The American tobacco industry is at an inflection point. While financial forecasters anticipate a continued revenue growth of 

approximately $4 billion annually through 2026

, the means by which the formidable industry thrives are in flux.

assessment from the 2020 National Health Interview Survey

 showed approximately 1 in 5 Americans were current tobacco users of any kind at the time. But only 12.5% of all adults were using combustible cigarettes—the lowest prevalence of smokers in nearly 60 years of data. The traditional deliveries of tobacco are becoming less common among the newest generation of users.

 published last month showed that while current e-cigarette use—defined as any use in the last 30 days—was on the decline among young adult Americans, daily use is on the climb. What that indicates, against the context of reduced daily combustible cigarette use, is a shift in the prioritization of tobacco delivery. Young adults are no longer experimenting with e-cigarettes; they are habitually using them in place of combustible products.

“And transitioning from occasional use to daily use is an indication of some form of nicotine dependence, because now you have to use it daily,” investigator Ellen Boakye, MD, MPH, a postdoctoral fellow with the Johns Hopkins Ciccarone Center, told 

. “And research has shown that for people who use e-cigarettes daily, particularly among young adults, they are more likely to transition to combustible cigarette use.”

For decades, a multifactorial and comprehensive public health strategy to reduce the rate and burden of combustible cigarette use among young adults, adolescents and children has been carried out by factions of organizations, experts and legislators. Just as these strategies neared the closest they’ve been to completion, the goal posts have moved. E-cigarettes are becoming the common tobacco delivery product among the next generation of nicotine-addicted users, just a decade after their introduction to the market was under-met by the regulatory powers of the US Food and Drug Administration (FDA).

Now, whether it be strategic or coincidental, new federal efforts to curb tobacco use among young Americans is colliding directly with this major shift in tobacco product preferences. The FDA is attempting to put e-cigarettes and flavored tobacco in check before long-term damage is done to nationwide cessation efforts. But is it too little, too late?

The Family Smoking Prevention and Tobacco Control Act was signed into law June 2009, placing more distinct restrictions on tobacco product marketing toward children. Key national provisions from the act include bans on sales to minors; tobacco-brand sponsorship of sports, entertainment, or other social/cultural events; promotional giveaways of sample tobacco products; and more. It also increased the FDA’s capability in regulating nicotine and ingredient levels in tobacco products, as well as in banning characterizing product flavors aside from menthol and tobacco.

The 2009 law “empowered the FDA to regulate tobacco and nicotine products for the first time,” Rob Crane, MD, et. al wrote for 

 last year. Just as importantly, it preempted state and regional government from their own regulation standards for tobacco product manufacturers.

“The usual argument for preemption is that companies have difficulty complying with different regulations in different localities,” Crane and colleagues wrote. “However, an industry that promotes nicotine addiction should not be granted such considerations. Doing what works to reduce youth nicotine use is a far more important imperative.”

In the immediate years following the act, current tobacco product use among US high school students decreased from 24.2% in 2011 to 19.6% in 2017, per annual 

National Youth Tobacco Survey (NYTS) data

. In those 7 years, cigarette use among high school students halved from 15.8% to 7.6%.

The significance and timing of these changes imply public health strategy and marketing standards set by the 2009 act are responsible—to which some extent they are. But that’s excluding the whole truth. From 2011 to 2013, as the rate of combustible cigarette use among adolescents substantially dropped, the rate of e-cigarette use skyrocketed—a 3-fold increase in use among smoking-naïve students in middle school and high school during that time, 

Early e-cigarette marketing and messaging were mostly excluded from the rigors set by the Family Smoking Prevention and Tobacco Control Act, American Lung Association (ALA) Assistant Vice President of National Advocacy Erika Sward told 

 stating the FDA could not regulate e-cigarettes as drug delivery devices.

The suit was after the FDA seized vaping devices for inhaled nicotine from Smoking Everywhere Inc. and NJOY in 2008; the agency claimed the devices were unsafe, unapproved products falsely marketed as combustible cigarette alternatives. The ruling judge at the time stated the FDA provided no evidence that e-cigarettes were “any more an immediate threat to public health and safety than traditional cigarettes.” Sward described the mass influx of e-cigarette products and ill-defined FDA regulation standards as a “perfect storm” for rampant use among youths.

“So the FDA was trying to figure out how it was going to regulate e-cigarettes as a tobacco product once this court case was decided in 2010,” she said. “And then we had a number of years of stalling, but at the time, the early-use products were pretty, pretty bad.”

Over the next decade, competing thoughts on the matter of e-cigarette utility and health risks resulted in 

. States such as New York set precedent for establishing indoor e-cigarette and vape bans similar to those in place for cigarettes. San Francisco outright banned flavored vapor products including menthol. Thirty states passed a vaping device or e-cigarette taxation. Finally, the 

Federal Food, Drug, and Cosmetic Act was amended in 2019

 to raise the federal minimum age to buy tobacco products to 21 years old, with strict fines and penalties in place for noncompliant retailers.

 for tobacco product review applications for vapor and smokeless products in July 2017—meaning companies with products available under lesser-defined regulatory standards as far as 6 years ago had until this month to submit premarket applications for FDA review. Sward described the move as a “open welcome to come on the market,” despite there being lesser regulation keeping manufacturers in check. After decades of waged war against combustible cigarette safety and marketing standards, the agency’s moves against e-cigarettes were softened by agency capability and timeline of action.

“I think there's an inherent false belief that once the FDA were to allow a product on the market, it would be ‘safe’,” Sward said. “But I think that there's no inherent right to sell a product that is dangerous to its consumers. And there is a certain role…the federal government has in protecting the nation's public health, whether that be through vaccinations, whether that be through clean air, whether that be through making sure that tobacco products are very carefully regulated across the board.”

Public health officials were also daunted by the initial marketing behind the first generations of e-cigarettes. Sward likened the industry’s messaging to those used by tobacco companies in the 1950s and 60s: “making claims that they were less harmful without any sort of scientific evidence,” while also targeting younger demographics with unique and appealing flavors.

Whether e-cigarettes are safe, less harmful than combustible cigarette options, or beneficial tools for smoking cessation are 3 entirely separate thoughts that generally get wrapped together as 1 point in the argument for their lessened regulation on the US market. Experts express caution at endorsing even any 1 of those messages as completely true, though.

“I truly believe that if e-cigarettes were safe, or effective in helping smokers quit, and somebody had figured that out, they would have made a beeline to the (FDA) Center for Drug Evaluation and Research really quickly,” Sward said. “Because they would have known that they could have made a ton of money selling that product to ultimately help smokers quit.”

Sward added the discussion around e-cigarette safety risks is often muddled by the fact that vaping devices are heterogenous; Juul and NJOY create products with different function and pods with different ingredients and chemical exposures. She called the belief any of these devices are safer than combustible cigarettes an industry-borne claim—one that the FDA had opportunities and evidence to challenge for more than a decade now. “I mean, the FDA not only left the barn door open, but they actively drove the horses out,” she said.

Clinical experts see a bit more complexity in defining the role of e-cigarettes as a smoking alternative or cessation tool. Boakye alluded to upcoming research by her colleagues that shows combustible cigarette users who are looking to quit are generally more successful when transitioned to e-cigarettes. That outcome would alter perspective on the 2 currently established facts that combustible cigarette use is gradually declining, and daily e-cigarette use is climbing—especially if the latter trend is buoyed by former combustible cigarette smokers.

If the climb in daily e-cigarette use is represented by tobacco-naïve users, though, there are greater potential risks. Addiction is highly prevalent with any nicotine product, and there are currently no evidence-based nor expert-supported cessation methods for young daily e-cigarette users.

“There's a lot of evidence to actually support this gateway hypothesis, where young adults who are using e-cigarettes are more likely to transition to combustible cigarettes use more so if they are using it daily,” Boakye said. “But some looking at it from the other end among combustible cigarettes users who want to quit daily use, it may actually be helpful.”

There is also an issue of heightened health risks in users alternating between combustible and electronic cigarettes, regardless of which they started with. “The benefits of e-cigarettes are actually realized only when smokers are able to transition fully to e-cigarettes, not when they are using both concurrently,” Boakye said.

Boakye’s team is trying to interpret e-cigarette impact more intricately, assessing the role of individual device characteristics and patient demographics in the transition from occasional to daily use. “Because if we get to know the device characteristics, then the FDA can regulate such characteristics so that people who are experimenting with e-cigarettes will not be likely to move on to the more harmful patterns of use,” she explained.

It would be fruitless for clinicians, investigators, regulators and users alike to altogether disregard the unique factors of e-cigarettes as they become better defined, Boakye said. She stressed frontline physicians to question the intricacies of patient tobacco use.

“Health care providers should follow the conversation, they should gain comfort in asking their patients—and also comfort in being able to respond to patients who are inquisitive enough to ask about e-cigarettes, because it's very important,” she said.

Recent events have only emphasized the issue of clearly defining the FDA’s role in regulating e-cigarettes. The agency issued a 

marketing denial order to Juul Labs in late June

, requiring the most popular e-cigarette and vaping device company in the country to remove all its products from retail and marketing.

The FDA’s unprecedented order followed a review of Juul’s premarket tobacco product applications, in which the agency deemed evidence supporting the toxilogical profile of Juul products were insufficient. The FDA described “insufficient and conflicting data” regarding the e-cigarette and vaping devices’ genotoxicity and user exposure to harmful chemicals via proprietary vape pods. Additionally, they cited concerns over the potential harmful use of third-party vape pods with a Juul device—or vice versa—similar to Sward’s concern over heterogenous products with similar usability but differentiating components.

 and received a temporary marketing stay from the US Court of Appeals while the agency conducted its investigation into product safety. Though much of the ban’s discourse is focused on the constitution, prevalence and burden of a handful of chemicals observed in the company’s vape pods, the overarching opinions on the role of e-cigarettes is discernable in both side’s arguments—and they’re somewhat nontangential. The FDA would argue that Juul caters to young, tobacco-naïve users without sufficient proof of a positive benefit-risk profile, Juul argues that e-cigarettes are a successful cigarette cessation tool for smokers.

Juul—which as of 2020 had comprised two-thirds of the US e-cigarette market—has stated approximately 2 million adult smokers have quit combustible cigarettes through aid of their products. “We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health,” Juul Labs chief regulatory officer Joe Murillo said in a 

The agency and supporting experts, meanwhile, seem focused on the long-term public health impact of a would-be ban for Juul. Previous FDA commissioner 

 at the time of the initial marketing ban that Juul was the “fulcrum of the youth vaping crisis,” driven by the company’s product and marketing practices.

“FDA is right to be circumspect,” he wrote. “Electronic devices offer opportunity for adult smokers to transition off combustible products but must be conceived, marketed by responsible actors.”

Kevin Walton, PhD, chief of the clinical research grants branch at the National Institute on Drug Abuse (NIDA), discussed the actions against Juul in concert with another FDA decision from earlier this year: 

a proposed ban on menthol-flavored cigarettes

. The prevailing argument against menthol flavoring is the same against flavored e-cigarette and vape pods: they can serve as something of a gateway to daily use.

“To ban menthol is part of the regulatory effort to reduce the attractiveness of cigarettes,” Walton said. “It's very common for youth who use (cigarettes) to start off with menthol, because it's a less harsh flavor. And so it's easier to start smoking, using that thought.”

While Walton is interested in learning more from upcoming research and the FDA’s deliberation on Juul and similar e-cigarette products, he maintained that a key regulatory priority should be on fixed nicotine levels for any approved products, as well as improving access to cessation treatments—especially among underserved populations who may be more adversely impacted by the likes of menthol cigarette and e-cigarette marketing.

I think that these changes the FDA has proposed could have a really big, positive impact for reducing smoking, and we'll just have to see how those processes go forward,” he said. “Making tobacco less addictive and less attractive seems like an appropriate way to move forward.”

Boakye echoed the idea that the real key to combating any public health effect of cigarette products should focus on nicotine; smoking cessation is a major individual accomplishment, but complete nicotine abstinence is the ultimate goal. Lost amid the argument that e-cigarettes are a beneficial smoking cessation tool is the fact that some e-cigarette users are trying to quit those products as well, she said. Greater options to aid them are necessary as long as they are available.

Sward maintained hope that that some of the tobacco products currently in the FDA’s crosshairs are eventually removed from market, saying this current time is “the closest we’re going to get as a nation to a fresh start” in the public health push for mitigated smoking harms. But regardless of the FDA’s fight against Juul, menthol, and everything in between, the affected users are owed help that’s been lacking for years.

“We need to do more as a nation to put into place policies and systems for cessation,” Sward said. “And I think that is something that that that we owe to the people who were essentially allowed to be addicted by a country that didn't always pay attention to what the tobacco companies were doing.”

Articles

The agency has taken new action against Juul while experts worry about youth addiction and health impacts. But the e-cigarette market has been already well established in the US.

Up in Smoke: The FDA's Retroactive Fight to Limit E-Cigarettes

A recent study analyzed the effects of foveal thickness fluctuation on visual and morphologic outcomes of anti-VEGF treatments for 

The findings suggest foveal thickness fluctuation was significantly associated with visual acuity and foveal photoreceptor status.

“Thus, the morphologic and functional prognoses of eyes with BRVO may improve with the identification of the characteristics of eyes with greater foveal thickness fluctuation and consequently controlling the foveal thickness fluctuation more strictly,” wrote study author Akitaka Tsujikawa, MD, PhD, Kyoto University.

As BRVO may cause macular edema (ME), the disease can be controlled with anti-VEGF treatments. The treatments, however, are not curative and require additional anti-VEGF treatments at recurrence.

Still, the long-term results, optimal anti-VEGF treatment regimens, and the comprehensive effects of ME recurrence remains unknown. The current study thus examined the effects of foveal thickness on the outcomes of anti-VEGF treatments for BRVO-ME.

The retrospective, observational case series study examined 309 treatment-naive patients (309 eyes) with BRVO-ME between 2012 and 2021 at a multicenter retinal practice. Each patient had foveal thickness assessed at each study visit.

The main outcome evaluated the logarithm of the minimal angle of resolution (logMAR) best-corrected visual acuity (BCVA) and the defect length of the foveal ellipsoid zone (EZ) band using OCT.

At baseline, the data show the mean logMAR BCVA was 0.30 ± 0.30 and the mean foveal thickness was 503 ± 162 μm. Moreover, the number of anti-VEGF injections for BRVO-ME was 5.8 ± 4.6 during the mean follow-up period (50.6 ± 22.2 months).

Investigators noted the final examination revealed the mean logMAR BCVA and foveal thickness values were significantly improved in comparison to those at the baseline. Multiple regression analyses further showed that age, baseline logMAR BCVA, and foveal thickness fluctuation had significant associations with the final logMAR BCVA (β = 0.20, 0.35, and 0.30, respectively).

Other significant associations included foveal thickness fluctuation (divided into groups 0 – 3 in ascending order) with logMAR BCVA and the defect length of the foveal EZ band at the final examination.

Data suggest the defect lengths of the foveal EZ band were longitudinally shortened in groups 0 and 1 and were slightly prolonged in groups 2 and 3. The logMAR BCVA was improved in groups 0 and 1 and worsened slightly in groups 2 and 3.

Foveal Thickness Fluctuations in Anti-VEGF Treatment for Branch Retinal Vein Occlusion: A Long-term Study

Data show foveal thickness fluctuation was significantly associated with logMAR BCVA and the defect length of the foveal EZ band. 

Foveal Thickness Fluctuation Associated with Visual Acuity in Eyes with BRVO  

High intake of water was not associated with a reduced risk of 

, according to new findings from a large, population-based study.

In fact, higher water intake appeared to be linked to a slightly higher prevalence of DED and DED-related symptoms according to the data.

“Based on these findings, advising dry eye patients to increase water intake is not justifiable,” wrote study author Jelle Vehof, MD, Department of Ophthalmology, University of Groningen, University Medical Center Groningen. “To fully understand any effect of water consumption on dry eye, future interventional studies should be conducted.”

Determining modifiable risk factors and interventions that help prevalent DED development may lessen the burden of the disease. It has been linked to substantial reductions in quality of life and yields a significant economic burden, with hard to treat symptoms.

Clinicians may recommend drinking more water to alleviate DED symptoms, but there is a lack of research assessing the effect of water intake on ocular surface health. Vehof and colleagues hypothesized that greater intake is associated with lower risk of DED.

The current study included participants from the population-based Lifelines cohort study, which examined health-related behaviors in those living in the north of the Netherlands (n = 167,729).

Investigators assessed DED using the Women’s Health Study (WHS) dry eye questionnaire as the main outcome. The frequently-used questionnaire asks questions including “How often do your eyes feel dry (not wet enough)?”, “How often do your eyes feel irritated?”, and “Have you ever received a diagnosis of dry eye?”.

Meanwhile, a food frequency questionnaire calculated total water intake stemming from beverages consumed, foods ingested, and the metabolic breakdown of the ingested macronutrients and alcohol. Investigators additionally calculated 24-h urine volume to provide information about the acute hydration status of the patient and validate the questionnaire’s findings.

From the Lifelines population, 51,551 individuals had available data and were thus included in the study. The prevalence of WHS-defined DED was 9.1% and were more likely to occur in females than males. Mean total water intake was 2491 ml/day, with beverage water contributing 62% of total water consumed with trest made up of food water (28%) and metabolic water (10%).

The data show a greater water intake was tied to a higher risk of having WHS-defined DED in all analyses. After correcting for comorbidities and medications, the odds ratio (OR) or having DED was 1.011 per 100 ml/day (95% confidence interval [CI], 1.004 - 1.017; 

Then, after adjustments for all comorbidities and medications, each 100 ml of urine volume increased the risk of having WHS-defined DED with around 1% (OR: 1.010 per 100 ml/day; 95% CI, 1.005 - 1.015; 

Excluding participants with report clinical diagnosis of DED still revealed higher total water intake was associated with increased odds of having symptomatic DED in all models (OR, 1.010 per 100 ml/day; 95% CI, 1.006 - 1.1015; 

The relationship between habitual water intake and dry eye disease

Both a higher self-reported water intake and a greater measured 24-h urine volume were tied to an increased DED prevalence. 

Higher Water Intake May Be Linked to Greater Risk of Dry Eye Disease 

 is generally accompanied by various complications, with acute chest syndrome (ACS) leading as one of the most severe. A new study examined the relationship between the 13-valent pneumococcal vaccine (PCV13) and the incidence of acute chest syndrome in children with sickle cell disease. 

Based on the recent results, investigators wrote that Streptococcus pneumoniae (S pneumonaie) should be considered when making decisions related to public health going forward. Prior to this research, the significance of S pneumoniae's role in relation to acute chest syndrome wasn't clear. 

However, when investigators assessed the association of PCV13 implementation in the general pediatric population with the incidence of acute chest syndrome in children with sickle cell disease, they found that the vaccine served as an important defense method since it reduced the prevalence of acute chest syndrome in this population. 

Prevalence of Acute Chest Syndrome in Children with SCD

A team of investigators led by Zein Assad, MD, Department of General Pediatrics, Pediatric Infectious Disease and Internal Medicine, Robert Debré University Hospital, Assistance Publique-Hôpitaux de Paris, conducted a cohort study using data from a national hospital-based French surveillance system. 

The interrupted time-series analysis included patient records of children under the age of 18 with sickle cell disease who were hospitalized in France between January 2007-December 2019. Of the total 107,694 hospitalizations within these parameters, there were 4007 episodes of acute chest syndrome.

The main outcomes and measures included the monthly incidence of acute chest syndrome per 1000 children with SCD over time as analyzed by segmented linear regression with auoregressive error. Also, the monthly incidence of hospitalization for vaso-occlusive crisis (VOC), asthma crisis, and acute pyelonephritis per 1000 children with SCD within the same time period as the control outcomes.

After PCV13 was implemented in 2010, there was a significant decrease in the incidence of acute chest syndrome with -0.9% per month. By 2019, investigators reported there was an estimated cumulative change of -41.8%.

There was little variation in results across different age groups and sensitivity analyses produced the same results, which included the incidence of acute chest syndrome that was adjusted for vaso-occlusive crisis over time. For the 3 control outcomes, no change was observed.

"PCV13 implementation was associated with an important reduction in the incidence of ACS in children with SCD," investigators wrote. "This vaccine benefit provides new evidence of the key role of 

 in ACS and should be considered when estimating outcomes associated with current PCVs and the potential benefit of next-generation PCVs in children."

Incidence of Acute Chest Syndrome in Children With Sickle Cell Disease Following Implementation of the 13-Valent Pneumococcal Conjugate Vaccine in France

The implementation of 13-valent pneumococcal conjugate vaccine (PCV13) was associated with an important reduction in the incidence of acute chest syndrome in children with sickle cell disease. 

New Evidence of S Pneumoniae in Acute Chest Syndrome

Investigators for the first time ever have begun to learn trends and clinical features for pediatric patients with 

A team, led by Soya Kobayashi, Department of Pediatric Hepatology and Gastroenterology, Saiseikai Yokohama City Tobu Hospital, described the clinical features of pediatric patients with eosinophilic gastroenteritis.

There is a lack of studying looking at large numbers of cases of eosinophilic gastroenteritis in pediatric patients from a single center.

In the retrospective study, the investigators examined 860 pediatric patients with eosinophilic gastroenteritis at a single center between April 2007 and December 2017. The participants were aged between 1-15 years.

Each patients underwent an endoscopy for gastrointestinal symptoms of unknown causes. Of this group, 12,7% (n = 109) were diagnosed with EGE based on the diagnostic criteria developed by the research group of the Ministry of Health, Labour and Welfare of Japan for eosinophilic gastrointestinal disorder in 2015.

The investigators looked at symptoms, comorbidities, endoscopic findings, pathological findings, treatments, and outcomes.

There were 71 male patients and 38 female patients diagnosed with eosinophilic gastroenteritis included in the study. The median age at diagnosis was 11 years.

The most prevalent complaint among patients was abdominal pain, which occurred in 76.1% (n = 83) of participants, as well as diarrhea, which occurred in 23.9% (n = 26) of participants.

The results also show upper and lower gastrointestinal endoscopies resulted in normal findings for 29.4% (n = 32) of participants.

The most common treatment used was a combination of the elimination of foods suspected of causing eosinophilic gastroenteritis and anti-allergic agents. This occurred in 45.9% (n = 50) of cases.

The outcomes of symptom disappearance was found in 39.4% (n = 43) of participants, while symptom improvement occurred in 48.6% (n = 53) of patients.

“For gastrointestinal symptoms of unknown cause in children, EGE should be considered as a differential diagnosis,” the authors wrote. “Although the symptoms and endoscopic findings are nonspecific, cracked mucosa may be a specific endoscopic finding for pediatric EGE. Elimination diet and/or anti-allergic drugs were effective in most patients with pediatric EGE.”

Earlier this year, the US Food and Drug Administration (FDA) the first ever treatment for 

 (EoE), another eosinophilic gastrointestinal disease (EGID).

The FDA approved dupilumab (Dupixent) in May for the treatment of adult and pediatric patients 12 years and older weighing at least 40 kg with EoE.

 on the biologic found that nearly 10 times as many patients treated with dupilumab achieved histological disease remission during the study, with 59% achieving histological disease remission compared to 6% of the placebo group.

The efficacy and safety of Dupixent in EoE was studied in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial consisting of two 24-week treatment periods that were conducted independently in separate groups of patients.

In Part A of the trial, 60% of the 42 patients who received dupilumab achieved the pre-determined level of reduced eosinophils in the esophagus compared to 5% of the 39 patients who received a placebo.

Similarly, in Part B, 59% of the 80 patients who received the biologic achieved the pre-determined level of reduced eosinophils in the esophagus compared to 6% of the 79 patients who received a placebo.

Clinical Features of Pediatric Eosinophilic Gastroenteritis

The most common complaint among patients was abdominal pain followed by diarrhea.

Investigators Describe Clinical Features of Pediatric Eosinophilic Gastroenteritis

 requires regular management with a dermatologist. However, the quality of the physician-patient relationship is an important determining factor in the patient's outcome. 

A couple of investigators sought to understand if there were any differences in the amount of time spent with patients who have psoriasis. They focused specifically on the association between a patient's race and ethnicity and time spent with a dermatologist for psoriasis treatment. 

Kevin K. Wu, MD and April W. Armstrong, MD, MPH, from the Department of Dermatology at Keck School of Medicine, University of Southern California, performed a cross-sectional study of data gathered from the National Ambulatory Medical Care Survey from 2010-2016.

The investigators adjusted for age, sex, type of visit (follow-up or new patient), visit complexity based on the number of reasons for visit, insurance status, psoriasis severity on the basis of systemic psoriasis treatment or phototherapy, and complex topical regimen (3 or more topical agents) in their multivariable linear regression analyses. 

According to the study, a weighted estimate revealed 4,201,745 patient visits for psoriasis. Race and ethnicity were self-reported by patients. The statistical tests utilized were 2-tailed with a 2-sided 

A significant difference in the average patient age across racial and ethnic demographics was discovered, along with the use of complex topical regimen.

Asian patients: 37.2 years; 11.8% on complex topical regimen

Hispanic patients: 44.7 years; not reported

Black patients: 33.3 years; 1.5% on complex topical regimen

White patients: 54.8 years; 1.1% on complex topical regimen

The patient group that received the longest mean duration during visits was non-Hispanic Black patients averaging 20.7 minutes. Hispanic or Latino patients showed a similar duration to non-Hispanic White patients with 15.7 and 15.4 minutes, respectively. 

The mean duration for Asian patients was 39.9% shorter than that of White patients, with the average time spent with Asian patients being 9.2 minutes. When assessing the Asian patient group alongside all non-Asian patients as a single group, the mean duration of time with Asian patients was 40.6% shorter. 

Investigators noted that despite their tendency to present with more severe psoriasis compared with individuals of other races and ethnicities, the results showed that Asian patients receive significantly less time with a dermatologist. 

These data aligned with previous studies that found this demographic was less likely to receive counseling from physicians compared with White patients. However, the reason for the presence of these differences is unclear. 

Investigators speculated that unconscious bias, cultural differences in communication, or residual confounding could be possible factors, but that further research is necessary to understand the underlying etiology responsible for the variations observed in this study. 

Some limitations that were acknowledged included the self-reported visit duration by physicians or their staff, and the missing data on race and ethnicity that were inferred with the sequential regression method. Additionally, among those who didn't report race and ethnicity, separate unknown characteristics could have played a role in visit duration.

Based on these data, investigators concluded that when comparing the racial and ethnic demographics of patients with psoriasis, dermatologists spend significantly less time with Asian patients than any other group.

"Dermatologists need to allow sufficient time to develop strong physician-patient communication regardless of patient background," they wrote. 

Differences in Face-to-Face Time Spent With a Dermatologist Among Patients With Psoriasis Based on Race and Ethnicity

Despite their tendency to present with more severe psoriasis compared with other races and ethnicities, Asian patients receive significantly less time with a dermatologist.

Research Reveals how Psoriasis Treatment Differs Based on Patient Race, Ethnicity

A promising dual pathway inhibitor molecule for the treatment of 

chronic obstructive pulmonary disease (COPD)

 has reached significant marks in phase 3 data and will now be considered by the US Food and Drug Administration (FDA).

Verona Pharma announced trial results from its pivotal phase 3 ENHANCE-2 study showing that novel inhaled ensifentrine nebulizer therapy was associated with a significant and clinically meaningful improvement in forced expiratory volume over 1 second (FEV

) among patients with COPD versus placebo.

With non-peer reviewed, unpublished findings announced Tuesday, Veron shared intention to submit a New Drug Application (NDA) for ensifentrine as a COPD treatment in early 2023—dependent on outcomes from the coinciding ENHANCE-1 study.

Ensifentrine is an investigational dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4)—a pair of enzymes associated with COPD bronchial and inflammatory effect. The agent was shown in prior phase 2 trials to significantly improve patient lung function and quality-of-life outcomes when used as either a monotherapy or add-on to maintenance bronchodilator in patients with COPD.

The ENHANCE-2 trial is part of a phase 3 randomized, double-blind, placebo-controlled program to assess the efficacy and safety of ensifentrine as either a monotherapy or add-on to long-acting muscarinic antagnonist (LAMA) or long-acting beta agonist (LABA) bronchodilators, versus placebo.

The patient population for ENHANCE-1 and ENHANCE-2 included approximately 800 patients with moderate to severe symptomatic COPD across North America and Europe. Patients in ENHANCE-2 were randomized to either 3 mg nebulized ensifentrine or placebo twice daily over 24 weeks.

Investigators sought a primary endpoint of lung function improvement per FEV

 area under the curve (AUC) at 0-12 hours post-dose in week 12. They additionally sought safety outcomes over 24 weeks, and secondary efficacy endpoints including peak and morning trough FEV

, COPD symptoms and health-related quality of life via St. George’s Respiratory Questionnaire (SGRQ) and Evaluating Respiratory Symptoms (E-RS) scores, and exacerbations.

Patients treated with ensifentrine reported a 94 mL change in mean FEV

 <.0001). Investigators additionally observed significant improvements for treated subgroups based on sociodemographic and clinical backgrounds, including age, smoking status, disease severity and more.

 of treated patients reached 146 mL at 0-4 hours post-dose in week 12 (

 <.0001), and increase in morning trough FEV

 = .0017). Investigators noted the latter secondary endpoint confirms a twice-daily dosing regimen for ensifentrine treatment in COPD.

Additionally, patients treated with ensifentrine reported a 42% reduction in COPD exacerbations over 24 weeks versus placebo (

 = .0109), as well as clinically-important differences in E-RS and SGRQ scores at week 24.

Ensifentrine was observed to have good tolerability in ENHANCE-2, with a similar safety profile to placebo. Commonly observed adverse events included pneumonia, gastrointestinal effects and cardiovascular events.

 accompanying the findings, Verona president and chief executive officer David Zaccardelli, Pharma, said the successful ENHANCE-2 findings and the ENHANCE-1 findings anticipated for later this year are expected to support the company’s NDA submission to the FDA.

“We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible,” Zaccardelli said.

Investigator Antonio Anzueto, MD, professor of medicine and chief of the pulmonary section at South Texas Veterans Healthcare System, highlighted the discernible improvements to lung function and retained safety associated with ensifentrine.

“I am extremely excited by the clinically meaningful 42% reduction in the rate of exacerbations observed over 24 weeks in these symptomatic patients, many receiving background therapym,” he said. “Based on these meaningful results, I believe ensifentrine, if approved, will be an important new class of bronchodilator and non-steroidal anti-inflammatory therapy for COPD patients providing a much needed alternative to existing treatments.”

New phase 3 ENHANCE-2 data support a potential submission by Verona Pharma to the FDA.

Ensifentrine Significantly Improves COPD Lung Function, Exacerbations

New findings suggest a lack of association between SARS-CoV-2 infection and autoimmunity related to the development of 

No relationship between infection and development was observed after screening more than 50,000 youth patients in diverse populations of Colorado and Bavaria, Germany.

“Long-term follow-up of persons with preexisting autoimmunity is necessary to determine whether SARS-CoV-2 accelerates progression to clinical diabetes,” wrote study author Marian Rewers, MD, PhD, Barbara Davis Center for Diabetes, University of Colorado School of Medicine.

The increased incidence of clinical diabetes has been reported in children with prior COVID-19 infection. Thus, Rewers and colleagues noted it may be plausible that the virus may trigger autoimmune response to the islets or hasten metabolic decompensation in individuals with established islet autoimmunity.

The hypothesis tested was that previous SARS-CoV-2 infection was associated with autoimmunity which predicts future T1D. In 2020 and 2021, a cross-sectional screening for islet autoantibodies was offered to individuals aged 1 to 18 years participating in the Autoimmunity Screening for Kids (ASK) in Colorado and children aged 1 to 10.9 years enrolled in Fr1da study in Germany.

Autoantibody-negative children were additionally followed-up with after detection of SARS-CoV-2 antibodies with blood sample collection every 3 months in Bavaria.

The study defined past SARS-CoV-2 infection by the presence of antibodies to both SARS-CoV-2 receptor binding domain and nucleocapsid proteins. Additionally, autoantibodies to insulin, glutamic acid decarboxylase, islet antigen 2, and zinc transporter 8 autoantibodies were measured using comparable methods.

The study outcomes included the presence of multiple or single high-affinity islet autoantibodies that carry a 50% and 30% risk of progression to clinical diabetes in 5 years, respectively. Investigators used multivariable logistic regression to assess independent associations between previous infection and islet autoimmunity and testing for interactions by study site.

The findings identified prior SARS-CoV-2 infection in 1524 (32.3%) of 4717 Colorado youths (median age, 8.6 years; 50.3% female) and in 2862 (6.1%) of 47,253 Bavarian children (median age, 3.9 years; 48.9% female).

Data show multiple islet autoantibodies were detected in 21 youths from Colorado (0.45%) and in 141 Bavarian children (0.30%). Further, 26 (0.55%) and 54 (0.11%) of Colorado and Bavarian youths were positive for a single high-affinity islet autoantibody, respectively.

Investigators noted the prevalence of multiple or single high-affinity islet autoantibodies did not significant differ between youths with previous SARS-CoV-2 infection compared to those without previous infection in Colorado (1.18% vs 0.91%, 

The findings additionally suggest previous infection was not significantly associated with the presence of multiple islet autoantibodies (odds ratio, 1.06 [95% CI, 0.59 - 1.80]; 

 = .83) or a single high-affinity islet autoantibody (odds ratio, 1.34 [95% CI, 0.70 - 2.44]; 

 = .36) after controlling for confounders.

No significant interaction between study site and the association with SARS-CoV-2 infection, sex, age, or family history of T1D was reported.

Rewers noted the limitations of the study included the low prevalence of autoantibodies, weakening the ability to detect an increase in risk associated with SARS-CoV-2 infection. As well, the cross-sectional design did not allow determination of the time of autoantibody development before or after infection.

SARS-CoV-2 Infections and Presymptomatic Type 1 Diabetes Autoimmunity in Children and Adolescents From Colorado, USA, and Bavaria, Germany

The screening of more than 50,000 youth patients in diverse populations of Colorado and Bavaria, Germany reported no association between infection and T1D. 

SARS-CoV-2 Infection Not Associated with Autoimmunity Related to T1D Development 

A new study observes a higher incidence of acute myocardial infarction (AMI) in patients with 

 during the late night time/early morning hours – as compared with morning or daytime hours.

The study also found a higher incidence of chest paints in these patients during the night.

The investigative team, led by Fang Zhao, MM,  of the Tianjin Chest Hospital in China, sought to investigate the circadian rhythm and clinical characteristics of patients with acute myocardial AMI combined with OSA.

“Among the many factors causing AMI, OSA has received considerable attention in recent years as one of the risks for coronary heart disease,” the team wrote. Their study aimed to provide potential insight into “early prevention and treatment for these patients.”

Zhao and team observed 148 patients with AMI admitted to Tianjin Chest Hospital between September 2017 and December 2018. They included patients with the first onset of AMI, patients who had undergone percutaneous coronary intervention, and those with AMI combined with OSA.

Patients were then divided into 3 time-period groups based on their sleep–wake rhythm: 22:00-5:59, 6:00-13:59, and 14:00-21:59. The team then analyzed and compared sleep-monitoring data, blood routine, biochemical indicators, and coronary angiographic parameters among the 3 groups.

Sleep was monitored using a portable sleep-monitoring system (ApneaLink Air) over a 7-day period.

Of the 148 total patients with AMI selected for the study, 70 (47%) had a sleep schedule of 22:00-5:59, and 46 (66%) of these patients experienced chest pains. Further, 44 patients (30%) slept between 06:00–13:59, and 26 (60%) had chest pains.

There were 34 (23%) patients in the 14:00–21:59 sleep group, and 17 (50%) had chest pains.

Patients with obstructive sleep apnea who sleep between 22:00 PM and 5:59 AM had higher incidences of acute myocardial infarction and chest pains, a new study observes.

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