Category: ACR

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.

The American College of Rheumatology Releases Two Updated Guidelines for Treatment of Juvenile Idiopathic Arthritis

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The following is a press release from the ACR dated today:

The American College of Rheumatology (ACR) released two updated guideline papers for the treatment and management of Juvenile Idiopathic Arthritis (JIA). These two guidelines are companions to previously updated JIA guidelines released by the ACR and Arthritis Foundation in 2019 covering the treatment of polyarthritis, sacroiliitis, uveitis and enthesitis. One paper provides updates on the pharmacologic management of JIA, focusing on treatment of oligoarthritis, temporomandibular (TMJ) arthritis and systemic JIA (sJIA), with and without macrophage activation syndrome (MAS). The other focuses on non-pharmacologic therapies, medication monitoring, immunizations and imaging, irrespective of JIA phenotype.

The original JIA guidelines were published in 2011 and 2013, and this update reflects the ever-changing rheumatology field with new criteria on how to define disease and new medications to treat those diseases.

“As rheumatologists, our patients and caregivers expect us to review the literature and weigh the evidence so that we can suggest the best treatments, while also considering their preferences,” said Karen Onel, MD, Chief of the Pediatric Rheumatology Division at the Hospital for Special Surgery in New York and the lead investigator of the guidelines. “The field has changed tremendously since the 2011 and 2013 efforts, so we needed to adapt our guidance to the times in order to offer our patients the most nimble and state-of-the-art care possible.”

One example of where the guideline team has adapted is in their recommendations for using disease-modifying antirheumatic drugs (DMARDs). The guideline on the pharmacologic management of JIA emphasizes early use of conventional synthetic and biologic disease-modifying antirheumatic drugs. This is a much different treatment approach than what was previously recommended.

“For many years, treatment of JIA consisted of corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, bracing and surgery. There were no DMARDs and even if there were, they were not tested or used in children,” said Dr. Onel. “These guidelines stress the early use of conventional synthetic and biologic DMARDs and the avoidance of glucocorticoids and NSAIDs. In fact, for systemic JIA the guidelines suggest using biologic DMARDs as a first line. We have turned the pyramid upside down.”

Two areas of importance for the non-pharmacologic paper were guidance on how to monitor drug toxicities for children with JIA and the importance of immunization. Laboratory test monitoring recommendations for medications such as NSAIDs, methotrexate, and hydroxychloroquine can be found on pages 6-9. There was strong support for the use of immunizations in children with JIA and specific guidance for children with JIA receiving immunosuppression, not on immunosuppression, and children who are under-immunized or unimmunized can be found on pages 10-11. Additionally, the guideline recommends the use of physical therapy and occupational therapy interventions and a healthy, well-balanced, age-appropriate diet.

Though the scope of the two guidelines differs, one thing they have in common: the importance of shared decision-making with the patient/caregiver.

“Not every decision will be appropriate for every patient, which is why it was so instrumental to receive input from both patients and caregivers when creating these recommendations,” said Dr. Onel.

While the guideline was being developed, the COVID-19 pandemic began, and COVID-19 immunization became possible. As none of the currently available vaccines against COVID-19 are live vaccines, recommendations for use in JIA should be similar to those stated for inactivated vaccines. While specific guidance on immunizing children with rheumatic diseases against COVID-19 is still lacking, the ACR has published guidance on COVID-19 vaccines for adults with rheumatic and musculoskeletal diseases.

At the time the manuscript was approved for publication, the Pfizer-BioNTech COVID-19 vaccine was approved for emergency use in children 5-15 years of age in the U.S and FDA approved for adolescents 16-18. In addition, two new medications were also approved while the guidelines were developed. These will be considered for future updates.

“There were areas that we didn’t consider at the start that now belong. The guidelines will have to be updated again. But that is a sign of a growing and changing field,” said Dr. Onel.

Like many other ACR guidelines, the updated guidelines for JIA were 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 are available at on the ACR website.

PS: Hi, I helped with this!! Check out the other teams involved (pdf).

Updated Guideline Introduces New Recommendations for Use of Medications Around Total Hip and Knee Replacement

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The following is a press release from the ACR dated 2/28/2022:

The American College of Rheumatology (ACR) and the American Association of Hip and Knee Surgeons (AAHKS) released a summary of their updated guideline for the Perioperative Management of Antirheumatic Medication in Patients with Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty.

The guideline, updated from the organizations’ 2017 joint guideline on the same topic, includes recommendations for people with systemic lupus erythematosus (SLE), spondyloarthritis (SpA), juvenile idiopathic arthritis (JIA), rheumatoid arthritis and other forms of inflammatory arthritis (IA). It also includes a list of medications patients should continue to take through surgery and a list of medications to withhold prior to surgery.

“Patients with rheumatic diseases such as rheumatoid arthritis or psoriatic arthritis are at a much higher risk for adverse events, particularly infections, after total hip and total knee replacement,” said Susan M. Goodman, MD, attending rheumatologist at the Hospital for Special Surgery and co-principal investigator of the guideline. “Some risk factors for infection, such as disease severity or overall disability, are not modifiable, but immunosuppressing medications used to treat rheumatic musculoskeletal diseases are an accessible target where perioperative management may decrease risk. New data and medications have become available since our last guideline in 2017, so we felt it was important to update our recommendations.”

That new data prompted guideline investigators to recommend withholding biologic medications in patients with IA, withholding medication for a dosing cycle prior to surgery and scheduling the surgery after that dose is due. For example, if a patient takes their medication every four weeks, the patient should withhold a dose of medication and schedule surgery on the fifth week after their last dose.

Another important recommendation is to continue treating patients with severe SLE with biologics, but to withhold biologics in less severe cases where there’s little risk of organ damage. The guideline recommends shortening the time between the last dose of JAK inhibitors and surgery, from seven to three days, to avoid early flares.

The updated guideline also includes recently introduced immunosuppressive medications, anafrolumab and voclosporin, which are used to treat SLE. Although the medications are included in the guideline, there is no published, peer-reviewed data regarding their use in the perioperative period. The medications do increase the risk of infection, and therefore their use in patients with severe SLE would merit review by the treating rheumatologist in consideration of surgery.

“While these new medications do not have any data as of yet related to joint replacement surgery, the guideline development team felt it was important to include them to allow for a discussion of the risks, benefits and shared decision making between doctor and patient,” said Bryan D. Springer, MD, first vice president of AAHKS and co-principal investigator of the guideline.

A full manuscript has been submitted for journal peer review and is anticipated to be jointly published in rheumatology and surgical journals in summer 2022. The summary of the guideline recommendations can be viewed in full 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.

ACR Applauds Bipartisan Letter Urging Congressional Action to Avoid Looming “Medicare Cliff”

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The following is a press release from the ACR that came out today.

The American College of Rheumatology (ACR) applauds the 247 Members of Congress who signed a letter urging Congressional leadership to address several cuts that would reduce Medicare reimbursements for health care providers by nearly 10 percent starting Jan. 1, 2022. These cuts would severely impact rheumatology practices already straining to recover from the COVID-19 pandemic, potentially jeopardizing patient access to care.

“The ACR thanks Reps. Bera and Bucshon, and all the other members of Congress who are calling on Congressional leadership to address the looming ‘Medicare cliff,’” said David Karp, MD, PhD, president of the ACR. “Extending physician payment adjustments for an additional year will help maintain providers’ operational stability that is still affected by the pandemic and ensure people living with rheumatic diseases do not see their care disrupted.”

Spearheaded by Representatives Ami Bera (D-CA) and Larry Bucshon (R-IN), the letter calls on Congress to addresses the imminent payment cuts stemming from an expiring adjustment to the Medicare Physician Fee Schedule (PFS) as well as the Medicare sequester and the Statutory Pay-As-You-Go (PAYGO) Act that cumulatively would cut reimbursements by a total of 9.75 percent next year.

The letter also calls for a future effort to establish broader, long-term reforms to ensure stability within the Medicare payment system as well as adequately incentivize high-quality care. Noting that the Physician Fee Schedule has failed to keep up with inflation over the years, the lawmakers argue that cuts to specialty providers could seriously jeopardize the stability of America’s health care delivery system at a time when so many providers are still only beginning to recover from the disruption caused by COVID-19.

Background on the “Medicare Cliff”

The looming payment cuts, which have been colloquially referred to as the “Medicare Cliff” stem from a confluence of three separate provisions that are all set to be implemented at the same time.

At the end of 2020, Congress attempted to mitigate the financial impact of the pandemic on health care providers by including a one-time 3.75 percent payment increases for all PFS services in the Consolidated Appropriations Act of 2021. This payment adjustment afforded some short-term stability for health care professionals struggling with the impact of the COVID-19 pandemic but is expiring at the end of the calendar year while providers still struggle with COVID’s impact.

At the same time, providers are also facing a 2 percent cut due to the expiring moratorium on the Medicare sequester. The sequester – which automatically cuts Medicare spending across-the-board – has been in place since 2013 but has almost always been suspended by Congress. The current suspension expires at the end of this year.

Finally, providers are facing an additional 4 percent payment cut due to the Pay-As-You-Go (PAYGO) budget rule, which requires mandatory spending increases to be offset by tax increases or cuts to other areas of mandatory spending. Because the American Rescue Plan that Congress passed earlier this year did not include such an offset, the PAYGO rule will be triggered unless Congress decides to waive it.

View the letter here.

ACR Responds to 2022 Medicare Physician Fee Schedule Proposed Rule

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The following is a press release from ACR dated Weds, September 15.

In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) shared its perspective on the CY 2022 Medicare Physician Fee Schedule and Quality Payment Program proposed rule.

“We are especially appreciative of CMS’ continued recognition of the value of complex care provided by rheumatologists and other cognitive care specialists by continuing to operationalize the Evaluation and Management (E/M) coding changes that were set in motion over the last few years. As our nation’s healthcare system continues to navigate the challenges of a global pandemic, we also appreciate the policies and flexibilities set forth by CMS to help alleviate these challenges while we all work to provide quality care for our patients,” said David Karp, MD, PhD, president of the ACR. “In light of ongoing volatility and unknowns in the healthcare system, we would also like to share our concerns with some other aspects of the proposed rule – especially the proposed decrease in the conversion factor, CMS’ proposed implementation of the rheumatology MIPS Value Pathway and a new proposal for EHR interoperability and digital quality measures.”

The ACR’s specific comments and concerns are outlined as follows:

Evaluation and Management Services

The ACR appreciates CMS’ ongoing commitment to implementing recent changes to E/M codes that more appropriately reflect the value of cognitive specialists and urges the agency to continue monitoring how the updated codes are operationalized. The ACR also appreciates the proposed rule’s revisions to the long-standing policy on billing for split (or shared) visits but wants to ensure that these changes don’t become burdensome for providers, especially as it relates to time tracking for the “substantive performance” of the provider, as this can introduce the potential for billing errors.

Telehealth Flexibilities

CMS has proposed extending several of the telehealth flexibilities that were implemented at the start of the public health emergency through the end of 2023.  The ACR appreciates this additional flexibility and recommends that the direct supervision waiver allowing a supervising physician to serve patients using real-time, interactive audio-video technology be made permanent. This would immediately provide timely access to cognitive services for Medicare beneficiaries and relieve an undue burden to an aging population.

The ACR also supports CMS’ proposal to permanently adopt a code (G2252) for an extended virtual check-in. This allows a provider to briefly check in with an established patient using any form of synchronous communication technology, including audio-only, and will be especially beneficial to patients in rural areas.

Conversion Factor Reduction, Physician Work and Practice Expense (PE) Relative Value Changes

The ACR shares the concerns raised by many specialty provider groups about CMS’ proposal to reduce the conversion factor by 3.75% in 2022 and urges the agency to maintain the current rate at least through 2023. The proposed reduction comes at a time when physician practices and hospitals are facing unprecedented uncertainty about their futures amid the COVID-19 pandemic. Implementing reductions now would have a damaging impact on an already strained system.

Concerning the proposed updates to the Relative Value Units (RVUs), the ACR recognizes that CY 2022 is the final year of a four-year transition period to update the practice expense (PE) component with the latest pricing data for supplies and equipment. In conjunction with this final year of the equipment pricing update, CMS is also proposing an update to the clinical labor pricing component in CY 2022, which could result in temporary distortions for provider reimbursement. To minimize disruptions to physician practices, the ACR recommends CMS use a similar four-year transition to implement the clinical labor pricing update.

EHR Interoperability & Digital Quality Measures

While the ACR is overall encouraged by CMS’ efforts to broaden the standardization of clinical data and increase electronic health record (EHR) interoperability, the ACR has several concerns with how the agency’s proposed recommendations will impact practices – particularly smaller practices with fewer financial resources. As a next step for moving forward, the ACR recommends CMS conduct an environmental landscape assessment of EHR software capabilities that should consider factors such as costs to practices, specialty-specific templates and reports, registry participation and patient portal access. This should help establish a clearer picture of practices’ reasonable ability to meet CMS’ proposed digital health goals and avoid a situation where providers are held accountable for factors that are beyond their control.

Rheumatology MIPS Value Pathway (MVP)

The ACR is pleased that the proposed rule includes a new MIPS Value Pathway (MVP) for rheumatology as proposed by the ACR and looks forward to working with the agency to ensure that it is implemented successfully. However, the ACR has several concerns with the proposed rollout of the MVP program and the lack of details that have been provided thus far. In particular, the ACR recommends delaying setting a deadline for sunsetting traditional MIPS until the agency can evaluate the success of implementing MVPs.

For more details, view the ACR’s full comment letter (PDF).

ACR Webinar: Reproductive Health & Rheumatic Disease – Sept 14 @ 7 pm ET

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The following is an upcoming webinar from the ACR. Please note that this post has a major focus on cisgender folks and contains binary gendered language. It’s likely the webinar will as well.

Rheumatic diseases are lifelong conditions that affect over 54 million Americans, often during their childbearing years. Rheumatic diseases disproportionately impact women and certain rheumatic diseases are more prevalent in minority populations than they are in the general population.

On Tuesday, September 14, 2021, at 7 pm EDT, the American College of Rheumatology (ACR) and its Simple Tasks campaign will host a FREE webinar for patients, health care professionals, media and the general public on reproductive health and rheumatic disease. Attendees can expect discussion and resources from a panel of leading experts in rheumatology care, reproductive health, and parenting.

To register for the webinar, please visit rheum4you.org.

During the 90-minute webinar, experts will cover:

  • Family planning with rheumatic disease, including fertility, contraception, male reproductive health, treatment considerations for men and women, and medication compatibility.
  • Pregnancy and rheumatic disease, including the impact of pregnancy on rheumatic disease, the role of the rheumatology provider in your care during pregnancy, genetic factors, and medication compatibility.
  • Parenting with rheumatic disease, including tips for managing the treatment of a child with rheumatic disease, parenting while managing a chronic disease, breastfeeding, compatible medications, and occupational and physical therapy tips for caring for your child.

Panelists:

Webinar Moderator:

  • Cheryl Crow – Occupational Therapist, OTR/L and Founder of “Arthritis Life” multi-media platform and Podcast Host

You can view the recording below:

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.

Rheumatology Patients on Immunosuppressive Medications Qualify for Third COVID-19 Vaccine Dose

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The following is a press release from the ACR released within half an hour of this post:

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices today recommended that rheumatology patients being actively treated with high-dose corticosteroids, alkylating agents, antimetabolites, tumor-necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory receive a third dose of the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines.

The approval came one day after the FDA announced it would be revising the current emergency use authorizations (EUA) for the two mRNA vaccines to permit a third dosage in certain immunocompromised patients. The recommendation applies for ages 12 and older for individuals receiving the Pfizer-BioNTech vaccine and18 and older for patients receiving the Moderna vaccine. The new EUA is specifically for the two mRNA vaccines and does not extend to recipients of the Johnson & Johnson vaccine currently.

“This will be enormously important for our immunocompromised patients, and we are thankful to the FDA and CDC for hearing our concerns, recognizing the needs of this population and moving forward,” stated ACR President Dr. David Karp. “We look forward to working with the agencies as they communicate this new recommendation.”

The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary vaccine series, and patients and providers should stick to the same brand for the third dose, if possible. No determination was made on the safety of receiving one of the mRNA vaccines if a patient initially received the Johnson & Johnson shot.

All immunocompromised patients, including those who receive an additional mRNA dose should continue to follow prevention measures, including:

  • Wearing a mask
  • Staying 6 feet apart from those they don’t live with
  • Avoiding crowds and poorly ventilated indoor spaces until advised otherwise by their healthcare provider
  • Close contacts of immunocompromised people should be strongly encouraged to be vaccinated against COVID-19.

These preventative measures remain critical due to real-world data that shows immunocompromised individuals are more likely to have a lower response to the initial vaccine dosage and are more likely to experience breakthrough infections. According to the CDC, 40-44 percent of hospitalized breakthrough cases are immunocompromised patients.

In a recent randomized trial of a third dose of Moderna vaccine in transplant recipients, 33 – 50 percent of those who had no detectable antibody response to an initial mRNA vaccine series developed one with a third dose, and the proportion of the group who are seropositive increased to 68 percent with the third dose. No serious adverse events were reported, and the symptoms reported were consistent with previous doses, with mostly mild or moderate symptoms reported.

The CDC noted that the effectiveness and accuracy of antibody testing are still being evaluated. Patients who are moderately to severely immunocompromised should discuss a third dose with their providers.

“Not all medications that our patients take have been shown to have significant effects on responses to vaccination. Patients should ask their provider if they are likely to see a beneficial effect from additional vaccination,” Dr. Karp said. “Luckily, we have not seen any safety signals in patients with autoimmune and rheumatic diseases from the COVID-19 vaccines, so there should be no concern for the third dose.”

The ACR’s COVID-19 Vaccine Clinical Guidance Task force is meeting Monday, Aug. 16 to discuss potential changes to the ACR’s clinical guidance and expect to share recommendations shortly after.

For more on this, you can also check out the recent town hall webinar from ACR now uploaded to YouTube.

Wednesday Town Hall on Effectiveness of COVID-19 Vaccination in Immunosuppressed Patients

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How effective COVID-19 vaccines have been in immunosuppressed and rheumatic disease patients remains an incompletely answered question. The American College of Rheumatology (ACR) has organized an expert panel to share details on what we are learning from real-world data collection efforts and answer questions from the audience.

Speakers include:

  • Michael R. Anderson, MD, MBA, FAAP, FCCM, FAARC, Senior Advisor at the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, D.C., and a key leader on the federal COVID-19 monoclonal antibody therapeutics team
  • Marcus Snow MD, Rheumatologist at Nebraska Medicine; Assistant Professor of Internal Medicine, University of Nebraska Medical Center; and Chair of ACR Committee on Rheumatologic Care
  • Kwas Huston MD, Rheumatologist at Kansas City Physician Partners and Clinical Associate Professor of Medicine, University of Missouri Kansas City
  • Alfred Kim MD, PhD, Assistant Professor, Division of Rheumatology, School of Medicine at Washington University in St. Louis
  • Jean Liew, MD, MS, Assistant Professor, Rheumatology, Boston University School of Medicine

The webinar is scheduled for 7 pm Eastern/4 pm Pacific on Wednesday, August 4. Register Online for free access and to submit questions.

Update: if you missed this webinar, the recording is below: