FDA Approves Stelara for Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
The FDA approved an expanded indication for Janssen Biotech, Inc.’s Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents. Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has become a leading therapeutic option for dermatologists and their patients, with only four doses a year after two starter doses.
The approval of Stelara for the adolescent indication in moderate to severe plaque psoriasis is based on data from a Phase 3 study designed to evaluate the efficacy and safety of subcutaneous administration of Stelara in patients aged 12 years or older. At least two-thirds of patients receiving Stelara were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician’s Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis). Safety findings for adolescent patients treated with Stelara were consistent with those seen in studies in adults with plaque psoriasis.
FDA Accepts Ortho Dermatologic’s NDA for Novel Plaque Psoriasis Treatment, IDP-118
The FDA has accepted Ortho Dermatologic’s New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis. The PDUFA action date is June 18, 2018.
If approved, IDP-118 will be the first topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use. The most common adverse events were contact dermatitis (7.4 percent ) and application site pain (2.6 percent).
Ortho Dermatologics is a division of Valeant Pharmaceuticals International, Inc.
Abbvie’s Risankizumab Performs Well in Phase 3 Psoriasis Studies
Top-line results from three pivotal Phase 3 clinical trials show that risankizumab, an investigational interleukin-23 (IL-23) inhibitor, met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) across all three studies versus placebo or adalimumab (based on trial design). Results were reported by Abbvie, which noted that risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.
Ortho Dermatologics: Long-term Efficacy Data for Siliq
Siliq (brodalumab) injection provided sustained high levels of skin clearance (PASI 100) over more than two years in patients with moderate to severe psoriasis, according to data presented at the 2017 Fall Clinical Dermatology Conference in Las Vegas and reported by Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc.
Results from the long-term extension study (AMAGINE-2) found that Siliq provided sustained high levels of skin clearance (PASI 100) over more than two years in those with moderate to severe psoriasis. Further, a sub-analysis group of patients who received any dose of brodalumab in the induction phase and Siliq during the maintenance and long-term extension (LTE) phases demonstrated similar response rates. Patients who received either study dose of brodalumab in the induction phase and SILIQ throughout the maintenance and LTE phases at week 120, had a PASI 100 response rate of 59.0 percent (N=178), and PASI 90 response rate of 76.4 percent (N=178). At week 52, the same set of patients had a PASI 100 response rate of 63.4 percent (N=290) and PASI 90 response rate of 85.9 percent (N=290). At week 120, Siliq continued to be generally well-tolerated with a safety profile comparable to that observed in the 52-week period.
Results of a Phase 3, multicenter, randomized, double-blind, placebo-controlled study (AMAGINE-1) of the efficacy of brodalumab in a subset of patients with prior exposure to ustekinumab, demonstrated that SILIQ was similarly efficacious with improved skin clearance in patients both with and without prior ustekinumab exposure. Among patients receiving continuous Siliq, rates of 100 percent reduction in PASI score (PASI 100) was 65.2 percent (43 of 66) and 76.5 percent (n=13 of 17) in ustekinumab-naive and -experienced patients at week 52, respectively. PASI 90 were 75.8 percent (50 of 66) in ustekinumab-naive and 88.2 percent (15 of 17), in ustekinumab-experienced patients.
Study: Risk of Indoor Tanning Dependency Highest in Women with Depressive Symptoms
More than one in five young, white women who have used indoor tanning at least once in the past year show signs of being addicted to the high dose of ultraviolet (UV) radiation from tanning beds.
In addition, women with symptoms of depression were three times more likely to meet the criteria for having a tanning dependence.
The findings, published online in Cancer, Epidemiology, Biomarkers & Prevention, demonstrate that for some young women, education about cancer risks from tanning may not be enough to make them stop.
One indoor tanning exposure is associated with an approximately 20 percent increase in the risk of developing melanoma, and a 29 to 67 percent increased risk of developing non-melanoma skin cancer during a person’s lifetime. And the risk adds up: with each additional indoor tanning exposure, her lifetime cancer risk increases by about 1 or 2 percent. Indoor tanning currently accounts for about 10 percent of melanoma and non-melanoma skin cancers in the US.
The researchers interviewed almost 400 non-Hispanic white women between the ages of 18 and 30 who had reported tanning indoors at least once in the past 12 months.
Those who met the criteria for indoor tanning dependence were more likely to weigh the perceived benefits, such as an improved appearance, over the perceived risks, including developing cancer. However, the strongest association the researchers observed was between indoor tanning dependence and depression.
Previous studies have shown frequent tanners show a preference to UV light even when blinded, and experience a dopamine response in their brains similar to other addictions. Other research in mice has also found that UV light stimulates an opioid response in their brains.
National Rosacea Society Awards New Grants; Call for 2018 Proposals
The National Rosacea Society (NRS) awarded funding for three new studies, in addition to continuing support for three ongoing studies, as part of its research grants program.
Dr. Benjamin Kaffenberger, MD assistant professor of dermatology at the Ohio State University in Columbus, and colleagues were awarded $25,000 to develop a computer program for a rosacea scoring system that will identify and count rosacea lesions and measure redness to provide reliably reproducible scores for physicians and patients. Their goal is the creation of open-source, freely available software that may easily be used by scientific investigators, clinicians and patients to speed diagnosis and assessment, and to help make research easier and more consistent.
Raja Sivamani, MD associate professor of clinical dermatology at the University of California-Davis, and colleagues were awarded $25,000 to study how the skin and eyelid lipids are altered in individuals with cutaneous and ocular rosacea, and whether any deficiencies lead to the papules and pustules of rosacea as well as the eye dryness and irritation of ocular rosacea. They will also study how medications might alter the lipid profile to restore both the skin barrier and tear film stability.
Hester Lim, MD a postdoctoral research fellow in dermatology at Johns Hopkins University School of Medicine in Baltimore, and colleagues were awarded $25,000 for a retrospective study of the association of rosacea with gastrointestinal (GI) disease over a five-year period, as well as the possible impact of medications in the relationship between rosacea and GI disease, including malabsorption, celiac disease, irritable bowel syndrome, Helicobacter pylori infection and others. The cases studied will include all individuals with a diagnosis of rosacea in the Johns Hopkins electronic medical record database since 2011.
The NRS also continues to fund three studies in 2017 by Anna Di Nardo, MD associate professor of dermatology at the University of California-San Diego, and colleagues, who are continuing their investigation of cathelicidin antimicrobial peptides and the nervous system; Luis Garza, MD, associate professor of dermatology at Johns Hopkins University, who is studying the DNA of rosacea; and Wenqing Li, MD assistant professor of dermatology at Brown University in Providence, RI, who is investigating how hormone use and hormone levels associated with menopause and pregnancy may affect the risk of developing rosacea.
Researchers interested in applying for 2018 grants may obtain forms and instructions through the research grants section of the NRS website, rosacea.org. The deadline for submitting proposals to receive a research grant in 2018 is June 15, 2018.
A high priority is given to studies relating to rosacea’s pathogenesis, progression, mechanism of action, cell biology and potential genetic factors. Proposals relating to epidemiology, predisposition, quality of life and relationships with environmental and lifestyle factors may also be considered.
Sensus Healthcare Launches SRT-100 for Keloid Prevention and Treatment in China
Sensus Healthcare, Inc. launched the SRT-100 in China for the treatment and prevention of keloids with Chindex Medical Limited.
SRT-100 launch activities were organized by Chindex Medical in conjunction with the International Congress of Dermatologic & Aesthetic Surgery International League (DASIL) in Shanghai, followed by additional activities in Beijing.
In July 2017, SRT-100 received clearance from the China Food and Drug Administration for the treatment and prevention of keloids. Chindex Medical is focused on preventing and treating keloids associated with Cesarean sections and Sensus has developed a special applicator for use with the SRT-100 for this indication. The SRT-100 previously received clearance in China for the treatment of non-melanoma skin cancer.
Gut Microbiome May Affect How Metastatic Melanoma Responds to Immunotherapy
The gut microbiome can influence how metastatic melanoma responds to immunotherapy, researchers from The University of Texas MD Anderson Cancer Center report in the journal Science.
Patients with metastatic melanoma treated with anti-PD1 checkpoint blockade have their disease controlled longer if they have a more diverse population of bacteria in the gut or an abundance of certain types of bacteria, according to the team’s analysis of fecal samples to assess patients’ gut microbiomes.
“You can change your microbiome, it’s really not that difficult, so we think these findings open up huge new opportunities,” says study leader Jennifer Wargo, M.D., associate professor of Surgical Oncology and Genomic Medicine, in a news release. “Our studies in patients and subsequent mouse research really drive home that our gut microbiomes modulate both systemic and anti-tumor immunity.”
Wargo and colleagues are working with the Parker Institute for Cancer Immunotherapy to develop a clinical trial that combines checkpoint blockade with microbiome modulation.
Research has shown that a person’s microbiome is a modifiable risk factor that can be targeted by diet, exercise, antibiotic or probiotic use or transplantation of fecal material, adds lead co-first author Vancheswaran Gopalakrishnan, PhD.
Wargo and colleagues note that there is still much to learn about the relationship between the microbiome and cancer treatment, so they urge people not to attempt self-medication with probiotics or other methods.
Sun Dermatology Launches Absorica Tracker App to Help Patients
Sun Pharma launched an Absorica Tracker App to help patients get the most out of their treatment. The interface is designed to help users to monitor their progress with Absorica (isotretinoin) treatment with features like medication and appointment reminders, monthly tips and checklists, and a progress tracker that uses a camera function and allows patients to take a photo of themselves at each step of their treatment journey.
Absorica is indicated for patients 12 years of age and older to treat severe recalcitrant nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. Absorica can cause serious side effects, including birth defects, and serious mental health problems. The Absorica Tracker App allows patients to monitor their treatment process, and understand the necessary elements for success.
The new Absorica Tracker App capabilities include:
• My Progress Tracker: Allows users to visually see how their skin is developing over time
• My Plan: Includes monthly tips and checklists to keep patients on track for success
• Medication Reminders: Used to remind patients to never miss a dose
• Appointment Reminders: Helps ensure that patients see their healthcare professional on time
• Medication Guide: Includes important information about ABSORICA
This product does not replace advice from healthcare professionals or any iPLEDGE requirements. Patients must take Absorica exactly as prescribed, and must follow all the requirements of the iPLEDGE Program.
This product does not replace advice from healthcare professionals or any iPLEDGE requirements. Patients must take Absorica exactly as prescribed, and must follow all the requirements of the iPLEDGE Program.
“In today’s mobile-centric world people are using their phones to track everything, from their steps to their food intake. The development of an App is useful to those who are willing to fully commit themselves to the ABSORICA treatment process,” said Dr. Hillary Baldwin, MD, a board-certified dermatologist. “The App was designed to support patients from start to finish and help them possibly achieve the more clear skin they desperately seek.”
The ABSORICA Tracker App is available for free download in the App Store or Google Play Store.
Take 5
with Bradford A. Conlan, Chief Executive Officer and Co-Founder of Bimini Technologies
Regenerative medicine is Bradford A. Conlan’s passion. As the co-founder and CEO of Bimini Technologies, the parent company of Puregraft and Kerastem, Mr. Conlan has spent much of his career bringing “regenerative therapies” from the bench to the bedside. Puregraft fat grafting is already a reality, and now Mr. Conlan is hopeful that Kerastem technology may harness the power of regenerative medicine to help reverse hair loss in a select group of individuals. Mr. Conlan spoke to Practical Dermatology® about the promise of this technology and what he hopes the future will bring.
Sweet Spot
“The majority of the hair loss market is focused on men with late stage hair loss, and men and women with early stage hair loss are often overlooked. Kerastem focuses on males with Grade I-III hair loss and females with grade I-II hair loss. These individuals are not eligible for hair transplants, and likely not adequately helped by topical or oral medications. We don’t treat hair transplant patients. Our product focuses on patients with early hair loss who are in between drugs and transplants. There may also be a role for Kerastem as polytherapy to augment hair transplants or medications in the future.”
One and Done
“We are a one-time autologous treatment. Patients walk in and get local anesthesia, and we remove 200cc’s of fat, place it in the Kerastem device, hit go, and then have a vial of cells that are injected into the scalp. These are adipose-derived regenerative cells that contain an abundant source of stem cells and growth factors. Our cells seem to reduce inflammation, create new blood supply, and reduce ischemic reperfusion injury to the hair follicle.”
Compelling Study Results
“We conducted a prospective, randomized, single-blind, multi-center trial of 70 male and female hair loss patients in the US that began enrollment in October 2016. There was a high-dose, low-dose, fat, and saline arm in this trial. We saw an 89 percent response rate at 24 weeks for the lower dose. We found that the dose really matters as the higher dose can have a negative effect. We now know for certain that the lower dose of 20 million cells works the best by far. We are incredibly encouraged by these results.”
Full-Blown PMA
“We are now going to run an approval trial and look forward to pursuing a full-blown pre-market approval (PMA) in the US. Kerastem will be regulated as a device and a biologic, and this may be the first regenerative medicine-based approval for hair loss. This means that treatment will be on label and it can be marketed as such to patients.”
Liposuction Upsell
“We are focusing on plastic surgeons first as they regularly perform liposuction, and Kerastem can be a nice liposuction upsell to the patient.”
