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Psoriasis: Amgen Biosimilar Candidate Compared Favorably To Humira in Phase 3 Study

Richard Markus MD PhD Amgen Executive Medical Director Global Development and Medical AffairsDermatologistsBlog.com Interview with:
Richard Markus MD PhD
Amgen Executive Medical Director
Global Development and Medical Affairs

 


DermatologistsBlog.com: What are the main findings of the study?

Dr. Markus: This was a head to head  double-blind study against Humira® (adalimumab) that evaluated safety and efficacy of ABP 501 compared to adalimumab in adult patients with moderate to severe plaque psoriasis. The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment and we are pleased to announce that we met our primary endpoint. The PASI percent improvement from baseline to week 16 was within the predefined equivalence margin. Additionally, the safety and immunogenicity were comparable for ABP 501 and adalimumab.

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Melanoma: Neuropilin-2 Gene Expression Correlates With Malignant Progression

Byungwoo Ryu, PhD. Assistant Professor of Dermatology Director of Biomarker Research Program Boston University School of Medicine 609 Albany Street, J-502 Boston, MA 02118DermatologistsBlog.com Interview with
Byungwoo Ryu, PhD.
Assistant Professor of Dermatology
Director of Biomarker Research Program
Boston University School of Medicine
609 Albany Street, J-502
Boston, MA 02118
DermatologistsBlog: What are the main findings of the study?

Dr. Ryu: We performed a retrospective correlation study of Neuropilin-2 (NRP2) expression with malignant progression using small cohorts of FFPE melanoma tissue samples in order to evaluate potential value of the NRP2 as a prognostic marker for cutaneous melanoma.   We used a unique qRT-PCR assay technique that we developed for the quantitative measurement of gene expression in the FFPE tissue specimens and we found that:

1) NRP2 expression levels are positively correlated with disease progression;

2) There is a positive correlation between NRP2 expression and Breslow depth in a group of primary melanoma tissue samples.

These findings suggest NRP2 may be a useful biomarker for malignant progression of melanoma and may be a useful tool for the early identification of melanoma patients at high risk of metastasis.
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Comparing Spitzoid with Conventional Malignant Melanoma

Rossitza Lazova, MD Associate Professor of Dermatology and Pathology Director, Dermatopathology Fellowship Yale Dermatopathology Laboratory New Haven, CT 06520-8059DermatologistsBlog.com Interview with:
Rossitza Lazova, MD
Associate Professor of Dermatology and Pathology
Director, Dermatopathology Fellowship
Yale Dermatopathology Laboratory
New Haven, CT 06520-8059

DermatologistsBlog: What are the main findings of the study?

Dr. Lazova: We compared clinicopathologic characteristics and mortality risk associated with Spitzoid malignant melanoma (SMM) and conventional malignant melanoma (CMM). Our study included 30 patients diagnosed with SMM and 30 patients with CMM matched by age, gender, and Breslow thickness. The presence of solar elastosis differed significantly between the two groups (p<0.0001) and was observed more commonly in association with conventional malignant melanoma. No significant differences were observed for pre-biopsy clinical impression, anatomic location, mitotic rate, or presence of ulceration. Mortality risk did not differ between SMM and CMM.

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Indoor Tanning: What is International Prevalence?

Eleni Linos, MD, DrPH Department of Dermatology, University of California, San FranciscoDermatologistsBlog.com Interview with:
Eleni Linos, MD, DrPH
Department of Dermatology,
University of California, San Francisco

 

DermatologistsBlog.com: What are the main findings of the study?

Dr. Linos: We found that 35% of adults report they have used indoor tanning at some point in their lives, and 13% report they have used indoor tanning in the past year. 17% of teenagers in the US report they have ever used indoor tanning, 10% have used it in the past year. Also, we estimated over 450,000 new cases of skin cancer attributable to indoor tanning each year in the regions examined. This number is alarming. To put this number into context,we show that the number of skin cancer cases due to indoor tanning is higher than the number of lung cancer cases due to smoking in the same regions. Clearly, the mortality associated with lung cancer is far greater than that for skin cancer, and smoking causes many other health risks. However, this number of potentially preventable cancers is striking.

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Melanoma: Genetic Tumor Markers Can Predict Response Ipilimumab Treatment

Dr. Ahmad Tarhini, MD, PhD Associate Professor of Medicine, Clinical and Translational Science Department of Medicine Division of Hematology/Oncology University of PittsburghDermatologistsBlog.com Interview with:
Dr. Ahmad Tarhini, MD, PhD
Associate Professor of Medicine, Clinical and Translational Science
Department of Medicine
Division of Hematology/Oncology
University of Pittsburgh

DermatologistsBlog.com: What are the main findings of the study?

Dr. Tarhini: In evaluating the patients’ tumors at baseline (before initiating treatment with ipilimumab), we found that the differential expression of a relatively small group of genes that can be characterized as being immune related can significantly distinguish patients who benefited from ipilimumab immunotherapy versus those who did not.
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Melanoma Survival Decreased in Men Living Alone

DermatologistsBlog.com Interview with:
Hanna Eriksson, MD, PhD
Department of Oncology and Pathology
Karolinska Institutet, Karolinska University Hospital
Stockholm. Sweden;

DermatologistsBlog.com: What are the main findings of the study?

Dr. Eriksson: We found that men living alone have a decreased survival in cutaneous malignant melanoma as compared to men living with a partner even after full adjustments including age, level of education and histopathologic prognostic factors. This was in part explained by more advanced stages of disease at diagnosis for men living alone

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Melanoma: Longer Telomeres May Explain Some Familial Predisposition

Carla Daniela Robles-Espinoza, PhD student Experimental Cancer Genetics Wellcome Trust Sanger Institute Hinxton, UKDermatologistsBlog.com Interview with:
Carla Daniela Robles-Espinoza, PhD student
Experimental Cancer Genetics
Wellcome Trust Sanger Institute
Hinxton, UK

DermatologistsBlog.com: What are the main findings of the study?

Answer: Approximately 40% of familial melanoma cases can be explained by rare variants in a handful of genes, such as CDKN2A, CDK4, TERT and BAP1, but the causes of more than half of familial cases still remain unexplained. Here we set out to identify new high-penetrance susceptibility genes by sequencing the DNA of 184 melanoma patients that do not have mutations in these genes. We identified some families in which the gene POT1 is deactivated by specific mutations, leading to increased telomere length in carriers. This suggests that these variants predispose to melanoma formation via a direct effect on telomeres, the regions that protect our chromosomes from damage.
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Psoriasis: UV Light Treatment Did Not Diminish Systemic Markers of Inflammation

Plaque Type Psoriasis

DermatologistsBlog.com Interview with:
Dr. Charlotta Enerbäck MD, PhD
Ingrid Asp Psoriasis Research Center
Department of Clinical and Experimental Medicine, Linköping University
Linköping, Sweden.

DermatologistsBlog.com: What are the main findings of the study?

Dr. Enerbäck: We observe an increase in the plasma levels of several markers associated with cardiovascular risk in psoriasis patients. Several of these markers correlate with BMI and WHR and are therefore most likely the result of the increased prevalence of the metabolic syndrome in patients with psoriasis. The levels of the markers were effectively diminished by treatment with the TNF-α inhibitor but they were not reduced by UVB treatment. This lack of reduction in cardiovascular risk markers after UV therapy suggests that this commonly used treatment might have a limited effect on the systemic inflammation and risk of cardiovascular co-morbidities in psoriasis. It also suggests that, in addition to alleviating psoriasis symptoms, systemic treatment with TNF-α inhibitors might also serve to reduce the risk of cardiovascular co-morbidities seen in psoriasis patients.
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Both Invasive and In-Situ Melanomas Raise Risk of Second Melanoma

Danny Youlden BSc Biostatistician Queensland,AustraliaDermatologistsBlog.com Interview with:
Danny Youlden BSc
Biostatistician
Queensland,Australia


DermatologistsBlog.com: What are the main findings of the study?

Answer: We found that all people who have been previously diagnosed with melanoma, whether it be invasive or in situ, had a significantly increased relative risk of a subsequent primary invasive melanoma – five and a half times higher following a first primary invasive melanoma and four and a half times higher after an in situ melanoma.  Another main finding was that the greatest relative risk tended to occur on the same part of the body as the original lesion, particularly when the first melanoma was on the head.  However, the relative risk remained elevated irrespective of body site, sex, age at first diagnosis and time between diagnoses.
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Toenail Fungus: No Improvement with Laser Treatment

dr_tyler_hollmig
DermatologistsBlog.com Interview with:

S. Tyler Hollmig, MD
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
As of September 2014:
Assistant Professor and Director of Cosmetic Dermatology, Stanford

DermatologistsBlog.com: What are the main findings of the study?

Dr. Hollmig: The potential utility of lasers for treating toenail fungus has been a hot topic in dermatology over the past number of years.  Many podiatrists and physicians already use lasers in this capacity despite a lack of strong evidence in favor of treatment efficacy.  We sought to evaluate the clinical and mycological clearance of toenails treated with 1064-nm neodymium:yttrium-aluminum-garnet laser versus no treatment via a randomized, controlled trial.  Our study found no significant mycological culture or clinical nail plate clearance with 1064-nm neodymium:yttrium-aluminum-garnet laser compared with control.

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HPV: Computerized Image Analysis May Distinguish Potentially Progressive Disease

Dr. Anant Madabhushi MD Associate Professor and Director of the Center for Computational Imaging & Personalized Diagnostics Case Western University Cleveland, OhioDermatologistsBlog.com Interview with:
Dr. Anant Madabhushi MD
Associate Professor and Director of the Center for Computational Imaging & Personalized Diagnostics
Case Western University
Cleveland, Ohio

DermatologistsBlog.com: What are the main findings of the study?

Dr. Madabhushi: Computerized image analysis of HPV associated head and neck tumor tissue specimens allows for discriminating between patients who go on to have disease progression versus those who do not.
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Rosacea: Systemic Safety Profile of MIRVASO Gel

Nathalie Wagner Clinical Pharmacokinetics manager Interview with: Global clinical development Galderma R&D – Sophia Antipolis/FranceDermatologistsBlog.com with:
Nathalie Wagner
Clinical Pharmacokinetics manager Interview with:
Global clinical development
Galderma R&D – Sophia Antipolis/France

DermatologistsBlog.com: What are the main findings of the study?

Answer: The important outcome of our study is  the pharmacokinetic evidence supporting the good systemic safety profile of MIRVASO gel, the first treatment approved in the USA for facial erythema of rosacea.

This study is the first published maximal usage PK trial for a topical dermatological product. The objectives of this trial were:

-       To evaluate the systemic exposure under conditions that would maximize the potential for brimonidine absorption, in a manner that is consistent with Instructions for use of the product.

-       To compare this systemic exposure to the one observed with normal use of brimonidine tartrate ophthalmic solution, approved by the FDA in 1996 under the brand name of “Alphagan”

This study demonstrated that the brimonidine blood levels are low, in the pg/mL range, and that there is no systemic accumulation over time with daily use. Furthermore, the systemic exposure to brimonidine under maximal usage conditions of MIRVASO gel is significantly lower than the systemic levels observed with the approved ophthalmic solution (brimondine tartrate 0.2%).

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