Infectious Disease

ACR recommends a step-by-step strategy to immunomodulatory remedy for MIS-C related to COVID-19

December 21, 2020

3 min read

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Disclosure:
The researchers report financial support from the ACR. Henderson reports on Childhood Arthritis and Rheumatology Research Alliance salary support and consultancy fees from Sobi. In the study you will find all relevant financial information from all other authors.

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A step-by-step approach to immunomodulatory drugs is recommended for children with multisystem inflammatory syndrome associated with COVID-19, with IVIG and glucocorticoids being considered the first-tier agents, as evidenced by updated guidelines from the American College of Rheumatology.

On June 18, the ACR announced for the first time its “Clinical Instructions for Pediatric Patients with Inflammatory Multisystem Syndrome in Children (MIS-C) in connection with SARS-CoV-2 and hyperinflammation in COVID-19”. This document was added later in November with a new flow chart and recommendations for the first MIS-C immunomodulatory treatment. The resulting “Version 2” of the guide was published this month in Arthritis & Rheumatology.

“The recommendations contained in this document should be interpreted in the context of this changing landscape and will be changed prospectively as our understanding of COVID-19 improves,” wrote Lauren A. Henderson, MD, MMSc and colleagues. Source: Adobe Stock

“Unlike adults, the vast majority of children with COVID-19 have mild symptoms.” Lauren A. Henderson, MD, MMSc, from Boston Children’s Hospital and Harvard Medical School, and colleagues wrote. “However, there are children with significant respiratory disease, and some children may develop a hyperinflammatory response similar to that seen in adults with COVID-19. Additionally, in late April 2020, reports were published of children with another clinical syndrome, similar to Kawasaki disease (KD) and toxic shock syndrome. These patients often had evidence of previous exposure to SARS-CoV-2. “

“While this constellation of symptoms has gone by many names, we will use Multisystem Inflammatory Syndrome in Children (MIS-C) for the purposes of this discussion,” they added. “There is an urgent need to provide guidance to health care providers evaluating patients for whom MIS-C is a diagnostic consideration for a number of reasons. In addition, pediatric rheumatologists are often asked to recommend immunomodulatory therapy for patients with a hyperinflammatory condition due to acute SARS-CoV-2 infection. “

For the original guidelines, the ACR assembled a task force made up of nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric intensive care doctor. At the first meeting of the panel on May 22nd, members formed four working groups to answer clinical questions related to MIS-C and hyperinflammation in COVID-19. Each working group produced preliminary statements that were supported by evidence and shared with the entire task force.

The members then conducted two anonymous voting rounds and two webinars in which they discussed the results in order to reach a consensus. They also used a nine-point scale to determine the appropriateness of each statement, with consensus rated as either low, medium, or high based on the dispersion of votes along the numerical scale. Approved guidelines had to be rated either moderate or high on the consensus scale.

For the final revision, the working group leaders identified guidelines that should be changed based on clinical experience and the newly available literature. Panelists reviewed these revised statements along with supporting literature before a webinar in October to discuss the proposed changes. An anonymous vote was held to approve revised guidelines that achieved moderate or high consensus.

The first guidelines published in June included 40 final guidelines and a flow chart showing the diagnostic pathway for MIS-C. The revised policy released in December includes a new flowchart and 22 revised statements, including recommendations for initial immunomodulatory treatment.

Following these recommendations, patients with suspected life-threatening MIS-C may require immunomodulatory treatment before the full diagnostic evaluation can be completed. Gradual progression of immunomodulatory therapies should be used for treatment of MIS-C, with intravenous immunoglobulin (IVIG) being considered the first-stage therapy. Glucocorticoids should be used as adjunctive therapy in patients with severe disease or as intensification therapy in patients with refractory disease. IVIG should be given to MIS-C patients who are hospitalized and / or who meet criteria for Kawasaki disease.

Treatment for MIS-C should include high-dose IVIG – typically 2 g per kg based on ideal body weight. Providers should evaluate cardiac function and fluid status in patients with MIS-C prior to IVIG treatment, although those with depressed cardiac function may require close monitoring and diuretics when IVIG is administered.

A second dose of IVIG is not recommended in patients with refractory MIS-C due to the risk of volume overload and hemolytic anemia associated with high IVIG doses. Serial laboratory tests and cardiac exams should guide the response and rejuvenation of immunomodulatory treatment. Patients may take 2 to 3 weeks – or even longer – to limit immunomodulatory medication.

The guidelines also contain some restrictions.

Although their work is supported by scientific literature and recommendations from public health institutions, the guideline authors cautioned that the available data remain of poor quality and are often extrapolated from adult experience.

“This approach is particularly problematic when asking clinical questions about MIS-C that have previously been reported primarily in children,” wrote Henderson and colleagues. “This unique manifestation of COVID-19 in children and adolescents underscores the need to prioritize and fund rigorous research in the pediatric population. Currently, our understanding of pediatric SARS-CoV-2 infections is rudimentary and will continue to change as higher quality evidence becomes available. “

“Therefore, the recommendations contained in this document should be interpreted in the context of this changing landscape and will be changed prospectively as our understanding of COVID-19 improves,” they added. “For these reasons, this guide does not replace the critical role of clinical judgment, which is essential in addressing the unique needs of individual patients.”

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