New Guideline Introduces Recommendations for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases

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The following is a press release from ACR dated today. Also, I helped with this!

New Guideline Introduces Recommendations for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases | Not Standing Still's Disease

The American College of Rheumatology (ACR) released a summary of its new treatment guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs). The effectiveness and safety of vaccines may differ in rheumatology patients as compared to the general population. The guideline summary provides recommendations on topics such as broadened indications for some vaccines in patients on immunosuppressants, medication management at the time of vaccination, and safe approaches to the use of live attenuated vaccines in patients on immunosuppressive medications.

“Patients worry about the safety of vaccines and the potential for inducing a disease flare. Providers are concerned whether rheumatic diseases and the medications used to treat them could blunt the effectiveness of vaccines,” said Anne R. Bass, MD, Professor of Clinical Medicine, Hospital for Special Surgery and Weill Cornell Medicine in New York. “They also want to know whether certain vaccines should be given to protect rheumatology patients who are outside the age range for which they are typically recommended. This guideline was designed to address these issues.”

A few highlights of the new guideline include:

  • Pneumococcal vaccination should be administered to all RMD patients taking immunosuppressive medications.
  • Seasonal influenza vaccination should be administered to RMD patients even if their disease is active, they are taking high- dose glucocorticoids, and/or they are on rituximab.
  • Methotrexate should be held for two weeks after influenza vaccination if disease activity allows.
  • In RMD patients on rituximab, vaccines other than influenza should be administered at least 6 months after the last rituximab dose.

One recommendation that differs from current standards is to administer the rotavirus vaccine in the first 6 months of life to infants who have been exposed to tumor necrosis factor (TNF) inhibitors in utero. Rotavirus is a contagious virus that is most common in infants and young children. Currently, pediatricians postpone vaccination in these TNF-inhibitor exposed children until they are a year old.

The guideline also recommends a shorter interval between the last dose of a biologic disease modifying anti-rheumatic drug (DMARD) and administration of a live attenuated (a weakened form of the germ that causes the disease) vaccine.

“This new guideline recognizes that some patients, particularly very young children with autoinflammatory conditions, simply cannot stay off their medications for very long without having a severe flare of their disease. However, those patients still need to get vaccinated,” said Dr. Bass.

The guideline recommends giving the adjuvanted (an ingredient of a vaccine that helps promote a better immune response) influenza vaccination to patients under 65.

“This might come as a surprise to some providers since it hasn’t been directly tested in that age group, but there are no safety signals in the older population,” said Dr. Bass. “There might be concerns about lack of insurance coverage for vaccines recommended outside the typical age range, but the guideline itself will be a useful resource when discussing reimbursement with insurance companies.”

Recommendations for COVID-19 vaccination in RMD patients was not included in the guideline. Readers can refer to the CDC for the most up-to-date recommendations for COVID-19 vaccination, including for patients on immunosuppressive medications. Recommendations about holding immunosuppressive medications at the time of non-live attenuated virus vaccination in this guideline differ from those recommended around the time of COVID-19 vaccination in the ACR COVID-19 Vaccine Guidance.

“This is because prior to the introduction of COVID-19 vaccines in late 2020, there was little population-level immunity to the SARS-CoV-2 virus, and maximizing vaccine efficacy was a public health imperative,” said Dr. Bass.

A full manuscript has been submitted for journal peer review and is anticipated to be published in rheumatology journals in early 2023. The complete summary of the guideline recommendations can be viewed on the ACR website.

CMS Announces a Huge Step Forward for Chronic Pain Management

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The following is from an email that Cindy Steinberg, Director of Policy & Advocacy at US Pain Foundation, sent this morning (7-18-22).

Dear Pain Warriors,

CMS announced their intention to improve pain care for Americans over 65 or disabled by paying separately for physicians to spend more time with chronic pain patients creating and modifying treatment plans and coordinating team-based comprehensive chronic pain care.

CMS explained their proposal in the recently released draft Medicare Physician Fee Schedule (PFS) for 2023 and are seeking comments on this proposal by September 6, 2022. The PFS is a 2000-page document that we are reviewing but we wanted to make you aware of this important development. We intend to issue a call to action in the coming weeks with more detailed information on what is being proposed, how to comment and points you may consider making in your comment.

Here are some questions and answers you may have now:

Why should pain patients care about this?

Many people with chronic pain report that they are unable to find doctors who will treat them. One reason this is the case is that chronic pain is complex and finding the right treatments that will help patients can be a lengthy trial and error process. Doctors often do not have enough time with each patient to make this economically viable for them. We hope that payment for additional time spent with patients will incentivize doctors to spend more time helping people with pain.

Is this definitely going to happen?

It is highly likely this will go forward but in order to ensure that it does, people with pain need to comment and express support for this proposal.

What is the number one finding and recommendation from the PMTF Report that CMS is taking action on?

Finding: Current best practice in pain management is an individualized, multidisciplinary treatment approach combining a number of different treatment modalities.

Recommendation 1: Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes.

How do I find the document that CMS released?

Click here. (Chronic Pain Management is discussed in Section 33.)

ACR Applauds FTC Decision to Investigate PBM Business Practices

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The following is a press release from the American College of Rheumatology:

The American College of Rheumatology applauds the Federal Trade Commission’s decision to investigate the business practices of pharmacy benefit managers (PBMs), which continue to increase PBM profit margins while placing the burden of skyrocketing drug costs on America’s most vulnerable patients, including those living with chronic and severe rheumatic diseases.

This welcomed news follows sustained calls from the rheumatology community for greater oversight over the insurance middlemen who drive up drug costs for our patients. The FTC investigation is a critical step toward greater transparency and oversight over PBMs’ opaque business practices, as well as the enactment of meaningful drug pricing reforms that will reduce costs and expand access to important therapies for our patients.

While PBMs were originally conceived to help manage the complexities of prescription drug benefits, they have since become massive, consolidated, profit-driven enterprises that exercise immense control over our patients’ access to needed treatments. Their business practices are detrimental to policy efforts to curb the high cost of prescription drugs.

The FTC announced today it will examine the role of PBMs, which are hired by insurers to negotiate rebates and fees with drug manufacturers as well as develop drug formularies that impact reimbursement to pharmacies for patient medications. Citing “complicated and opaque methods to determine pharmacy reimbursement, prevalence of prior authorizations and other administrative restrictions and the use of specialty drug lists surrounding specialty drug policies” as some areas of investigation, the FTC noted it has received more than 24,000 public comments to date regarding the potential investigation of PBMs.

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.

Abivax Reports Promising ABX464 Phase 2a One-Year Maintenance Results in Rheumatoid Arthritis

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Below is a press release dated today (3/10/22) from Abivax:

The Quick Basics

Out of the 40 patients who enrolled into the ABX464 maintenance study, 23 patients have now reached the first year of treatment and all achieved at least an ACR201, with 19 and 12 patients achieving ACR50 and ACR70 respectively.

Long-term safety profile (50mg ABX464 once daily + MTX) favorable and consistent with previous observations.

The induction and maintenance results support further clinical development of ABX464 in RA and potentially other rheumatology indications.

The clinical induction and maintenance data in ulcerative colitis and rheumatoid arthritis underpin the potential of ABX464 to address a broad range of chronic inflammatory diseases.

In G7 countries, the market for ulcerative colitis, Crohn’s disease and rheumatoid arthritis is expected to grow to approximately USD 50B in 2026.

The Full Press Release

Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today reports promising results from its phase 2a maintenance trial in rheumatoid arthritis (RA) after one year of continued daily treatment with 50mg ABX464.

Continue reading “Abivax Reports Promising ABX464 Phase 2a One-Year Maintenance Results in Rheumatoid Arthritis” →

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.

Autoimmune Community Institute to Host Inaugural Autoimmune Health Equity Summit [postponed]

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Update:

With deep sadness, the Autoimmune Community Institute announces today that we must postpone the Inaugural Autoimmune Health Equity Summit originally planned for Saturday, March 12 due to technical issues. 

While compiling our pre-recorded interviews to create the final product, we noticed that the video from some of our amazing speakers did not record. This error is not one that could have been foreseen or prevented, as this is the first time an error like this has occurred. As a result, we felt it necessary to postpone the event to rectify these issues and ensure our speakers can be seen and heard properly.

Dr. April Moreno, Founder at Autoimmune Community Institute has provided the following statement:

“Unfortunately, we experienced technical difficulties with the video service platform and will need time to correct some of the recordings for the event.”

Despite these unfortunate setbacks, registration will continue to be open for the postponed event, which will now occur on March 19, 2022, at 12pm Pacific Time (3pm Eastern Time. We continue to look forward to hosting the event and apologize again for any inconvenience or disappointment. 

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The following is a press release dated March 7 from the Autoimmune Community Institute.

The Autoimmune Community Institute is dedicated to autoimmune health equity through community-based research and support services. The all-volunteer team strives to fulfill that mission by creating spaces for diverse autoimmune voices and experiences in community-centered research design, community support, and health equity advocacy every single day.

Today, ACI is taking a momentous step to further its mission and fulfill its goals by announcing the Inaugural Autoimmune Health Equity Summit. The ACI Health Equity Summit is our signature event to highlight the importance of diversity and representation in autoimmune communities.

This free event will discuss the importance of diversity and representation in research, policy, advocacy, and community support services; as well as the difference between equality and health equity and why we must work toward equity in all policies. Participants will also be introduced to some of our excellent partners in autoimmune health serving diverse communities.

The summit is designed for autoimmune patients, clinicians, researchers, and anyone who works with or has an interest in autoimmune topics. It will be held on March 12, 2022, at 12 pm Pacific Time (3 pm Eastern Time). Registration for the event is now open here! 

Please share this event widely within your networks. The staff at ACI is extremely excited to be hosting this event, and cannot wait to see you there!

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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.