Learn more about what treatments are on the rise for plaque psoriasis, the latest management advice and what trends are shaping the future of the disease. 

The changing treatment landscape of plaque psoriasis

POLL: What dermal fillers do you most often inject?

This week’s edition of The Mainstream Patient features stories on sweat reduction, vitamin C serums and sensitive skin, the importance of sebum, plus more.

Study: Depression, Anxiety Reduce Likelihood of Achieving Minimal Disease Activity in PsA Patients

A new study in Arthritis Care & Research found depression and anxiety reduces the possibility of achieving minimal disease activity in patients with psoriatic arthritis.

Biologic Therapy for Psoriasis May Reduce Heart Disease

A study found psoriasis patients treated with biologic therapy had a significant reduction in high-risk plaque in heart arteries over 1 year.

New treatments continue to expand therapy options, but a cure remains elusive.

The Cyberwar Against Health Care Practices

How hackers plan to attack your practice—and what you can do about it.

The Role of Vitamin D in Keloid Scar Treatment

A recent study in the Journal of Cosmetic Dermatology examines the safety and efficacy of using vitamin D intralesional injection for the treatment of keloid scars.

Risankizumab Submitted for Regulatory Approval to FDA, EMA for Psoriatic Arthritis

AbbVie announces the submission of regulatory filings for risankizumab to the FDA and EMA seeking approval for the drug as a treatment for psoriatic arthritis.

Laser Device Purchases Are Guided by Multiple Factors

Determine whether a laser device is a good investment for a specific practice and, if so, how to choose the right piece of equipment.

The Cutaneous Connection: Episode 21- Oxytocin and Skin Aging

In this episode, Nicole Hayre, MD, FAAD, discusses her research on the link between the "love hormone" oxytocin and younger-looking skin.

Baricitinib Shows Hair Regrowth in Phase 3 Study for AA

Eli Lilly and Incyte announce results from its phase 3 study evaluating baricitinib 2 mg and 4 mg for the treatment of alopecia areata, making it the first Phase 3 study with top-line results in patients with the hair disorder.

Emerging Agents Augment Melasma Modalities

An array of agents for blocking visible light and lightening skin are joining the armamentarium to treat melasma. Despite this expanding number of therapeutic interventions, melasma is a chronic, therapeutically challenging disease for which there is no cure, so treatment plans should address both management of the disease and patient expectations.

Phase 2b Trial of Topical Isotretinoin for CI Reaches 50% Enrollment

Timber Pharmaceuticals' phase 2b trial of isotretinoin for congenital ichthyosis (CI) has reached 50% enrollment.

Articles

ICYMI, some of this week’s featured content includes stories on the cyberwar against health care practices, the link between oxytocin and skin aging, baricitinib for alopecia areata, plus more.

Weekly Roundup: April 5-9, 2021

Topical formulation could equal the efficacy of oral isotretinoin with a reduced risk of adverse effects.

Timber Pharmaceuticals has randomized 50% of patients for the Phase 2b CONTROL study (NCT04154293), according to the company’s press release.1 The study will examine the use of TMB-001 (topical isotretinoin) in patients with moderate to severe congenital ichthyosis (CI) and focuses on X-linked ichthyosis and lamellar ichthyosis. Target enrollment is 45 patients aged nine years and older. CI is a group of keratinization disorders that cause dry, thickened and scaling skin. The condition often manifests at birth.

“Oral isotretinoin has been used off-label to treat CI for decades,” says Alan Mendelsohn, MD, EVP and Chief Medical Officer at Timber Pharmaceuticals, Basking Ridge, New Jersey. “It is the only drug that has been shown to be effective through large, well-controlled clinical studies that date back to the early 1980’s. The issue with oral isotretinoin relates to safety - whereas in acne most patients can see a dramatic improvement with a short-term course of treatment at 1mg/kg/day, in CI potentially higher doses with more diffuse application are needed.”

Mendelsohn believes that by delivering adequate concentrations of isotretinoin locally, it will be possible to replicate the documented efficacy of the treatment without the safety issues of oral isotretinoin.

“The mainstays of treatment have been hydration and lubrication of the skin [such as bathing with lubricating oils, lubricating ointments] while also adding agents that are keratinolytic, i.e. temporarily remove the thickened skin [such as salicylic acid, propylene glycol, urea]. These treatments, however, relieve symptoms but do not treat the underlying conditions of increased keratinization of the skin,” says Mendelsohn.

The study’s ability to attract participants reflects the need for treatment options, he notes. Due to the coronavirus disease 2019 (COVID-19) pandemic, travel to study sites was complicated. “By introducing telemedicine and at-home photography, patients already enrolled could at least be examined remotely for changes in their skin,” says Mendelsohn.

He anticipates reviewing a full data set internally in the third quarter of 2021, with a conference with the FDA late in the fourth quarter to discuss moving on to a full phase 3 trial if results so warrant.

1. Timber Pharmaceuticals Announces 50% Enrollment in Phase 2b CONTROL Study in Congenital Ichthyosis. Timber Pharmaceuticals. 

https://www.newmediawire.com/news/timber-pharmaceuticals-announces-50-enrollment-in-phase-2b-control-study-in-congenital-ichthyosis-5216441

Timber Pharmaceuticals's phase 2b trial of isotretinoin for congenital ichthyosis (CI) has reached 50% enrollment.

New treatment modalities and novel compounds are expanding the armamentarium for managing melasma and preventing relapse, said Pearl E Grimes, MD, in her update on this challenging skin disease at Maui Derm 2021.

®’ editorial advisory board member, is the director of The Grimes Center for Medical and Aesthetic Dermatology, director of the Vitiligo and Pigmentation Institute of Southern California, and clinical professor of dermatology at the David Geffen School of Medicine at UCLA, all in Los Angeles.

Her presentation highlighted new solutions to optimize melasma management and identified cautions that could negatively impact outcomes.

Photoprotection from ultraviolet light has been a long-standing element in the melasma management algorithm. However, findings from recent studies indicating that visible light is also a trigger for the pathogenic pathway have spurred research showing the benefits of photoprotection strategies using iron oxide sunscreens that block visible light, Grimes noted.

“Using these modalities in our practice, we are seeing they have a significant positive impact in patients with melasma,” Grimes said. “Oral 

 extract has also been investigated as a novel photoprotective agent in melasma. Recent data suggest that [it] also blocks visible light, and it has shown benefit as an adjunctive modality for melasma patients in several randomized studies.”

Current evidence from histological studies suggesting that melasma likely represents a phenotype of photodamage carries implications for long-term management, Grimes noted.

In addition to photoprotection, topical lighteners have a cornerstone role in managing melasma. Most lighteners used currently act via tyrosinase inhibition. Hydroquinone has been the major workhorse in this category for 60 years. However, new and emerging agents are showing substantially greater efficacy, according to Grimes.

Newer options for treating hyperpigmentation include cysteamine, methimazole, silymarin, tranexamic acid (TA), glutathione, melatonin, and new combination formulations. Most of these agents also inhibit tyrosinase activity, but some have different or multimodal mechanisms of action and have been used with varying routes of administration, Grimes said.

TA is one example. This antifibrinolytic agent suppresses angiogenesis, mast cells, and arachidonic release. It has been used orally, topically, and intralesionally with good results, she said. However, Grimes pointed out some concerns with TA—including an almost-universal risk for relapse after treatment is stopped and a risk for inducing thromboembolic phenomena.

“Although thromboembolic events are uncommon or rare in studies investigating TA for dermatologic conditions, patients should be screened for thromboembolic risk factors,” she advised.

Procedural interventions are strategic partners in the multimodality approach for melasma.

Chemical peels are part of the armamentarium for treating melasma as a second-line regimen, and superficial peels are preferred for treating melasma in darker-skinned patients.

“Findings from a meta-analysis showed that for patients with Fitzpatrick phototypes IV to VI, increasing the depth of the peel also increases the risk of more [adverse] effects or deleterious outcomes,” Grimes said.

Maximizing outcomes with peels requires a combination approach, in which a topical lightener is used for 2 to 4 weeks preceding the peel and between procedures, she said, adding that in her opinion, the daily regimen is key to achieving best-possible results.

Grimes pointed out that multiple recent studies also show that microneedling can have a role in melasma treatment when used in combination with a topical lightening agent. But there are certain caveats.

“In my experience, it is essential to have patients on a daily topical lightening agent when using microneedling. Without it, there is a significant risk for development of postinflammatory hyperpigmentation,” Grimes said.

Light-based treatments using lasers or intense pulsed light (IPL) sources may target deeper pigmentation along with a vascular component of melasma that is much more prominent than previously thought.

“Very tiny telangiectasia can often be seen when closely examining patches of melasma,” said Grimes. “Although these vessels were once considered a result of what patients had used for treatment, they are now known to be part of the melasma spectrum.”

Only fractional 1550/1540 nm nonablative lasers are approved by the FDA for treating melasma. However, treatment with a low-fluence Q-switched Nd:YAG laser may be the best option for refractory cases of melasma, according to Grimes. Excellent results can also be achieved using IPL sources in Fitzpatrick skin types II, III, and sometimes IV, she added.

However, because of the risk for significant complications, IPL should be used with extreme caution in darker-skinned patients. “The Q-switched ruby and erbium:YAG lasers are best avoided completely,” she said.

Despite the expanding number of therapeutic interventions, the fact remains that melasma is a chronic and therapeutically challenging disease for which there is no cure. Moreover, relapses are almost universal, said Grimes. Therefore, establishing realistic expectations for outcomes remains a critical aspect of the therapeutic consultation.

“Whereas we can cure postinflammatory hyperpigmentation of the face often caused by acne by treating the inciting condition, it is essential to articulate to patients with melasma that their pigmentary disorder requires long-term management,” Grimes said. “Meanwhile, we continue to have hope that the quest to find new therapies for this psychologically devastating condition will lead to options that are more durably efficacious.”

Grimes has conducted clinical research and/or served as a consultant for Procter & Gamble, Clinuvel Pharmaceuticals Ltd, L’Oréal, Johnson & Johnson, LaserOptek, VT Technologies, Incyte, Pfizer Inc, and DermaForce.

1. Grimes PE. Update 2021: disorders of pigmentation. Presented at: Maui Derm Live In-Person Dermatology CME Conference and Maui Derm Connect Virtual Dermatology CME Conference; January 25-29, 2021; Maui, Hawaii; virtual.

Eli Lilly and Company and Incyte Corporation announced positive results from its phase 3 study evaluating the safety and efficacy of baricitinib (Olumiant) 2 mg and 4 mg in adult patients with severe alopecia areata (AA).

"For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair," said Lotus Mallbris, MD, PhD, vice president of immunology development at Eli Lilly. "We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata."

Baricitinib is a once-daily, oral JAK inhibitor approved in the United States and over 70 countries as treatment for adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The medication was also recently approved in the European Union and Japan for the treatment of moderate to severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy, according to a press release.

Most recently, the FDA granted baricitinib Breakthrough Therapy designation for the treatment of AA.

 Currently, there are no FDA-approved treatments for AA.

The study (BRAVE-AA2), is a multicenter, randomized, double-blind, placebo-controlled study enrolled 546 adults with a Severity of Alopecia Tool (SALT) score ≥ 50 and a current episode of severe AA lasting at least 6 months but no more than 8 years. The patient population included participants from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S.

Investigators evaluated the safety and efficacy of baricitinib 2 mg and 4 mg in study patients. Both doses met the primary efficacy endpoint of demonstrating a statistically significant improvement in scalp hair regrowth compared to placebo at Week 36.

The safety profile of baricitinib in BRAVE-AA2 was consistent with previous safety profiles in patients with RA and AD. The study reported no deaths, major adverse cardiovascular events (MACE), or venous thromboembolic events (VTEs).

According to the release, BRAVE-AA2 is the first Phase 3 study with top-line results in patients with AA.

"These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata," said Brett King, MD, PhD, associate professor of dermatology at Yale School of Medicine. "This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease."

Additional data from BRAVE-AA2 will be available in the first half of 2021, with detailed results from the BRAVE program expected to be presented at a future medical conference, as well as published in a peer-reviewed journal.

"Significant unmet need exists in the treatment of alopecia areata," said Abby Ellison, research director at the National Alopecia Areata Foundation (NAAF). "We appreciate Lilly's important work in this area and are excited that these data could bring us closer to a potential new treatment option for patients."

1. Baricitinib is first jak-inhibitor to demonstrate hair regrowth in phase 3 alopecia areata (Aa) trial | Eli Lilly and company. Accessed April 9, 2021. https://investor.lilly.com/news-releases/news-release-details/baricitinib-first-jak-inhibitor-demonstrate-hair-regrowth-phase

Podcasts

Buying laser equipment can be a good way to diversify a practice’s income streams, but like any major investment for a practice, detailed research is key. In a presentation at the virtual ODAC Dermatology, Aesthetic & Surgical Conference,

 Nazanin Saedi, MD, assistant professor at Thomas Jefferson University and director of the Jefferson Laser Surgery and Cosmetic Dermatology Center in Philadelphia, Pennsylvania, detailed best practices for understanding the local market, weighing the financial impact of such a purchase, and gauging patient interest in laser procedures.

According to a 2019 study by the American Society for Dermatologic Surgery on laser/light device procedures that year, the most common laser, light, and energy-based procedures were for sun damage and wrinkles. The remainder of the 4.1 million total procedures were, in descending order of popularity, for facial redness, laser hair removal, melasma/brown patches, acne, scars, tattoo removal, and birthmarks. Approximately 90% of aesthetic patients aim to improve texture abnormalities, pigmentation problems, or vascular conditions.

These are the macro trends affecting dermatology across the specialty. A given practice’s patient population will likely vary to some degree from that overarching data. A look at the demographics of that population, including age and gender, may provide some guidance. Obtain more detailed information by adding questions or creating a questionnaire to include in patients’ paperwork indicating possible interest in cosmetic procedures, which ones, and prior treatment history. This helps identify patients’ main areas of concern, such as wrinkles, pigmentation, vessels, or excessive hair.

Perform due diligence on competitors offering similar services, including MediSpas and aesthetic and cosmetic physicians. If there is an opening in the local market, the most important differentiator is expertise. Dermatologists need to perfect their skills with any new equipment. Staff should also be well-informed about the new services offered so that they can inform patients about what to expect and potential benefits/risks.

Take the time to analyze approximate patient demand, office space required, schedule availability, overhead costs, and time and money spent on staff training. This helps identify possible devices that are a good fit for the practice’s needs.

Gauge overhead and profit margin, and determine a break-even point. It is also crucial to compare devices and calculate the amount of profit per unit of time. Buy only one device at a time; don’t purchase another device until a profit is achieved on the first one.

Beware of hidden costs for devices—consumables, maintenance, follow-up visits (which count as lost revenue), and service contracts that can be up to $10,000 per year.

It is also important to understand financing options, including buying, renting, leasing, or purchasing a used device. When renting devices, the lasers are usually not the latest ones on the market; however, renting can help you determine if you have enough demand to actually purchase the item. Leasing is typically more expensive, but it may make more financial sense as the technology continues to change. Used devices may be tricky because there are many counterfeit items. Reliability and quality also may be an issue with used devices, and service contracts for used devices might be a challenge to negotiate or decipher.

Other considerations include treatment time (if it is, indeed, worth your time), possible need for additional staff, availability of extra space, need for multiple treatments, and potential ability to delegate treatments.

When deciding which device to buy, it is important to review the data, watch multiple demonstrations to get a feel for the device, and speak with colleagues about nuances, patient experiences, and real-life complications.

In addition, be sure to purchase a device that has a good track record and places safety first.

Saedi reported no relevant or financial disclosures.

1. Saedi N. Selecting the best devices when starting out. Presented at: ODAC Dermatology, Aesthetic & Surgical Conference; January 14-17, 2021; virtual. Accessed March 12, 2021. 2. 

https://www.asds.net/Portals/0/Images/body-procedures-survey-results-infographic-2019.jpg

AbbVie Inc. announced the application submissions for regulatory approval of risankizumab (Skyrizi, AbbVie) to the FDA and EMA for the treatment of psoriatic arthritis (PsA) in adults, according to a press release announcing the filings.

Risankizumab, an interleukin (IL)-23 inhibitor that works by binding to the p19 subunit of IL-23, is thought to be associated with various chronic immune-mediated diseases such as psoriasis.

Most recently, risankizumab 150 mg was FDA-approved in April 2019 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.

 The approved dose of 150 mg consists of two 75 mg subcutaneous injections administered at week 0,4 and then subsequently every 12 weeks.

The filings are supported by positive data from two phase 3 trials (KEEPsAKE-1, NCT03675308; KEEPsAKE-2, NCT03671148). Both trials are multicenter, double-blind, randomized, placebo-controlled and investigating the efficacy and safety of risankizumab in adult patients with active PsA.

KEEPsAKE-1 observed risankizumab in PsA patients who had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD). Meanwhile, KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs.

Both studies had a primary endpoint of achievement of an American college of Rheumatology (ACR) 20 response at week 24. Secondary endpoints included a change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI), and of achievement of a Psoriasis Area and Severity Index (PASI) score of 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, with the long-term extension remaining blinded to investigate the long-term safety, tolerability, and efficacy of risankizumab in patients who have completed the placebo-controlled period.

Results of the studies showed risankizumab demonstrated significant improvements in disease, skin clearance, and physical function at week 24 when compared to placebo.1 Significantly more patients treated with risankizumab achieved the primary endpoint of ACR20 response at week 24 vs placebo in both studies.

Additionally, the safety profile of risankizumab in the studies was consistent with the safety profile of risankizumab in plaque psoriasis, with no new safety risks observed, according to the release.

"Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome,” said Michael Severino, MD, vice chairman and president of AbbVie. “Despite advancements, many patients cannot find relief from the signs and symptoms of this disease. We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

Risankizumab is currently undergoing various phase 3 trials investigating the drug as a treatment for psoriasis, Crohn's disease, ulcerative colitis and PsA.

1. Abbvie submits regulatory applications for skyrizi® (Risankizumab) in psoriatic arthritis to fda and ema. AbbVie Inc. Accessed April 7, 2021. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-for-skyrizi-risankizumab-in-psoriatic-arthritis-to-fda-and-ema-301264138.html

Risankizumab Submitted for Regulatory Approval to FDA, EMA for Psoriatic Arthritis  

Treating keloid scars continue to be a particular challenge for dermatologists due to the scars oversized nature, continued growth, and difficult treatment. 

While intralesional corticosteroid injection is considered first-line treatment for keloids, a recent study in the Journal of Cosmetic Dermatology1 (JCD) examined vitamin D efficacy treating keloids using intralesional injection. Vitamin D slows the progression of tissue fibrosis by keloid fibroblasts and inhibits collagen synthesis in dermal fibrosis, according to the study, making the vitamin a key player in cell proliferation and differentiation.

The study, which evaluated the efficacy of intralesional injection of vitamin D in the treatment of keloids, both clinically and ultrasonically, included 40 patients with keloids. Patients were injected weekly with intralesional vitamin D at a dose of 0.2 ml (200,000 IU) per 1 cm lesion

The keloid scars were evaluated before and after treatment with the Vancouver Scar Scale (VSS) and by a high-resolution ultrasound using B mode. Study patients received 3 to 4 sessions.

Results showed a statistically significant reduction in VSS after treatment with the vitamin injection (p value ≤0.001) along with a highly significant improvement in ultrasonic keloid scar thickness post-treatment (P value ≤0.001). From this data, study investigators concluded that intralesional vitamin D is a safe and effective treatment of keloid scares. Additionally, ultrasound is useful in assessing keloid improvement after treatment.

1. Mamdouh M, Omar GA, Hafiz HSA, Ali SM. Role of vitamin D in treatment of keloid. J Cosmet Dermatol. Published online March 26, 2021:jocd.14070. doi: 10.1111/jocd.14070

A recent study in the Journal of Cosmetic Dermatology examines the safety and efficacy of using vitamin D intralesional injection for the treatment of keloid scars.  

The Role of Vitamin D in Keloid Scar Treatment 

While physicians worked to keep their practices financially afloat and dealt with the coronavirus disease 2019 (COVID-19) pandemic, hackers kept busy too.

From January 2020 to October 2020, there were 730 publicly disclosed security breaches with more than 22 billion records exposed.1 Health care made up 25% of those breaches with nearly 8 million records exposed. Ransomware was by far the most popular attack method in 2020, making up 46% of the breaches.

“The success that cybercriminals had in 2020 extorting sizable payouts from medical practices of all sizes ensures that ransomware will indeed remain the top cybersecurity threat in 2021,” says Dave Martin, vice president of extended detection and response at cybersecurity firm Open Systems. “Ransoms like the $670,000 paid by University Hospital [in] New Jersey last September only encourage further attacks. And while larger institutions can clearly pay bigger ransoms, cybercriminals do not overlook smaller practices, which can be tempting targets of opportunity—particularly those with lax security.”

With health care workers focused on the pandemic response, experts say hackers are taking advantage and ramping up their attacks, so it is vital that practices of all sizes be more vigilant than ever about cybersecurity. Ransomware—malware that encrypts a practice’s data and demands a fee to unlock the encryption—is entering a new phase that makes a security breach even more costly, says Gary Salman, CEO of Black Talon Security, LLC, a cyber defense firm for medical professionals.

“Now doctors are seeing 2 ransom notes,” Salman says. “The first ransom note says, ‘I’ve locked all your data; if you want [them] back, pay me $50,000.’ The second note says, ‘And by the way, maybe you have a good backup, but guess what. I have all your data and if you don’t pay me an additional $50,000, I’m going to publish all your data.’” Salman says sites on the dark web are run by these threat groups, and data from doctors’ offices show patient information, including photographs, health history forms, and other private details.

Many of these hacker groups operate as businesses and can be very sophisticated, says Matt Ferrante, market leader of Cyber and Information Security Services at the advisory and accounting firm Withum. “They sometimes know exactly what your cyber insurance policy is, and they know what’s going to potentially be covered under the policy,” Ferrante says. “And if they don’t know, they’ve often already done the intelligence on your business, and they know what it’s worth.”

If a practice experiences a ransomware attack, Matt Reid, senior health information technology (IT) consultant with the American Medical Association, says to take 2 actions immediately: Contact the FBI and the practice’s IT vendor. “Federal agencies have resources that can support medical practices during a ransomware attack—and that’s clearly an important component—but also work with your health IT vendor or internal IT support staff to try to partition off the segment of the network that has ransomware as fast as possible,” Reid advises.

Martin says that all compromised devices, including desktop PCs, laptops, and smartphones should be disconnected from the network by unplugging ethernet cables, disabling Wi-Fi networks, and switching to airplane mode.

If a practice has cyber insurance, Ferrante recommends contacting the provider and ensuring all requirements are met. This may involve an assessment of the attack. “If it’s not independently assessed, it may not be covered under the cyber insurance policy,” he says.

Although some experts advise never paying a ransom to regain access to data because doing so just encourages more attacks, that is often more idealistic than practical. “What we find in almost 100% of the cases is that the doctor has to pay because the threat actors are very sophisticated nowadays, and they will find all the backups,” Salman says. “Many of these doctors have their data being backed up [in] the cloud, and with a majority of the attacks that we’re dealing with right now, the hackers have figured out how to get into the doctor’s cloud backup and destroyed [it].”

Physicians often have a false sense of security when it comes to cloud storage. “We see that a lot of people are either in the cloud or they’re moving to the cloud,” Ferrante says. “Cloud simply means somebody else’s computer. Just because Amazon and Microsoft are secure doesn’t automatically translate to you being secure or your organization being secure. It has to be secured appropriately within those environments.”

During a ransomware attack, hackers will also encrypt the server and all workstations, so when the doctors attempt to recover their data from their backups, the data are not there. “So as a practitioner, you’re basically put into a situation where you have no choice; you have to pay the ransom, because under the HIPAA [Health Insurance Portability and Accountability Act] laws, the patients’ data [have] to be available,” Salman says.

In most cases, paying the ransom results in the data being released because if the hackers don’t turn over the data, victims won’t pay any more. The more sophisticated players have customer support lines and will offer to fix any data corrupted from their software, Salman says. “They literally have testimonials on their website encouraging you to pay because these people were victims and they got their data back, so ‘You should pay me too because you’ll get your data back,’” he says.

Following a breach, practices will often go on a cybersecurity shopping spree, buying all kinds of software to prevent it from happening again, but Ferrante says that’s usually not effective. “It has to be applied the right way, and you really need the expertise to make sure that it’s scalable and set up correctly,” he explains. “Otherwise, it’s not going to function properly.”

New threats to defend against ransomware may constitute the biggest threat to most practices, but it is far from the only one. As regulators require more patient access to data, payers interchange more data with providers and services like telehealth grow in popularity.

Experts in the cybersecurity field often recommend a practice conduct a cybersecurity assessment. This will look at all the organization’s digital entry points, and then the cybersecurity firm will do a penetration test, “simulating” hackers and looking for weak points.

“It’s not just about data loss. It’s about also potentially being able, like a hacker would do, to cripple an organization,” Ferrante says. “Data shows that about 70% to 75% of backups fail during a critical incident.”

He says that many practices don’t do an assessment because they think they are cost prohibitive for smaller organizations. “This sounds like kind of an expensive prospect to have all this done, but it’s not because it’s scalable and really depends on the size of your footprint.”

A small practice might have an assessment done for $1000, which is far less than the cost of the average breach. Ferrante says assessments should be done by true cybersecurity experts, not just a general IT firm. Just like in medicine, there are general practitioners and specialists, and cybersecurity requires specialization to be done right. In most cases, experts say an assessment can be done remotely, and when complete, the practice is provided a list of vulnerabilities it can address as money allows.

“What medical practices should be doing is asking their IT companies who’s protecting them,” Salman advises. “If hackers break into the IT company and attack the practice, there’s probably nothing that practice can do to defend themselves against that. Ask them if they are being independently audited on a monthly basis by a dedicated cybersecurity firm. If the answer is no, they need to understand why.”

IT vendors also have many employees working from home, and practices need to know how they are being protected as well. “These are the people who have credentials to your environment,” Ferrante says. If their security is lax, hackers can gain access to a physician’s network by breaching an IT worker’s home computer.

Ferrante adds that a cybersecurity expert should conduct a full assessment of a practice’s vulnerabilities, particularly because of the number of devices utilizing the network during the COVID-19 pandemic.

For practices working with local hospital systems, Reid recommends checking with them about receiving donated cybersecurity services. Thanks to changes in the Physician Self-Referral Law, also known as Stark Law, hospitals and health systems can now legally offer expertise and assistance to medical practices to help protect patient data.

As practices start to transition back to the office, Reid says it is important to remember to change network access. To support home workers, extra access may have been granted to IT vendors, electronic health record providers, consultants, or support staff who no longer need it. Also, office computers that have sat dormant for months need checked to make sure they have been patched with the most current operating system and security updates.

One of the best things a practice can do is budget for cybersecurity, Salman says. “This isn’t 2017, when the risks were a lot lower than they are now,” he says. “[Practices] have to implement cybersecurity solutions from a specialty company, not just their IT vendor.” Preventing a breach in the first place with proper security is far cheaper than dealing with the business disruption and ransom payment, he adds.

Practices also shouldn’t rely solely on cyber insurance. Ferrante says that after a major data breach, a policy may not provide enough money to cover all the expenses and can’t do anything to repair the practice’s reputation.

But above all, a practice always should make sure it has the basics in place, such as antivirus software and firewalls. “There are a lot of simple things that can be done to improve your protection, minimize the severity of an attack, and ensure a speedy recovery,” Martin says. “First off, you need to routinely back up your files to a device that is not connected to the network. This is important because the latest ransomware tools, such as Ryuk, actively seek and delete backups on devices attached to the network. These secure backups will be key to your restoration efforts.”

Avoiding common password mistakes is another way to dramatically improve your practice’s security posture. They should be at least 8 characters long and consist of a mix of letters, numbers, and symbols; be changed regularly; and not reused. Also, be sure to change any default passwords on any devices, Martin says.

“Lastly,” Martin advises, “be sure to continually remind yourself and your employees to never click on an even remotely questionable link, regardless of who the sender is.”

1. Quinlan R. Healthcare security: ransomware plays a prominent role in COVID-19 era breaches. Tenable. March 10, 2021. Accessed March 11, 2021. https://www.tenable.com/blog/healthcare-security-ransomware-plays-a-prominent-role-in-covid-19-era-breaches

The National Rosacea Society (NRS) reports that although patients with rosacea have access to more treatment options than ever before and management plans tailored to their individual profiles, “many people are still intreated or using therapies that may not be optimally suited for their individual cases.”

As a result, NRS designated April as Rosacea Awareness Month “to educate the public on this potentially serious disorder estimated to affect more than 16 million Americans and to urge those who suspect they may have it to see a dermatologist for the most up-to-date plan for effective therapy.”

 Richard Gallo, MD, PhD, discusses the modalities and management strategies that are improving outcomes for this challenging skin disease. Gallo is the Irma Gigli Distinguished Professor and chairman of the Department of Dermatology at the University of California San Diego School of Medicine, an NRS trustee, and a member of the 

Q: What’s the biggest hurdle between advances in rosacea treatment/management and cure?

Gallo: That depends in part on what one would consider as “cure.” If you consider cure to mean adequate treatment of all the phenotypes and symptoms, then we’re getting closer and closer. For some patients, we could achieve that now. If you consider cure the absence of recurrence of the phenotype, without any type of treatment, I think we’re still 5 to 10 years away.

Gallo: As an investigator who’s been involved in rosacea research for over 2 decades, I believe there’s a lot more opportunity to improve treatment for this disease, particularly figuring out strategies to inhibit the trigger and treating the redness associated with rotation.

Q: NRS predicts continued growth in rosacea cases, and research projects the rosacea treatment industry will be worth $2.6 billion by 2025.2 What’s driving that?

Gallo: It’s growing on the back of rising incidence of disease, an aging population, and unhealthy eating habits. But environmental exposure and lack of recognition of the disease also [play a big role]. The NRS and other resources have ongoing initiatives to raise awareness, but there’s a lot more to do.

Q: Are people with skin of color affecting those increases?

Gallo: Yes, dark-skinned patients, Black [people], and other patient populations with Fitzpatrick scores of IV to VI [rosacea has been very much underdiagnosed in], primarily because of an inability of many dermatologists to detect the erythema associated with rosacea on skin of color. One of the biggest things we can do is increase awareness among dermatologists and improve training in residency programs to address that.

Q: With all the concerns about accessibility and affordability, what can dermatologists do to match the right drug with the right patient?

Gallo: Drugs get on formulary partly based on cost of course—OK, largely based on costs—but also based on hard data for the pharmacists on the formulary committee to assess the efficacy of different drugs. There needs to be increased support for research that clearly defines the benefits of alternative treatments, indicates to the people making the decision which drugs to include, defines what goes on in formulary, and identifies what different combinations of drugs need to be available for adequate treatment. That is all essential for the best care of rosacea sufferers.

Q: Will coronavirus disease 2019 (COVID-19) have a lingering impact on rosacea, including limiting research funding and the ability to conduct in vivo studies?

Gallo: The necessary restrictions put in place to limit the pandemic greatly interfered with both laboratory-based and clinical trials. So COVID-19 has had a pretty significant impact on the scientific community. Governmental priorities for spending on medical research have shifted somewhat to those aligned with COVID-19— which, of course, I believe is appropriate. But on the other hand, perhaps this situation helps increase the general public’s recognition of the importance of medical research. There may be some opportunities there. Mask wearing is a big issue. It’s quite likely that we’ll see the general population wearing masks more frequently for a long time. Masks and the change in facial environment that masks induce [are] likely to be recognized increasingly as a trigger for rosacea.

Q: Many of NRS educational materials focus on diagnostic guidelines as well as treatment and management. what are some factors that may be overlooked?

Gallo: It’s not uncommon for a dermatologist to interact with a rosacea sufferer who’s had prior experience with chronic use of high- dose antibiotics and, of course, the use of such high-dose antibiotics promotes antibiotic resistance. One of the important things to explain to patients is that rosacea is not an infectious disease. We’re not attempting to eliminate all the bacteria or other organisms, such as mites that live on the skin. These are a natural part of the skin microenvironment. The treatment for rosacea aims to decrease the ability of that environment to trigger rosacea. That can be a little bit different for each person. Patients need to understand that a trial-and-error approach is necessary.

Q: NRS is conducting a survey on the impact of rosacea on social situations.3 what tips do you have for helping patients address this concern?

Gallo: Community forums and organizations such as NRS have been really, really important in helping patients when they get the diagnosis of rosacea to connect with other people who have this skin disease. One of the most important aspects of treating patients with rosacea is to let them know they’re not alone and to acknowledge that the impact on their well-being can be quite dramatic. Videoconferencing has, perhaps, exacerbated the situation. People are expected to be seen very close up in their computer monitor. In many cases, that amplifies the redness of rosacea, the papules, and the pustules. That’s not just potentially embarrassing; it can interfere with performing a critical part of their occupations.

Q: What will be the biggest headlines about rosacea in 2021?

Gallo: I don’t have a crystal ball, but I wish I knew. My dream would be that a cure for rosacea would be discovered, but I don’t think that’s going to happen. I do think we’ll see a number of new treatment options.

Gallo reported no relevant or financial disclosures.

1. Rosacea awareness month to highlight broad range of treatment options. News release. National Rosacea Society. February 2021. Accessed
March 13, 2021. https://www.rosacea.org/press/2021/february/ rosacea-awareness-month-to-highlight-broad-range-of-treatment-options

2. Rosacea treatment market worth $2.6 billion by 2025 |CAGR 6.8%. News release. Grand View Research. January 2019. Accessed March 20, 2021. https:// www.grandviewresearch.com/press-release/global-rosacea-treatment-market

3. The impact of rosacea on social situations. National Rosacea Society. Accessed March 20, 2021. https://www.surveymonkey.com/r/9L57Q3P

2021 Rosacea Report

Patients with psoriasis treated with biologic therapy, which are protein-based infusions to suppress inflammation, had a significant reduction in high-risk plaque in heart arteries over 1 year, according to new research published in 

Chronic inflammation in people with psoriasis is associated with a higher risk of developing coronary artery disease. Further, biologic therapy medications are proteins that are given by injection or infusion and suppress the inflammation process by blocking the action of cytokines, which are proteins that promote systemic inflammation, according to the study authors.

Previous research has shown a clear link between psoriasis and the development of high-risk coronary plaque. However, the current study provides characterization of a lipid-rich necrotic core, a dangerous type of coronary plaque made up of dead cells and cell debris that is prone to rupture, which can lead to a heart attack or stroke.

“Having inflamed plaque that is prone to rupture increases the risk of heart attack five-fold within 10 years,” said study senior author Nehal N. Mehta, MD, MSCE, FAHA, in a press release.

The analysis involved 209 middle-aged patients, between 37 and 62 years of age, with psoriasis and who participated in the Psoriasis Atherosclerosis Cardiometabolic Initiative at the National Institutes of Health. Of these participants, 124 patients received biologic therapy and 85 patients in the control group were treated only with topical creams and light therapy, according to the study authors.

The researchers performed cardiac computed tomography scans on all study participants before they started therapy and 1 year later to measure the effects of biologic therapy on arteries of the heart.

At the start of the study, participants with psoriasis had low cardiovascular risk by conventional cardiovascular risk scores. Severe psoriasis was associated with higher body mass index, high-sensitivity C-reactive protein, and higher levels of coronary artery plaque.

After 1 year of treatment, patients who received biologic therapy were compared with the control group. Researchers found biologic therapy was associated with an 8% reduction in coronary plaque. In contrast, those in the control group experienced slightly increased coronary plaque progression, according to the study authors.

Even after adjusting for cardiovascular risk factors and psoriasis severity, patients treated with biologic therapy had reduced coronary plaque.

“There is approximately 6%-8% reduction in coronary plaque following therapy with statins,” Mehta said in a press release. “Similarly, our treatment with biologic therapy reduced coronary plaque by the same amount after one year. These findings suggest that biologic therapy to treat psoriasis may be just as beneficial as statin therapy on heart arteries.”

The study did have implications for people with psoriasis and possibly for those with other chronic inflammatory conditions, such as HIV, lupus, and rheumatoid arthritis, who also have increased risk of heart disease, according to the authors.

“We have never before been able to show healing of an inflamed plaque like this in humans. Biologic therapy reduces systemic inflammation and immune activation, and it has a favorable impact on improving overall vascular health,” Mehta said in a press release. “Imagine if we can treat both psoriasis and coronary heart disease with one therapy—that is the question to be asked in future studies.”

The findings of the study should be interpreted with caution because it was limited by a short follow-up period and a relatively small number of patients, according to the authors. Future studies should involve larger, randomized controlled studies to better understand how changes in coronary plaque may lead to a reduction in heart attacks and strokes in people with psoriasis, according to the study authors.

This article originally appeared on our sister publication 

1. Biologic therapy for psoriasis may reduce heart disease. American Heart Association. 

https://newsroom.heart.org/news/biologic-therapy-for-psoriasis-may-reduce-heart-disease#:~:text=DALLAS%2C%20September%2015%2C%202020%20%E2%80%94,Circulation%3A%20Cardiovascular%20Imaging%2C%20an%20American

. Published September 15, 2020. Accessed January 7, 2021.

found anxiety and depression symptoms reduced the possibility of achieving sustained minimal disease activity in psoriatic arthritis (PsA).

“The number of comorbidities may be variable in PsA patients, but around 50% of patients are afflicted by at least one comorbidity,” the study investigators wrote. “Anxiety and depression are important comorbidities that have hitherto been less addressed. Emotional well-being is now strongly recommended to be included in the updated PsA Core Domain Set for randomized controlled trials and longitudinal observational studies.”

“Both depression and anxiety were identified as key domains of health when developing the PsA impact of disease [PsAID] questionnaire, a questionnaire that is used to calculate a score reflecting the impact of PsA from the patients’ perspective,” they stated. “In clinical practice, one aims to treat disease to attain a state of minimal disease activity [MDA] or, ideally, remission to improve long-term outcomes. Coates et al have defined criteria for MDA in PsA. Currently, there are few publications reporting the relationship between mental health and achieving MDA.”

In order to determine if there was a link between depression and anxiety and achieving sustained minimal disease activity in PsA, investigators observed 743 adult patients at the University of Toronto Psoriatic Arthritis from 2008 to 2017.

Depression or anxiety were defined as a 38 or lower on the Mental Component Summary score of the SF‐36 questionnaire, 56 or lower on the Mental Health sub‐scale score, or a diagnosis or treatment for either anxiety or depression from a rheumatologist.

The number of study participants that had anxiety or depression was 331 based on the first definition, 364 based on the second, and 211 based on the third.

Study results showed 45.36% (337) participants failed to achieve sustained MDA. Also, both depression and anxiety were found to be linked to a decreased possibility of achieving sustained MDA,with ORs of 0.3 (P < .0001), 0.34 (P < .0001) and 0.47 (P < .0001) based on the 3 definitions, respectively.

Additionally, other factors associated with a decreased likelihood of achieving sustained MDA were the Charlson comorbidity index and the presence of fibromyalgia.

“We demonstrate that the presence of depression/anxiety, regardless of the method used to define it, is associated with a lower probability of achieving sustained MDA in PsA patients,” the study investigators concluded, “Comprehensive management of PsA should therefore include measures for addressing anxiety and depression so that more patients achieve a state of MDA.”

1. Wong A, Ye JY, Cook RJ, Gladman DD, Chandran V. Depression and anxiety reduce the probability of achieving a state of sustained minimal disease activity in patients with psoriatic arthritis. Arthritis Care & Research. n/a(n/a). doi:https://doi.org/10.1002/acr.24593

Study: Depression, Anxiety Reduce Likelihood of Achieving Minimal Disease Activity in PsA Patients 

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