ACR Update on Tocilizumab/Actemra Shortages

Posted on by Grayson

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

Posted on by Grayson

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

Posted on by Grayson

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:

Dungeons & Diagnoses

Posted on by Grayson

Have you ever wondered what Dungeons & Dragons would be like if it were a little more like real life where healing potions and quick fixes weren’t the norm?

 

Come check out Dungeons and Diagnoses, a 5th edition podcast with a twist from Global Healthy Living Foundation.

 

logo for dungeons and diagnoses

Our heroes explore the cast kingdom of Gaedia. A land filled with the same perils and monsters you may be familiar with as the traditional Dungeons and Dragons, but with Grumm, a Half-Orc Barbarian, Sailor, and Bard, who struggles with his half-bred heritage and its lingering effects on their body. Taakrand, an Aasimar Druid and Monk whose near-featureless form made their adoptive parents send them to train at a druidic monastery.

 

And then there’s me, Elrohir – a Wood Elf Ranger who transitioned into adulthood and was rejected by their Coven as a result. Think a trans version of Robin Williams’ Peter Pan in Hook and you’re pretty close to picturing El.

 

Will our heroes overcome the evil invasion of eldritch Nihil and its armies? Can they discover and cure what ails an elder Dragon before it’s too late? Tune in to find out and hear for yourself the mystical adventure of Dungeons and Diagnoses!

 

You can find the pod on the GHLF website or wherever you catch your pods!

New ACR White Paper Highlights Health Care Challenges Affecting the Rheumatic Disease Community

Posted on by Grayson

The following is a press release from ACR released on May 11:

The American College of Rheumatology (ACR) today announced the launch of a new white paper, “Rheumatic Diseases in America: Confronting the Challenge,” which provides an overview of the current health care challenges facing the rheumatic disease community and highlights the importance of receiving timely and appropriate treatment from a rheumatology health professional.

Released during Arthritis Awareness Month, the white paper aims to educate policymakers, health care professionals, members of the media and the general public about rheumatic diseases, which affect approximately 54 million adults and at least 300,000 children in the United States alone.

“Rheumatology is a broad discipline that covers a wide variety of diseases that affect a person’s joints, musculoskeletal systems, immune system and many other organs,” said Dr. Suleman Bhana, Chair of the ACR’s Communications and Marketing Committee. “With this white paper, we aim to create an accessible, introductory resource for those interested in learning more about rheumatic disease, current treatment options, and the health care and lifestyle challenges patients with rheumatic disease face.”

The white paper is written and designed to appeal to multiple audiences and consists of four key sections:

I. Rheumatology 101

This section provides an introduction to what a rheumatic disease is, describes the role of a rheumatologist, and discusses the importance of early and appropriate treatment. Patients and their family members – particularly those who may have been recently diagnosed with a rheumatic disease – may find this section helpful in understanding what to expect after a diagnosis. Health care professionals may also find this section to be an important resource for conversations with patients to reinforce the importance of timely and accurate diagnosis, and why coordinating care between specialists is so important.

There are over 100 different rheumatic diseases and conditions, some of the most common include: rheumatoid arthritis, lupus, gout, scleroderma, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and Sjögren’s syndrome. This white paper discusses what some of these diseases are and how they affect different parts of the body.

II. Rheumatic Diseases: Prevalence & Impact

Rheumatic diseases in America are extremely common. According to the CDC, an estimated 54 million Americans – 1 in 4 – have a doctor-diagnosed rheumatic disease and some studies have suggested that the actual number of Americans living with these diseases is even higher when accounting for symptoms reported by undiagnosed individuals. The economic toll of rheumatic diseases is also significant. The total cost of rheumatic diseases was recently estimated to be as high as $304 billion annually – greater than the total cost of cancer care in the United States.

For policymakers, the media and the general public, this white paper provides useful statistics that call attention to rheumatic diseases as a public health issue, why solutions are urgently needed to improve patients’ quality of life, and why rheumatology health care professionals are uniquely equipped to help patients manage these diseases.

III. Emerging Trends in Rheumatology

Providers may find the white paper’s discussion of emerging trends in rheumatology – including biosimilars and telehealth – to be helpful in their practice. Rheumatology is a constantly changing field of medicine and these issues will become increasingly important for patients, providers, and the public to understand.

Biosimilars (copies of biologic drugs that are intended to work in the same way as their reference products) represent a new and promising area of rheumatic disease treatment. However, educating patients and providers about their use will continue to be crucial to ensuring their uptake. While recent research has shown that rheumatologists generally have a good understanding and acceptance of biosimilar products, a recent survey found that 29 percent of rheumatic disease patients were unsure whether they had been prescribed a biosimilar drug.

Telehealth, the adoption of which has been catalyzed by the COVID-19 pandemic, represents another important emerging trend in the practice of rheumatology. As many as 66 percent of rheumatic disease patients had an appointment via telehealth in 2020 and these services have been shown to especially benefit individuals with disabilities, those who are in a nursing home, and those living in an area where they would have to travel long distances for treatment.

IV. Access, Affordability & Lifestyle Challenges for People Living with Rheumatic Disease

People living with rheumatic diseases face a variety of access, affordability, and lifestyle challenges associated with their disease. This white paper provides an overview to the public policy issues related to these challenges such as a growing rheumatology workforce shortage, insurer practices that restrict access to care, and rising drug prices that threaten to make treatment unaffordable for many who rely on specialty medications to manage their symptoms.

Solutions are needed to address these issues – and others – that affect the rheumatic disease community. This white paper presents readers with the latest opportunities to get involved with the ACR and Simple Tasks to advocate for better public policy.

To download and read the white paper, CLICK HERE.

ACR COVID-19 Vaccine Guidance Recommends Vaccination, Addresses Immunosuppressant Drugs & Patient Concerns

Posted on by Grayson

The following is a press release from ACR dated February 11.

The American College of Rheumatology (ACR) has released its COVID-19 Vaccine Clinical Guidance Summary that provides an official recommendation to vaccinate rheumatology patients with musculoskeletal, inflammatory and autoimmune diseases.

“Although there is limited data from large population-based studies, it appears that patients with autoimmune and inflammatory conditions are at a higher risk for developing hospitalized COVID-19 compared to the general population and have worse outcomes associated with infection,” said Dr. Jeffrey Curtis, chair of the ACR COVID-19 Vaccine Clinical Guidance Task Force. “Based on this concern, the benefit of COVID-19 vaccination outweighs any small, possible risks for new autoimmune reactions or disease flare after vaccination.”

The guidance was developed by a multi-disciplinary panel of nine rheumatologists, two infectious disease specialists, and two public health experts and is intended to give direction to providers treating rheumatology patients on how to best use COVID-19 vaccines, as well as facilitate implementation of vaccination strategies for rheumatology patients.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” said Dr. David Karp, President of the ACR. “We hope the guidance will provide them evidence-based reassurance that their patients will benefit from being vaccinated and guidance on how to best incorporate it into their treatment plans to maximize vaccine efficacy.”

Important considerations and caveats on how to approach vaccination are included for patients with high disease activity and/or those taking immunosuppressant treatments. These include recommendations to modify certain treatments such as methotrexate, JAK inhibitors (e.g., baricitinib, tofacitinib, upadacitinib) and some biologics (e.g., abatacept and rituximab) that alter the immune system’s response in ways that might affect vaccine response.

The panel based their recommendations on the use and timing of immunomodulatory medications on evidence extrapolated from their immunologic effects as they relate to other vaccines and vaccine types. As such, these and other recommendations made by the task force should be considered ‘conditional.’

“There was vigorous debate on several topics such as the expected magnitude of benefit of vaccination for patients receiving therapies that substantially alter or suppress the immune system (e.g., high dose steroids),” said Curtis. “Ultimately, the task force agreed that in almost all cases, proceeding with vaccination and obtaining at least a partial response would be better than deferring vaccination, since deferring provides no protection at all. Given the lack of direct evidence for these vaccines in rheumatology patients, the panel applied general immunologic principles observed with other vaccines to make recommendations on how to increase the likelihood of a favorable vaccine response.”

“For example, an RA patient with well-controlled disease may benefit from holding a dose of methotrexate immediately following vaccination,” added Karp. “In the case of drugs with long dosing intervals such as rituximab, there are some circumstances where it may be beneficial to time the vaccine around when the last dose was given to maximize the vaccine’s efficacy. We encourage clinicians to study the charts we’ve provided in the summary for details on how they can time various medications to ensure maximum success.”

Given the uncertainty surrounding when alternative vaccine types will become available, the task force focused on the two mRNA COVID-19 vaccines available in the U.S. at the time of their deliberation. No preference for one vaccine over another was stated, and patients are recommended to receive whichever of the mRNA vaccines is available to them.

“With efficacy about the same for both vaccines, we felt it was not important which brand patients received. Realistically, many individuals will not have a choice, as availability varies by site and region. Therefore, it was important to assure providers and patients this was not a factor to consider when discussing vaccination. However, patients should stick to the same vaccine brand for both injections,” stated Curtis.

The ACR has voiced that recommendations in the guidance should not replace clinical judgement, and decisions about individual patients should be made as part of shared decision-making with patients that considers their underlying health condition(s), disease activity level, current treatments, risk of exposure to SARS-CoV-2 and geography. Patients are also encouraged to continue following all public health guidelines regarding mask wearing, physical distancing and other preventive measures even after vaccination.

Future changes are expected to the guidance as more safety and efficacy data about the existing two mRNA vaccines, other vaccine platforms, and vaccine response specific to rheumatic disease patients become available.

“This is very much a ‘living document,’ and the task force already has plans to evaluate additional data in the coming weeks,” said Curtis. “We desperately need direct evidence from high quality research. To reach that goal, we would issue a call to action for patients, providers and researchers to mobilize and support the important research efforts that are underway to study vaccine effectiveness and safety in rheumatology patients.”

The ACR is hosting a town hall with members of the task force on Tuesday, Feb. 16, at 7:30 p.m. EST to discuss the guidance and answer questions about the recommendations. Members of the press are invited to attend and encouraged to register online. Questions about the guidance can be submitted when registering.

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.

Calling Rheumatology Patients – Research Opportunity

Posted on by Grayson

There is a study going on that may help researchers learn more about the design of clinical trials. Further, this research will support the use of patient values when designing clinical trials. This will help ensure that evidence on treatments applies to the patients who will be using them.

You may be eligible if you:

  • Are 18 years of age or older
  • Have access to a device with internet

That’s it! It doesn’t matter where you live or what diagnoses you have. I did this and it was a fun hour-long conversation. I highly encourage people to participate!

Interested? Complete this brief screening survey where they ask basic demographic information (takes 5-10 minutes). You will be asked to provide your email address if you are willing to be contacted to participate in a one-on-one interview.

For more, check out this post on Arthritis Research Canada.

American College of Rheumatology Launches Digital Health Coaching Program for Black and Latina Women with Lupus

Posted on by Grayson

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

The American College of Rheumatology (ACR), in partnership with Pack Health, launched two digital health coaching programs to reduce health disparities among Black women and Latinas living with systemic lupus erythematosus (lupus). The ACR’s Collaborative Initiatives (COIN) department, which houses The Lupus Initiative, will lead the efforts.

The ACR is launching the programs to address a lack of digital health coaching options for the lupus community. The ACR’s COIN department, which concerns itself with advancing health equity and eliminating health disparities, sought funding and community support to create tools that will assist Black women and Latinas living with the disease. Hopefully, having a digital health coaching program specific to this population will help with navigating daily barriers and issues they face in self-management.

The first program is a one-year, $100,000 medical education grant. It runs until Oct.15, 2021, and will provide digital health coaching for 15 individuals with lupus for three months.

The goals are to:

  • Increase patient self-efficacy to engage in recommended lifestyle behaviors and adhere to treatment recommendations;
  • improve adherence to recommended lifestyle and behaviors; and
  • produce insights into program acceptability, patient barriers and lupus disease burden, among other things.

The second program, known as Lupus Engagement through Activity and Digital Resources (LEADR), is a two-year, $299,000 grant-funded through the Office of Minority Health. It will run until Oct. 30, 2022 and plans to reach 200 Black and Latina women in Georgia. LEADR aims to:

  • Encourage more medical providers to discuss and refer their patients to a digital health coaching program,
  • increase physical activity among Black women and Latinas with lupus, reduce negative health outcomes associated with lupus, and ultimately reduce lupus health disparities.

“Building on evidence-based approaches, LEADR’s community-driven health equity model is a unique way to address the complex, multi-faceted need for more providers to recommend physical activity and adherence among African American women and Latinas with lupus,” said Rosalind Ramsey-Goldman, MD, chair of the ACR’s Collaborative Initiatives Committee. “The ACR is singularly qualified, and positioned, to develop and implement a lasting program that improves physical activity among this particular population.”

The ACR has partnered with Pack Health, a health coaching company specializing in providing digital support to people with chronic conditions, to execute the programs. Pack Health will create curriculums and deliver one-on-one health coaching to the target populations. The ACR will lead the programs and leverage its membership, collaborations and TLI resources to achieve the outcomes.

“The focus of these programs is to develop and provide meaningful, data-driven, one-on-one support to improve the self-management skills for people with lupus,” said Kelly Brassil, PhD, RN, Pack Health’s Director of Medial Affairs. “Pack Health’s key objectives are to conduct literature reviews and collect qualitative data to understand patient needs and experiences, use what we learn to inform program development, and, in turn, better serve the needs of the lupus community. Additionally, we plan to enhance and specialize our physical activity content for individuals living with lupus, with a special emphasis on Black and Latina women.”

Lupus is a chronic disease that causes systemic inflammation affecting the skin, joints and multiple organs like the kidneys, heart and brain. It is estimated that 1.5 million Americans have a form of the condition.  According to the Centers for Disease Control and Prevention, Black women are three times more likely to get lupus than white women, and lupus is also more common in Hispanic, Asian, and Native American and Alaskan Native women. Additionally, Black and Hispanic women usually get lupus at a younger age and have more severe symptoms, including kidney problems, than women of other groups.

Reflection on my lowest sed rate ever

Posted on by Grayson

My sed rate today was FIVE. That is the lowest it has EVER been since it was tracked starting in November 1993.

(For those outside immune system things, sed rate is a way to measure inflammation in the body. Normal results are between 0-20.)

I haven’t updated this graph in a while, but this is my sed rate from 2010 to 2017.

line graph of sed rates from 2010-2017 showing markers in the mid20s to high-40s until 2015 when it drops to normal levels

Yes, I still keep an excel file with my labs because I’m a nerd.

I started Kineret the last day of July 2015, and this graph clearly demonstrates how integral that medication has been for me.

I had to switch insurances and rheumatologists to get on this med since my previous doc wasn’t treating me for SJIA. Instead, they were treating me for polyarticular. It’s clear that some of the things we did helped because, yes, I have always had multiple joints involved. However, the medications weren’t targeting the right areas on their own.

That dip in 2012 is when I was on Enbrel and Arava. I felt like shit all the time, and the Arava quickly began damaging my liver. It had gotten so bad quickly that I had to stop it immediately. We had already tried methotrexate – twice – and I couldn’t tolerate it. I stuck with Enbrel for a while as I tried to get my fibro under control, but changed in early 2014 to Cimzia which clearly didn’t do much of anything.

None of that is even comparable to being a kid and having a rate in the 60-80 range regularly. No wonder I was hurting all the time, especially without treatment.

I still get enraged here and there at my previous doc. She refused to try Kineret with me, despite me bringing in case studies, journal articles, and personal accounts. Frankly, she wasn’t willing to entertain any of the SJIA meds because most of the research was on kids. [Insert snarky comment about how we need research on adults with SJIA because I know I’m not alone here.]

Old doc and I were on a research call together a few weeks ago. I really wish there had been an opportunity to call out this misstep without names. Alas, there wasn’t – and I’m trying to do better at being professional. I suffered for nearly three years though. I absolutely could have easily died from my SJIA during that time, let alone complications or my mental health.

For now, I’ll happily celebrate this low level of inflammation and consider writing my old doc to help her do better with future patients.