Category: ACR

The following is a press release from Monday this week. Note that it contains cisheterosexist language.

Today, the American College of Rheumatology (ACR) published the 2020 Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. This is the first, evidence-based, clinical practice guideline related to the management of reproductive health issues for all patients with rheumatic diseases. With 131 recommendations, the guideline offers general precepts that provide a foundation for its recommendations and good practice statements.

“This guideline is paramount, because it is the first official guidance addressing the intersection of rheumatology and obstetrics and gynecology (OB-GYN),” said Lisa Sammaritano, MD, lead author of the guideline. “Rheumatic diseases affect many younger individuals; however, little education has been provided to rheumatology professionals on current OB-GYN practices. The guideline [and more detailed online appendices] presents vital background knowledge and recommendations for addressing reproductive health issues in the full spectrum of rheumatology patients, with additional focus on specific diagnoses that require more detailed recommendations such as systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS).

The guideline provides 12 ungraded good practice statements and 131 graded recommendations that are intended to guide care for rheumatology patients except where indicated as being for patients with specific conditions or antibodies present. Good practice statements are those in which indirect evidence is compelling enough that a formal vote was considered unnecessary; these are ungraded and are presented as suggestions rather than formal recommendations. The recommendations were separated into six categories: contraception, assisted reproductive technology (fertility therapies), fertility preservation with gonadotoxic therapy, menopausal hormone replacement therapy, pregnancy assessment and management, and medication use.

While some of the recommendations are strong, many of the recommendations presented are conditional due to a lack of data. Pregnant women are not generally enrolled in clinical studies; and few maternal health studies focus on rheumatology patients. A few notable recommendations from each category include:

Contraception

• Strong recommendation for women with rheumatic disease who do not have lupus or APS to use effective contraceptives with a conditional recommendation to preferentially use highly effective IUDs or a subdermal progestin implant.
• Strong recommendation against using combined estrogen-progestin contraceptives in women who test positive for anti-phospholipid autoantibodies (aPL) or APS

Assisted Reproductive Technology (Fertility Therapies)

• Strong recommendation for fertility therapy in women with uncomplicated rheumatic disease who are receiving pregnancy-compatible medications, whose disease is stable, and who test negative for aPL. Specific recommendations also address patients testing positive for aPL and suggest an anti-blood clotting procedure.
• Conditional recommendation against increasing prednisone dosage during fertility therapy procedures in lupus patients.

Fertility Preservation

• Conditional recommendation against testosterone co-therapy in men with rheumatic disease receiving cyclophosphamide (CYC) and a good practice suggestion to cryopreserve sperm before CYC treatment in men who desire it.
• Conditional recommendation for monthly gonadotropin-releasing hormone agonist co-therapy for premenopausal women with rheumatic disease who are receiving monthly CYC injections/infusions to prevent premature ovarian insufficiency.

Pregnancy Assessment and Management

• Strong good practice suggestion to counsel women with rheumatic disease, who are considering pregnancy, on the improved maternal and fetal outcomes associated with entering pregnancy during low disease activity.
• Conditional recommendation to treat lupus patients with low-dose aspirin daily (81 to 100 mg) starting in the first trimester. For women testing positive for aPL who do not meet the criteria for obstetric or thrombotic APS, it is conditionally recommended to preventatively treat with a daily aspirin (81 to 100 mg) starting early in pregnancy and continuing through delivery.

Menopause and Hormone Replacement Therapy

• A good practice suggestion to use hormone replacement therapy in postmenopausal women with rheumatic disease who do not have lupus or have a positive aPL test; and who have severe vasomotor symptoms, have no contraindications, and desire treatment.
• A conditional recommendation for hormone replacement therapy in women with lupus and without aPL.
• Conditionally recommend against treating with hormone replacement therapy for women with asymptomatic aPL, and strongly recommend against hormone replacement therapy for women with any form of APS.

Medication Use (Paternal and Maternal)

• Strongly recommend against use of CYC and thalidomide in men prior to attempting conception.
• Strong recommendation against the use of NSAIDs in the third trimester.

Individuals involved in the development of the new guideline included rheumatologists, obstetrician/gynecologists, reproductive medicine specialists, epidemiologists, and patients with rheumatic diseases. ACR guidelines are currently developed using the 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 that are largely based on the quality of the available evidence.

“This guideline should open avenues of communication between the rheumatologist and the patient, as well as between the rheumatologist and the OB-GYN,” said Dr. Sammaritano.  “A better understanding of the risks and benefits of reproductive health options will enhance patient care by providing safe and effective contraception, improving pregnancy outcomes by conceiving during inactive disease periods, and allowing for continued control of rheumatic diseases during and after pregnancy with the use of well-suited medications.”

A draft of the guideline was presented during the 2018 ACR/ARP Annual Meeting in Chicago. Since that time, the guideline team has condensed the original three-part draft into a single, concise manuscript, with detailed background and discussion now available online. The guideline development team also incorporated color-coded flow charts to highlight common decision-making points to make it user friendly.

The paper containing the full list of recommendations and supporting evidence is available at  https://www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines/Reproductive-Health-in-Rheumatic-Diseases.

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

Today, the American College of Rheumatology (ACR), in partnership with the Arthritis Foundation (AF), released the 2019 ACR/AF Guideline for the Management of Osteoarthritis of the Hand, Hip and Knee. The ACR periodically updates guidelines to reflect any advances in management added to the literature since the last publication, which in this case was 2012.

Osteoarthritis (OA) is a common rheumatic disease that affects the entire joint, involving the cartilage, joint lining, ligaments, and bone. It is characterized by breakdown of the cartilage (the tissue that cushions the ends of the bones between joints), bony changes of the joints, deterioration of tendons and ligaments, and various degrees of inflammation of the joint lining (called the synovium). According to the Arthritis Foundation, approximately 27 million Americans suffer from the disease. Establishing effective management and treatment for OA is an ongoing goal in rheumatology.

“Patients with osteoarthritis can vary quite a bit in how the disease affects them. They might have a single joint, a few joints or many joints that are involved where symptoms can occur throughout adult life,” said Sharon Kolasinski, MD, a practicing rheumatologist who served as lead author for the guideline update. “The new guideline recognizes not only the variety of clinical presentations of OA, but also the broad array of treatment options available.  Clinicians and patients can choose from educational, behavioral, psychosocial, mind-body, physical and pharmacological approaches. It’s important to remember that treatment for OA is not one size fits all. Over time, various options might be used then reused or changed in response to a change in the patient’s symptoms.”

For the first time, the new guideline incorporates direct patient participation in its development. OA patients, who were recruited through a partnership with the Arthritis Foundation, were especially instrumental in emphasizing the role of shared decision making when choosing treatment options such as those with conditional recommendations.

“We are proud to have been involved in this work and to facilitate the important contributions of the patient and parent partners,” said Cindy McDaniel, Arthritis Foundation’s Senior Vice President of Consumer Affairs. “Their lived experiences truly helped to guide this project.”

Between the extensive literature review and patient insight, the updated guideline includes several differences since the 2012 recommendations. Of note, exercise remains an important intervention in the updated recommendations, with a strong body of literature supporting its use for almost all patients with OA. Below are other recommendations included in the update:

• Strong recommendations (previously conditional) for self-efficacy/self-management programs, use of tai chi for knee and hip OA, topical NSAIDs for knee and hand OA, oral NSAIDs and intra-articular steroids for knee and hip OA.
• A new conditional recommendation for balance exercises for knee and hip OA and duloxetine for knee OA.
• A conditional recommendation for using topical capsaicin in patients with knee OA (previously conditional against).
• New conditional recommendations for using yoga, cognitive behavioral therapy, radiofrequency ablation and kinesiotaping for first carpometacarpal and knee OA.
• A conditional recommendation against using manual therapy with exercise for knee and hip OA (previously was conditionally for usage).
• A strong recommendation against transcutaneous electric nerve stimulation for knee and hip OA (previously was a conditional recommendation).
• A new conditional recommendation against using intra-articular hyaluronic acid injections in first carpometacarpal and knee OA.
• A new strong recommendation against using hyaluronic acid injections in patients with hip OA.

Additionally, recommendations were made against the use of bisphosphonates, hydroxychloroquine, methotrexate, PRP injections (in hip and knee OA), stem cell injections (in hip and knee OA), tumor necrosis factor inhibitors and interleukin-1 receptor antagonists. “A number of agents have been tested and fail to show adequate benefit to justify their use, while others will require additional investigations to clarify their place in the OA armamentarium,” said Dr. Kolasinski. “The recommendations against usage of these therapies reflects the fact that pharmacologic options remain limited for the management of OA. A broad suggested research agenda is outlined in the guideline to address this gap.”

The paper containing the full list of recommendations and supporting evidence is available at https://www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines/Osteoarthritis

The following is a press release from ACR dated last Thursday:

The American College of Rheumatology (ACR) today commended leaders in the United States Senate for introducing the bipartisan Safe Step Act of 2019 (S. 2546), legislation that would place reasonable limits on step therapy, a troubling practice that requires patients to try—and fail—treatments preferred by their insurance company and pharmacy benefits manager before a doctor-prescribed option can be approved.

“With the Senate introduction of the Safe Step Act, we are one step closer to removing a treatment barrier that hurts patients,” said Angus Worthing, MD, FACR, FACP, a practicing rheumatologist and chair of the ACR Government Affairs Committee. “We applaud Congressional leaders for recognizing that forcing patients to ‘fail first’ through harmful step therapy practices puts them at unnecessary risk, prolongs pain and discomfort, worsens patient outcomes, and undermines the clinical judgment of medical professionals across the country. We urge Congress to quickly pass the Safe Step Act so that patients can appropriately seek exceptions to ‘fail first’ policies and quickly start accessing the treatments they need.”

Introduced in the Senate this week by Senators Lisa Murkowski (R-AK), Bill Cassidy (R-LA), Doug Jones (D-AL), and five other bipartisan co-sponsors, the Safe Step Act would implement transparent guidelines to prevent inappropriate use of step therapy in employer-sponsored health plans and create a clear process for patients and doctors to seek reasonable exceptions. The legislation builds on reforms passed in 25 states to address this pervasive practice that delays effective care and puts patients at unnecessary risk. While state efforts to limit insurers’ use of step therapy are an important development, Congressional action is needed to address the use of step therapy in employer-provided plans, which are regulated by federal law.

If enacted, the legislation will go a long way towards removing the treatment barriers created by step therapy.

According to a 2019 national patient survey conducted by the ACR, almost half (46.49%) of respondents who are receiving treatment for a rheumatic disease reported that their insurance company subjected them to step therapy.

A 2016 survey by the Arthritis Foundation found that most respondents experienced negative health effects from treatment delays caused by step therapy. According to the survey:

• More than 50% of all patients reported having to try two or more different drugs prior to getting the one their doctor had originally ordered;
• Step therapy was stopped in 39% of cases because the drugs were ineffective;
• Step therapy was stopped in 20% of cases due to worsening conditions; and
• Nearly 25% of patients who switched insurance providers were required to repeat step therapy with their new carrier.

A version of the Safe Step Act (H.R. 2279) was introduced in the House of Representatives in April by Representatives Raul Ruiz, MD (D-CA) and Brad Wenstrup, DPM (R-OH), two physicians who have encountered step therapy in their own practices.

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

Americans living with rheumatic disease face significant healthcare challenges, according to a national patient survey released this week by the American College of Rheumatology and its Simple Tasks™ public awareness campaign.

More than 1,500 U.S. adults living with rheumatic disease responded to the survey, which asked a range of questions related to healthcare access, affordability and lifestyle. The results come as patients, providers and policymakers throughout the U.S. recognize Rheumatic Disease Awareness Month (RDAM).

Key survey findings include:

• Even though 90 percent of respondents reported having health insurance coverage, nearly 60 percent said they had difficulty affording their medications or treatments in the past year.
• Almost half of patients receiving treatment for a rheumatic disease reported that their insurance company subjected them to step therapy, a process that requires them to try – and fail – treatments preferred by the insurance company before a doctor-prescribed option can be approved, even when a patient’s doctor is uncertain the insurer-preferred option will be effective.
• One-quarter of respondents reported out-of-pocket costs greater than $1,000 per year for treatment, while six percent of patients reported out-of-pockets costs greater than $5,000 per year.
• Close to 60 percent of respondents are currently being treated by a rheumatologist or have been referred to seek treatment by a rheumatologist. However, two-thirds had to wait more than 30 days after referral before getting an initial appointment with a rheumatologist.
• Almost two-thirds of patients reported that their rheumatic disease limited their ability to perform simple tasks such as eating, getting dressed, cooking, or running errands.

“These findings make clear that Americans living with rheumatic disease – regardless of age, gender, or income level – struggle to find affordable care,” said Paula Marchetta, MD, MBA, president of the ACR. “To address these challenges, it is crucial for patients, clinicians, and policymakers to work together to improve access to rheumatology care so that patients can live longer, healthier, and more fulfilling lives.”

Rheumatology patients recently joined the ACR on Capitol Hill to urge lawmakers to support legislation that would improve patient access by expanding the rheumatology workforce and placing reasonable limits on the use of step therapy.

Last year, the ACR examined access, affordability, and lifestyle challenges in the 2018 Rheumatic Disease Report Card, which graded each of the 50 states and the District of Columbia on the factors associated with an individual’s ability to live well with a rheumatic disease. The 2019 survey provides additional context to these challenges by asking patients directly how their disease impacts daily life.

According to the Centers for Disease Control and Prevention (CDC), an estimated one in four Americans – 54 million U.S. adults –  have been diagnosed with a rheumatic disease, an umbrella term that includes conditions such as rheumatoid arthritis, lupus, gout, osteoarthritis, Sjögren’s syndrome, juvenile idiopathic arthritis, and hundreds of lesser known diseases.

Hundreds of thousands of children also live with arthritis and other rheumatic diseases. The CDC estimates that as many as 300,000 children in the U.S. have some type of juvenile arthritis. Rheumatic diseases are the nation’s leading cause of disability and generate $140 billion in annual health costs. Although there is no cure for rheumatic disease, early intervention and diagnosis by a rheumatologist can help patients manage symptoms and lifestyle limitations to live healthier and more active lives.

The Rheumatic Disease Patient Survey was conducted by the American College of Rheumatology using the online polling tool SurveyMonkey Audience. The survey was conducted June 28-29, 2019, among a nationally representative sample of 1,517 adults ages 18 and older living in the United States.

To learn more about the survey and view an executive summary of the results, visit http://simpletasks.org/Survey.