Now it can be told! VMX late-breaking research
AAD’s 2020 VMX presented the latest groundbreaking observations in four areas of research: Clinical Studies/Pediatric; Procedural Dermatology; Basic Science/Cutaneous Oncology/Pathology; and Clinical Trials. Presenters provided summaries of their research and these previously unpublished results offer critical data and information in recent investigations and clinical practice.
Late-breaking Research: Clinical Studies/Pediatric
Scott Elman, MD, resident in dermatology and internal medicine at Brigham and Women’s Hospital, shared his international group’s research (led by Drs. Joseph Merola and Victoria Werth) to create and validate the first-ever classification criteria for discoid lupus erythematosus (DLE). DLE is the most prevalent form of cutaneous lupus and one with a high burden on quality of life. To date, lack of classification criteria has led to problematic heterogeneity in clinical trials. “It is our hope that these first validated classification criteria for DLE will provide investigators with a foundation upon which to base observational and interventional trials, and a common language with which to communicate effectively about this patient population,” Dr. Elman said. His group looks forward to creating classification criteria for other subsets of cutaneous lupus moving forward.
Nevine A. Dorgham, MD, PhD, lecturer of dermatology at Cairo University, presented a research about “the effect of adding combined oral contraceptives or metformin to laser hair removal treatment on the quality of life of polycystic ovarian syndrome patients with hirsutism.” This research included a team of four dermatologists and one gynecologist to investigate 150 hirsute female patients with PCOS over one year treatment period, to evaluate whether laser hair reduction alone (1st group), combination with Metformin (2nd group) or COCP (3rd group) will give the best response. “Our results recommend doing hormonal profile for all hirsute patients, and also prefer using COCP pills along with LHR in hirsute female patients with PCOS, due to its great and sustained impact over treatment results and quality of life in such patients,” Dr. Dorgham said.
Michelle Hao, an MD candidate and research fellow under Mei Chen, MD, and David Woodley, MD, at the University of Southern California, presented the results of a pilot clinical trial investigating intravenous gentamicin therapy for recessive dystrophic epidermolysis bullosa (RDEB) patients. RDEB patients have severe skin fragility, mucocutaneous blistering, and compromised wound healing resulting from a deficiency of type VII collagen. The group is developing and optimizing intravenous gentamicin readthrough therapies to create new type VII collagen and improve wound healing as well as quality of life in RDEB patients with nonsense mutations. “About 30% of RDEB patients carry nonsense mutations, and intravenous gentamicin therapy may address the widespread erosions and systemic symptoms seen in these patients. We envision that intravenous gentamicin therapy may provide these patients with a novel, low cost, minimally-invasive and readily available therapy that can be administered intermittently to improve wound closure and skin fragility,” Hao said.
Amy Paller, MD, Walter J Hamlin professor and chair of dermatology at Northwestern University Feinberg School of Medicine, presented data from the study of dupilumab in children aged 6 to 12 years with severe AD, which was pivotal for the recent FDA approval of dupilumab for moderate-to-severe AD in this age group (Dupilumab Significantly Improves Atopic Dermatitis in Children Aged ≥6 to <12 years: Results From Phase 3 Trial (LIBERTY AD PEDS)). “In this study meaningful and statistically significant improvements were noted for the entire group, but weight made a difference in best dosing,” Dr. Paller said. “Children weighing <30 kg responded best to 300 mg every 4 weeks of dupilumab and children >30 kg to 200 mg every 2 weeks.”
In a separate presentation, Dr. Paller shared her data from an exploratory Phase 1 trial of the first topical gene therapy for lamellar ichthyosis (First in Human use of a Novel In Vivo Gene Therapy for the Treatment of Autosomal Recessive Congenital Ichthyosis: Results of a Phase I/II Placebo Controlled Trial). “Topical application of multiple copies of the TGM1 gene (coding for the missing transglutaminase 1 protein) in a non-integrating, non-replicating viral vector led to expression of functional transglutaminase 1 protein in its proper position in epidermis without any evidence of toxicity,” Dr. Paller said. “If future studies continue to be promising, a once weekly application of the medication could turn around the highly visible scales and erythema of lamellar ichthyosis.”
In her late-breaking presentation on the longest longitudinal study of skin microbiome evolution in infants and mothers, Kimberly Capone, PhD, Head of Microbiome Platform, Johnson & Johnson Consumer Health, said, “This study provides strong evidence of the evolving nature of our skin microbiome, how that relates to skin barrier development, and offers important insights for product use and development. For infants and young children, we want to ensure that we can protect their skin, and as it matures, help it be resilient and prevent skin conditions.”
Adam Reich, MD, PhD, professor of dermatology at the University of Rzeszów in Rzeszów, Poland, presented the first results on the efficacy and safety of 2 secukinumab dosing regimens in pediatric patients with moderate-to-severe plaque psoriasis in an ongoing, randomized, multicenter, open-label study (NCT03668613). Patients aged 6 to < 18 years with moderate-to-severe plaque psoriasis were stratified at baseline by weight and randomized 1:1 to receive subcutaneous secukinumab at low or high relative dose. Patients receiving either dose of secukinumab experienced rapid clearance of psoriatic lesions, as evidenced by increasing PASI75, PASI90, PASI100, and IGA 0/1 response rates through week 12. Along with improved skin clearance, patients in both treatment arms also experienced improved quality of life through week 12. “Preliminary results of this ongoing 4-year study indicate that secukinumab is highly efficacious in rapidly clearing lesions in pediatric patients with moderate-to-severe plaque psoriasis,” he said. “Importantly, the safety of secukinumab that we observed in these pediatric patients appears consistent with that previously observed in adults.” A second phase 3 trial comparing secukinumab with placebo and etanercept in pediatric patients is currently ongoing (NCT02471144), with initial results expected soon.
Late-breaking Research: Procedural Dermatology
Enzo Berardesca, MD, from the University of Miami, presented research showing that a cosmetic cream containing 4% capryloyl glycine applied BID for a few months can contrast unwanted hair growth in women. The study has been performed on 69 healthy female subjects and hair growth quantified with Thrichoscan software. Total hair density, terminal hair density, and vellus hair density showed statistically significant differences (p<0.001) during the 4 months treatment. “The treatment resulted as a safe alternative to traditional methods to be used alone or in combination with other techniques to reduce unwanted hair,” Dr. Berardesca said.
Elizabeth Tanzi, MD, director of Capital Laser & Skin Care, revealed the results of a prospective, multi-center pivotal clinical trial involving 62 participants to evaluate the safety and effectiveness of Soliton’s Acoustic Subcision device for the temporary improvement of the appearance of cellulite. A panel of independent blinded physicians (n=3) assessed pre- and 12-week post-treatment photos. The panel’s scoring showed a mean reduction in the 6-point simplified Cellulite Severity Scale (CSS) of 1.16 representing a 32.5% improvement from the baseline CSS scores. Additionally, 85% of the treated cellulite sites were graded as improved, much improved or very much improved using a Global Aesthetic Improvement Scale. Without anesthesia, the participants rated the pain during treatment an average of 2.4 (0 to 10 scale with 0 being no pain). No unexpected or serious adverse events were reported. “Soliton’s RAP is a non-invasive procedure that requires no downtime and the results continue to improve for months after the treatment,” Dr. Tanzi said. “I believe patients are looking for a simple, safe and effective answer to cellulite, and this Acoustic Subcision device appears to provide that.”
The dermatologic surgery group at the University of Pennsylvania investigated the frequency of synchronous skin cancers in the operative zone of an index skin cancer. Leora Aizman, BS, dermatology oncology clinical research fellow, shared their findings that 53.5% of patients presenting for Mohs micrographic surgery had a synchronous skin cancer within 5 cm of the index skin cancer and, of these patients, 35.1% required treatment alterations that impacted surgical or reconstructive management of the index lesion. “Neighboring synchronous cancers are common in chronically sun-damaged skin and important to detect and diagnose before initiating skin cancer surgery,” Aizman said.
Patricia Froes Meyer, PhD, explained the mechanism of thermal action of microfocused ultrasound and the production of neocolagen. The effects of this technique were analyzed through histology, immunohistochemistry, and clinical results. Thirty volunteers were treated with just one application and analysis after 45 days. There was an increase in the amount of fibroblasts, blood vessels, and inflammatory cells, in addition to the production of type 1 collagen, phagocytosis of adipose tissue, and presence of fibrosis. The clinical results also confirmed the lifting effect at 45 and 90 days.
Banu Farabi, MD, dermatology resident at Ankara University School of Medicine in Turkey, shared her study focusing on treating patients with infraorbital dark circles with combined micro-needling and trichloroacetic acid 10% compared with CO2 laser therapy. “Combination of micro-needling and 10% trichloroacetic acid peels resulted in significant improvement in infraorbital dark circles with minimal adverse effects compared to CO2 laser,” Dr. Farabi said. “The combination of trichloroacetic acid 10% and micro-needling showed encouraging results on improving periorbital hyperpigmentation within 4 weeks and seems like a cost-effective and quick office procedure.”
According to recent research, “medium depths caustic agents can be safely used for treating patients with skin of color,” said Frans Maruma, MD, Mmed, DipHivMed, AAAM, FC-Derm, a senior lecturer and research fellow at the University Of Free State, South Africa. In his quasi-experimental research, participants with melasma attained significant improvement from baseline MASI scores following a sequential Trichloroaceticacid-based chemical peeling protocol with no major adverse events reported. “With further research, medium depth chemical peels could see a comeback as part of the therapeutic armament for dyschromias affecting the skin of color,” Dr. Maruma said.
Jeremy B. Green, MD, of Skin Associates of South Florida/Skin Research Institute presented interim data for the first study of DaxibotulinumtoxinA for Injection (DAXI) in the treatment of dynamic forehead lines (FHL) in conjunction with glabellar lines (GL). The study enrolled 60 patients who were first treated with DAXI for GL and, two weeks later, were treated for FHL with one of four escalating doses of DAXI. Patients were followed for up to 38 weeks. Four weeks after DAXI injection in the frontalis muscle there was a statistically significant improvement in the appearance of FHL at all studied doses. “The forehead is the most challenging location for botulinum toxin injections, as to achieve an aesthetically appealing appearance at onset, we often concede duration of effect,” Dr. Green stated. “Based on our findings, DAXI is safe and effective and substantially improved the appearance of FHL at all doses tested.”
Late-breaking Research: Basic Science/Cutaneous Oncology/Pathology
Surya Ravichandran, a third-year medical student at Duke University School of Medicine, presented research on the impact of body parameters on the efficacy and toxicity of PD-1 inhibitor, pembrolizumab, for the treatment of advanced melanoma. Sarcopenia, which is defined as muscle failure due to adverse changes that accrue across a lifetime, as well as body mass index (BMI) were the body parameters used to assess efficacy and toxicity differences. “Sarcopenia was not predictive of efficacy or toxicity associated with pembrolizumab treatment of patients with advanced melanoma,” Ravichandran said. “However, BMI, a routinely measured and readily available baseline patient characteristic, was associated with treatment-limiting toxicity.” Knowledge that patients with higher BMI are at higher risk of treatment-related toxicity may help inform clinical decision-making and provide anticipatory guidance when choosing the right therapy for an individual patient.
During his late-breaking presentation “Beyond PASI 100,” Andrew Blauvelt, MD, MBA, lead investigator of the VOYAGE 1 trial and President of Oregon Medical Research Center, shared results from a sub-analysis of VOYAGE 1 & 2 data that compared symptoms and molecular findings in psoriasis patients achieving clear skin with either guselkumab or adalimumab. Patients with clear skin on guselkumab had fewer symptoms, better quality of life, and more normalization of aberrant gene expression in skin when compared to patients with clear skin on adalimumab. A subset of psoriatics demonstrated persistent molecular dysregulation in skin that was associated with persistent symptoms. These findings suggest that unresolved abnormal gene expression, or the “molecular scar” of psoriasis, in cleared lesional skin may account for persistence of psoriasis-associated symptoms. “Importantly, clearing skin with drugs utilizing different mechanisms of action may lead to differential consequences for patients,” Dr. Blauvelt said.
Juliana Berk-Krauss, MD, dermatology resident at SUNY Downstate, in collaboration with researchers at NYU Grossman School of Medicine, its Perlmutter Cancer Center, and Harvard University, shared their study that identified the largest yearly declines in deaths due to melanoma ever recorded. Their data showed that death rates among white Americans — the group that accounts for almost all cases of melanoma — climbed 7.5% between 1986 and 2013, but then dropped by nearly 18% over the next three years. This trend was observed despite an ongoing increase in melanoma incidence. The authors propose that a decline of this magnitude — not seen in other common cancers, such as prostate, breast, or lung — is likely due to the introduction of 10 new therapies for advanced melanoma over the last decade. According to co-senior study author David Polsky, MD, PhD, “Because these therapies profoundly reduce deaths from melanoma, they are now considered the backbone of how we treat this cancer.”
Nikolai Klebanov, MD, an incoming dermatology resident at the Harvard Combined Dermatology Residency Program in Boston, shared his research on how gene expressions of tumor necrosis factor (TNF), and interleukins (IL)17 and IL23 in tumor samples correlate with survival in patients with different types of malignancies. Dr. Klebanov worked with Lourdes Perez-Chada, MD, MMSc, clinical research fellow, and Joseph Merola, MD, MMSc, vice chair of clinical trials and innovation and associate professor at Harvard Medical School, to analyze data in The Cancer Genome Atlas (TCGA) linking expression of genes in tumors measured with RNA-Seq to eventual patient survival outcomes. “We found relatively few associations that could potentially be harmful for survival,” Dr. Klebanov said. “On a purely mechanistic level, these data seem to support the theoretical safety of TNF, IL17, and IL23 inhibitor use in patients with active or recent malignancy, which is an area of great unmet need in psoriasis research. Further work is needed to explore the genetic effects of immunomodulator medications on cancer outcomes.”
Late-breaking Research: Clinical Trials
Mark Lebwohl, MD, chairman of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, presented the results of a study of roflumilast, a potent PDE4 inhibitor, in the topical treatment of psoriasis. Roflumilast cream was studied in a three-arm, double-blind placebo-controlled trial: 0.3% cream was compared to 0.15% cream or vehicle applied once daily for 12 weeks. The primary endpoint was defined as clear or almost clear skin and at least 2 grades of improvement on an investigator global assessment scale of 0 – 4 at week 6. There was significant improvement as early as week 2 and significant dose-related improvement at the primary endpoint. Improvement increased further at week 8 and continued through week 12. In intertriginous sites which were studied separately, 85.7% of patients achieved clear skin at week 8, and over 90% achieved clear skin at week 12. There was also rapid improvement in itch. Topical roflumilast was well tolerated and this study proved that topical PDE4 inhibition is an effective way to treat psoriasis. “Topical roflumilast represents a novel nonsteroidal therapy that is highly effective and safe even on steroid-sensitive areas,” Dr. Lebwohl said.
Gil Yosipovitch, MD, a dermatologist at the University of Miami Miller School of Medicine, presented findings on the efficacy and safety of oral difelikefalin (DFK) in patients with chronic kidney disease-associated pruritus (CKD-aP). CKD-aP is a common and burdensome condition for which there are no FDA-approved treatments. In a recent phase 3 study, intravenous DFK demonstrated efficacy and was well tolerated in patients with CKD-aP undergoing hemodialysis. Dr Yosipovitch’s results were from the first randomized, phase 2, dose-ranging study of oral DFK in patients with stage 3-5 CKD, most of whom were not on hemodialysis. Oral DFK 1.0 mg met the primary endpoint, demonstrating significantly greater improvement from baseline at week 12 in the weekly mean of the daily Worst Itching Intensity Numerical Rating Scale scores versus placebo. “Significantly greater improvements were observed as early as week 2 and maintained through week 12,” Dr. Yosipovitch said. “Oral DFK was generally well tolerated, with a safety profile consistent with intravenous DFK. The 1.0-mg DFK oral dose was identified as the optimal dose and will be evaluated in phase 3 trials in patients with CKD-aP.
Dedee Murrell, MD, presented new positive data from the Phase 2 Part B open-label trial in pemphigus, BELIEVE-PV, demonstrating clear dose response with decreased daily corticosteroid usage. The study also demonstrated a response rate increased with duration of treatment to six months while maintaining a favorable safety profile. “The significance of this Phase 2 Part B trial is that rilzabrutinib, a reversible covalent oral BTK inhibitor, demonstrated a 40% complete remission (CR) rate after 24 weeks of treatment while the median corticosteroid (CS) dose was reduced to 6 mg. It is also very encouraging to see that 60% and 87% of patients achieved control of disease activity (CDA) — the primary endpoint — by the 4th and 12th week, respectively, which is unusually fast,” said Dr. Murrell, who is professor and head of the department of dermatology at The St. George Hospital Clinic School, University of New South Wales in Sydney, Australia, and the principal investigator of the ongoing PEGASUS Phase 3 trial.
Melinda Gooderham, MD, SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, Ontario, Canada, presented efficacy and safety results from JADE MONO-2, the second abrocitinib monotherapy study in patients aged 12 years and older with moderate-to-severe atopic dermatitis. This randomized, double-blind, placebo-controlled, phase 3 study was designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy. The co-primary end points were an IGA score of clear (0) or almost clear (1) skin (with improvement of ≥ 2 grades from baseline) at Week 12 and at least 75% improvement in EASI score at Week 12. The key secondary endpoint was the proportion of patients achieving Peak Pruritus Numerical Rating Scale response (improvement of ≥ 4 points from baseline) at Weeks 2, 4, and 12. The proportion of patients who achieved an EASI-90 response was also included. Safety was assessed via incidence of adverse events and laboratory monitoring. Dr. Gooderham noted that “The results of the study showed that abrocitinib significantly improved signs and symptoms in patients with moderate-to-severe atopic dermatitis, including for itch — one of the most bothersome symptoms of AD — and was generally well tolerated.”
In his recently published late-breaking abstract, James V. Cassella, PhD, from Concert Pharmaceuticals described new efficacy analyses and positive results from a Phase 2 dose-ranging study of its oral Janus Kinase inhibitor, CTP-543. Using more stringent response criteria, these analyses showed that following 24 weeks of treatment, patients with moderate-to-severe alopecia areata had dose-related and clinically meaningful improvement in hair regrowth. “With the large unmet need for patients suffering from alopecia areata, these significant and highly encouraging results provide a firm foundation for advancing CTP-543 into pivotal Phase 3 testing,” Dr. Cassella said.
Tomoko Fujimoto, MD, director of Ikebukuro Nishiguchi Fukurou Dermatology, Japan, presented Phase 3 Pivotal study results for sofpironium bromide gel. The study confirmed the efficacy and safety of sofpironium bromide gel, 5%, administered for 6 weeks in 281 Japanese patients with primary axillary hyperhidrosis. All primary and secondary efficacy endpoints in the study were met and achieved statistical significance. “With these new findings, sofpironium bromide gel has the potential to be widely used as the first-line drug for treatment of primary axillary hyperhidrosis in Japan, contributing to quality of life improvement of many currently suffering patients,” Dr. Fujimoto said.
Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, D.C., presented the results of a 32-week Phase 3 trial evaluating the use of tralokinumab evert 2 weeks with concomitant topical corticosteroid (TCS) in adults with moderate-to-severe atopic dermatitis (AD). Tralokinumab is an investigational fully human monoclonal antibody that specifically targets IL-13, a key driver of inflammation in AD. Significantly more patients achieved the primary end-points clear or almost clear skin (IGA 0/1) or EASI 75 (75% improvement in extent and severity of lesions) with tralokinumab + TCS vs. placebo + TCS at week 16. A high proportion (90%) of week 16 responders randomized to continue with tralokinumab Q2W, maintained the response at week 32. A similarly high proportion maintained response when randomized to continue with tralokinumab Q4W. The overall frequency of AEs was comparable to placebo over 32 weeks. “Tralokinumab plus TCS demonstrated significant improvements in measures of overall disease severity, skin clearing, itching, and quality of life over TCS alone. We are encouraged by the high level of sustained response seen in this patient population,” Dr. Silverberg said.
Kenneth Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee, presented the first results from the BE READY phase 3 study, which evaluated efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, in patients with moderate-to-severe plaque psoriasis. This pivotal 56-week, double-blinded, placebo-controlled, randomized withdrawal trial met both its co-primary endpoints, reporting superior PASI 90 and IGA 0/1 responder rates compared to placebo after 16 weeks of treatment with bimekizumab (90.8% and 92.6% vs 1.2% and 1.2%), alongside high response levels after one dose and high Week 16 PASI 100 responder rates (68.2%). High response levels were maintained in Week 16 PASI 90 responders who continued to receive bimekizumab every 8 weeks (PASI 90 at Week 56: 91.0%) or every 4 weeks (86.8%). “The high levels of skin clearance seen in this trial, even after a single dose, accompanied by outstanding durability of these responses over one year, suggest that bimekizumab could provide a truly meaningful difference for patients,” Dr. Gordon said. “These results are further validated by those presented by Professor Kristian Reich, from the BE VIVID ustekinumab comparator trial.”
Eric Simpson, MD, MCR, professor in the department of dermatology at Oregon Health and Science University in Portland, presented the results of two similarly designed Phase 3 trials, investigating the efficacy and safety of tralokinumab, an investigational, fully human monoclonal antibody specifically inhibiting IL-13, in 1596 adults with moderate to severe atopic dermatitis (AD) over 52 weeks. In both studies, tralokinumab demonstrated superiority over placebo in all primary and secondary endpoints at week 16. Significantly more patients achieved clear or almost clear skin (IGA 0/1) or EASI 75 (75% improvement in extent and severity of lesions) with tralokinumab Q2W at week 16. Significant and early improvements were also seen in all key secondary outcomes including itch and quality of life measures. For those achieving response at week 16, the majority of patients randomized to continue with tralokinumab Q2W maintained the response at week 52 without any TCS. The overall frequency of AEs was comparable to placebo over 52 weeks. “We need more long-term treatment options for patients with moderate-to-severe AD,” Dr. Simpson said. “These Phase 3 results with tralokinumab are the first presented in AD for a biologic that specifically targets IL-13, which is suggested to be a primary effector cytokine driving inflammation in AD.”
Christoph Abels, MD, PhD, medical director of Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany, reported the outcome of the Phase 3a study confirming efficacy of a 1% glycopyrronium bromide (GPB) cream, in primary axillary hyperhidrosis, following 4 weeks of once-daily application. In addition, the safety of the 1% GPB cream was very good, only view Adverse Drug Reactions occurred that were primarily mild to moderate in severity. “The significant reduction of sweat production together with the patient-reported outcome measures, HDSS and HidroQoL, confirmed the very good efficacy and demonstrated significantly improved quality of life for patients suffering from primary axillary hyperhidrosis,” said Dr. Abels, adding that the long-term open-label study over 72 weeks will gather further efficacy and safety data to support these placebo-controlled results and to allow for application of market authorization in the EU.
Kirstine Belongie, PhD, MSc, from Mitsubishi Tanabe Development Pharma America presented top line phase 2 data on oral selective melanocortin-1 receptor agonist MT-7117. The compound was superior to placebo in reducing light-associated pain symptoms in patients with erythropoietic protoporphyria (EPP) and X-Linked Protoporphyria (XLP) at 16 weeks. “In EPP/XLP, oral MC1R agonist (MT-7117) demonstrated onset of effect within a few weeks that was significantly improved by six weeks,” Dr. Belongie said.
Richard B. Warren, MD, PhD, professor and honorary consultant dermatologist at the Dermatology Centre Salford Royal NHS Foundation Hospital, University of Manchester, shared data from the IMMerge Phase 3 open-label study evaluating adult patients with moderate to severe plaque psoriasis. The study showed risankizumab demonstrated superiority to secukinumab meeting the primary and secondary endpoints at week 52. “These new data are critical as they underscore that lasting, complete skin clearance is a realistic treatment goal for people living with psoriasis,” Dr. Warren said.
Kristian Reich, MD, PhD, Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany, presented late-breaking research reporting first results from the BE VIVID phase 3 study of bimekizumab, an IL 17A and IL-17F inhibitor, in patients with moderate-to-severe plaque psoriasis. This pivotal 52-week, randomized, double-blinded, active comparator- and placebo controlled trial met its co-primary and secondary endpoints; significantly more patients achieved PASI 90 and IGA 0/1 with bimekizumab at Week 16 than with placebo or ustekinumab. Responses were durable; 81.6% of bimekizumab-treated patients achieved PASI 90 at Week 52 compared to 55.8% with ustekinumab. Bimekizumab-treated patients also had significantly higher PASI 100 responder rates at Weeks 16 (58.6%) and 52 (64.2%) compared to ustekinumab (20.9% and 38.0%). “Bimekizumab treatment led to rapid, durable complete skin clearance, demonstrating superior levels of clinical responses compared to ustekinumab and placebo after 16 weeks and compared to ustekinumab over one year,” Dr. Reich said. “Together with the results of the BE READY study, presented by Professor Gordon, this strengthens our belief in bimekizumab’s potential to raise the bar for achieving long-lasting clear skin for people living with psoriasis.”
The first biologic trial for pityriasis rubra pilaris (PRP) was presented by Teri Greiling, MD, PhD, assistant professor of dermatology at Oregon Health & Science University. The investigator-initiated single arm trial treated 12 subjects with moderate-to-severe PRP with ixekizumab for 24 weeks, with promising results. “Treatment with ixekizumab for 24 weeks was associated with a mean reduction in PASI from 24.8 to 9.7, and a median reduction in DLQI from 18 to 3,” reported Dr. Greiling. “No serious or unexpected adverse events occurred during the trial. Furthermore, the subjects with the highest reduction in PASI remained clear at week-36, with no recurrence of disease off therapy.” She added that subjects had a mean reduction in dermal expression of IL-17A, providing further evidence for the role of the Th17 pathway in PRP.