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

A new study lends support to the established clinical safety profile of 2 mg baricitinib in adult patients with atopic dermatitis.

To date, 6 double-blind, randomized, placebo-controlled studies—as well as 2 long-term extension studies—have been conducted to evaluate the safety and efficacy of the selective Janise kinase (JAK) 1 and 2 inhibitor as either a monotherapy or combination therapy.

Led by Brett King, MD, PhD, Department of Dermatology, Yale School of Medicine, an investigative team performed an integrated analysis of all 8 studies to further evaluate the baricitinib’s safety through 2.4 years of follow-up.

Their analysis included 2 datasets—one that compared baricitinib with placebo during the 16-week period in the trials, and another that reported on estimated incident rates (IRs) of adverse events in all those who received baricitinib at any time.

As such, across all clinical trials, 1598 patients received once-daily baricitinib 2 mg for 1434.2 patient-years of exposure. Furthermore, 45.6% were treated for ≥1 year, and 2.1% were treated for ≥2 years.

Compared with placebo, a higher proportion of patients experienced ≥1 treatment-emergent adverse events (57.9% vs 51.6%).

In both treatment groups, most of the events were considered mild (baricitinib 2 mg, 32.8%; placebo, 29.9%) or moderate (baricitinib 2 mg, 22.2%; placebo, 18.3%) in severity.

Even more, the placebo group saw a higher frequency of serious adverse events (2.7%, IR = 9.2) compared with the baricitinib group (1.6%, IR = 5.2).

In the placebo-controlled dataset, the most frequently reported treatment-emergent adverse events were nasopharyngitis, headache, upper respiratory tract infection, nausea, diarrhea, and herpes simplex.

As for the baricitinib-only dataset, serious adverse events were those in the Medical Dictionary for Regulatory Activities (MedDRA) system organ classes Skin and subcutaneous tissue disorders and Infections and infestations.

The investigators also reported that a similar proportion of patients in both groups discontinued the study drug due to adverse events.

Among all patients who received baricitinib, “the most common MedDRA system organ class for permanent discontinuation was Skin and subcutaneous disorders (21.4%) with 50% of these events reported as worsening of dermatitis atopic.”

The most common MedDRA system organ class leading to temporary interruptions was Infectious and infestations (61%).

However, serious infections and opportunistic infections were found to be low in frequency and similar between treatment arms. Herpes simplex was notably higher for baricitinib 2 mg (3.8%) than for placebo (2.8%), but rates decreased with extended exposure to the JAK inhibitor.

There were no reported malignancies, gastrointestinal perforations, or major adverse cardiovascular events for baricitinib in the placebo-controlled period.

In the baricitinib-only dataset, 5 malignancies were reported, as well as 2 major adverse cardiovascular events, 1 peripheral venous thrombosis, and 1 arterial thrombosis. There were no pulmonary embolisms, deep vein thromboses, or deaths.

Therefore, the investigators concluded the safety analysis was notably consistent with the already established safety profile of bariticitinib 2 mg, a recommended started dose for those with moderate-to-severe atopic dermatitis.

“The observed patterns and rates of common treatment-emergent adverse events were similar or numerically lower with prolonged exposure to baricitinib 2 mg,” they added.

Although there were few cases of major adverse cardiovascular events and other malignancies linked with baracitinib, the investigators acknowledged their longer latency period.. Therefore, a longer treatment duration can help further elucidate the true risks for these adverse events.

“Atopic dermatitis is a chronic disease and additional long-term data will be essential to further understand other potential risks with extended baricitinib 2 mg exposure,” King and team concluded.

Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials

American Journal of Clinical Dermatology.

This article was initially published by our sister publication 

Articles

Initial rates of common treatment-emergent adverse events from baricitinib 2 mg appear to remain stable or decrease with prolonged exposure.

Study Confirms Safety Profile of Baricitinib Dose for Atopic Dermatitis

Zoe Diana Draelos, M.D., is a consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. She is investigator, Dermatology Consulting Services, High Point, N.C., and a Dermatology Times Editorial Advisor and co-medical editor.

Q: What is the best way to insert a difficult pierced earring?

Piercing of the ears and other body areas has seen a tremendous resurgence in the United States and around the world. It is a form of personal expression and body adornment among many individuals wishing to wear piercing jewelry for a variety of social and emotional reasons. Pierced ears are the most common; however, recommendations for pierced-ear care can be generalized to other body piercings.

It can become difficult to insert a pierced earring for many reasons. The most common cause is simply increased friction between the ear hole and the earring. This is most easily remedied by putting petroleum jelly on the earring post and then inserting it into the ear. The petroleum jelly will lubricate the earring to reduce friction. Forcing the earring into the hole can damage the skin, creating epidermoid cysts within the earlobe that can be painful and a source of foul- smelling drainage. This occurs when a small piece of viable skin is forced beneath the skin surface, creating a cyst. Lubricating the earring with petroleum jelly is especially important in patients with earlobe cysts.

The second most common problem causing earring-insertion difficulty is a keratin plug in the earring hole from skin debris. The skin lining the earring hole continues to slough corneocytes, which can create a keratin plug. It is best to remove the plug by pushing the earring through the hole backward (pushing the earring post from the posterior earlobe to the anterior earlobe). This will remove the plug and allow earring insertion to proceed smoothly.

Q: Can you leave in pierced earrings while sleeping?

It is not advisable to sleep with pierced earrings in your ears, although many women prefer not to remove their earrings at night. The earlobe is a thin piece of skin and easily can tear if the earring becomes caught and pulled on hair or bedclothes at night. Stud- type earrings are less prone to earlobe damage than longer dangling earrings or larger hoops. It is recommended that women who prefer to wear earrings continually select a small stud for safety.

Q: How can you improve earring wear in mature individuals?

Many mature individuals discontinue wearing pierced earrings because the earlobes become thinned with age. This is due to loss of subcutaneous fat in the earlobes. Subcutaneous fat loss occurs over the entire body, but it may be most noticeable in the earlobes because the floppy lobes can no longer support an earring and tend to flip forward.

This problem can be remedied easily. One solution is to purchase larger-diameter pierced-earring stud backs that will support the earlobe. These backs can be purchased from a jeweler and worn with all stud earrings. Another option is to put a plastic disk over the posterior earlobe around the earring post, over which the back is pushed to keep the plastic disk in place. Both solutions will allow the earlobe to remain flat.

A second solution is to inject hyaluronic acid filler into the earlobe. The needle is placed into the lower rim of the earlobe, and hyaluronic acid can be injected into the center of the earlobe by using a fanning motion to fill the entire earlobe, taking care to preserve the earlobe shape. The filler should be massaged to be sure that no lumps are present and that an even, thin layer of filler has been deposited over the entire ear lobe. Since earlobes do not move, the hyaluronic acid has a long duration (9-12 months).

For most patients, it is not necessary to inject a full syringe. When injecting into other areas of the face, save 0.5 cc and inject half into each earlobe for an excellent reconstruction result. The filler will make the earlobe thicker and less likely to tear from earring use while also eliminating earlobe wrinkles from redundant skin.

In this month's Cosmetic Conundrums column, Dermatology Times Chief Medical Editor Zoe Diana Draelos, MD, discusses how to solve common challenges associated with pierced earrings.

Solving Pierced Earring Challenges 

features stories on perioral dermatitis and why millennials are opting for brow lifts over injectables. Plus, 

provides in-depth guides to fraxel lasers and microcurrent facials. Meanwhile, 

dives into how to treat “flat acne” and 

highlights one dermatologist’s skincare routine to treat her rosacea.

Everything You Need To Know About Fraxel Lasers

Everything You Need To Know About Microcurrent Facials

I Thought I Just Had Dry Skin, But It Was Actually Perioral Dermatitis

More Millennials Are Opting for Surgical Brow Lifts Over Noninvasive Treatments

Flat Acne is Trending on Skincare Reddit—But How Do You Treat it?

Derm Diaries: ‘I’m A Dermatologist With Rosacea. Here’s How I Treat It.’

This week’s edition of The Mainstream Patient features stories on fraxel lasers, microcurrent facials, perioral dermatitis, brow lifts, plus more. 

The Mainstream Patient: April 12, 2021

During the COVID-19 pandemic, the incidence of children developing Kawasaki disease (KD) was significantly higher than that for other infectious diseases, suggesting that KD arises as a result of 

 infections, investigators concluded in a recent study.

, provides evidence contradicting the dominant theory for KD development—that KD is associated with contact or droplet transmission of pathogens similar to how respiratory syncytial virus (RSV) causes respiratory tract infections and rotavirus causes gastrointestinal infections.

KD is an acute, self-limited, febrile disease predominately detected in children aged 6 months to 5 years. According to the American Heart Association, the disease is 

 by inflammation of the blood vessels, particularly the coronary artery, potentially causing permanent arterial damage, aneurisms, and heart attacks.

Past evidence has suggested that KD can occur in patients who are genetically predisposed to the disease after being exposed to certain environmental triggers. However, despite long-term research, investigators are still unsure of what exactly causes KD development.

Since February 2020, when the first outbreak of COVID-19 occurred, Japanese officials heavily encouraged handwashing, mask wearing, and social distancing and issued a state of emergency lasting from April 7 to May 25, 2020. These measures decreased the spread of SARS-CoV-2, the virus that causes COVID-19, and other pathogens transmitted through contact or droplets, giving an opportunity to investigate whether the incidence of KD did as well.

To conduct the multicenter, longitudinal, cross-sectional study, the investigators analyzed the number of admissions for KD and infectious diseases at 6 hospitals in Fukuoka, Japan and 11 nationwide hospitals between 2015 to 2020.

A total of 1649 pediatric patients with KD and 15,586 with infectious diseases were admitted. The median (interquartile range) age for patients with KD was 25 (13-43) months, and 54.6% (n = 901) were boys.

There was no significant change in the number of KD-related admissions between April and May in 2015 to 2019 compared with the same months in 2020 (mean [SD], 24.8 [5.6] vs 18.0 [4.0] monthly admissions; 27.4% decrease; adjusted incidence rate ratio [aIRR], 0.73; 95% CI, 0.48-1.10; 

Conversely, there was a significant decrease in admissions linked to contact- or droplet-transmitted respiratory (mean [SD], 157.6 [14.4] vs 39.0 [15.0] admissions per month; 75.3% decrease; aIRR, 0.25; 95% CI, 0.17-0.35; 

 < .001) and gastrointestinal (mean [SD], 43.8 [12.9] vs 6.0 [2.0] admissions per month; 86.3% decrease; aIRR, 0.14; 95% CI, 0.04-0.43; 

 < .001) infections from April to May in 2015 through 2019 compared with the same time frame in 2020.

After the Japanese COVID-19 state of emergency was lifted in June to December 2020, the number of patients with KD significantly decreased by 45% in the 6 Fukuoka hospitals and 47% in the 11 nationwide hospitals compared with the same months in 2015 to 2019. However, the decrease was not comparable to the 68.9% decrease observed for respiratory infections. A smaller 18.2% decrease was observed for gastrointestinal infections.

“These persistently low RSV and rotavirus incidence rates suggest that people continued engaging in infection-preventive behaviors (eg, physical distancing, hand washing, and wearing masks) even after the COVID-19 state of emergency was lifted,” wrote the investigators.

The investigators suggested that the persistence of KD decrease may be linked to airborne transmission partially being blocked by COVID-19 preventive measures or potential KD-causing environmental triggers were reduced as a consequence of restricted socioeconomic activity, leading to reduced motor vehicle emissions and shutdowns of power plants and factories.

The limitations associated with the study included the limited potential for generalizability and the inability to definitively determine PD pathogenesis.

“Despite these limitations, we believe that the results of this work provide intriguing clues toward clarification of the pathogenesis of KD and the establishment of preventive methods for KD,” wrote the investigators.

This article was initially published on our sister publication 

1. Hara T, Fununo K, Tamanura K, et al. Assessment of pediatric admissions for Kawasaki disease or infectious disease during the COVID-19 state of emergency in Japan. Published online April 6, 2021. Accessed April 8, 2021.

Given the high prevalence of Kawasaki disease during the pandemic, Japanese investigators determined that droplet or contact transmission of pathogens is likely not a major route causing the development of the disease.

COVID-19 Pandemic Provides Glimpse Into Potential Cause of Kawasaki Disease in Children

Poll

POLL: Have you seen a rise in aesthetic procedures at your practice since the pandemic began?

The latest articles from our April issue;

Coverage from the Inaugural Symposium for Inflammatory 

An exclusive video interview with Melissa Stenstrom on the importance of skin cancer screenings and sun protection;

A glimpse at what to expect from Dermatology Times this week.

What’s New on Dermatology Times: April 12-16

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.

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