ACR Applauds Dedicated Arthritis Research Funds in the NDAA

Posted on by Grayson

The following is a press release issued by the ACR on December 14, 2023:

Full title: ACR Applauds Lawmakers for First-Time Dedicated Arthritis Research Funds in the National Defense Authorization Act

Today, the American College of Rheumatology (ACR) celebrates the first new medical research line item in the Congressionally Directed Medical Research Program (CDMRP) in eight years for arthritis research under the Department of Defense’s (DoD) C recently passed National Defense Authorization Act (NDAA) for fiscal year 2024.

“Investment in arthritis research will not only benefit those serving in our armed forces, but also the thousands of Americans, including many veterans, living with arthritis,” said Deborah Dyett Desir, MD, president of the American College of Rheumatology. “Efforts from this program will not only help curb the costs associated with managing and treating this disease but will also spur innovations and a better understanding of arthritis in the servicemember population.”

Arthritis research has been funded through the DoD’s Peer Reviewed Medical Research Program (PRMRP) at varying levels since 2009, but given the many priorities of the PRMRP, funding is not guaranteed. The ACR and Arthritis Foundation have advocated for this CDMRP line item to designate specific funding annually to arthritis research and advance research on arthritis risks, outcomes, and treatments among service members. The ACR thanks House appropriations leaders for recognizing the necessity and value of arthritis research in the DoD with this $10M annual line item for arthritis research.

“We know that one in three veterans are diagnosed with arthritis, and it is the second-leading cause of medical dismissals from the military.  This funding is critical to advancing arthritis research and I’m optimistic that we will see the impact and benefits of this investment for years to come,” Dr. Desir concluded.

Young Rheumatology Patients Not Counseled on Sexual Health

Young Rheumatology Patients Not Counseled on Sexual Health

Posted on by Grayson

Brittany M. Huynh, MD, MPH, presented an abstract at ACR Convergence of her paper, Adolescent and Young Adult Rheumatology Patient Reports of Reproductive Health Screening and Counseling in the Clinical Setting.

In this paper, Huynh and her colleagues found that only 38% of pediatric rheumatologists were screening patients between 14-23 years of age for sexual activity. Only 17% of patients surveyed had conversations with their rheumy about pregnancy prevention.

Thankfully, this number was higher for the 36% of surveyed patients that were on teratogenic drugs — those that would harm a fetus. 54% of these patients were screened for sexual activity and 44% were counseled on avoiding pregnancy. However, only 62% of these patients knew their medications would harm a fetus.

We already know that there’s a general lack of these conversations happening across healthcare. Many healthcare providers don’t feel like they know enough about this topic to talk to their patients. Others may struggle with getting their pediatric patient alone to have these conversations without a parent or caregiver present.

As a sex educator, I also wonder how many of these conversations were affected by the overturn of Roe v. Wade. Many clinic systems and professional organizations have struggled with how to highlight the importance of this issue. That’s especially true in states banning similar conversations or punishing healthcare providers for having them.

For any rheumatology professionals looking into how to have these conversations, consider reaching out! I’m always happy to talk shop, consult, or work with your clinic on how to best serve this population.

Photo from The Gender Spectrum // VICE

The Still’s disease Continuum

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Earlier this year, rheumatologists at EULAR reached a consensus that Adult-Onset Still’s Disease and Systemic-Onset JIA are the same disease.

A new study using data from the International AutoInflammatory Disease Alliance Network registry has proved this decision correct. Despite some minor differences across age groups, this is in fact the same disease.

You can read the full journal article on the BMJ.

The Association of Rheumatology Professionals Selects Long Time Physical Therapist to Lead the Organization

Posted on by Grayson

The following is a press release issued by the ACR on Nov 14, 2023:

Today, the Association of Rheumatology Professionals (ARP), a division of the American College of Rheumatology (ACR), announced the appointment of Aileen Ledingham, PT, MS, PhD as the ARP’s  58th president during ACR Convergence 2023, the ACR’s annual meeting.

“The ARP has been a professional home for me for more than a decade—providing the support, resources and educational value needed to excel in my rheumatology career,” said Ledingham. “To now be trusted to lead this organization and all it does to serve rheumatology health professionals and their patients is a true honor.”

As an ARP member, Ledingham has held various leadership positions including co-chair of the ACR membership & awards committee and chair of the ARP eLearning subcommittee. She has also been a member of the ACR finance and education committees, and the ARP nominations and appointments committee. For the past few years, she has been a member of the ARP executive committee as secretary and president-elect leading up to her appointment as ARP president.

Ledingham earned a bachelor’s degree in physical therapy from Northeastern University, a master’s degree in pediatric physical therapy from Long Island University, and a doctorate in rehabilitation sciences from Boston University. She is currently a physical therapist clinical scientist working at Mount Auburn Hospital in Cambridge, Massachusetts. Her research interest is in the field of knee osteoarthritis, specifically on how to help patients use exercise and physical activity to improve their quality of life.

Ledingham’s term begins this month along with the recently appointed 2023-2024 ARP Executive Committee:

  • President Elect – Adam Goode, PT, DPT, PhD
  • Secretary – Becki Cleveland, PhD
  • Immediate Past President – Kori Dewing, ARNP, DNP
  • Practice Committee Chair – Annelle Reed, CPNP, MSN
  • eLearning Committee Chair – Adena Batterman, MSW
  • ARP AMPC Chair – Priscilla Calvache, MSW, LCSW
  • Member-at-Large, Finance – Jillian Rose-Smith, MSW, MPH, PhD
  • Member-at-Large – Bharati Bhardwaja, PharmD, BCPS, LSSBB
  • Member-at-Large – Yvonne Golightly, PT, MS, PhD
  • Committee on Research Liaison – Kaleb Michaud, PhD
  • Committee on Government Affairs Liaison – Donald Miller, PharmD, FASHP
  • ACR Representative – Sam Lim, MD, MPH

The ARP, which serves more than 1,200 members, exists to equip rheumatology professionals with the tools needed to provide quality care for patients with rheumatic and musculoskeletal diseases. ARP members include nurses, nurse practitioners, occupational therapists, physician assistants, physical therapists, pharmacists, practice managers, researchers, social workers and other non-physician professionals in various rheumatology and healthcare settings.

About the Association of Rheumatology Professionals

The Association of Rheumatology Professionals (ARP) is a division of the American College of Rheumatology built by rheumatology professionals, for rheumatology professionals. Our goal is to empower rheumatology professionals by providing education, advocacy, and practice management tools. For more information, visit rheumatology.org/about.  

type 1

Type 1

Posted on by Grayson

A few years ago, I came across Noah Averbach-Katz in Star Trek: Discovery. He, along with his wife Mary Wiseman and their friend Anthony Rapp, play some of my favorite characters — and are some of my favorite actors.

Yesterday, they released a short film they’ve been working on for a while. This is Anthony’s directorial debut and a story written by Noah about trying to seek out Type 1 Diabetes supplies at the end of the world.

Noah, who has T1D, does so much to raise awareness of the scary situations that many of us who rely on daily medication face — the shortages, the emotions, and rationing to stay alive.

I’m especially happy to see that T1International supplied support. Backing this project is one of the coolest things I’ve ever had the opportunity to do, too, and I’m so grateful for how it turned out.

You can read the Playbill article about the short film — and watch it below!

COVID Might Raise Odds for Still’s Disease

Posted on by Grayson

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.

Survey on Rheumatoid Arthritis and Exercise

Survey on Rheumatoid Arthritis and Exercise

Posted on by Grayson

We are exploring the preferences and opinions of different types of exercise in adults with Rheumatoid arthritis. If you are older than 18 years and have been diagnosed with Rheumatoid Arthritis, you are eligible to participate.

What is the purpose of this study

This research aims to identify the exercise preferences of individuals with Rheumatoid Arthritis. The opinion on a new type of exercise, known as Blood Flow Restricted training, will also be explored.

What will I do

You will be asked to complete a ~15-minute online survey. The survey will contain questions regarding current pain scores and activity levels, exercise preferences, and your perception of blood flow restricted training.

Risks

While we do not believe there are any inherent risks associated with this research, you will be asked some questions pertaining to your perceived levels pain. Some of these questions could elicit feelings of distress.

The expected benefits of the research

We cannot guarantee or promise that you will receive any benefits from this research. However, the results of this research will be used to guide future exercise interventions tailored to individuals with RA, which may improve the quality and acceptability of research in this field.

What happens to information about me

All records containing personal information will be confidential and no information which could lead to your identification will be released unless required by law. Data will be kept for 5 years. Results will be reported in scientific publications and industry reports in a way in which you cannot be identified. Your data will remain anonymous.

Questions about the research, complaints, or problems

If you would like more information about the study, please download the Participant information sheet (participant information sheet) or email hunter.bennett -at- unisa.edu.au if you have any questions.

 

Click here to learn more

FDA Approves Actemra Biosimilar TOFIDENCE™ (tocilizumab-bavi) by Biogen

Posted on by Grayson

The following is a press release dated Sept 29, 2023:

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy.

“The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.

The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.

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EU has its first RoActemra biosimilar — Tyenne

Posted on by Grayson

The following is an except from an article on Pharmaphorum, dated Sept 20, 2023:

The biosimilar of IL-6 inhibitor tocilizumab, called Tyenne (formerly MSB11456), has been approved for the same indications as Roche’s brand, including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome and severe COVID-19.

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ACR Launches Biosimilar Patient Education Campaign for Rheumatic Disease Awareness Month

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The following is a press release issued by the ACR September 12, 2023.

The American College of Rheumatology (ACR) today launched its patient education campaign, Biosimilars & You: A Guide to for Patients with Rheumatic Disease as part of Rheumatic Disease Awareness Month (RDAM). The campaign aims to help individuals diagnosed with a rheumatic disease better understand what biosimilars are and that these therapies may offer a treatment option as safe and effective as the original biologic they are based upon.

A 2023 survey looking at US patients’ attitudes about biosimilars found that patients expressed a desire to know more about biosimilars in general and specifically about how they compare with original biologics, their benefits, and their cost. The ACR, in consultation with practicing rheumatologists and rheumatology health professionals, developed resources, which include a video; an infographic; a patient fact sheet, and additional materials, to meet this need.

“Biosimilars are a class of medications that rheumatologists have long been prescribing in the US and Europe to successfully treat rheumatic conditions,” said Marcus Snow, MD, chair of the ACR Committee on Rheumatologic Care and spokesperson for RDAM 2023. “They go through a very stringent review process with the FDA and are verified to be just as safe as the biologics they are based upon. With so many new biosimilars available this year, we knew patients would have questions and providers would be seeking resources to share with their patients.”

More than 58.5 million American adults have been diagnosed with a rheumatic disease, and an estimated 300,000 children live with some type of juvenile arthritis. Prior to the advent of biosimilar therapies, there has been only one medication healthcare providers could prescribe for their patients with rheumatoid arthritis, psoriatic arthritis, lupus, and several other rheumatic diseases over the past decade. With new biosimilars available, the hope is that in addition to more options for treatment, there may also be potential for cost savings for patients. However, this has yet to be determined.

“With more and more biosimilars becoming available, it’s important to note that they are not synonymous with a ‘generic drug’ because they are not identical to the original biologic,” Snow said. “The difference between biosimilars and the original reference biologic compares to the difference between two buildings created from the same blueprints. The buildings will look the same, be the same height and have the same number of rooms and functionality. But they might have different paint colors, doorknobs, or other small differences. However, those differences do not change how the building functions; both have a sound foundation. ”

The ACR aims to be a one-stop shop for patients and their healthcare providers to learn more about biosimilars. View all biosimilar resources from the patient education campaign at www.RDAM.org.