Category: covid-19

Still’s Disease Onset After mRNA COVID-19 Vaccine

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An 82-year-old woman was diagnosed with still’s disease following an mRNA COVID-19 vaccination. Onset after age 80 is really uncommon, making this an interesting study.

Now, it’s important to remember that these kinds of reactions are incredibly rare. Less than 30 patients have had this happen. Please still get your COVID-19 vaccines if you’re medically able to do so.

Check out the full case study:

Nishioka H, Shirota S (January 02, 2024) Adult-Onset Still’s Disease After an mRNA COVID-19 Vaccine in an Older Woman. Cureus 16(1): e51540. doi:10.7759/cureus.51540

COVID Might Raise Odds for Still’s Disease

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That’s according to a new study published this month.

People are at less risk for Still’s than they are for some diseases, suggesting a hierarchy as published in this study.

hierarchy of prevalence

This could also be due to the possibility of Still’s Disease already being a predetermined factor in the body, with COVID merely activating it.

More study is needed.

Lim, Sung Ha & Ju, Hyun & Han, Ju & Lee, Ji & Lee, Won-Soo & Bae, Jung Min & Lee, Solam. (2023). Autoimmune and Autoinflammatory Connective Tissue Disorders Following COVID-19. JAMA Network Open. 6. e2336120. 10.1001/jamanetworkopen.2023.36120.

Taiwan: Actemra Approved to Treat COVID-19

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The following is a press release issued today by Chugai Pharmaceutical:

Chugai Pharmaceutical Co., Ltd.(TOKYO: 4519) announced that Chugai Pharma Taiwan Ltd., a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Actemra® (tocilizumab) intravenous (IV) formulation for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

This approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study) and three placebo-controlled, randomized, double-blind, multicenter, global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study).

About Actemra

Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for seven indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, adult Still’s disease, and SARS-CoV-2 pneumonia. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.

As you may know, Actemra is one of a small number of medications FDA-approved for both SJIA and AOSD.

A New Perspective on COVID-19 Risk Aware Conversations in Healthcare

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Following my Cleveland Clinic journey, I sent a follow-up to the provider who ordered testing to talk more. She was not seeing the heart rate change that she expected with POTS. She was concerned, though, about the rise in my systolic BP during the test – especially since my seated BP is always fine.

So, I’ve scheduled a cardiology appointment more locally. Today, while filling out the pre-screening questionnaire, I was delighted to see the way this COVID-19 risk aware conversation was framed.

Importance of a Mask For an upcoming appointment with • It is very important that you wear a mask, especially since you are now in a healthcare environment. • Many of our patients here are at a higher risk for serious injury or death from infection than most people. • We do everything we can to keep everyone safe: you, our other patients, and everyone taking care of you. • What we DO know about COVID-19 is that wearing a mask helps you stay safe and helps prevent the spread of the disease to others, especially knowing that we have a number of people here who are at higher risk. • I am asking you to do something that I am also doing: wearing a mask. • By wearing a mask, I'm reducing the risk for you, too. • I ask that you do the same to keep me safer... and the other patients that we treat here. Thank you for your cooperation. *Indicates a required field. *Are you willing to wear a mask? Yes, willing to wear a hospital provided mask No, not able or willing

Why in the world is this the first time I’ve seen a good example of this conversation??

What about you – have you seen similar notices?

Extending Telehealth for Medicare Recipients

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The following is an email from the US Pain Foundation dated yesterday, March 21:

Since access and coverage of telehealth has been a wonderful and safe convenience for people with chronic pain during the pandemic, we have been closely following government policy around telehealth coverage and want to update you on recent developments.

Last week, President Biden signed into law HR 2471, the Consolidated Appropriations Act of 2022 which finalized the fiscal year 2022 federal budget and included a number of provisions to extend Medicare telehealth coverage implemented as part of the government’s response to COVID-19. The COVID-19 Public Health Emergency (PHE) has not yet officially ended but is expected to end sometime in the next few months. HR 2471 will extend Medicare telehealth coverage for 151 days or approximately five months after the PHE ends. These extensions include the following:

  • Patients’ Location – Medicare beneficiaries can continue to receive coverage for telehealth services from wherever they are located within the U.S., including their homes. Before the PHE, telehealth coverage was restricted to beneficiaries being located in hospitals and certain provider locations in order to receive coverage for telehealth.
  • Eligible Practitioners – Medicare beneficiaries can continue to receive coverage for telehealth services from physical therapists and occupational therapists.
  • Mental Health Coverage – Medicare beneficiaries can continue to receive coverage for telehealth services from mental health providers without the requirement of an in-person visit within six months of the first telehealth service with that provider nor the requirement of an in-person visit every 12 months.
  • Audio-only Telehealth – Medicare beneficiaries can continue to receive coverage for telehealth services using audio-only technology.

This is great news for Medicare beneficiaries! However, although Medicare coverage policies tend to be a bellwether for changes in private payer and Medicaid coverage, please keep in mind that private payer and Medicaid coverage for telehealth services varies by state.

Forty-three states and the District of Columbia (DC) have laws that govern private payer reimbursement of telehealth but what specific services and providers are covered varies greatly. And, while all 50 states and DC now reimburse for some types of telehealth services in Medicaid, many of the reimbursement policies have restrictions and limitations. It is important to check with your state Medicaid program or private insurer to find out what telehealth services are covered.

You can learn more about the efforts that the US Pain Foundation takes around advocacy – including ways to get involved – here.

New Kawasaki Disease Guideline Released by American College of Rheumatology and Vasculitis Foundation

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The following is a press release dated March 8:

The American College of Rheumatology (ACR), in partnership with the Vasculitis Foundation (VF), released a new guideline for the management of Kawasaki disease that addresses diagnostic issues relating to Kawasaki disease, the treatment of high-risk patients, and the management of convalescent patients.

Kawasaki disease is a vasculitis that is most common in children under 5 years old. It makes blood vessels in the body (particularly those that supply blood to the heart) become inflamed. This guideline is the final companion to three other ACR/VF vasculitis guidelines released in July 2021.

“Kawasaki disease continues to be an area of evolving understanding in clinical treatment,” said Mark Gorelik, MD, an Assistant Professor at Columbia University Vagelos College of Physicians and Surgeons in New York, and the lead investigator of the guideline. “There are various degrees of severity in this disease and a set of complications and therapies that rheumatologists should be aware of. These guidelines will help clinicians better treat patients by augmenting existing guidelines from the American Heart Association, especially for complex patients seen by rheumatologists.”

The guideline provides eleven treatment recommendations, a good practice statement that all Kawasaki disease patients should be initially treated with intravenous immunoglobulin (IVIG), and an ungraded position statement on the use of either non-glucocorticoid immunosuppressive therapy or glucocorticoids for patients with acute Kawasaki Disease and persistent fevers after repeated treatment with IVIG. The strong recommendations include prompt treatment of incomplete Kawasaki disease, aspirin therapy, and obtaining an echocardiogram in the setting of shock. The conditional recommendations include use of IVIG with other adjuvant agents for patients with high-risk features for IVIG resistance and/or coronary artery aneurysms.

“IVIG is the central therapy for patients with Kawasaki disease and should be administered as soon as the diagnosis of Kawasaki disease is made. IVIG significantly reduces the rate of coronary artery aneurysms,” said Dr. Gorelik.

Two recommendations in the new guideline differ from current standards. Currently, all patients with Kawasaki disease are treated essentially identically. The guideline recommends higher risk patients be treated with short courses of corticosteroids at time of first diagnosis. The guidelines also recommend that physicians can choose to use either low or high dose aspirin for therapy, since there is no evidence that either higher or lower doses are more effective for preventing vascular complications.

“Kawasaki disease is the leading cause of acquired heart disease in children,” said Joyce Kullman, Executive Director of the Vasculitis Foundation. “This guideline will hopefully take the guesswork out of determining which treatments might work best for newly diagnosed patients, or patients who have been under treatment for a while without success.”

While the guideline was being developed, the COVID-19 pandemic began. A novel multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 emerged with some features suggestive of Kawasaki disease. The ACR has published a separate clinical guidance on MIS-C, but further study is needed to understand the relationship between MIS-C and Kawasaki disease.

“Based on clinical experience with many MIS-C patients, recognition and differentiation of MIS-C from classic Kawasaki disease is important. Patients who meet criteria for Kawasaki disease should be treated using the therapies discussed in this guideline. Additional study is needed to determine optimal treatment for MIS-C with and without Kawasaki disease features,” said Dr. Gorelik.

Like many other ACR guidelines, the guideline for Kawasaki disease was developed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, which creates rigorous standards for judging the quality of the literature available and assigns strengths to the recommendations. The papers containing the full list of recommendations and supporting evidence is available on the ACR website.

Fifth Update of ACR COVID-19 Vaccine Guidance Supports Fourth Doses for High-Risk Rheumatic Disease Patients

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The following is a press release issued by ACR today:

The American College of Rheumatology has issued an updated version of its COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases that includes support for supplemental and booster doses (often patients’ third or fourth doses), recommendations for timing of those injections in relation to immunomodulatory medication use, and revised guidance for pre- and post-exposure prophylaxis with monoclonal antibody treatment.

The guidance recommends that all rheumatic disease patients receive a booster dose after their primary vaccine series, as recommended by the CDC. Patients who are expected to have mounted an inadequate vaccine response due to using immunosuppressant treatments (as outlined in Table 3 of the guidance), should take a third mRNA vaccine dose as part of their primary vaccination series prior to their booster, for a total of four doses. These recommendations for primary vaccination, supplemental dosing, and booster doses apply regardless of whether patients have experienced natural COVID-19 infection.

The CDC currently recommends third mRNA doses be taken at least 28 days after the first two mRNA doses and booster doses be taken at least five months after completion of the primary vaccination series. Based on the availability of evidence, patients should try to take the same mRNA vaccine for their third dose but may use either if the initial brand is unknown or unavailable. No additional primary shot for the Johnson & Johnson (J&J) vaccine is approved at this time, but a booster dose of an mRNA vaccine is recommended at least two months following the primary J&J shot.

“It remains important for rheumatology providers to assess the vaccination status of all patients with rheumatic diseases,” said Dr. Jeffrey Curtis, Chair of the ACR COVID-19 Vaccine Guidance Task Force. “Initially, it might have been acceptable to just ask a patient if they have been vaccinated. There is now more nuance with supplemental and booster dose recommendations that should prompt us to ask patients not only whether they have been vaccinated, but with what, how many times, and how recently.”

The guidance also continues to support the use of pre-exposure and post-exposure monoclonal antibody prophylaxis for high-risk autoimmune and inflammatory rheumatic disease patients when/if available for use, noting that the FDA has limited the use of some monoclonal antibody therapies in light of the current conditions. For example, neither bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab, are licensed nor available under emergency use authorization (EUA) given their lack of activity against the Omicron variant, the dominant strain circulating in the U.S.

The updated recommendations can be found on the ACR website. Statements in bold are those that have been revised or added in the most current version of the document. These changes are also summarized in the Appendix Table. An important set of guiding principles, foundational assumptions and limitations are mentioned in the Supplemental Table.

A peer-reviewed manuscript with additional details on the clinical studies, data, and discussion points that influenced the recommendations has been submitted for publication to Arthritis & Rheumatology. It will be made available on the ACR website once published.

COVID-19 Infection in a Toddler

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Content note: death and autopsy of a toddler

covid-19 infection in a toddler

I recently found a journal article about COVID-19 infection that everyone needs to read. Published in August, it should have been on everyone’s minds as people decided the fate of children returning to school.

Ismael Gomes, Karina Karmirian, Júlia T. Oliveira, Carolina da S.G. Pedrosa, Mayara Abud Mendes, Fernando Colonna Rosman, Leila Chimelli, Stevens Rehen. SARS-CoV-2 infection of the central nervous system in a 14-month-old child: A case report of a complete autopsy. The Lancet Regional Health – Americas, Volume 2, 2021, 100046, ISSN 2667-193X, https://doi.org/10.1016/j.lana.2021.100046.

A 14-month old Black baby girl died due to COVID-19. Four months before her death, she fell ill. Doctors assumed she had viral meningitis. She was hospitalized multiple times between then and her death. By the time they suspected pneumonia, she was just on the cusp of becoming unstable. The child died within days.

 

Findings

For those of us who need the findings in plain language:

  • Microthrombosis – Thrombosis is when a blood clot forms in a blood vessel. Microthrombosis simply means that these blood clots are incredibly small. These were found in the child’s left ventricle (heart), thyroid, and kidneys.
  • Pulmonary Congestion – Excess fluid in the lungs, which often leads to a lack of oxygen in the blood.
  • Interstitial Oedema – Swelling within the lungs in the areas surrounding the air sacs in the lungs.
  • Lymphocytic Infiltrates – A non-cancerous or benign build-up of white blood cells. These were found in the child’s right ventricle (heart), the mucous bits within the throat, tongue, stomach, intestines, liver, and more.
  • Bronchiolar Injury – A complication connected to blunt trauma and injuries during intubation. Without proper treatment, this can lead to pneumonia and other life-threatening conditions.
  • Collapsed Aalveolar Spaces – A complete or partial collapsed lung. Some of these spaces were filled with collections of protein and inflammatory cells.
  • Cortical Atrophy – The loss of brain cells called neurons. Other conditions that can lead to this include stroke, dementia, seizures, a traumatic brain injury, Huntington’s disease, AIDS. “The brain weight (635 grams) was about 33% less than normal for age.”
  • Severe Neuronal Loss – The death of brain cells. This often occurs in those with conditions that are linked to brain and cardiovascular health.
  • Hemorrhagic Foci – A type of bleeding within the brain.
  • Spongiosis – Parts of the brain turn into sponge-like tissues. Her brain became sponge-like.
  • Gliosis – A process where your body creates new or very large glial cells (which support nerve cells). These cells can cause scars and lesions on the brain.
  • Macrophages – We know that one, right?
  • Diffuse white matter edema – Swelling in the white matter.
  • Neuronal Mineralization – Tissue within the brain turns into minerals.
  • Encephalopathy – Brain swelling.
  • Overproduction of cytokines, leading to systemic inflammation.
  • Other Issues Found
    • Laryngitis.
    • Infection in the salivary glands.
    • Fewer lymph-related cells in the tonsils, thymus, appendix, and lymph nodes.
    • Swelling and blood clots within the esophagus.
    • Stomach congestion, blood in the mucous, gastritis.
    • Steatosis, or fatty liver disease.
    • Necrosis or dying tissue in and around the pancreas.
    • Blood clots within the pelvic region.
    • The taste and smell center of the brain was not around due to softening.
    • A breakdown in the blood-Cerebral Spinal Fluid barrier.

I want to highlight that MIS-C – or Multisystem Inflammatory Syndrome in Children – is similar to both Kawasaki Syndrome and Macrophage Activation Syndrome. Many of these are symptoms that those of us familiar with those conditions are very aware of. And, again, this child’s brain began to turn into a literal sponge.

 

Please continue to wear your mask, especially if you’re at higher risk.

2021 Care Rationing Survey

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2021 Care Rationing Survey - #NoBodyIsDispoable Fat Legal Advocacy, Rights, & Education Project - Have you struggled with or delayed getting medical care during the pandemic? Are you a provider concerned about care rationing at your organization? Please take this survey.

The #NoBodyIsDisposable Coalition and the Fat Legal Advocacy, Rights, & Education Project have created a short survey to hear from people who are being denied medical care because of limited medical resources. Responses will be used to help advocate for fair medical treatment.

This survey was created to help gather the stories of folks who are having trouble getting medical care during COVID. Stories will be shared to create awareness and support advocacy. (Respondents can choose whether or not to share anonymously.)

Who should take the survey?

Please take the survey if you or someone you know had a hard time getting medical treatment during COVID due to limited medical personnel and supplies/equipment shortages and you suspect part or all of the reason you did not receive necessary care was based on discrimination including but not limited to your weight, disability, race, age, or other factors.

Take the survey if you have been delaying necessary medical care because you worry if you do get COVID that you will be deprioritized for life-saving medical treatment based on your weight, disability, race, age, or other factors.

Take the survey if you work at a health care organization and have concerns about the care rationing policy, or how it is implemented.

Link to the Survey

The survey is available in English and Spanish.

Please help spread the word. They will be reviewing answers on an ongoing basis.

ACR Update on Tocilizumab/Actemra Shortages

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The following is a press release issued by the ACR as of yesterday, August 17, 2021:

The American College of Rheumatology (ACR) is actively engaged with the FDA Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for tocilizumab to be used for the treatment of COVID-19 in some hospitalized adult and pediatric patients.

The manufacturer has indicated in an Aug. 16 update that providers may currently find tocilizumab IV supplies to be unavailable due to high demand, but they expect IV stock replenishments by the end of August. Measures are being taken to expedite replenishments and increase manufacturing capacity and supply wherever possible, but they have indicated additional intermittent shortage periods may occur in the months ahead if the COVID-19 pandemic continues at the current pace.

According to their statement, subcutaneous formulations (pens and pre-filled syringes) continue to be available for patients prescribed tocilizumab for FDA-approved indications, and these are not authorized for treatment of COVID-19 patients under the EUA.

Providers experiencing trouble obtaining tocilizumab IV or any other issues related to COVID-19 can contact the ACR at COVID@rheumatology.org.