ACR Launches New Toolkit Aimed at Measuring RA Outcomes

The following is a press release issued by the ACR today August 9, 2023:

The American College of Rheumatology (ACR) is excited to announce the launch of its brand-new Rheumatoid Arthritis (RA) Measures Toolkit. In recent years, the landscape of RA care has witnessed remarkable progress, greatly improving outcomes for patients living with this chronic condition. The key to this success: vigilant monitoring of disease activity and functional status, which has enabled rheumatologists to tailor therapies and optimize treatment outcomes. The new RA Measures Toolkit will help rheumatologists and their practices harness the power of standardized RA outcome measures.

“There are currently no national resources available for rheumatologists that guide the effective implementation, collection, and use of disease activity and functional status outcomes for people with RA,” said Jinoos Yazdany, MD, MPH, Professor of Medicine and Chief of Rheumatology at San Francisco General Hospital, University of California, San Francisco and one of the lead authors of the RA Measures Toolkit. “We wanted to develop a tool that allows our community to share best practices and innovations in collecting RA outcomes.”

The toolkit includes a wealth of resources like training guides for nurses and medical assistants who are administering RA outcome surveys (e.g., RAPID-3, PROMIS-PF or patient global assessments), copies of the ACR recommended RA outcome measures (including versions in Spanish and Chinese), sample workflows that rheumatologists are using in different electronic health record systems, and videos featuring best practices from rheumatologists with highly effective strategies for collecting RA measures.

The toolkit also includes guidance on utilizing the ACR’s RISE registry, a powerful tool for tracking performance on the collection of RA measures. With RISE, rheumatologists can effectively monitor and evaluate the implementation of RA measures in their practice and track performance in the Quality Payment Program (QPP).

The new toolkit is not just an asset when it comes to providing rheumatologists with standardized outcome measures for assessing disease activity and functional status for people with RA, it’s also helpful for training medical staff on collecting RA outcome measures.

“Collecting RA outcome measures accurately and efficiently requires a team-based approach that includes nursing staff. Proper training of staff ensures that surveys are administered accurately and consistently, leading to reliable data collection,” said Yazdany. “Moreover, training can help staff engage patients, emphasizing the importance of collecting this information. By providing training materials for staff, the toolkit saves time and allows rheumatologists to focus on taking care of patients.”

The authors of the toolkit interviewed dozens of rheumatologists and their staff to gather best practices and innovations for collecting RA outcomes.

“The information gathered in the toolkit allows our community to learn from both the successes and challenges encountered by our colleagues. The toolkit includes examples of successful clinic workflows, tips for efficient RA outcome measure collection, as well as interviews with high-performing practices,” said Dr. Yazdany.

The RA Measures toolkit e-book can be viewed in full online at https://ratoolkit.kotobee.com/#/.

ACR Significantly Concerned with MedPAC’s Latest Recommendations to Cut Part B Drug Reimbursement

The following is a press release from ACR dated June 15, 2023:

The American College of Rheumatology (ACR) today expressed disappointment that the Medicare Payment Advisory Commission (MedPAC) has recommended yet another cut to physician reimbursement for infusing life-altering treatments as part of its June 2023 Report to the Congress: Medicare and the Health Care Delivery System.

In a letter to MedPAC, ACR took issue with the organization’s recommendation to Congress to keep a six percent add-on payment for the lowest-cost drugs, reduce the add-on payment for mid-to-high-level drugs, and add a payment cap for the costliest drugs.

“While we support efforts to rein in the cost of prescription drugs, we firmly believe that this policy would jeopardize provider practices and patients’ health by reducing access to life-changing provider-administered therapies,” said Douglas White, MD, PhD, president of the ACR. “We urge Congress to address the high cost of drugs at the root cause, like the opaque pharmacy benefit manager business practices, and not at the expense of providers.”

In its recommendation, MedPAC asserted that providers prescribe and administer the highest-price medications in order to receive higher reimbursement. ACR firmly rejects this premise. Administering Medicare Part B drugs in provider offices requires rheumatologists to buy the drug in bulk, maintain full-time staff to administer the treatment, and only bill Medicare after it has been given to the patient.

The six percent of the average sales price (ASP) add-on does not incentivize high-cost treatments, but rather offsets the costs of acquiring, storing, and administering treatments. As written, MedPAC’s recommendation would force providers to cut back on offering cutting-edge therapies or offer these medications at a loss, severely limiting patients’ access to medication and threatening practice viability.

“As providers, it is our job to prescribe the most appropriate treatment for our patients. The add-on payments are not considered in our clinical decision-making. We are concerned that policymakers are concentrating on these add-on payments rather than focusing on policies that address the true cause of drug prices,” said Christina Downey, MD, chair of ACR’s Government Affairs Committee. “The ACR will always express concern when provider payments to administer drugs are eschewed by widely supported policies. Hopefully, the bipartisan movement to reform the PBMs industry will yield meaningful change, and patients will see the benefits.”

A hand is over a blanket while the person the hand belongs to is under the blanket

JIA Patients More At-Risk for Psychiatric and Sleep Conditions

The following are excerpts from an article on Rheumatology Advisor from June 2, 2023:

Incidence and burden of psychiatric disorders are increased among patients with juvenile idiopathic arthritis (JIA), which may be related to environmental stressors and genetic susceptibility, according to study findings published in ACR Open Rheumatology.

The most common conditions were sleep disorders, mood disorders (such as depression), anxiety disorders, and suicidal ideation. I don’t see sleep disorders as psychiatric in nature, but they’re often classified as such. It’s really silly when we think about it. No amount of therapy will help anyone stop their brain from interpreting chronic pain as a reason to wake up from REM. (That is called alpha-wave intrusion, by the way, and is incredibly common for chronic pain sufferers.)

Researchers concluded, “[P]atients with JIA are at increased risk of developing psychiatric disorders, resulting in an increased burden of psychiatric comorbidities, both in childhood and when reaching adulthood.”

You can read the Rheumatology Advisor article in full here as well as check out the full journal article from Bénédicte Delcoigne, AnnaCarin Horne, Johan Reutfors, and Johan Askling.

First-line use of biologics may lead to favorable outcomes in sJIA

The following is an article released May 15, 2023, by Contemporary Pediatrics:

A study in patients with new-onset systemic juvenile idiopathic arthritis (sJIA) found most patients treated with biologics had desirable short-term clinical outcomes combined with decreased use of glucocorticoids (GCs).

The 73 patients in the study, who were enrolled at numerous sites, were aged 6 months to 18 years at disease onset and had a fever for at least 2 weeks, arthritis in 1 or more joints for at least 10 days, a rash, and generalized lymphadenopathy, among other symptoms, and had received initial treatment with biologics or nonbiologic GCs. Participants were treated according to 1 of 4 plans chosen by their physicians, which included 2 biologics (interleukin [IL]-1i and IL-6i, both with or without GC) and 2 nonbiologics (methotrexate with or without GC and GC alone); 63 patients (86%) were enrolled in the biologic treatments and 10 (14%) in the nonbiologics. Investigators collected clinical data at baseline and 2 weeks as well as at 1, 3, 6, 9, and 12 months following enrollment.

In choosing a treatment plan, many health care providers reported that they initiate treatment of sJIA with a biologic agent most of the time. They said this is because of the likelihood of the biologic’s effectiveness for systemic features, minimizing systemic glucocorticoids, and the possibility of effectiveness for arthritis. Of the 10 clinical sites that enrolled 3 or more patients, 8 sites assigned all their patients to the biologics.

At 9 months, 57% of patients achieved the primary outcome of clinical inactive disease (CID) without current GC use and 75% had a clinical juvenile arthritis disease activity score at or below 2.5 with no fever and no current GC use. Patients in the biologic and nonbiologic groups had similar outcomes, but 4 of the 6 patients evaluated for CID in the nonbiologic group had initiated biologics during the study. Outcomes at 12 months were similar to those at 9 months. Of the patients receiving biologics who subsequently started methotrexate, 1 of 6 had CID without concurrent GC use at 9 months.

Beukelman T, Tomlinson G, Nigrovic PA, et al. First-line options for systemic juvenile idiopathic arthritis treatment: an observational study of Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans. Pediatr Rheumatol Online J. 2022;20(1):113. doi:10.1186/s12969-022-00768-6

If you want to read the full journal article cited above, you can do so here.

Outcomes of Biologic Agent Switching Studied in JIA

The following is an article released by Rheumatology Advisor:

Switching between biologic agents is common among patients with juvenile idiopathic arthritis (JIA), with inadequate response being the most reason for the switch, according to study results published in Journal of Clinical Rheumatology.

Participants were aged 18 years and younger and were diagnosed with JIA before the age of 16 years. The diagnosis was consistent with the International League of Rheumatology Societies criteria. In addition, eligible participants received treatment with more than 1 biologic agent between January 2009 and 2022.

The study authors concluded that clinicians and researchers should be alert to the need for patients undergoing JIA treatment to change protocols. They noted, “[A total of 25%] of patients undergoing biological drug treatment may require biological agent switching.”

You can read the full article here.

Research links immune cell receptors to asthma, inflammatory lung disease

The following is from the Cleveland Clinic as posted on Medical Express:

Researchers discovered a new way a protein called MCEMP1 contributes to severe inflammation in the airway and lungs. The discovery, published in Nature Communications, provides critical information for developing therapeutic interventions to treat long-term lung conditions, including asthma, on a biological level.

The study was conducted in a lab led by Jae Jung, Ph.D., chair of the Cancer Biology Department, director of the Infection Biology program, and director of the Sheikha Fatima bint Mubarak Global Center for Pathogen & Human Health Research.

Severe asthma is caused by airway inflammation in response to a trigger, like allergens or air pollution. The inflammation causes the airway to swell up and become narrower and stiffer, which makes breathing difficult. Asthma currently affects more than 25 million people in the U.S and 300 million people worldwide.

Inflammation is part of innate immune response, or the process the body uses to summon immune cells to combat pathogens. Inhalers treat the inflammation in the airway, but do not address the underlying biological causes of the recurring inflammation.

Mast cells release histamines and elicit other immune responses that cause allergic inflammation, so researchers examined what proteins on that cell are critical to prompting a severe immune response.

So, what is MCEMP1?

MCEMP1 is a surface-level protein on mast cells. Previous research implicated MCEMP1 in multiple inflammatory lung diseases in addition to asthma, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

When MCEMP1 expression was eliminated on the surface of the mast cell, researchers saw reduced airway inflammation and lung damage. The study showed that MCEMP1 was associated with elevated mast cell numbers. Researchers observed higher rates of inflammation and lung function defect when MCEMP1 was expressed on mast cells.

MCEMP1 is expressed highly in lung cells, but its expression is induced during immune response in other parts of the body as well. That shows the value in searching for MCEMP1 function in other parts of the body, Dr. Choi says.

“Understanding how this mechanism works in the lung not only provides us with a path to new therapies for asthma, but it could be a finding that helps us map out similar functions in other inflammatory diseases in the lung and throughout the body,” she says.

You can read the full open-access journal article on Nature.

FDA approves 20-valent pneumococcal conjugate vaccine for infants 6 weeks and older

The following is a press release issued by Pfizer on April 27, 2023. I am sharing this to help spread the word and have not been asked or incentivized to do so by Pfizer.

The U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

Read more

Emapalumab Induces Remission of MAS

Amazing news! Emapalumab can help treat Macrophage Activation Syndrome (MAS)!

an illustration of ifny
Source

The brand name for emapalumab is Gamifant. It’s FDA-approved to treat hemophagocytic lymphohistiocytosis (HLH), which is pretty similar to MAS in many respects.

The following paragraph is from a summary on Contemporary Pediatrics:

Emapalumab, a fully human anti-interferon-γ (IFNγ), demonstrated efficacy for inducing remission of macrophage activation syndrome (MAS) secondary to systemic juvenile idiopathic arthritis (sJIA) or adult-onset Still’s disease (AOSD) in patients who failed standard care with high-dose glucocorticoids, with or without anakinra (Kineret; Sobi) and/or cyclosporin, according to a recent study.

This is amazing news. MAS is a terrifying secondary condition. It is most common in SJIA and AOSD, but can pop up in lupus and other conditions. If you want to learn more about MAS itself, I covered a session on the condition at the 2017 ACR annual meeting. You can learn more about the immunology on Frontiers.

Normal treatment involves a ton of gluticosteroids and often Anakinra/Kineret. That doesn’t do it for enough patients, though. It’s important to note that there was a small N (or participant number) of 14. However, by week 8, 13 of the 14 patients had achieved remission. That’s not shabby at all.

Most importantly, no deaths were reported during the trial and the long-term follow-up. That’s amazing for a condition that has a mortality rate between 20-53%.

This was a phase II, open-label, single-arm trial conducted in the US, UK, Spain, Italy, and France. I was also happy to see that Dr. Alexei Grom, who I interviewed several years ago, was a part of this study.

Read more of the summary on Contemporary Pediatrics. Or, you can read the full journal article, Efficacy and safety of emapalumab in macrophage activation syndrome, here.

ACR Endorses Strengthening Medicare for Patients and Providers Act

The following is a press release issued by the ACR as of yesterday, April 24, 2023:

Today, the American College of Rheumatology (ACR) commended the introduction of the Strengthening Medicare for Patients and Providers Act (H.R. 2474), a bipartisan bill intended to update Medicare physician payments to reflect the impact of the broader economy on physician practices.

The legislation, introduced by Reps. Raul Ruiz, M.D. (D-CA), Larry Bucshon, M.D. (R-IN), Ami Bera, M.D. (D-CA), and Mariannette Miller-Meeks, M.D. (R-IA), would adjust the Medicare Physician Fee Schedule (MPFS) based on inflationary updates measured by the Medicare Economic Index (MEI).

“For too long, specialty providers, like rheumatologists, have faced considerable uncertainty regarding their ability to continue providing needed care to patients,” said Douglas White, MD, PhD, president of the American College of Rheumatology. “The Strengthening Medicare for Patients and Providers Act represents a long-overdue adjustment to the Medicare Physician Fee Schedule that will help stabilize physician practices and ensure that beneficiaries have timely access to rheumatological care.”

The MPFS is the only major fee schedule without an automatic inflationary update. Consequently, Medicare provider reimbursement has failed to keep pace with broader economic realities. Recent analysis from the American Medical Association (AMA) demonstrates that when adjusted for inflation, Medicare physician payments declined 26% from 2001 to 2023, as consumer and practice costs rose.

“This legislation would allow Medicare to more accurately reflect the cost of practicing medicine, which has increased dramatically in recent years,” said Christina Downey, MD, chair of ACR’s Government Affairs Committee. “ACR looks forward to working to advance this important policy reform that will help build a sustainable payment system and protect access to care for patients with serious, chronic diseases.”