The COVID-19 pandemic has forced many dermatology offices to close, greatly reduce hours, or shift to a telemedicine model. As this situation continues to evolve and change on a daily basis, Practical Dermatology is offering special coverage of how COVID-19 is affecting the dermatology industry, strategies for coping, and potential ways to help. Visit PracticalDermatology.com/COVID-19 for updates. Practical Dermatology wishes all of our readers health!
FDA Greenlights Pfizer’s Eucrisa for Children As Young As Three Months With AD
The FDA approved Pfizer’s Eucrisa ointment, 2%, for children as young as age 3 months with mild to moderate atopic dermatitis (AD).
Eucrisa was previously approved for use in adults and children 2 years of age and older. It is the first and only steroid-free, topical prescription medication for mild to moderate AD patients as young as 3 months of age.
“Families often spend hours each day attempting to ease their child’s eczema symptoms, affecting both infants and caregivers. This is a struggle I see in my daily practice, and it can take a toll on the entire family,” says Lawrence Eichenfield, MD, chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego, vice chair of the Department of Dermatology, and a professor of Dermatology and Pediatrics at UC San Diego School of Medicine, in a news release. “The approval of a steroid-free treatment option for this age group offers potential relief for these very young patients.”
“Despite atopic dermatitis often manifesting during infancy, there are few approved treatment options for this population available today,” adds Richard Blackburn, Global President, Inflammation & Immunology, Pfizer. “We are committed to making a meaningful difference to patients’ lives, and with this indication extension, we look forward to now helping many of the youngest children suffering with eczema.”
The approval for the expanded indication of EUCRISA was supported by data from a Phase 4, open-label, clinical study designed to assess the safety of crisaborole ointment in infants aged 3 months to less than 24 months with mild-to-moderate AD, with effectiveness as an exploratory endpoint. In this study, crisaborole ointment, 2%, was well-tolerated and demonstrated effectiveness in patients with mild-to-moderate AD with no new safety signals identified.
Positive Phase 3 Results for Medimetriks and Otsuka’s AD Drug
Medimetriks Pharmaceuticals, Inc. and Otsuka Pharmaceuticals Co. Ltd.’s MM36 (difamilast) performed well in two Phase 3 Japanese clinical trials in adult and pediatric atopic dermatitis (AD) patients.
Difamilast is a novel topical, non-steroidal phosphodiesterase IV (PDE4) inhibitor for the treatment of mild to moderate AD. Otsuka entered into a licensing agreement with Medimetriks, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights for difamilast in the United States.
The two trials were conducted as multicenter, randomized, double-blind, vehicle-controlled parallel-group studies. In the adult study, 1% difamilast ointment or the vehicle was applied twice daily for four weeks. In the pediatric study, 0.3% or 1% difamilast ointment or the vehicle was applied twice daily for four weeks.
Therapeutic effects were assessed using the Investigator’s Global Assessment (IGA). In both the adult and pediatric trials, the IGA success rates, the primary endpoints as defined as the proportion of subjects whose IGA score was 0 (clear) or 1 (almost clear) and with improvement by at least 2 grades, were higher in the active-drug-treatment groups than in the vehicle groups, and the differences were statistically significant. No major adverse reactions were identified. Trial outcomes will be analyzed further and findings will be announced at a scientific conference.
FDA Grants Breakthrough Status for Baricitinib in AA
The FDA has granted Breakthrough Therapy designation to Eli Lilly and Company and Incyte Corporation’s baricitinib for the treatment of alopecia areata (AA).
Baricitinib is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
“Patients with AA currently do not have any FDA-approved treatment options available to them,” says Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly. “AA not only causes hair loss but also may be a psychosocial burden for people living with this disease. At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore baricitinib’s potential to become the first approved treatment option for these individuals.”
The FDA Breakthrough Therapy designation is based on the positive Phase 2 results of Lilly’s adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib versus placebo in adult patients with AA. In the Phase 2 portion of the BRAVE-AA1 study up to Week 36, there were no new safety signals with no serious adverse events reported. The reported treatment-emergent adverse events (TEAEs) were mild or moderate and the most common included upper respiratory tract infections, nasopharyngitis and acne.
Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 double-blind study (BRAVE-AA2), are currently assessing the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.
CLOSE UP with Emma Guttman-Yassky, MD, PhD
Dupilumab has changed the way atopic dermatitis (AD) is treated in adults and adolescents, but it doesn’t work for every patient. More drugs that treat AD are needed, just as multiple medications targeting various components in the inflammatory process are approved and used in psoriasis, says Emma Guttman-Yassky, MD, PhD, the Sol and Clara Kest Professor and Vice Chair for Research at the Department of Dermatology, Director of the Center for Excellence in Eczema, and Director of the Laboratory of Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai Medical Center in New York. And promising results from a Phase 2b study suggest that lebrikizumab, a novel monoclonal antibody targeting Interleukin-13 (IL-13), may be the next up to plate for AD. Dr. Guttman-Yassky and colleagues recenty published a study on the new medication in JAMA Dermatology. She spoke to Practical Dermatology® about the results and why IL-13 may be the most significant cytokine involved in AD.
WHY IS THIS TOPIC IMPORTANT TO STUDY?
Dr. Guttman-Yassky: Look how many drugs we now have for psoriasis patients with moderate-to-severe disease, and eczema is a more common disease than psoriasis. We need more drugs that will be able to clear more AD patients. Dupilumab is a good drug, but not all AD patients will respond to it. Additional drugs and drug combinations are needed to achieve clearance in all patients.
DESCRIBE THE RESEARCH AND YOUR FINDINGS.
Dr. Guttman-Yassky: In the study, patients received lebrikizumab (Dermira) injections every 2 weeks or every 4 weeks. Lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate-to-severe AD while demonstrating a favorable safety profile. This drug targets only IL-13 and what we see from this study is that the improvement is in the same ballpark as dupilumab, which targets IL-4 and IL-13 signaling (with the caveat that the studies were not conducted at the same time). This suggests that IL-13 may be perhaps the most important cytokine in AD pathophysiology. Further, patients show a high level of treatment success with an agent targeting a single cytokine. This treatment can provide additional benefit on existing treatments for our patients with eczema with very good safety.
WHAT ARE THE NEXT STEPS?
Dr. Guttman-Yassky: The FDA granted lebrikizumab a fast track for AD in December 2019. Phase 3 trials are underway. The next step is to get it approved and hopefully we will look at approval when the Phase 3 trials are complete in the next two years.
Changing Lives, One Veteran at a Time
Ohio Dermatologist offers free scar revision to wounded vets
By Denise Mann, MS
When Jorge Garcia-Zuazaga, MD, founder of Apex Dermatology in Northeast Ohio, watched news coverage of the Boston Marathon bombing unfold in 2013, he was inspired by the way medical volunteers stepped up to the plate in the immediate wake of the explosions and in the months thereafter.
Dr. Garcia-Zuazaga knew he wanted to give back to his community by combining his military experience as a prior flight surgeon with his passion for dermatology.
And from there, his Purple Heart Project was born. This project provides complementary scar revision treatments to wounded vets.
The Purple Heart Project was launched a few years ago and continues to grow.
“Scarring doesn’t just impact your physical appearance, it can go much deeper and by helping vets heal their physical scars, we can also begin to alleviate their emotional ones and get them on a path toward a new beginning,” he tells Practical Dermatology®.
To be eligible, veterans must fill out a form and the request is evaluated by a physician committee that meets quarterly. Treatment is reserved for veterans who have been wounded in combat. Once a recipient is selected, he or she comes into the office for medical evaluation and if deemed appropriate, Dr. Garcia-Zuazaga and colleagues will develop a treatment plan.
So far, Dr. Garcia-Zuazaga and his team have provided scar revision to dozens of veterans.
And he has no plans to stop now. “The great thing about this program is that we are transforming people’s lives by doing dermatology. At the end, that’s what matters,” he says.
For more information on the Purple Heart Project, visit www.apexskin.com/purpleheartproject/
Calling All Readers: We want to feature dermatologists who are using their skills and time to give back to their communities. Let us know about your pro bono work. Email us at Dmann@bmctoday.com or Editor@bmctoday.com
Remembering Haines Ely, MD
This past month we lost a giant in dermatology, Haines Ely, MD. I am fortunate to have known Haines, as did so many dermatologists who he befriended, taught, and mentored over his life. While I could provide volumes on how brilliant, incisive, and Renaissance-like Haines was, it would be impossible to recreate the magic that he provided and the person he was to anyone who never had the pleasure of meeting him. Suffice it to say: he broke the mold and no one will recreate the person he was in totality. Many of us who knew him are lucky enough to be able to aspire to his greatness, but it is doubtful we will come close. Until nearly his last breath, he was trying to help dermatologists with advice ranging from life-hacks to the wisdom of N-acetylcysteine, zinc, and hydroxychloroquine for COVID-19 (I might add, well before this was “common knowledge”).
My thoughts go out to his wife, Jenny and loving family. Additionally, I particularly am aware of the role he played in RxDerm/Dermchat, having been involved from the beginning. His family of 1,400 dermatologists involved in this endeavor that he loved from the mid-1990s to his unfortunate passing will always be in his debt.
—Joel Schlessinger, MD
FDA Approves Lilly’s Taltz for Treatment Of Pediatric Patients with Psoriasis
The FDA has approved a supplemental Biologics License Application (sBLA) for Eli Lilly and Company’s Taltz (ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
“As I have often seen in my clinic, psoriasis is particularly challenging for children and adolescents, resulting in itchy and painful symptoms that can feel especially embarrassing for pediatric patients during a crucial developmental period in their young lives,” says Jennifer Cather, MD, Modern Research Associates, Dallas, TX. “In the Phase 3 pediatric study, half of patients treated with Taltz achieved completely clear skin after only 12 weeks of treatment. These results and the subsequent FDA approval make a strong case for Taltz as an effective treatment option for doctors to consider for pediatric patients with moderate to severe plaque psoriasis.”
The safety, tolerability and efficacy of Taltz in patients ages 6 to under 18 was demonstrated in a randomized, double-blind, placebo-controlled Phase 3 study that included 171 patients with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving a 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician’s Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12.
Patients were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference:
- 89 percent of patients treated with Taltz achieved PASI 75 compared to 25 percent of patients treated with placebo.
- 81 percent of patients treated with Taltz achieved sPGA 0,1 compared to 11 percent of patients treated with placebo.
Taltz also met all major secondary endpoints in the study (P<0.001), which included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4.
Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with Taltz every four weeks is consistent with the safety profile in adult patients with plaque psoriasis, with the exception of the frequencies of conjunctivitis (3%), influenza (2%) and urticaria (2%). In this clinical trial, Crohn’s disease occurred at a greater frequency in the Taltz group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total of four Taltz-treated subjects (2.0%) in the clinical trial. The Taltz safety profile has been studied across 13 clinical trials in adult subjects with plaque psoriasis, with over 5,000 patients receiving Taltz, with a total exposure of over 17,000 patient-years.
Lilly says it will work with insurers, health systems and providers to ensure patients are able to access this treatment. Contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit www.lilly.com.
BiomX’s BX001 for Acne-Prone Skin Performs Well in Phase 1 Trial
BiomX Inc.’s lead candidate BX001 for acne-prone skin met its primary endpoint of safety and tolerability for both doses of BX001 as well as a statistically significant reduction of Cutibacterium acnes (C. acnes) levels for the high dose of BX001 compared to placebo, according to a Phase 1 study.
BX001 is a topical gel comprised of a cocktail of naturally occurring phage targeting C. acnes to improve the appearance of acne-prone skin.
“We are excited to announce positive data demonstrating for the first time that this topically applied phage cocktail, developed through our proprietary discovery platform, showed activity against a bacterial target and was able to demonstrate a statistically significant reduction in C. acnes levels on the skin in a safe and tolerable manner. These results warrant advancing the program to a Phase 2 study,” says Jonathan Solomon, CEO of BiomX, in a news release. “We are carrying out additional analyses on the BX001 clinical data, as well as evaluating the implications of the ongoing COVID-19 pandemic on our clinical development timelines, and intend to provide an update on the timing of the Phase 2 trial when we report our first quarter 2020 financial results.”
Isdin Taps Professional Golfer Jessica Korda As New Sports Ambassador
Professional golfer and LPGA star Jessica Korda is ISDIN’s new sports ambassador. As part of the campaign, Korda is sharing how she keeps her skin looking its best on and off the golf course with ISDIN products.
“ISDIN formulates unique and innovative products with advanced ingredients that are recommended by dermatologists all over the world,” says Rob D’Urso, ISDIN US Country Manager, in a news release. “We were thrilled to learn that Jessica Korda uses ISDIN Eryfotona Actinica SPF 50+ every day, which offers effective, high SPF sun protection with DNA Repairsomes to reverse the harmful effects of UV radiation.”
