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

Dr. Goldberg is Director of Skin Laser & Surgery Specialists of New York and New Jersey, Director of Mohs Surgery and laser research, Mt. Sinai School of Medicine, and Adjunct Professor of Law, Fordham Law School.

Dr Shot is a leading dermatologist in his community and is known for his expertise in cutaneous infectious diseases. He has a private dermatology practice and is on staff at several local hospitals and a nearby major university dermatology residency program. He is considering setting up his office to provide COVID-19 vaccines.

David J. Goldberg, MD, JD, director of Skin Laser & Surgery Specialists of New York and New Jersey, past director of Mohs and laser research at Icahn School of Medicine at Mount Sinai, and adjunct professor of law at Fordham University School of Law in New York, New York.

Shot also has a rigorous Occupational Health and Safety Administration program in his office. Some of his staff have already received their vaccines in other facilities. However, many of his unvaccinated staff members are under age 30 years and are increasingly concerned about the risk of infection in younger people. They ask him to administer their COVID-19 vaccinations.

He understands their concerns about potential exposure but is equally concerned about what his liability will be if they have an adverse reaction to his administration of their vaccinations. Shot is well aware that 1 of the vaccines, (Comirnaty; Pfizer-BioNTech) now has full FDA approval. He knows that the US government and many states now mandate that certain groups be vaccinated. Will that protect him from his staff suing him?

A close parallel to Shot’s issue occurred almost 20 years ago when the White House announced its smallpox vaccination plan. The first people to be vaccinated would be 500,000 military personnel, then health care workers, and finally, in 2004, the vaccine would be made available to the public at large. The original plan was to start immunizing health care workers by December 15, 2002. The “immunity provisions” of the Homeland Security Act would be there to provide some immunity (against possible lawsuits) for those administering the vaccine—the program was halted early, in 2003.

Section 304 of the Homeland Security Act provides immunity for “covered per- son(s) deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox.” The act defines person to include health care institutions. Deeming health care providers of the smallpox vaccine to be de facto employees of the public health service means that any claims for their negligence must be filed against the federal government under the Federal Tort Claims Act (FTCA).

However, the FTCA waives sovereign immunity of the United States and allows for certain tort claims to be made against the United States and its “employees.” It should be noted that, in general, the federal government is substituted

for the defendant employee physician in such situations. If the smallpox example applies to the current coronavirus vaccine, Shot should have immunity for most problems associated with the vaccine. Will his staff have a cause of action against the federal government if they have complications from the vaccine?

Previous case law suggests that aggrieved plaintiffs rarely can recover from the government for risks that the government was aware it was creating. Because the risks of the COVID- 19 vaccine are increasingly well described, by choosing to immunize a given class of people, the government is making a knowing discretionary decision to expose that class of people to the risks. This well-described “discretionary authority doctrine” makes it unlikely Shot’s staff will be able to bring a case against the US government.

Despite this legal rationale, it is impossible to know exactly what would happen if such legal action arose. Legal scholars have suggested that the best analogy to future similar litigation is the atomic fallout in which people downwind from nuclear test sites sued the government for injuries allegedly caused by exposure. In those cases, a higher appellate court ruled that since the government had decided to expose these people to nuclear fallout, knowing the risks of fallout, the government was not liable under the FTCA.

The Homeland Security Act, as written, would require that in order to recover monetary damages under the FTCA, people injured by the COVID-19 vaccine prove that the government, or people acting on its behalf, were negligent in administering the vaccine. Simply proving the vaccine harmed them will not be enough. Injured plaintiffs would have to show that (1) there was no screening for contraindications and/or (2) treated persons were not informed of the reasonable risks of the vaccine. Shot and the US government will likely have no liability as long the issues are well documented and there is an appropriate explanation of the public policy issues behind administering of the vaccine.

Articles

In this month's Legal Eagle column, David J. Goldberg, MD, JD, addresses the question of what private practice dermatologist have to consider with Covid-19 vaccines. 

Is There Liability if I Vaccinate My Staff and Something Goes Wrong?

and joined the MJH Life Sciences team in April 2021. She graduated from Kent State University in 2018 with a bachelor's degree in journalism and a minor in sociology. Linda used to work as a creative writer for 

 and was a technical writer/regulatory specialist/purchasing agent at GM Industrial before coming on to the team. She enjoys reading, traveling, and learning new perspectives. You can reach her at 

Amgen and Kyowa Kirin Co., Ltd announced positive data from a phase 2 study (NCT03703102) of AMG 451/KHK4083 (Amgen and Kyowa Kirin Co), a potential first-in-class anti-OX40 fully human monoclonal antibody, was presented at the European Academy of Dermatology and Venereology (EADV) 30th annual virtual congress. AMG 451/KHK4083 is in development for the treatment of moderate to severe atopic dermatitis (AD).

Emma Guttman-Yassky, MD, PhD, was the lead investigator of the study. She is the system chair for the Department of Dermatology and Waldman professor of dermatology and immunology, Icahn School of Medicine at Mount Sinai and director of the Center for Excellence in Eczema, and the Laboratory of Inflammatory Skin Diseases at Mount Sinai, New York, New York. 

“The phase 2 results are both positive and exciting,” said Guttman-Yassky. “They show improvement across all 4 dose groups compared to placebo and highlight the potential of OX40 antagonism to help patients. I hope that future clinical development data will further elucidate the significance and potential of AMG 451/KHK4083 in the treatment of moderate to severe atopic dermatitis.”

The multicenter, randomized, double-blind, placebo-controlled trial investigated both the safety and efficacy of AMG 451/KHK4083 in adult patients with moderate to severe AD that was not controlled with topical treatments. 

The study met the primary objective, according to the press release, showing statistically greater improvements from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks with all 4 subcutaneous doses of AMG 451/KHK4083 compared to placebo (600-mg every 2 weeks [Q2W] = -57.4%; 600-mg Q4W = -49.7%; 300-mg Q2W = -61.1%; 150 mg Q4W = -48.3% vs placebo = -15%; P < .001).

All patients in the treatment arms of AMG 451/KHK4083 achieved improvements compared to placebo at week 16, and continued to improve afterwards for key secondary endpoints. This included achieving at least a 75% reduction from baseline in EASI score (EASI 75), an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least 2-point reduction from baseline (IGA 0/1), and at least a 4-point reduction from baseline in pruritus Numerical Rating Scale (NRS) score (PNRS 4).

Common adverse events (AEs) reported in at least 5% of patients were pyrexia (mild to moderate), nasopharyngitis, worsening of atopic dermatitis, and chills. The events of pyrexia did not lead to treatment discontinuation.

"We are very pleased to present data from our phase 2 study assessing the efficacy and safety of AMG 451/KHK4083 in chronic, recurrent, moderate to severe atopic dermatitis at the EADV congress," said Yoshifumi Torii, PhD, executive officer, vice president, head of R&D division of Kyowa Kirin, Japan. "The results show inhibition and deletion of the OX40-expressing cells may provide an important new approach to treating moderate to severe atopic dermatitis, with the potential to help patients maintain responses."

"Atopic dermatitis affects nearly 30 million people a year and is known to have an extremely negative impact on patients' lives," said David M. Reese, MD, executive vice president of research and development at Amgen, Thousand Oaks, California. "These data provide strong evidence of the potential of AMG 451/KHK4083 for patients, and we look forward to studying this treatment further in phase 3 clinical trials, which we expect to begin in the first half of 2022."

1. Amgen and Kyowa Kirin present positive late-breaking data from phase 2 study of AMG 451/KHK4083 in adult patients with moderate-to-severe atopic dermatitis at EADV congress. Cision PR Newswire. Press Release. Published October 2, 2021. Accessed October 8, 2021. 

https://www.prnewswire.com/news-releases/amgen-and-kyowa-kirin-present-positive-late-breaking-data-from-phase-2-study-of-amg-451khk4083-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-at-eadv-congress-301391185.html

 Amgen and Kyowa Kirin announce positive study data from their phase 2 trial of AMG 451/KHK4083. 

AMG 451/KHK4083 Phase 2 Study Data Released

Galderma announced the presentation of new phase 2 data supporting the efficacy of nemolizumab at the virtual 30th annual European Academy of Dermatology and Venereology (EADV) congress.

Nemolizumab is a humanized monoclonal antibody created to block signaling from the IL-31 receptor.

Results from 2 key trials of nemolizumab treatment every 4 weeks demonstrate rapid effectiveness and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new evidence that highlights PN disease burden.

"We are delighted to share new analyses and clinical trial data which reinforce nemolizumab’s therapeutic potential and comprehensive benefits across prurigo nodularis and atopic dermatitis,” said Baldo Scassellati Sforzolini, global head of R&D, Galderma, Far Hills, New Jersey. “The scientific evidence for the critical role that the IL-31 pathway plays in the inflammatory process is growing and we are committed to continuing our work diligently to bring nemolizumab to patients living with these debilitating skin conditions.” 

Nemolizumab significantly reduces itch in PN

Data from a secondary analysis of the phase 2 trial evaluating the onset of action in itch and sleep disturbance in patients with moderate to severe PN was revealed. Within 48 hours, nemolizumab had significantly reduced severe itch over 3 times more effectively than placebo (-19.5% vs -5.8%, respectively, p = .014) and decrease in itch, which was maintained for the duration of the study. 

At day 4, approximately one fourth of patients were already demonstrating strong reduction in severe itch responses to treatment with nemolizumab, compared to no responses for the placebo group (23.5% vs 0%, p < .001) and at 12 weeks, over 50% of PN patients demonstrated a response to nemolizumab treatment (52.9% vs. 8.3%). Also, nemolizumab led to a 4 times greater improvement in sleep disturbance vs placebo at day 4 (-19.8% vs -4.3%, p = .012), with continued improvement through week 4.

"Prurigo nodularis is associated with a markedly impaired quality of life [QoL] and frequent sleep deprivation,” said Sonja Ständer, MD, lead study investigator, professor for dermatology, University Hospital Muenster, Germany. “This analysis highlights nemolizumab’s rapid onset of action bringing itch reduction within 48 hours of the first dose, and a significant improvement in sleep as early as day 4 for moderately to severely affected patients. This symptomatic relief translates into a meaningful improvement in day-to-day life for these patients.

Direct anti-inflammatory effect suggested for nemolizumab leading to early improvement in AD

New and consistent findings for nemolizumab in AD were also presented from a secondary post-hoc analysis of the phase 2b data in adult patients with moderate to severe AD, according to the press release. 

Nemolizumab demonstrated a significant improvement in the clinical signs and symptoms of AD at week 1 of treatment, as indicated by scoring AD (SCORAD), which increased through week 16. This included early improvement of erythema and excoriation, suggesting a direct anti-inflammatory effect, whereas improved skin dryness vs placebo could be a consequence of a beneficial effect of nemolizumab on the skin barrier, the release explained.

"This analysis is important as it points to the direct anti-inflammatory effect of nemolizumab and builds our understanding of its mechanism of action bringing rapid and profound reduction in itch sensations and skin lesions for patients living with atopic dermatitis,” said Jean-David Bouaziz, lead investigator, Department of Dermatology, Saint-Louis Hospital, France.

Improvement in signs and symptoms of AD in adolescent patients

A third abstract considered the pharmacokinetics (PK), safety, and efficacy during nemolizumab treatment of AD in adolescent patients. In patients aged 12-17 with moderate to severe pruritus, nemolizumab achieved an improvement in rash, itch, sleep and QoL, and biomarkers.

This is an update to earlier data released in April 2021.

Galderma presents new nemolizumab data at EADV reinforcing rapid onset of action and consistent relief of symptoms for people with prurigo nodularis and atopic dermatitis. Galderma. Press release. Published September 29, 2021. Accessed October 8, 2021. 

https://www.galderma.com/news/galderma-presents-new-nemolizumab-data-eadv-reinforcing-rapid-onset-action-and-consistent

Nemolizumab phase 2 clinical trial data for patients with prurigo nodularis and atopic dermatitis was recently released at the EADV.

EADV Releases Nemolizumab Phase 2 Data

 reveals Rachel Maddow's skin cancer surgery and 

talks about a new AI app to diagnose skin issues. Also, 

dives into how to avoid tech neck. Finally, 

explains how to treat an infected piercing and 

features a bill being reintroduced to get wigs covered by Medicare.

Rachel Maddow Reveals She Had Skin Cancer Surgery

This New High-Tech Face Analyzer Diagnoses Your Skin in 30 Seconds

How to Avoid Tech Neck in the Age of Zoom

A Dermatologist Breaks Down How to Treat an Infected Piercing in 7 Easy Steps

The Different Levels, Stages & Intensities of Eczema — Plus How to Treat Them

This week’s edition of The Mainstream Patient features stories about skin cancer, a new app developed to diagnose skin issues, and more!

The Mainstream Patient: October 11, 2021

Poll

POLL: Are TikTok trends for skin care causing more bad than good?

 and joined the MJH Life Sciences team in September 2019. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and trying new restaurants. You can reach her at 

examined information provided to clinicians and stakeholders regarding antimicrobial resistance (AMR) in the treatment of impetigo. 

Impetigo is a contagious bacterial infection that affects the superficial skin layers and the topical agents prescribed for the condition are seeing increased worldwide AMR, causing treatment failure. In response, the Worldwide Health Organization (WHO) developed a global action plan on AMR but omitted AMR stewardship program information for topical antibiotics.

The review used literature searches—clinical trials, research studies, clinical guidelines, consensus papers, and reviews (if they provided original data)—published between January 2008 and May 2019 to examine the status of AMR to current topical antibiotics in impetigo, current therapeutic behavior, and concordance with antimicrobial stewardship principles, according to the authors.

The articles were selected by impetigo management relevancy, clinical efficacy, treatment safety, and antimicrobial resistance. Of the 198 articles found, 19 met the inclusion criteria and were considered by 2 international panels who convened to discuss the search output. The panel discussions were then used in the development of the manuscript. 

The authors concluded that while published antimicrobial stewardship guidelines have focused on systemic antibiotics, very few have evaluated the topical antibiotic prescribing practices for impetigo treatment.

“The appropriate use of topical ozenoxacin (Xepi; Biofrontera Inc) can help eradicate impetigo while minimizing AMR,” they wrote.

Schachner LA, Lynde CW, Kircik LH, et al. Treatment of impetigo and antimicrobial resistance. J Drugs Dermatol. 2021;20(4):366-372. doi: 10.36849/JDD.2021.5795.

A recent review evaluates the information provided to clinicians regarding antimicrobial resistance in impetigo treatment. 


Impetigo Treatment and Antimicrobial Resistance 

Journal of Clinical, Cosmetic and Investigational Dermatology

explored the efficacy and pain association of daylight photodynamic therapy (daylight-PDT) compared to conventional PDT (cPDT) for the treatment of actinic keratosis (AK).

The investigators used Embase and PubMed to search for clinical articles that were published on the efficacy of daylight-PDT using the keywords “daylight photodynamic therapy” and “actinic keratosis.” There were no limits placed on the search time frame, however, it only included studies published before May 22, 2019. The studies were required to be in English and involve humans. A total of 9 relevant studies were included in the review.

cPDT uses either 5-aminolaevulinic acid (ALA) or methyl ester (MAL) as a topical photosensitizer to the affected area with AK. ALA is an early intermediate in the heme biosynthesis pathway and is also a precursor to the natural photosensitizer protoporphyrin IX (PpIX), according to the article. ALA non-selectively enters the cells, but the PpIX tends to accumulate in tumor cells. A blue or red light is then used to incubate the application. 

“The standard procedure for cPDT calls for occlusive treatment with a photosensitizer for 1 to 3 hours, allowing for enough time for accumulation of PpIX,” the authors wrote. “However, FDA approval for use of photosensitizers in the treatment of AK involves incubation periods of 3 hours for MAL, 18 hours for ALA, and 3 hours for nanoemulsions for ALA.”

After cPDT, patients report pain as the most common adverse event (AE). The discomfort of treatment, frequency of treatment, and the length of the procedures lead to the search of more tolerable PDT. 

For daylight-PDT to be considered a reasonable alternative to cPDT, it has to be effective in the short and long term, according to the study.

A meta-analysis of 6 randomized controlled trials that compared daylight-PDT and cPDT found daylight-PDT is noninferior to cPDT in the treatment of grade I and II AKs with 2 of the studies included in the analysis randomized, controlled, investigator-blinded, split-body, and multicenter. They were based in Australia and Europe and included 100 patients with grade I and II AKs. 

Both studies excluded individuals with severe AK with 2 hours of daylight exposure time 30 minutes after MAL application. The Australian study demonstrated a complete lesion response rate of 89.2% and 92.8% for daylight-PDT and cPDT, respectively, while the European study resulted in complete lesion response rates of 70% for daylight-PDT and 74% for cPDT. Daylight-PDT demonstrated noninferiority to cPDT at 12-week follow-up in both studies. After 6 months, the Australian study found that both daylight-PDT and cPDT maintained lesion clearance for 96% of grade I lesions.

For more details on the length of exposure and the joules of exposure 

. Patient satisfaction from both studies report daylight-PDT to be less painful than its counterpart with an average score of 0.7 and 0.8 out of 10 vs 4.4 to 5.7 in cPDT.

While efficacious, the authors wrote, daylight-PDT is less effective in moderate to thick AKs compared to thick AKs. A study found that at 3 months following daylight-PDT treatment, 73% of grade I lesions showed a complete response, compared to 63% of grade II lesions and 55% of grade III lesions. Twenty three percent of grade II and 39% of grade III lesions were reduced to a lower lesion grade. Also, weather (cloudy or sunny days) does not seem to be an issue for treatment, however going out in rainy weather should be avoided, researchers noted.

According to the article, 2 studies show that ALA may be slightly more effective than MAL. 

A randomized observer-blinded study with a split-face trial of 13 patients and a collective total of 177 grade I–III AKs compared daylight-PDT treatments using ALA nanoemulsion gel or MAL cream as the photosensitizer. The trial had grade I AKs treated once and grade II–III AKs treated twice with a 0.25-mm layer of photosensitizer. Overall, the nanoemulsion ALA daylight-PDT cleared 85% of the AKs vs MAL daylight-PDT cleared 74% of the total AKs (P =.099). 

Another study compared BF‐200 ALA—a nanoemulsion gel containing 7.8% ALA—to MAL in the treatment of mild to moderate AK with daylight-PDT in 52 patients from 7 centers in Germany and Spain. Similar clearance rates were seen in the 12 weeks following treatment for BF-200 ALA gel and MAL (79.8 ± 23.6% and 76.5 ± 26.5%, respectively, P < .0001). The sides treated with BF‐200 ALA gel also had lower 1‐year lesion recurrence rates (19.9%) compared with sides treated with MAL cream (31.6%) (P = .01). 

“Pretreatment of the skin prior to treatment with daylight-PDT is suggested to improve efficacy by increasing penetration of the ALA or MAL,” the authors wrote.

Treatment guidelines from groups of experts in both Europe and Australia have been independently published, but none for the United States.

Common AEs of daylight-PDT are mild and include erythema, blistering, itching, and crusting, with scarring being a rare occurrence.

Current evidence suggests that daylight-PDT is a safe and effective alternative to cPDT for thin to moderate AK lesions, according to the authors, but further studies are needed to determine the minimum exposure time necessary to minimize side effects. Also, physicans should be aware that daylight-PDT is a potential treatment option for patients with low pain tolerance or limited scheduling.

Raja K Sivamani serves as a medical editor for LearnHealth and as a consultant for Burt’s Bees, Dermala, and Tomorrow’s Leaf. The authors report no other conflicts of interest.

Nguyen M, Sandhu SS, Sivamani RK. Clinical utility of daylight photodynamic therapy in the treatment of actinic keratosis – a review of the literature. Clin Cosmet Investig Dermatol. 2019;12:427-435. doi:10.2147/CCID.S167498

Researchers examine whether daylight PDT is less painful but equally as effective as conventional PDT as treatment for actinic keratosis. 

 Study: Daylight PDT vs Conventional PDT for Actinic Keratosis Treatment 

Allergan Aesthetics, an AbbVie company, and SkinBetter Science announced in 

 that they used their DREAM (Driving Racial Equity in Aesthetic Medicine) initiative to support the development and distribution of the “The Full Spectrum of Dermatology: A Diverse and Inclusive Atlas.” This dermatology atlas will display images of the most-seen dermatology conditions in an array of skin tones.

The goal of the full-color atlas is to advance education among physicians, with the intent to visually teach dermatologists, dermatology residents, and other clinicians to recognize various skin conditions in different skin tones. This resource includes high-quality images taken by dermatologists trained in medical photography which provide side-by-side images of the most commonly seen dermatology conditions in a full spectrum of skin tones, according to the release.

The Atlas was developed by co-editors Misty Eleryan, MD, MS, a micrographic surgery and dermatologic oncology fellow at the University of California, in Los Angeles, and Adam Friedman, MD, professor and chair of dermatology at GW School of Medicine and Health Sciences, in Washington, DC, and published by SanovaWorks and Educational Testing & Assessment Systems. 

"To effectively diagnose and manage skin diseases in all patients, dermatologists need to be fluent in the diverse array of clinical presentations of even the most common skin diseases in all skin tones," said Friedman. "The investment being made by leaders of our dermatology community and industry in this innovative project validates and highlights its extraordinary importance."

"As physicians, we take an oath to do no harm to our patients; we can now better live up to this oath for ALL of our patients, especially those with darker skin, by educating ourselves on the variations of presentations of common dermatoses on all skin tones," said Eleryan,

The Atlas received funding from both SkinBetter Science and Allergan Aesthetics as it aligned with the DREAM initiative and it will make copies available to all dermatology residents and program directors in the United States.

"Understanding the need for racial equity in all sectors of society, Skinbetter Science and Allergan Aesthetics, as part of their DREAM Initiative, supports the Atlas' efforts to advance the education of healthcare practitioners. This comprehensive collection of images is designed to better serve the full spectrum of skin tones--hopefully providing physicians and other healthcare practitioners the opportunity to advance diagnosis," said Jonah Shacknai, executive chairman of SkinBetter Science, in Irvine, California.

"The DREAM Initiative is committed to furthering the principles of racial and ethnic diversity, inclusion, respect and understanding in the fields of dermatology and plastic surgery. We're proud of the release of this Atlas and continue to work with SkinBetter Science to create meaningful, positive change within our own companies, and with our customers," said Carrie Strom, senior vice president, AbbVie and president, Global Allergan Aesthetics, in Phoenix, Arizona.

Contributing fellows and members of the Atlas Advisory Committee include:

1. Dream initiative releases, the full spectrum of dermatology: a diverse and inclusive atlas. Published September 29, 2021. Accessed October 11, 2021. https://www.prnewswire.com/news-releases/dream-initiative-releases-the-full-spectrum-of-dermatology-a-diverse-and-inclusive-atlas-301383427.html

The two companies are using their DREAM initiative to support the diverse dermatology index. 

Allergan and SkinBetter Science Support Inclusive Atlas

Arcutis Biotherapeutics, Inc announced new patient-reported data that demonstrated topical roflumilast application resulted in significant reductions of burden and severity of itch. The once daily application of roflumilast cream also improved the quality of life (QOL) of patients in the DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) phase 3 pivotal studies in chronic plaque psoriasis, according to the 

 These data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress held from Sept 29 to Oct 2.

“Itch is the most frequently reported symptom associated with dermatologic conditions such as plaque psoriasis, scalp psoriasis, and seborrheic dermatitis, severely impacting patients’ quality of life. These robust and consistent data across multiple indications demonstrate that topical roflumilast significantly improved both the severity and burden of itch, that symptoms improved quickly and continued improving through the course of treatment,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in Chatham, New Jersey. 

He continued, “Meaningfully impacting symptoms that matter most to patients, such as itch, are at the core of Arcutis’ mission. Topical roflumilast continues to demonstrate strong efficacy with a safety and tolerability profile that, if approved, should enable chronic use and the ability to use across the body.”

Melinda J. Gooderham, MSc, MD, FRCPC, board certified dermatologist and medical director at the SKiN Center for Dermatology in Ontario, Canada, presented patient-reported outcome data from both DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream at the conference. Her presentation was detailed in the release.

According to the release, it showed the mean reduction in Worst-Itch Numeric Rating Scale (WI-NRS) score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as 2 weeks (mean change from baseline of -3.7 and -4.0 for roflumilast cream; -1.4 and -1.7 for vehicle; P<0.0001). 

Also, more than 2/3 of patients with a WI-NRS of 4 or greater at baseline achieved a reduction of 4 points or more with roflumilast cream compared to less than 1/3 of individuals using vehicle at week 8 (67.5% and 69.4% of patients using roflumilast cream compared to 26.8% and 35.6% using vehicle; P<0.0001). 

Overall QOL improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index (DLQI). Study results showed improvement of 65.2% from baseline in the DLQI score for roflumilast cream versus 12.7% vehicle in DERMIS-1, and a 69.4% improvement from baseline DLQI score roflumilast cream versus 9.0% vehicle in DERMIS-2 (P<0.0001).

Read more on topical roflumilast foam from our coverage of the 2 separate phase 2 studies that showed achieved reduction of itch in scalp and 

1. New data highlighting itch reduction with topical roflumilast in multiple dermatologic conditions presented at European Academy of Dermatology and Venereology Congress. GlobeNewswire News Room. Published September 30, 2021. Accessed October 6, 2021. 

https://www.globenewswire.com/news-release/2021/09/30/2306185/0/en/New-Data-Highlighting-Itch-Reduction-with-Topical-Roflumilast-in-Multiple-Dermatologic-Conditions-Presented-at-European-Academy-of-Dermatology-and-Venereology-Congress.html

Arcutis Biotherapeutics, Inc has released data from its DERMIS-1 and DERMIS-2 Phase 3 pivotal studies demonstrating that the topical significantly reduced the burden and severity of itch. 

Roflumilast Cream Data Show Positive Outcomes for Plaque Psoriasis

, Andrew Blauvelt, MD, MBA, a dermatologist and president of Oregon Medical Research Center in Portland, Oregon, discusses the newest phase 3 clinical data on tralokinumab (LEO Pharma). 

Tralokinumab is an investigational monoclonal antibody that specifically neutralizes interleukin (IL)-13, a key driver of atopic dermatitis (AD) and is currently being evaluated by the FDA. Hear what he has to say about the newest data from the ECZTEND (NCT03587805) trial in the video below. 

Videos

In this exclusive video interview with Dermatology Times®, Andrew Blauvelt, MD, MBA, discusses the newest phase 3 clinical data on investigational tralokinumab as a potential treatment option in atopic dermatitis.

Impetigo Treatment and Antimicrobial Resistance

Study: Daylight PDT vs Conventional PDT for Actinic Keratosis Treatment

Allergan and SkinBetter Science Support Inclusive Atlas

Roflumilast Cream Data Show Positive Outcomes for Plaque Psoriasis

New Data on Investigational Tralokinumab for Treatment of AD

The changing treatment landscape of plaque psoriasis