Over the study period, significant increases in the number of screening tests, as well as the ratio between the tests and hospital admissions, was observed.

Collaboration between dermatology and infectious disease clinics may help improve the diagnosis of sexually transmitted diseases such as syphilis, HIV, hepatitis B (HBV), and hepatitis C (HCV) in at-risk populations, according to results of a study that examined a collaborative effort by 2 Italian clinics. Results were published in the Journal of the European Academy of Dermatology and Venereology.

The investigators sought to analyze the number of screening tests performed in the dermatology and infectious disease clinics and to compare results obtained following adoption of the shared protocol with findings from the prior period. A secondary objective of the study was to assess the linkage with care of people newly diagnosed with sexually transmitted diseases. Consecutive patients who were referred to the clinics between January 2010 and December 2016, with ≥1 serologic screening test performed for HIV, HBV, HCV, and syphilis, were enrolled in the study.

Over the 7-year observation period, a total of 13,117 admissions for 9154 patients were gathered. Over the study period, significant increases in the number of screening tests, as well as the ratio between the tests and hospital admissions, was observed (P <.001 and P =.002, respectively).

Overall, 7.0% (644 of 9154) of individuals were diagnosed with ≥1 infection. Among the infections, the most common were syphilis in 41.9%, HBV in 25.7%, HCV in 21.4%, and HIV in 10.9%. Syphilis was reported primarily among Italians (72.5%) and men (75.7%), similar to HCV, whereas foreign-born individuals had mainly HBV infection (85.5%). Additionally, HIV was diagnosed more often among men (67.1%), with a similar proportion observed among Italians and foreign-born patients. Linkage to care was reported among 84.3% (543 of 644) of patients. 

The investigators concluded that accurate epidemiologic information about the distribution of sexually transmitted diseases is key for targeting screening, as well as for designing, implementing, and assessing intervention programs.

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Reference

Mandel VD, Tullio FD, Rugge W, et al. Optimization strategies for HIV, hepatitis and syphilis testing in infectious disease clinic and dermatology unit of Modena: seven-years results of collaboration experience [published online December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15390

Acute skin manifestations correlated with axial disease and were more common among young participants and those with higher body mass index. Photo Credit: BSIP/Science Source

Among individuals with psoriatic arthritis (PsA) and moderate to acute skin manifestations, axial disease is more common and has an earlier onset, according to a study recently published in the Journal of Dermatology. Additionally, anti-tumor necrosis factor-α inhibitors (anti-TNF- α) have demonstrated reduced efficacy among individuals older than 50 years.

This cross-sectional, retrospective study included 2116 individuals with psoriasis and was conducted in western Japan. Medical records were gathered and psoriasis and PsA were analyzed by physicians according to the Classification Criteria for Psoriatic Arthritis. Categorical data were examined using Fisher’s exact test and continuous variables by Student’s t-test, with confounding factors removed through logistic regression.

In this cohort, 13.5% (n=285) had a diagnosis of PsA. This was preceded by skin manifestations in 69.8% of cases, with a median time of 7 years between skin manifestations and arthritis onset. The 2 conditions occurred at the same time among 17.2%, and just 2.5% showed PsA before skin manifestations. The majority of cases were peripheral arthritis (73.7%), followed by dactylitis (35.4%), enthesitis (23.5%), and axial disease (21.8%). Acute skin manifestations correlated with axial disease (P =.03) and were more common among young participants (P =.01) and those with higher body mass index (P =.02).

TNF-α inhibitors were administered to 157 participants and were continued by 105, with 47 discontinuing them. This discontinuation correlated significantly with being older at the time of joint manifestations (50 vs 44 years; P =.01) and being older in general (55 vs 51 years; P =.04). Those older than 50 years were 3.65 times  more likely to discontinue TNF-α inhibitors (P <.01).

Limitations to this study included that the cohort exclusively included Japanese participants, a cross-sectional study design, and a lack of longitudinal observation.

The study researchers concluded that “13.5% of individuals with psoriasis in our large survey had PsA. Our finding that axial disease is present more frequently in patients with moderate [or] severe manifestations is new, as is the finding that TNF inhibitors are less effective in older patients with PsA, suggesting the presence of other overlapping conditions.”

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Reference

Tsuruta N, Narisawa Y, Imafuku S, et al. Cross-sectional multicenter observational study of psoriatic arthritis in Japanese patients: relationship between skin and joint symptoms and results of treatment with tumor necrosis factor-α inhibitors [published online January 10, 2019]. J Dermatol. doi: 10.1111/1346-8138.14745

E-mail accounts and passwords of former employees should be immediately deactivated so they can no longer access the network.

The privacy of patient data is protected by the Health Insurance Portability and Accountability Act (HIPAA) and the 2009 Health Information Technology for Economic and Clinical Health Act.1But the complexities of today’s high-tech methods of communication, data sharing, and data storage lay practices open to unforeseen and constantly changing threats, requiring vigilance and training of medical staff.

This second article devoted to cybersecurity takes a closer look at protecting patients’ privacy. To gain further insight into this complex subject, MPR interviewed Michael J Sacopulos, JD, CEO of Medical Risk Institute (MRI), a firm that provides “proactive counsel” to the healthcare community to identify where liability risks originate and to reduce or remove those risks. He is also General Counsel to Medical Justice Services. Mr Sacopulos is the coauthor of Tweets, Likes, and Liabilities: Online and Electronic Risks to the Healthcare Professional (Phoenix, MD; GreenbranchPublishing: 2018).

What do you think the greatest threat is to HIPAA in physicians’ practices?

Some of the issues I discussed in our previous interview are central in potential HIPAA violations. In particular, I’m talking about lack of cyber-hygiene, by which I mean the numerous human errors that can compromise patient privacy, even with the best software and firewalls. We already discussed the importance of training staff not to click into unknown e-mails often called “phishing” e-mails, which are cyber attacks that open the door to hackers to access your system or install malware on your computers. Teaching your staff to recognize these scams and malware e-mails is critical.

What other potential concerns might compromise privacy?

An important area of concern is the location where you and your staff access any practice-related Internet. If you have an employee, consultant, or contractor who works remotely – for example, a bookkeeper or someone who does medical billing – you need to be sure that several important things are in place.

Neither you nor your employee should be using the free Wi-Fi at Starbucks or the library or the airport, for example, to do any e-mailing or work on patient records, since those are not secure connections and can easily be hacked. Additionally, in a public place, a person sitting near you, or a passerby can catch a glimpse of a patient’s name or some other information or might even use their own cellphone to photograph it.

Employees who work from home should have a dedicated work space, such as a home office, with a door that closes and file cabinets that can be locked and secured from others. The office shouldn’t double as the guest room or children’s bedroom. And the employee should dedicate specific time and space to working on practice-related matters and not multitask. I’ve seen situations in which the person who does billing was working on generating electronic bills while trying to cook dinner for her family and having the computer or paperwork on the table.

Any conversations about patients, whether you are returning a patient’s call or whether your staff member is talking to an insurance company, should be conducted in private where no family members or others can hear you. One doctor was discussing a child’s bedwetting problem with a parent within earshot of his own children. It was a small town and the doctor’s children went to school with the child who had the bedwetting issue. Soon, it was public knowledge in the classroom and the other children teased the boy with the problem. This took place in the days before HIPAA was put into place, but the issue could just as easily take place today if patient-related conversations could be overheard.

Equally important is making sure there is a dedicated computer used for nothing other than practice-related matters. The computer should have a secure password and should not be shared by others, such as one’s children who are using it to do their homework or play video games.

Are there any software-related issues to be concerned about?

You should have good firewalls proper encryption for patient portals and modes of communication. It is extremely important to keep software supported and up to date. If the manufacturer recommends updates, they must be installed promptly so that your software remains secure. Updates are “patches,” which the manufacturer recommends if they find vulnerabilities. Older versions of software eventually are no longer supported by the platform, such as Microsoft. Beyond being unreliable, outdated software is vulnerable to cyber breaches. The government’s position is that if the software is not supported, this constitutes a per se violation.

How can a practice increase its security?

I cannot emphasize enough what I mentioned in the previous interview, which is to engage a professional IT expert to conduct and troubleshoot software issues or handle phishing e-mails and potential breaches. A professional IT expert should also conduct an annual risk analysis and advise on what needs improvement.

You should regularly review who in your practice has access to which type of information. Staff members who do not need to access patients’ electronic health records (EHRs), meaning they are not involved with the care of a given patient, should be prevented from accessing that patient’s records. The e-mail accounts and passwords of former employees should be immediately deactivated so they can no longer access your network. This is equally true if you have a storage area of paper files. The ex-employee’s key or swipe card should be returned and if there is a combination lock, the combination should be changed.

Lastly, make sure you have policies in place regarding your employees’ use of social media and e-mails and access.

What about the use of mobile devices?

Any cellphone used for your practice has to be password protected, so that if it gets lost or stolen, any information is secure. Most standard Androids and iPhones today have passwords that are encrypted and therefore secure.

Another concern relates to texts. Are your texts secure or not? And, equally important from a patient safety perspective, does the content of the text ever make its way into the patient’s chart? Conversations between physicians over text, or between the physician and the patient, need to be entered into the chart for continuity of care and so that if the phone is lost or stolen, no important patient information is lost.

If a physician or other practitioner uses a cellphone to photograph a patient — for example, a dermatologist has photographed a patient’s rash — this should also be entered into the patient’s chart as soon as possible.

Are there any other concerns related to photographs and patient privacy?

There are some obvious concerns. No photographs of a patient should appear anywhere outside of his or her chart — for example, nothing should ever be posted on the practice’s Website or newsletter, or on an employee’s social media.

I know that physicians sometimes use close-up photographs of de-identified patients at medical meetings for demonstration or to discuss a particular disease or condition — perhaps a rash or surgical incision. But the law is very clear that the picture can’t be identifiable as any particular person to anyone else, even a spouse.

I had a case in which a woman had a breast augmentation and the surgeon took a before/after picture of her torso, which was later used in a medical presentation — without identifying information, of course, and without revealing any other body parts such as face, head, arms or legs. But the patient brought a suit claiming that she had a unique freckle pattern on her chest that could be identifiable to some people. The case was settled.

My advice is to obtain a patient’s permission if you want to use any images in a conference or a journal article. This can be done quite easily with a one-page document that should remain in the patient’s chart. In my experience, very few patients will refuse to allow their de-identified photograph to be used if they understand that it is for the purpose of medical education of other healthcare professionals.

As cumbersome as it can be to set up appropriate protocols and adequately train staff, it is essential, not only to protect you from potential litigation or disciplinary action but also to protect patient privacy and enhance patient safety.

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Reference

1.    McCoy TH, Perlis RH. Temporal trends and characteristics of reportable health data breaches, 2010-2017. JAMA. 2018;320(12):1282-1283.

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In an effort to effectively address global health concerns, the WHO has announced the 13th General Programme of Work, a 5-year strategic plan spanning from 2019 to 2023.

The health of one country is the health of all countries. Diseases can travel around the world in days, along with the people and vectors that carry and transmit them. With environmental issues setting the stage for eruption of disease on a global level, it has become clear that the medical initiatives of 1 small village or town can only work if the world at large supports it.

In an effort to effectively address global health concerns, the World Health Organization (WHO) has announced the 13th General Programme of Work, a 5-year strategic plan spanning from 2019 to 2023 that hopes to ensure that “1 billion more people benefit from access to universal health coverage, 1 billion more people are protected from health emergencies and 1 billion more people enjoy enough better health and well-being.”

At the center of their efforts, the WHO first identified 10 key issues that are projected to threaten public health this year. At the very top of the list are air pollution and climate change, followed by noncommunicable diseases, pandemic influenza, fragile settings, antimicrobial resistance, recurring pathogens, weak primary care, and vaccine hesitancy. Rounding out the list are continued wide-scale risks of acquiring dengue fever and HIV, 2 diseases that can be largely contained.

Threat No. 1: Air Pollution and Climate Change

The WHO estimates that 7 million people die prematurely every year from diseases such as cancer, stroke, heart, and lung disease, of which about 90% of cases are associated with poor air quality. “Household air pollution using dirty cook stoves indoors causes around 4 million premature deaths every year. About 3 billion people cook using polluting open fires or dirty fuels. Almost half the deaths due to pneumonia in children aged less than 5 years are caused by soot inhaled from household air pollution,” explained María P. Neira, MD, director of the Department of Public Health, Environment, and Social Determinants of Health at the WHO.

Mortality is expected to increase by 250,000 deaths annually between 2030 and 2050 from climate-related malnutrition, malaria, diarrhea, and heat stress. “Awareness of the health effects of pollution and climate change is increasing, and there is much more evidence now that air pollution is responsible for many health issues, ranging from brain development in babies, to heart disease and stroke in adults,” Dr Neira added. The WHO is calling on countries to commit to reaching new designated air quality guideline levels by 2030.

Threat No. 2: Noncommunicable Diseases

Diabetes, cancer, and heart disease collectively cause 41 million deaths worldwide, accounting for more than 70% of global mortality. An estimated 15 million people between the ages of 30 and 60 years die prematurely, the vast majority of those from low- and middle-income countries. The WHO set goals to significantly reduce the 5 major risk factors for all these diseases by 2030, including tobacco use, physical inactivity, overuse of alcohol, poor diet, and air pollution.

Threat No. 3: Pandemic Flu

A pandemic is expected to happen again; the only questions are when and where it will start.

At this time, 153 institutions across 114 countries participate in the WHO’s Global Influenza Surveillance and Response System to monitor and track influenza infections around the world, the data from which are then used to prepare vaccines for the next influenza season. The biggest challenge is the potential for a new strain to develop, particularly in underdeveloped nations that cannot adequately prepare and respond to prevent an epidemic from spreading through global portals.

Threat No. 4: People in Fragile or Vulnerable Settings

Approximately 22% of the world’s population, or 1.6 billion people, live in areas where they are frequently displaced from their homes by war, famine, or climate disasters. One serious consequence for these displaced populations is the loss of access to basic healthcare services, which puts large populations at risk for outbreaks of disease that can then spread worldwide. The WHO has focused on providing continuity of quality care to those in fragile settings, including immunization services.

Threat No. 5: Antimicrobial resistance

The WHO predicts that the era of treating infections such as salmonella, pneumonia, tuberculosis, or gonorrhea with antimicrobial drugs is nearly done, with no other treatments set to replace them. The WHO’s global action plan focuses on increasing awareness, using preventive measures to reduce risks for infection, and careful antimicrobial stewardship among the medical community.

Threat No. 6: Recurring High-Threat Pathogens

There are a number of known diseases that could cause public health emergencies. Pathogens from Ebola to Zika, Nipah to Middle East respiratory syndrome coronavirus and Severe Acute Respiratory Syndrome, among others, are all listed on the international watch list for priority research called the WHO’s R&D Blueprint. These diseases have no effective treatments or vaccines, and can readily spread not only in rural areas but also within densely populated urban zones, particularly during active conflicts that limit access to care. In addition, the WHO continues to focus its efforts on Disease X, the unknown pathogen that can cause a global outbreak at any time.

Threat No. 7: Weak Primary Healthcare

Many countries, particularly those with fewer national resources, fail to provide adequate basic medical care for their populations, creating windows for opportunistic diseases to go unchecked and spread. An estimated half of the world’s population does not have access to care for even the most essential and basic needs. The WHO has committed to partnering with countries to help strengthen primary care globally in accordance with the Astana Declaration.

Threat No. 8: Vaccine Hesitancy

The 2019 WHO initiative states that vaccine hesitancy “threatens to reverse progress made in tackling vaccine-preventable diseases.” An estimated 2 to 3 million deaths annually are prevented by vaccination, which could be further extended to prevent another 1.5 million deaths through improved global vaccine coverage. 

One of the target diseases is measles, which has been a recurring issue in countries that were once close to eliminating the disease, including the United States. Globally, there has been a 30% increase in measles cases. “The resurgence of measles is of serious concern, with extended outbreaks occurring across regions, and particularly in countries that had achieved, or were close to achieving, measles elimination,” said Soumya Swaminathan, MD, deputy director general for programmes at WHO. “Without urgent efforts to increase vaccination coverage and identify populations with unacceptable levels of under- or unimmunized children, we risk losing decades of progress in protecting children and communities against this devastating, but entirely preventable, disease,” she added.

Threat No. 9: Dengue Fever

An estimated 40% of the world is now at risk of dengue fever as climate change increases the infectious season in primary areas such as Bangladesh and India while increasing the range of the disease to more temperate countries such as Nepal. Approximately 390 million additional infections are diagnosed per year. The WHO’s Dengue control strategy aims to reduce deaths by 50% by 2020. 

Threat No. 10: HIV

Despite tremendous advances in treatment, HIV continues to spread among those who have little or no access to effective treatments. WHO Regional Director for Africa Matshidiso Moeti, MBBS, initiated a call to action on January 18 to end HIV among children in West and Central Africa. “Diagnosis and treatment of children living with HIV is a major challenge. It is unacceptable that only 1 in 4 children living with HIV have access to treatment,” she said. “Most of the children with HIV are receiving suboptimal treatment regimens. This is a particular concern in the [subregions] where drug resistance rates are reaching over 60% in some areas, with only 30% of people on treatment successfully achieving viral suppression.”

Alarmingly, new populations at risk are also being identified. Young girls and women aged 15 to 24 years in sub-Saharan Africa now account for 1 in 4 HIV infections in that region, despite being only 10% of the population. “This is part of the reason why I made adolescent health a priority in the African Region,” Dr Moeti added.

To view the full program, please visit the WHO website.

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Reference

World Health Organization. Ten threats to global health in 2019. https://www.who.int/emergencies/ten-threats-to-global-health-in-2019. Accessed February 8, 2019.

The 2007 and 2008 shingles and varicella vaccination recommendations may have contributed to the declining herpes zoster hospitalization rates in some groups.

The 2007 and 2008 herpes zoster and varicella vaccination recommendations may have affected the declining herpes zoster hospitalization rates in targeted age groups, according to a study published in Vaccine.

The Centers for Disease Control and Prevention officially endorsed the 2005 recommendation from the Advisory Committee on Immunization Practices for the addition of a second booster dose at age 4 to 6 years in the varicella vaccine schedule, and the herpes zoster single-dose vaccine for people aged ³60 years, in 2007 and 2008, respectively. Currently, there are limited published data on the effect of the 2-dose varicella and single-dose herpes zoster vaccine recommendations on herpes zoster incidence in the United States. Therefore, this study examined trends in herpes zoster hospitalization rates and assessed the effect of both policy recommendations, using hospital discharge data.

Discharge data (2001-2015) were extracted to identify primary and secondary herpes zoster diagnoses from the Nationwide Inpatient Sample, which contains annual discharge data for a 20% sample of US hospitals and is the largest publicly available all-payer inpatient care database in the United States, containing roughly 8 million hospitalizations annually. Herpes zoster-associated hospitalization was defined by a first or second discharge diagnosis, indicated with specific International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), or ICD-10-CM codes. 

Annual total and age-specific herpes zoster hospitalization rates and average length of stay trends were examined. The average annual rates for the pre- and postzoster vaccination policy eras were compared (2001-2005 and 2012-2015, respectively). Researchers noted that the 2006 to 2011 period was treated as a transition period because of a vaccine supply shortage resulting from manufacturing issues. In addition, absolute change in herpes zoster hospitalizations was calculated.

Results suggested that the 2-dose varicella vaccination recommendation may have contributed to declining herpes zoster hospitalization rates among children (£14 years), and the 2008 herpes zoster vaccine may have also contributed to declining hospitalization rates for adults aged ³60 years. From 2001 to 2015, there were 400,651 herpes zoster hospitalizations, which accounted for 0.07% of all US hospitalizations during the study period. 

The number of herpes zoster hospitalizations increased in direct proportion with age: 0.07% in those aged 7 to 14 years, 0.06% in those aged 40 to 49 years, 0.07% in those aged 60 to 69 years, 0.12% in those aged 70 to 79 years, 0.16% among those aged 80+ years, and less than 0.05% in all other groups. In 2001, the annual incidence rate of herpes zoster hospitalizations was 8.6 per 100,000 population in the US and decreased to 6.8 per 100,000 population in 2015. Although there were steady increases in the overall rate of herpes zoster hospitalizations from 2001 to 2008, this significantly decreased between 2001 and 2015. 

Further, the largest decreases in herpes zoster hospitalization rates between 2001 and 2015 occurred in groups that were directly targeted by the 2007/2008 recommendations. The age-adjusted average annual change in hospital rates from pre- vs post-herpes zoster vaccine period was 1.9 fewer hospitalizations per 100,000 population (P <.001).

Overall, the study authors concluded, “The recent licensure of a new 2-dose recombinant sub-unit herpes zoster vaccine and expansion of the recommended age of herpes zoster vaccination to ³50 years should have significant [effect] in the [US] on vaccination coverage and herpes zoster hospitalizations over time, and continued surveillance will be necessary to measure this [effect].”

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Reference

Pham MA, Bednarczyk RA, Becker ER, Orenstein WA, Omer SB. Trends in U.S. community hospitalizations due to herpes zoster: 2001-2015. Vaccine. 2019;37:882-888.

Nuzyra is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.

Paratek announced the launch of Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). It is the first once-daily antibiotic approved to treat CABP and ABSSSI that is available in both an intravenous (IV) and oral formulation.

Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains. Specifically, it is indicated for CABP caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae and ABSSSI caused by S. aureus (methicillin-susceptible and -resistant isolates), S. lugdunensis, S. pyogenes, S. anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and K. pneumoniae.

Concurrently, Paratek announced the availability of 3 FDA-approved antimicrobial susceptibility tests (Hardy Diagnostics’ Omadacycline Susceptibility Disk [HardyDisk], Liofilchem Omadacycline MIC Test Strip, and Thermo Scientific Sensititre MIC Plate) to help guide clinicians toward the appropriate use of Nuzyra, and the KEYSTONE Surveillance Program, which provides access to current antimicrobial surveillance susceptibility data.

Nuzyra is available as 150mg strength tablets in 6-, 14-, and 16-count blisters, and as a 100mg lyophilized powder for IV infusion (after reconstitution and dilution) in single-dose vials.

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For more information call (833) 727-2835 or visit Nuzyra.com.

Omadacycline is noninferior to moxifloxacin for community-acquired bacterial pneumonia and noninferior to linezolid for acute bacterial skin infections.

HealthDay News — Omadacycline is noninferior to moxifloxacin for community-acquired bacterial pneumonia and noninferior to linezolid for acute bacterial skin infections, according to two studies published in the Feb. 7 issue of the New England Journal of Medicine.

Roman Stets, M.D., Ph.D., from the City Clinical Hospital in Zaporizhzhia, Ukraine, and colleagues randomly assigned adults with community-acquired bacterial pneumonia to receive omadacycline (386 patients) or moxifloxacin (388 patients), with a total treatment duration of seven to 14 days. The researchers found that omadacycline was noninferior to moxifloxacin for early clinical response (81.1 and 82.7 percent, respectively; difference, −1.6 percentage points; 95 percent confidence interval, −7.1 to 3.8). Omadacycline was also noninferior for the posttreatment evaluation rates of investigator-assessed clinical response (87.6 and 85.1 percent, respectively; difference, 2.5 percentage points; 95 percent confidence interval, −2.4 to 7.4).

William O’Riordan, M.D., from eStudySite in San Diego, and colleagues randomly assigned adults with acute bacterial skin and skin-structure infections to omadacycline (316 patients) or linezolid (311 patients), with total treatment duration of seven to 14 days. The researchers found that omadacycline was noninferior to linezolid in the modified intention-to-treat analysis with respect to early clinical response (84.8 and 85.5 percent, respectively; difference, −0.7 percentage points; 95 percent confidence interval, −6.3 to 4.9). With respect to investigator-assessed clinical response at the posttreatment evaluation, omadacycline was also noninferior to linezolid (86.1 and 83.6 percent, respectively; difference, 2.5 percentage points; 95 percent confidence interval, −3.2 to 8.2).

“Well designed clinical trials of omadacycline for the treatment of infections caused by multiple-drug-resistant gram-negative pathogens are needed to determine its real value as an antibacterial agent,” write the authors of an accompanying editorial.

Both studies were funded by Paratek, the manufacturer of omadacycline.

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Abstract/Full Text – Stets (subscription or payment may be required)
Abstract/Full Text – O’Riordan (subscription or payment may be required)
Editorial (subscription or payment may be required)

These findings indicate age-specific treatment approaches would likely benefit patients with atopic dermatitis.

Age-specific treatment modalities may be more beneficial for patients with atopic dermatitis (AD) across the life span, according to research that explored changes in the molecular profiles of people with moderate to severe AD. The findings were published in the Journal of Allergy and Clinical Immunology.

Researchers examined age-specific changes in blood and lesional/non-lesional tissues from patients with moderate to severe AD (n=246) and age-matched, healthy controls (n=72) via Singulex, quantitative reverse transcription-polymerase chain reaction, and immunohistochemistry. Participants were categorized into 18-40, 41-60, and 61+ age groups for analysis.

Although disease severity, as measured by SCORing Atopic Dermatitis (SCORAD), was similar across the age groups with AD (mean: ∼60; P =.873), dendritic cell infiltrates (CD1b+, FcεRI+; P <.05) decreased with age. Measures of T_H2 (IL-5, IL-13, CCL13, CCL18, CCL26) decreased significantly with age in participants with AD, but increased with age in controls. T_H22-secreted IL-22 also decreased with age in participants with AD only (P <.05), while T_H1- (IFN-γ, IL-12/23p40, STAT1, CXCL9; P <.05 for CXCL9) and T_H17-related markers (IL-17A, IL-20; P <.05 for IL-20) increased with age in both controls and patients with AD. 

Significant increases in terminal differentiation measures were observed in older participants with AD (LOR, FLG; P <.05), while decreases were observed in hyperplasia markers (epidermal thickness, K16, Ki67; P <.05 for K16) and S100As (S100A8; P <.01). Serum trends among participants with AD mimicked skin findings, with age-related T_H2 downregulation (CCL26; r=-0.32, P <.1) and T_H1 upregulation (IFN-γ; r=0.48, P <.01).

Study investigators concluded that these findings indicate age-specific treatment approaches would likely benefit patients with AD. “Therapeutic targeting with T_H2-, T_H22-, and T_H17/T_H1-specific antagonists are needed in order to understand the varying pathogenic roles of these axes in [atopic dermatitis]. Elucidating the differential patterns of immune skewing and barrier abnormalities among different [atopic dermatitis] phenotypes may be useful for developing personalized treatment approaches, especially in patients with recalcitrant [atopic dermatitis].”

Disclosures: Study authors disclose consulting fees and research funds received from Abbvie, Amgen, Anacor, AnaptysBio, Asana, Aventis, Baxter, BiogenIdec, Boehringer, Celgene, Dermira, Eli Lilly, Glenmark, Galderma, Innovaderm, Janssen, Kadmon, Kyowa, Leo Pharma, Mitsubishi Tanabe, Medimmune/Astra Zeneca, Novartis, Paraxel, Pfizer, Promius, Regeneron, Sanofi, Serono, Stiefel/GlaxoSmithKline, UCB, Vitae, and Xenoport.

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Reference

Zhou L, Leonard A, Pavel AB, et al. Age-specific changes in the molecular phenotype of patients with moderate-to-severe atopic dermatitis [published online January 24, 2019]. J Allergy Clin Immunol. doi: 10.1016/j.jaci.2019.01.015

Data collection included socio-demographic variables, comorbidities, treatment-related clinical events, immunosuppressant usage, concomitant treatment, and more.

Patients with moderate to severe atopic dermatitis using immunosuppressant treatment experience unsatisfactory outcomes, frequently need systemic steroid rescue therapy, and report many associated adverse events, according to a study published in PLoS One.

Researchers in this retrospective cohort study used data from the Truven Health MarketScan database to analyze the impact immunosuppressant treatment has on patients with atopic dermatitis. All patients included in this study had a pre-index baseline period that lasted 6 months and a post-index follow-up period that lasted 12 months. All patients were categorized into either the immunosuppressant arm that included treatments of cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil or a control arm that excluded treatments of systemic immunosuppressants, systemic corticosteroids, or phototherapy. Data collection included socio-demographic variables, comorbidities, treatment-related clinical events, immunosuppressant usage, concomitant treatment, and adjustments in dose or type of immunosuppressant.

The study included 4204 patients using an immunosuppressant to treat atopic dermatitis who were matched with 4201 controls using another form of treatment. During the post-index follow-up period for patients in the immunosuppressant arm, 68.5% were non-persistent, 84.6% received concomitant treatment, 36.3% required dose escalation, 7.6% required additional immunosuppressants, and 2.8% switched immunosuppressants. Significantly more patients in the immunosuppressant arm had immunosuppressant-related clinical events, required hospitalization (P <.0001), required immunosuppressant-related monitoring tests (P <.001), and had higher levels of healthcare resource utilization and associated costs.

Limitations of this study include using medical claim codes as a basis for diagnosis, which could lead to misclassification of patients. Also, using retrospective data means a direct causal relationship cannot be proven.

The researchers concluded that their study “highlights the unmet need for more effective long-term therapies for atopic dermatitis with improved safety profiles and reduced monitoring requirements.”

Disclosures: This study was supported by Sanofi and Regeneron Pharmaceuticals, Inc. Please refer to the reference for a complete list of authors’ disclosures.

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Reference

Armstrong AW, Huang A, Wang L, et al. Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis. PLoS One. 2019; 14(1):e0210517.