The Lancet examined if Tocilizumab in patients with severe COVID-19 could reduce the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia who received standard of care treatment. This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centers in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care center in Modena, Italy, between Feb 21 and April 30, 2020. The study interpretation was that the treatment with tocilizumab, whether administered intravenously or subcutaneously, might reduce the risk of invasive mechanical ventilation or death in patients with severe COVID-19 pneumonia.
April 29, 2020 - Chinese researchers published a study in PNAS concluding from preliminary data that Actemra improved clinical outcomes immediately in 20 patients with severe or critical COVID-19, and thus “is an effective treatment to reduce mortality.” Five days after treatment, 15 of the 20 patients (75%) lowered their oxygen intake, and 1 patient needed no oxygen therapy.
April 29, 2020 - UC San Diego Health has launched a Phase III clinical trial, part of a global effort, to assess whether a medication used to treat rheumatoid arthritis and other inflammatory disorders might also have therapeutic value for COVID-19 patients who have developed or at high risk of developing serious lung damage from SARS-CoV-2 infections.
March 19, 2020 - Genentech, a Member of the Roche Group, announced it is launching a Phase III trial to assess its marketed arthritis drug Actemra® (tocilizumab) as a treatment for adults with severe COVID-19.
Actemra COVID-19 Clinical Trials
Clinical Trial NCT02735707: A Phase 4 study Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP)
REMAP-CAP is a randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve the outcome of patients admitted to intensive care with community-acquired pneumonia.
Also, REMAP-CAP provides an adaptive research platform for evaluating multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness.
REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.
Clinical Trial NCT04372186: A Phase 3 Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (EMPACTA)
Clinical Trial NCT04409262: A Phase 3 Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia (REMDACTA)
Clinical Trial NCT04320615: A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA). The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous Actemra plus standard of care in hospitalized adults with severe COVID-19 pneumonia, compared to placebo plus standard of care.