EULAR: Tocilizumab recommended for new, relapsing giant cell arteritis
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Weekly tocilizumab 162 mg is recommended for giant cell arteritis in new or relapsing cases, alongside glucocorticoids that should eventually be tapered, according to an updated EULAR consensus statement on interleukin-6 inhibitors.
The update expands EULAR’s recommendations for the IL-6 pathway beyond rheumatoid arthritis and juvenile idiopathic arthritis, into GCA, Takayasu arteritis, adult-onset Still’s disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, severe COVID-19 and other conditions.
“At the time of the first consensus statement on IL-6 and IL-6R inhibition almost one decade ago, the only approved molecule targeting this pathway was tocilizumab and the approved indications were [rheumatoid arthritis (RA)], systemic juvenile idiopathic arthritis (sJIA) and, in Japan, Castleman’s disease (CD),” Daniel Aletaha, MD, of the division of rheumatology at the Medical University of Vienna, in Austria, and colleagues wrote in Annals of the Rheumatic Diseases. “Since then, several antibodies directed against IL-6 have undergone phase III trials.”
To establish a new consensus statement regarding the use of IL-6 inhibitors, Aletaha and colleagues formed a task force with experts in rheumatology, hepatology and infectious diseases, as well as a steering committee that included a patient representative, a health care professional, a gastroenterologist, a cardiologist and metabolism expert, an infectious disease specialist, a pediatric rheumatologist, nine adult rheumatologists, a fellow and a methodologist. Members of the steering committee hailed from Europe, Asia and North America.
Members performed a systematic literature review that focused on published records investigating IL-6 blockers in patients with inflammatory diseases. Following the completion of the review, the steering committee developed a series of statements for presentation to the larger task force.
To be accepted into the consensus statement, specific points were required to have an approval of at least 75% of the task force members. Subsequent votes dropped the necessary majority to 66% and then 50%.
The summarized list of statements includes recommendations for patients with RA, juvenile idiopathic arthritis GCA, Takayasu arteritis, adult-onset Still’s disease, Castleman’s disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19.
In patients with RA of at least moderate severity, use of an IL-6 inhibitor is acceptable for those who failed either a biologic or conventional synthetic DMARD. Patients with this indication can receive sarilumab (Kevzara, Sanofi) 200 mg every 2 weeks or tocilizumab (Actemra, Genentech) 162 mg weekly. These can be used in conjunction with methotrexate or as monotherapy, according to the task force. Additionally, patients should withdraw from therapy if a decision is reached and shared between physician and patient.
In patients with polyarticular-course JIA, only tocilizumab is recommended as an IV-therapy ever 4 weeks. Patients should receive methotrexate as well, unless they cannot tolerate it.
In patients with systemic JIA, tocilizumab is recommended as IV therapy every 2 weeks. In these patients, the drug should be administered without methotrexate.
Therapy with tocilizumab is recommended for patients with GCA who demonstrate new or relapsing disease. In these patients, 162 mg weekly is recommended, according to the task force. In addition, the therapy should be introduced alongside glucocorticoids, but glucocorticoids should be tapered following introduction.
In patients with Takayasu arteritis, therapy with tocilizumab is recommended for those who are aged 12 years or older in Japan. Similar to patients with GCA, 162 mg per week of tocilizumab is recommended, with glucocorticoid tapering following introduction.
In patients with adult-onset Still’s disease, tocilizumab therapy is recommended in patients with cases refractory to glucocorticoids. For patients in Japan, therapy is recommended at 8 mg per kg every 2 weeks.
In patients with Castleman’s disease, therapy with an IL-6 inhibitor is recommended in human herpesvirus-8-seronegative patients with symptomatic and multicentered disease. For those in Japan, tocilizumab is recommended at 8 mg per kg every 2 weeks or 162 mg per weekly. In the European Union and United States, siltuximab (Sylvant, Janssen Biotech) is recommended at 11 mg per kg every 3 weeks.
In patients with CAR-T-cell induced cytokine release syndrome, IL-6 inhibition is recommended in cases of “severe” or “life-threatening” disease. In these patients, tocilizumab is recommended in one instance at 8 mg per kg.
In patients with neuromyelitis optica spectrum disorder, IL-6 blockers are recommended for those with AOP4-IgG seropositive or negative-relapsing disease. In these patients, satralizumab (Enspryng, Genentech) is approved in Japan and the United States. However, in the United States, the therapy is only approved for seropositive patients. For these patients, the recommended dose is 120 mg at weeks 0, 2, 4 and every 4 weeks thereafter. The therapy can be administered as alone or with an immunosuppressant.
“This update, like the original version, is primarily based on evidence from clinical trials and, therefore, most of the items have a high [level of evidence] and grade of recommendation,” Aletaha and colleagues wrote. “However, clinical trials do not provide data for substantial numbers of adverse events or long-term outcomes.
“This consensus statement, like others, has been developed to provide guidance to not only rheumatologists and other experts but also patients and administrators, on what the [task force] regards as state-of-the-art in the context of managing patients with the use of drugs blocking the IL-6 pathway,” they added.
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