Juvenile idiopathic inflammatory myopathies (JIIM) are more often diagnosed in pediatric patients following COVID-19 infection if they are racial minorities, older, and present with non-classic cutaneous manifestations, according to a recent study.

Viral infections have been associated with JIIM, including juvenile dermatomyositis, juvenile polymyositis, and overlap myositis. Researchers believe that COVID-19 can cause genetically susceptible individuals to experience autoimmune diseases, including idiopathic inflammatory myopathies.

An association has been observed between COVID-19 infection and anti-melanoma differentiation-associated gene 5 antibody-related dermatomyositis, leading investigators to believe there is a connection between underlying autoimmune and inflammatory mechanisms.

As few studies analyzed JIIM following COVID-19 infection, investigators conducted a study analyzing JIIM cases including clinical characteristics in patients before and after the emergence of COVID-19. Patients were recruited for the study from The Children’s Hospital at Montefiore and were included if they had been diagnosed with JIIM before age 19 at the hospital.

Data was collected on exposure to COVID-19, along with demographic, clinical, and laboratory information. Participants were divided into pre-COVID and post-COVID groups, with the pre-COVID group containing individuals diagnosed with JIIM prior to January 1, 2020.

Of the 44 patients included in the study, 34 had been diagnosed pre-COVID and 10 post-COVID. Known exposure or infection of COVID-19 was seen in 5 of the 10 post-COVID patients. These patients more often were non-Hispanic Black or Asian, experienced disease onset at a higher age, and were observed with non-classic cutaneous manifestations.

Patients diagnosed post-COVID often had muscle weakness of greater severity than those pre-COVID, but rate of muscle weakness was similar between the 2 groups. The time from symptom onset to diagnosis also did not differ pre- and post-COVID.

Based on these results, investigators urged clinicians to consider JIIM even in cases without classic cutaneous manifestations. They also encouraged further investigation on how COVID-19 impacts JIIM compared to other viruses.

This article originally appeared on Contemporary Pediatrics.

Perfetto J, Yoo D, Tamashiro C, Perron M, Vasquez Canizares N, Wahezi D. Impact of SARS-CoV-2 on the Clinical Presentation of Juvenile Idiopathic Inflammatory Myopathies [abstract]. Presented at: ACR Convergence 2022, Philadelphia, Pennsylvania. November 11 to November 14, 2022.

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In a recent study, racial minorities of an older age with non-classic cutaneous manifestations were more often to present with juvenile idiopathic inflammatory myopathies after COVID-19 infection.

Juvenile Idiopathic Inflammatory Myopathies Following COVID-19 Infection

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

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Patients with a specific form of age-related macular degeneration (AMD), a leading cause of blindness in the United States, are also highly likely to have either underlying heart damage from heart failure and heart attacks, or advanced heart valve disease, or carotid artery disease associated with certain types of strokes, according to a new study from New York Eye and Ear Infirmary of Mount Sinai.

According to a news release, this research, published November 17 in 

, is the first to identify which types of high-risk cardiovascular and carotid artery disease are linked to the eye disorder. The findings could prompt increased screening to save vision, diagnose undetected heart disease, and prevent adverse cardiovascular events.

“For the first time, we have been able to connect these specific high-risk cardiovascular diseases to a specific form of AMD, the one with subretinal drusenoid deposits (SDDs),” lead author R. Theodore Smith, MD, PhD, a professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai, said in a news release.

Smith noted that the study is the first strong link between the leading cause of blindness, AMD, and heart disease, the leading cause of death worldwide.

“Furthermore, we also have strong evidence for what actually happens: the blood supply to the eye is directly diminished by these diseases, either by heart damage that diminishes blood supply throughout the body, or from a blocked carotid artery that directly impedes blood flow to the eye,” he said in the news release. “A poor blood supply can cause damage to any part of the body, and with these specific diseases, the destroyed retina and leftover SDDs are that damage. Retinal damage means vision loss, and can lead to blindness.”

According to the news release, AMD is the leading cause of visual impairment and blindness in people over 65 and is the result of damage to the central area of the retina called the macula, which is responsible for reading and driving vision. One major form of early AMD consists of small yellow cholesterol deposits called drusen, which form under a part of the retina called the retinal pigment epithelium (RPE). They can deprive the retina of blood and oxygen, leading to vision loss.

Drusen formation can be slowed by appropriate vitamin supplementation. The other major form of early AMD, subretinal drusenoid deposits (SDDs), are less well-known, and require high-tech retinal imaging to detect. These deposits contain a different form of cholesterol, and form above the RPE, and just beneath the light-sensitive retina cells, where the damage occurs and vision is lost. There is no known treatment for SDDs. Dr. Smith and a team of Mount Sinai researchers initially found that patients with cardiovascular disease or stroke were more likely to have SDDs. That first-of-its-kind research was published in the July issue of 

 This new study expands on that previous work, looking at a larger patient population, and identifies the specific severe forms of heart disease and carotid artery disease that caused the SDDs of AMD.

Researchers analyzed the eyes of 200 AMD patients with retinal imaging to determine which patients had SDDs. Patients answered a questionnaire about their history of cardiovascular disease. Of the 200 patients, 97 had SDDs and 103 had drusen only. Forty-seven of the 200 had severe heart disease (19 had heart damage from heart failure or heart attack, 17 serious valve disease, and 11 stroke stemming from the carotid artery). Forty of the 47 (86 percent) had SDDs. By contrast, of the 153 AMD patients who did not have these severe diseases, 57 had SDDs (43 percent). The researchers concluded that AMD patients with these severe cardiovascular diseases and stroke were nine times more likely to have SDDs than those without them.

“This work demonstrates the fact that ophthalmologists may be the first physicians to detect systemic disease, especially in asymptomatic patients,” says co-investigator Richard B. Rosen, MD,cChief of the Retina Service for the Mount Sinai Health System. “Detecting SDDs in the retina should trigger a referral to the individual’s primary care provider, especially if no previous cardiologist has been involved. It could prevent a life-threatening cardiac event.”

The next step is for researchers to focus on patients in cardiology and neurology clinics to further examine varying degrees of cardiovascular and carotid disease and assess that possible relationship of disease severity to AMD with SDD.

This study was funded by a Regeneron Pharmaceuticals Investigator-Initiated Study, Research to Prevent Blindness Challenge Grant, the Macula Foundation, a Bayer-Global Ophthalmology Award, and the International Council of Ophthalmology-Alcon Fellowship.

This article originally appeared on Ophthalmology Times.

Mount Sinai study is the first to identify that heart attack, stroke and heart failure are linked to a specific type of age-related macular degeneration.

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 Our goal and hope for year 3 is that with pharmacist intervention, we will be able to lower a patient's risk of having a cardiovascular event, stroke, heart attack.

I think these opportunities really encompass what CPESN is trying to demonstrate. That’s community pharmacies can provide value-based patient care services, make a significant impact on the health of patients, and provide those at scale with our entire CPESN network, remaining financially sustainable with reimbursement for those services.

 I think it's important to note that CPESN pharmacies throughout the country administered over 5 million vaccines, over 5.5 million vaccines

A win/win for community pharmacies and communities.

 He realizes with his pharmacy benefit that his employees are getting better services, better care, and they're getting it at a reduced cost.

 I think the most exciting thing about it is 1 word. We're helping them lead with these quality metrics. We have 99% of the state of network adequacy. So, they see our footprint across the state as being meaningful and achievable to get results.

 Not only are we trying to have the better health care for our patients in Nebraska Total Care, but also show value by saving Nebraska Total Care and Medicaid money.

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Hilary Baldwin, MD, medical director of the Acne Treatment & Research Center in Brooklyn, New York offered insight into the various treatments for 2 common skin conditions, acne and rosacea, at the 2022 SDPA Fall Conference.

She began with some background on why some people are prone to acne breakouts, and explained that acne is a chronic inflammatory disease of the pilosebaceous unit. During puberty, alteration of the sebaceous lipid profile, stress, irritation, cosmetics, and potential dietary factors lead to inflammation and the formation of different types of acne lesions. Cutibacterium acnes (c. acne) is the relatively slow-growing, typically aerotolerant anaerobic, gram-positive bacterium (rod) linked to the skin condition.

Baldwin said the average acne patient is on 2.3 different medications, and a combination therapy program is typically the most successful. She said medical professionals should take a clinical approach when treating acne patients and gave guidelines to consider:

Determine if lesions are inflammatory, comedonal, or a combination of both

Are the lesions mild, moderate or severe?

Is there psychological impairment due to the condition (if so, an aggressive approach to controlling the acne would be best)

Baldwin then gave an overview of the common acne medications available by prescription, including topical agents (tretinoin, tazarotene) that work by reducing keratinocyte proliferation and blocking inflammatory pathways for acne. Antibiotics, such as clindamycin with benzoyl peroxide, eliminate excess skin bacteria and reduce inflammation. The two prescriptions can be combined to reduce the likelihood of developing antibiotic resistance. A 20% azelaic acid has antibacterial properties and is as effective as many conventional acne treatments.

Rosacea is a chronic inflammatory disorder of the central face with multiple overlapping presentations. It typically occurs in patients who are genetically predispositioned (family history, twin concordance, autoimmune disorders. Baldwin said environmental factors can factor into the severity of the disease (ultraviolet exposure, alcohol, smoking, age). There are 4 specific types of rosacea:

Each type of rosacea has a unique set of symptoms and treatment options. Baldwin said patients need to explore and identify the products, irritants, and conditions that cause a rosacea flareup, so they are better equipped to avoid triggers.

Depending on the severity of the patient’s rosacea, there are various medical treatments available, such as topical creams alone or with oral medication. Topical medications include ivermectin, minocycline 1.5% foam, azelaic acid, and metronidazole. Baldwin said it’s important to treat all aspects of a patients's disease, because rosacea can have a negative psychosocial impact. As it is a chronic disease, the clinician should periodically inquire about the patient’s emotional and mental wellness.

This article originally appeared on Dermatology Times. 

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Each course of antibiotics during young adulthood was associated with a 2-4% increase in risk of developing type 2 diabetes, according to the results of a new analysis.

Using data from the Cardiovascular Risk in Young Finns Study (YFS) and the national FINRISK study, investigators determined each additional exposure to an antibiotic course was associated with increased risk of subset type 2 diabetes in both studies, with exposure to 5 or more courses associated with a potential doubling in risk of type 2 diabetes later in life.

“The results of this study show that prior exposure to systemic antibiotics was associated with increased risk of incident type 2 diabetes in more than 25,000 participants. Furthermore, prior exposure to antibiotics was also associated with overweight/obesity. The observed risks persisted even after adjustment for numerous potential confounding factors, including BMI at baseline,” wrote investigators.

As more and more data emerge detailing the impact of antibiotic exposure on intestinal microbiome and overall health, some have hypothesized these changes could contribute to increased risk of developing diabetes. The current study was born out of an interest in exploring the potential impact of antibiotic exposure on type 2 diabetes risk using data from the YFS and FINRISK studies.

Launched in 1978, the YFS 2209 participants aged 24-39 years in 2001 with data available related to exposure to antibiotic courses from 1993-2001, which provided investigators with information from 2209 individuals. Of these, 110 patients were diagnosed with diabetes. Using information obtained from clinical examinations conducted in 2001, 2007, and 2011, investigators assessed prevalence of diabetes beginning in and after 2001, with those with prevalent diabetes excluded from the analyses. For the purpose of analysis, investigators used 4 population-based cohorts derived from the National FINRISK studies for replication. These 4 population-based cohorts included 24,674 individuals. Of these, 1866 had incident diabetes. Overall, the total study cohort included 26,883 participants.

Upon analysis, investigators found prior antibiotic exposure, which was defined as more than 5 antibiotic courses, was associated with an increased likelihood of developing type 2 diabetes in both the YFS (OR, 2.29 [95% CI, 1.33-3.96]) and the FINRISK cohorts 

 compared to their counterparts with 1 or fewer antibiotic course exposures. When assessing the impact of exposure per course, results indicated each antibiotic course was associated with a 4% increase in likelihood of type 2 diabetes in the YFS cohort (OR, 1.043 [95% CI, 1.013-1.074]) and a 2% increase in likelihood in the FINRISK cohort (HR, 1.022 [95% CI, 1.016-1.029]).

Further analysis, which assessed risk of overweight/obesity associated with exposure to antibiotics, suggested exposure to antibiotics was associated with a 4% increase in likelihood of overweight/obesity in the YFS cohort (OR, 1.043 [95% CI, 1.019-1.068]) at the 10-year follow-up and a 2% increase in likelihood of overweight/obesity in the FINRISK cohort (OR, 1.023 [95% CI, 1.018-1.029]) at baseline. Investigators pointed out additional adjustments for confounders from early life in YFS and at baseline in FINRISK did not have an appreciable impact on the aforementioned findings.

“We found that prior exposure to systemic antibiotics was associated with increased risk for future type 2 diabetes and overweight and obesity. Our findings support judicious use of antibiotics. Future studies are needed to further investigate the relationship between antibiotic exposure and type 2 diabetes and excess body weight as well as to examine the direct impact of antibiotic exposure on human gut microbiome.”

This article originally appeared on Endocrinology Network.

1. Nuotio J, Niiranen T, Laitinen TT, et al. Use of antibiotics and risk of type 2 diabetes, overweight and obesity: the cardiovascular risk in young Finns study and the national FINRISK study. 

. 2022 Nov 18;22(1):284. doi: 10.1186/s12902-022-01197-y.

European research examines antibiotic exposure and its potential impact on future type 2 diabetes risk.

Antibiotic Exposure Linked to Increased Risk of Type 2 Diabetes Later in Life

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Now that the dust has settled over enactment of the Inflation Reduction Act, leaders across the industry should be taking stock and assessing how the law will impact their product portfolios and the bottom line. Although several open questions remain, pharmaceutical manufacturers can take actions to best position their organizations to either benefit from — or mitigate repercussions — of the new law. Specifically, executives should lay out strategies for addressing revenue optimization, evidence development planning and portfolio optimization.

The CMS will now dictate a “maximum fair price” for drugs selected for Medicare price negotiation. The price can’t exceed enrollment-weighted negotiated prices under Part D plans, average sales price (ASP) under Part B, and the percentage of the drug’s non-federal average manufacturer price based on “monopoly status” (see the table below). In addition, price increases under Medicare will now require the same rebate over the consumer price index as Medicaid and private sector price increases are factored into how the inflationary rebates are calculated.

Under this new framework, executives need to determine how to optimize revenue for assets that may undergo negotiations with CMS. One consideration is clearly pricing strategy from launch to time of negotiation. Price increases will become less flexible due to the mandatory rebate and the fact that CMS’ “fair price” will be based on an average price at the time of negotiation. Establishing the optimal launch price will have a substantial impact on revenue over the drug’s lifecycle. Pharmaceutical executives must weigh the trade-offs of a more aggressive pricing posture as this comes with downside risk including utilization management; commercial payer adoption of Medicare rules, as many have done for specialty tier co-sharing; and emboldening legislators to enact further price controls (such as pre-launch negotiations).

A second consideration centers around tightening and realigning cost structures to improve performance.

Price negotiation is new territory for the federal government. And parameters spelled out in the law pose new challenges for pharmaceutical companies. For instance, the reference to “maximum fair price” bodes poorly for manufacturers and suggests more of a “take it or leave it” situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price. Not taking outcomes into account — or minimizing their importance — would, in effect, result in a price being “assigned” rather than having it be based on the value of a drug versus other treatments in the same therapeutic area.

If this is the case, manufacturers may think about reprioritizing investment in developing real-world data to understand a drug’s relative effectiveness since the CMS price is not swayed by comparative data. On the other hand, if there is room to negotiate, this data will be quite critical. This is an exceptionally important distinction executives must understand to evaluate the impact of investing in comparative treatment studies. There are, of course, other benefits,of this data, which assists patients, providers and commercial payers in understanding the clinical and economic value, but the return on investment relative to other commercial priorities should be taken into account.

Although breakthrough innovation gets the most attention in analyst reports and the media, scientific advancements are most commonly incremental. For example, patients may benefit from incremental improvements in efficacy, safety, tolerability of drugs within the same therapeutic areas. These improvements, while seemingly minor, can have a meaningful impact on the patient experience. Consider the fact that Lipitor (atorvastatin), arguably the most effective statin, was the fifth drug in that class to market.

Executives will have to consider the potential implications of the Inflation Reduction Act on the commercial opportunity of treatments that may be perceived as having an incremental benefit and not rare disease since these treatments are excluded from CMS negotiations. There may be a risk that a first mover in the market will go through the CMS negotiation and artificially lower the price benchmark for newer entrants. Effectively, the new CMS reference price will cascade down to other treatments within the therapeutic class and place a higher hurdle on price and access.

The high risk/high rewar nature of the pharmaceutical industry requires a favorable return due to the significant upfront cost to run clinical trials. By most estimates, it costs between $1 billion and $2 billion to develop a new drug. And only 12% of drugs in clinical trials make it to market. Executives have to balance the IRA’s impact on price/access and resulting revenue as they consider future investments, especially if they perceive the therapy to have incremental value to a patient.

This article originally appeared on Managed Healthcare Executive.

The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price.

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