Treatment With Tremfya® (Guselkumab) Improved Psoriatic Arthritis Symptoms Through One Year

MedicalResearch.com Interview with:

Atul A. Deodhar, MD, MRCP, FACP, FACR Professor of Medicine Division of Arthritis & Rheumatic Diseases Medical Director, Rheumatology Clinics Medical Director, Immunology Infusion Center Oregon Health & Science University (OHSU) 

Dr. Deodhar

Atul A. Deodhar, MD, MRCP, FACP, FACR
Professor of Medicine
Division of Arthritis & Rheumatic Diseases
Medical Director, Rheumatology Clinics
Medical Director, Immunology Infusion Center
Oregon Health & Science University (OHSU) 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Phase 2, randomized, double-blind, placebo–controlled, multicenter trial was designed to evaluate the efficacy and safety of guselkumab (Tremfya®) compared with placebo in adults with active psoriatic arthritis, despite having received treatment with standard-of-care therapies, including anti-tumor necrosis factor (TNF)-alpha agents.

In an observed analysis presented at ACR 2017, more than 70 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 56.  Findings also showed that improvements in tender and swollen joints, skin clearance, pain and physical function, and patient-reported quality of life outcomes reported at week 24, were maintained through week 56 in patients receiving guselkumab maintenance therapy (subcutaneous injections every eight weeks).  Continue reading

Severe Psoriasis Linked To Increased Risk of Mortality

MedicalResearch.com Interview with:

Megan H. Noe MD, MPH Clinical Instructor and Post-Doctoral Research Fellow University of Pennsylvania, Department of Dermatology Perelman Center for Advanced Medicine Philadelphia, PA 19104

Dr. Megan Noe

Megan H. Noe MD, MPH
Clinical Instructor and Post-Doctoral Research Fellow
University of Pennsylvania, Department of Dermatology
Perelman Center for Advanced Medicine
Philadelphia, PA 19104

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previous research has shown that patients with psoriasis have higher rates of hypertension, diabetes, cardiovascular disease and chronic kidney disease that may put them at an increased risk of death.

Our research found that patients with psoriasis covering more than 10% of their body had almost double the risk of death than people of the same age with similar medical conditions, but without psoriasis.

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Cardiovascular Events Rise With Increased Duration of Psoriasis

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD Gentofte Hospital Department of Dermatology and Allergy Kildegårdsvej 28 2900 Hellerup Denmark 

Dr. Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Kildegårdsvej 28
2900 Hellerup
Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The majority cardiovascular events in psoriasis occur in patients at low risk by traditional cardiovascular risk calculators. It has been speculated that long-term exposure to systemic inflammation may increase the risk of adverse cardiovascular outcomes. Therefore, clinically available historical features such as disease duration may identify those at higher risk for cardiovascular disease.

Using a translational epidemiological approach, combining 18F-fluorodeoxyglucose positron emission tomography computed tomography scanning with nationwide epidemiological data of more than four million individuals, we provide the first convincing evidence to suggest a detrimental effect of psoriasis duration on cardiovascular disease beyond traditional cardiovascular risk factors, even in patients deemed “low-risk” by conventional risk scores. We found a 1% increase in future major adverse cardiovascular event risk per additional year of disease duration. This finding has an effect size similar to smoking, a well-established cardiovascular risk factor.

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Secukinumab Provides Sustained Improvements in Dermatology-Specific Quality of Life in Moderate to Severe Psoriasis Patients Through 3 Years of Treatment

MedicalResearch.com
Eric Hughes
Global Development Franchise Head Immunology & Dermatology
Novartis

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI).

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire.

SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated.

The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort.

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Secukinumab (Cosentyx) Provides Greater Improvement in Quality of Life, Work Productivity, and Daily Activity Than Ustekinumab (Stelara) in Moderate To Severe Psoriasis

MedicalResearch.com Interview with:
Eric Hughes, Global Head of Development, Immunology & Dermatology

Novartis Pharma AG
Basel, Switzerland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well established that psoriasis negatively affects quality of life and work productivity. However, how the treatments affect psoriasis severity (based on skin clearance, itch, pain and scaling symptoms), health-related quality of life (HRQOL), work productivity, and daily activity directly or indirectly (via other factors) are still largely unknown.

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis, and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

In CLEAR, a Phase 3b head-to-head study versus ustekinumab, secukinumab demonstrated sustained superior efficacy in clearing skin through Week 52, greater improvement in symptoms and HRQOL, greater relief of work and activity limitations, and a comparable safety profile. In this sub-analysis of the CLEAR study, Novartis was interested in examining the relationships among multiple variables that are thought to be important to patients with psoriasis. The direct and indirect (i.e. mediated) effects of treatment (secukinumab or ustekinumab) on psoriasis severity and patients’ HRQOL, work productivity, and daily activity were examined. The evaluation was conducted using structural equation modeling (or path analysis) and compared these relationships for secukinumab versus ustekinumab at 16 and 52 weeks. Structural equation modeling or path analysis is a statistical method that models the direct and indirect relationship between multiple patient-relevant outcomes simultaneously.

Goodness-of-fit statistics for all models were excellent confirming the robustness of the results. Results at Week 16 and at Week 52 for different Psoriasis Area and Severity Index (PASI) response categories (e.g. PASI 75, PASI 90, PASI 100) indicated that psoriasis treatment indirectly affected HRQOL and work productivity and daily activity, measured with the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaires, respectively.

Actually, greater effect of secukinumab over ustekinumab on DLQI was mediated by greater improvement of secukinumab in PASI response as well as by greater improvement in psoriasis-related symptoms (itch, pain and scaling). Greater effect of secukinumab over ustekinumab on work productivity and daily activity was mediated by greater improvement of secukinumab in psoriasis-related symptoms.

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Psoriasis Patients At Higher Risk for Multiple Pathological Fractures

MedicalResearch.com Interview with:
Dr. Jonathan L. Silverberg MD PhD MPH

Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

Dr. Jonathan Silverberg

Response: Psoriasis is associated with a number of potential risk factors for developing osteoporosis and pathological fractures, including including low vitamin D, chronic inflammation, higher rates of cigarette smoking and systemic corticosteroid usage. We hypothesized that adults with psoriasis have higher rates of osteoporosis and pathological fractures.

We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that psoriasis was associated with higher odds of osteopenia, osteoporosis, osteomalacia, ankylosing spondylitis, and pathological fractures. In particular, psoriasis was associated with vertebral, pelvic, femoral and tibial/fibular fractures. The associations between psoriasis and pathological fractures were more pronounced in women than men.

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Psoriasis: Efficacy and Safety of Guselkumab vs Humira for Moderate to Severe Disease

MedicalResearch.com Interview with:

Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center

Dr. Blauvelt

Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center

 MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker.  The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.

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Musculoskeletal Symptoms May Mark Onset of Arthritis in Psoriasis Patients

MedicalResearch.com Interview with:

Lihi Eder MD PhD Rheumatologist, Women’s College Hospital Scientist, Women’s College Research Institute Assistant Professor of Medicine, University of Toronto Toronto, ON, Canada

Dr. Lihi Eder

Lihi Eder MD PhD
Rheumatologist, Women’s College Hospital
Scientist, Women’s College Research Institute
Assistant Professor of Medicine, University of Toronto
Toronto, ON, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There significant delays in the diagnosis of psoriatic arthritis (PsA) among patients with psoriasis. Many patients with psoriasis experience musculoskeletal symptoms. The majority of them do not have PsA, but other non-inflammatory conditions such as fibromyalgia or osteoarthritis.

In this study, we aimed to assess whether the presence and the degree of musculoskeletal symptoms in psoriasis patients predict the development of psoriatic arthritis. We analyzed a cohort of 410 psoriasis patients who were followed over a period of 9 years. These patients did not have arthritis at baseline. The patients were assessed annually by a rheumatologist for signs of PsA. A total of 57 patients developed psoriatic arthritis during the follow-up period.
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Guselkumab Potentially Increases Treatment Choices For Psoriasis

MedicalResearch.com Interview with:

Prof. Dr. med. Kristian Reich Dermatologie, Allergologie Psoriasis- und Neurodermitis-Trainer Hamburg

Prof.  Kristian Reich

Prof. Dr. med. Kristian Reich
Dermatologie, Allergologie
Psoriasis- und Neurodermitis-Trainer
Hamburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Ustekinumab is an antibody against the p40 molecule shared by IL-12 and IL-23. The antibody shows a favorable benfit-risk profile in the treatment of psoriasis. IL-23 is regarded a key driver in psoriasis pathology. It is speculated that antibodies against the IL-23-specific subunit p19 may produce even higher levels of clinical response than ustekinumab or the anti-TNF antagonist adalimumab. Guselkumab is the first IL-23p19 antibody to publish phase III data in psoriasis.   
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Guselkumab Bests Adalimumab in Psoriasis Study

MedicalResearch.com Interview with:

Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center Portland, OR 97223

Dr. Andrew Blauvelt

Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center
Portland, OR 97223

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Findings from the guselkumab Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving the anti-interleukin (IL)-23 monoclonal antibody (mAb) achieved significant improvements in skin clearance compared with patients receiving placebo and patients receiving Humira® (adalimumab), a TNF blocker. The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab in the treatment of moderate to severe plaque psoriasis also showed the significant efficacy of guselkumab maintained through week 48 compared with adalimumab, and the robust efficacy of guselkumab in meeting all primary and major secondary endpoints.

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Psoriasis Associated With Increased Risk of Avascular Bone Death

MedicalResearch.com Interview with:

Psoriasis

Psoriasis

Hsien-Yi Chiu, MD/
Tsen-Fang Tsai, MD

Department of Dermatology, National Taiwan University Hospital
Taipei, Taiwan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is a chronic, immune-mediated disorder, characterized by red, itchy and scaly skin patches. Over the past several years, accumulating research had shown the effects of psoriasis go far deeper than the skin and psoriasis is associated with multiple comorbidities.

Psoriasis shares the inflammatory pathways and several contributing factors with avascular necrosis (AVN), a bone disease presented with death of trabecular bone and collapse of the bony structure. However, previous studies mostly focus on evaluation the increased risk of cardiovascular diseases in patients with psoriasis. No large scale studies have previously explored a potential association between psoriasis and AVN.

Our nationwide population-based cohort study investigated this risk in 28268 patients with psoriasis registered in the Taiwan National Health Insurance Research Database. The patients were matched, by age and sex, with 113072 controls without psoriasis. Both the patients and controls were followed to identify those who subsequently diagnosed with an AVN. The results showed that psoriasis was associated with a disease severity–dependent increase in avascular necrosis risk. Moreover, AVN risk was positively associated with male sex, age younger than 30 years, corticosteroid use, severe psoriasis, and concomitant psoriatic arthritis. People with severe psoriasis were 3 times more likely to develop AVN compared with the control group.

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Are Co-Morbidities in Psoriasis Overestimated?

MedicalResearch.com Interview with:

Psoriasis

Psoriasis

Mohammed D. Saleem, MD
Department of Dermatology
Wake Forest School of Medicine
Medical Center Boulevard
Winston-Salem, NC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Over the past several years’ numerous research studies have identified comorbidities associated with psoriasis. The media has increasingly become involved with presenting these findings and patients commonly bring these concerns to their physician. The comorbidities are often presented as a relative risk, which can overestimate the effects of exposure, especially when the incidence is quite small. Comorbidities presented as attributed risk or number needed to harm might be a better measure for understanding the association between an exposure and comorbidity.

We found that although the relative risk of many diseases associated with psoriasis can be quite large, the attributed risk was small.

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No Increased Risk of IBD Among Secukinumab-Treated Patients with Moderate to Severe Psoriasis in Phase 2 & 3 Clinical Studies

MedicalResearch.com Interview with:

Atul Deodhar, M.D., M.R.C.P. Rheumatology Oregon Health and Science University

Dr. Atul Deodhar

Atul Deodhar, M.D., M.R.C.P.
Rheumatology
Oregon Health and Science University 

MedicalResearch.com: What is the background for this study?

Response: Patients with psoriasis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS) are at an increased risk of developing inflammatory bowel disease (IBD) compared with the general population. It is important that we assess whether new therapies, including the recently approved interleukin-17A (IL-17A) inhibitor, secukinumab, have an acceptable profile in terms of the risk of IBD in patients with psoriasis, PsA, or AS.

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Taltz (ixekizumab) Can Improve Palmoplantar Psoriasis For Up To 60 Weeks

MedicalResearch.com Interview with:

Dr. Alan Menter MD Texas Dermatology Associates

Dr. Alan Menter

Dr. Alan Menter MD
Texas Dermatology Associates

MedicalResearch.com: What is the background for this study?

Response: Psoriasis on the palms and soles of the feet—also known as palmoplantar psoriasis of which there are 2 variants, plaque type or pustular, —can significantly affect a person’s quality of life and is often difficult-to-treat with available treatments. Researchers in this study set out to determine the efficacy and safety of Taltz (ixekizumab) through 60 weeks among patients with moderate-to-severe plaque psoriasis with significant palmoplantar involvement. Plaque psoriasis is the most common form of psoriasis appearing as raised, red patches covered with a silvery white buildup of dead skin cells which are often painful or itchy. This study was an analysis of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo-controlled trial.

In the first 12 weeks of this study, patients were randomized to receive placebo, etanercept (50 mg, twice-weekly) or 80 mg of Taltz every two weeks or every four weeks, following an initial starting dose of 160 mg. At 12 weeks, all patients received open-label Taltz every four weeks through 60 weeks.

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10-Year Mortality Risk Raised With Atopic Dermatitis, But Lower Than Psoriasis

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Hellerup Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In recent years, numerous studies have examined the impact of psoriasis and associated comorbidities, and found a reduced lifespan in particular among patients with severe disease. However, little is known about the impact and burden of adults with atopic dermatitis. We looked at the 10-year survival among patients hospitalized for atopic dermatitis, and compared these with patients hospitalized for psoriasis, as well as with subjects from the general population.

Our main finding was that, although the mortality risk was higher for atopic dermatitis compared with general population control subjects, the risk was significantly lower compared with psoriasis patients.

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Tildrakizumab Offers Potential New Psoriasis Treatment With Quarterly Dosing

MedicalResearch.com Interview with:
Dr. Kristian Reich
Professor of Dermatology at the Georg-August-University Göttingen and inflammation specialist Dermatologikum Hamburg in Germany

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: While there is ongoing research into the causes and triggers of psoriasis, recent studies have identified IL-23 as a main driver of the IL-23/IL-17 pathway which is now thought to be the predominant pathway in the psoriasis inflammatory cascade. Selective Inhibition of IL-23 may present a new targeted strategy for treating patients with the condition. The hope for molecules selectively targeting IL-23, specifically the p19 component of the cytokine, is that newer therapies, like tildrakizumab, can more selectively control the disease allowing more patients to achieve higher and even more durable clinical responses.

The two pivotal Phase-3 studies (reSURFACE 1 and 2) evaluated the efficacy and safety of the IL-23 inhibitor tildrakizumab in adult patients with moderate-to-severe plaque psoriasis, and results through week 28 were presented for the first time as part of the Late Breaking News Session at EADV.

In the reSURFACE 1 and 2 pivotal Phase-3 studies, tildrakizumab, a selective IL-23p19 inhibitor, was evaluated against placebo and etanercept to assess efficacy, safety and tolerability. The co-primary efficacy endpoint of the two placebo-controlled studies was a) the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoints of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28.

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Cosentyx Offers Longer-Term Treatment Option for Patients With Moderate To Severe Plaque Psoriasis

MedicalResearch.com Interview with:

Craig Leonardi, MD Adjunct Professor of Dermatology Saint Louis University School of Medicine Saint Louis, Missouri

Dr. Craig Leonardi

Craig Leonardi, MD
Adjunct Professor of Dermatology
Saint Louis University School of Medicine
Saint Louis, Missouri

MedicalResearch.com: What is the background for this study?

Response: A2304E1 is a multicenter, double-blind and open-label extension study to evaluate the long-term safety and efficacy of Cosentyx in patients with moderate to severe plaque psoriasis. Patients who completed 52 weeks of the core SCULPTURE and STATURE studies and re-consented to treatment were eligible for the extension, and continued the same Cosentyx dose and regimen that they were receiving in their core study. Patients did not have to achieve a PASI 75 response at the end of their core study to enroll.

A total of 642 patients entered the extension study: 168 continued on Cosentyx 300 mg every 4 weeks, 152 continued on Cosentyx 150 mg every 4 weeks, 172 continued on Cosentyx 300 mg retreatment-as-needed, and 150 continued on Cosentyx 150 mg retreatment-as-needed. At the end of Week 156, the study was open-label and patients could continue their assigned dose and regimen or switch to 300 mg every 4 weeks based on the investigator’s judgment.

Results presented at EADV focus on those patients from the SCULPTURE core study who enrolled in the extension study. The primary endpoint of this extension study was overall safety and tolerability. Secondary efficacy measures included the proportion of patients achieving PASI 75, PASI 90 and PASI 100.

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Patients With Psoriasis Have Coronary Calcium Scores Comparable to Diabetes

MedicalResearch.com Interview with:
Nehal N. Mehta, .MD., M.S.C.E. F.A.H.A.
Lasker Clinical Research Scholar
Section of Inflammation and Cardiometabolic Diseases
NIH

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is associated with accelerated cardiovascular (CV) disease; however, screening for CV risk factors in psoriasis remains low. Coronary artery calcium (CAC) score estimates the total burden of atherosclerosis. Psoriasis has been associated with increase CAC score, but how this compares to patients with diabetes, who are aggressively screened for CV risk factors, is unknown.

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Psoriasis Patients At Higher Risk of Serious Infections

MedicalResearch.com Interview with:

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

Dr. Jonathan Silverberg

Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is associated with a number of potential risk factors for developing serious infections, including impaired skin-barrier function, immune dysregulation, use of systemic immunosuppressant and biologic treatments. We hypothesized that adults with psoriasis have higher rates of serious infections.
We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that psoriasis was associated with multiple serious infections, including methicillin-resistant Staphylococcus aureus, cellulitis, herpes simplex virus infection, infectious arthritis, osteomyelitis, meningitis, encephalitis and tuberculosis. Rates of serious infections increased over all time.

Significant predictors of serious infections in patients with psoriasis included non-white race, lower estimated income quartile, and Medicaid, Medicare, or self-pay insurance status. These findings suggest that poor access to adequate dermatologic care may be associated with higher rates of infections.

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Genes That Activate Inflammation in Psoriasis Identified

MedicalResearch.com Interview with:
Ryuta Muromoto, Ph.D.
Department of Immunology,
Faculty of Pharmaceutical Sciences, Hokkaido University
Sapporo, Japan

MedicalResearch.com: What is the background for this study?

Dr. Muromoto: Psoriasis is an immune-mediated chronic inflammatory skin disorder that affects some 125 million people worldwide. It is characterized by itchy, scaly skin plaques. It has been known that a cytokine IL-17A, which is produced by immune cells, plays a central role in the development and maintenance of clinical features of psoriasis. IL-17A acts on keratinocytes and up-regulates anti-microbial peptides and a set of chemokines, that are important for immune cell infiltration. This immune cell feedback amplifies psoriatic inflammation. Also, other inflammatory cytokines such as TNF-alpha and interferon-gamma are up-regulated, and have been implicated in pathogenesis of psoriasis. So, the interplay between cytokines appears to be important for development of psoriasis through keratinocyte activation. In this study, we sought to clarify the actual role of IL-17A and its interplay with other cytokines in keratinocyte activation.

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Patients with Psoriatic Arthritis are at Increased Risk of Cardiovascular Disease

MedicalResearch.com Interview with:

Lihi Eder, MD, PhD Assistant Professor of Medicine, University of Toronto Scientist, Women’s College Research Institute,Room 6326 Women’s College Hospital Toronto, ON, Canada

Dr. Lihi Eder

Lihi Eder, MD, PhD
Assistant Professor of Medicine
University of Toronto
Scientist, Women’s College Research Institute,Room  6326
Women’s College Hospital
Toronto, ON, Canada 

MedicalResearch.com: What is the background for this study?

Dr. Eder: Psoriasis is a chronic immune-mediated skin disease affecting 2-3% of the general population. Psoriatic arthritis (PsA) affects 15-30% of patients with psoriasis. Until recently, only few studies assessed the risk of developing cardiovascular events in patients with PsA and while most studies found a higher cardiovascular risk in these patients, others reported cardiovascular rates that were similar to the general population.

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Potential Novel Therapeutic Target For Psoriasis Identified

MedicalResearch.com Interview with:

Professor Rudi Beyaert VIB - Inflammation Research Center Ghent University Department for Biomedical Molecular Biology Unit of Molecular Signal Transduction in Inflammation Technologiepark Ghent) Belgium

Prof. Rudi Beyaert

Professor Rudi Beyaert
VIB – Inflammation Research Center Ghent University
Department for Biomedical Molecular Biology Unit of Molecular Signal Transduction in Inflammation
Technologiepark Ghent) Belgium 

MedicalResearch.com: What is the background for this study? What are the main findings?

Prof. Beyaert: The interest of my laboratory is in understanding the molecular mechanisms that are responsible for the development of inflammatory diseases such as Crohn’s disease, multiple sclerosis, rheumatoid arthritis and also psoriasis, which is the topic of the published study. We already know that genetic factors can determine the onset of these inflammatory diseases, but how these genetic factors drive an inflammatory response is still largely unclear. We were specifically interested in the CARD14 gene, because patients with mutations in CARD14 have a very high chance to develop psoriasis. Psoriasis-associated mutations in CARD14 trigger specific skin cells (keratinocytes) to produce and release large amounts of other proteins that recruit and activate specific white blood cells driving an inflammatory response. We now discovered that this effect is dependent on the physical interaction of CARD14 with the protease MALT1 in keratinocytes, leading to the activation of its enzymatic activity and the MALT1-mediated cleavage and inactivation of a number of cellular proteins that normally keep our immune system in check. Treatment of skin cells with small compound MALT1 inhibitors prevents the CARD14-induced production of several pro-inflammatory mediators.
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Cosentyx Delivered Superior Sustained Psoriasis Clearance Compared To Stelara in One Year Study

MedicalResearch.com Interview with:

Dr. Andrew Blauvelt MD MPH President of Oregon Medical Research Center

Dr. Andrew Blauvelt

Dr. Andrew Blauvelt MD MPH
President of Oregon Medical Research Center 

MedicalResearch.com: What is the background for this study?

Dr. Blauvelt: Secukinumab (brand name Cosentyx)is a monoclonal antibody directed against interleukin 17A, a key cytokine involved in psoriasis pathogenesis. Efficacy and safety of secukinumab treatment for moderate-to severe psoriasis has been previously published. There are relatively few head-to-head comparison studies between biologic therapies for psoriasis, making direct comparison of these drugs difficult.

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Psoriasis Increases Blood Vessel Inflammation and Heart Disease Risk

Nehal Mehta, M.D., M.S.C.E., F.A.H.A. Lasker Clinical Research Scholar Section of Inflammation and Cardiometabolic Diseases NIHMedicalResearch.com Interview with:
Nehal Mehta, M.D., M.S.C.E., F.A.H.A
.
Lasker Clinical Research Scholar
Section of Inflammation and Cardiometabolic Diseases
NIH

Medical Research: What is the background for this study? What are the main findings?

Dr. Mehta: Psoriasis increases cardiovascular disease (CVD), and this study shows for the first time that the amount of psoriasis on the skin is mirrored in the blood vessels by increasing blood vessel inflammation.

Medical Research: What should clinicians and patients take away from your report?

Dr. Mehta: Even one plaque may be too many if we are seeing a relationship between skin disease severity and vascular inflammation.

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Psoriasis Elevates Risk of Migraines

psoriasis foundationMedicalResearch.com Interview with:
Alexander Egeberg, MD
Department of Cardiology
Herlev and Gentofte Hospital
Hellerup, Denmark

Medical Research: What is the background for this study? What are the main findings?

Dr. Egeberg: Psoriasis is a common chronic skin disease, with a strong inflammatory component. Within the last decade, our understanding of psoriasis have advanced significantly, and psoriasis is now widely regarded as a systemic disease, where the skin is a direct marker of disease activity. The inflammatory pathways in psoriasis have also been implicated in several central nervous system diseases such as depression, uveitis, and multiple sclerosis. Moreover, pain generation and sensitization can occur as a result of the pro-inflammatory mediators which are upregulated in psoriasis.

In the present study, we investigated the association between psoriasis and psoriatic arthritis, and the risk of new-onset migraine. The main finding was a psoriasis-severity dependent increased risk of new-onset migraine, and patients with severe skin psoriasis, and psoriatic arthritis appeared to have the highest risk.

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Psoriasis Patients Have Increased Risk Of Depression

Roger S. Ho, MD, MS, MPH, FAAD Assistant Professor The Ronald O. Perelman Department of Dermatology NYU Langone Medical CenterMedicalResearch.com Interview with:
Roger S. Ho, MD, MS, MPH, FAAD
Assistant Professor
The Ronald O. Perelman Department of Dermatology
NYU Langone Medical Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Ho: In recent years, the impact of psoriasis on quality of life has come to light. We have seen several studies show that patients with psoriasis experience worse quality of life because of their disease. Few studies however have examined the association between psoriasis and mental illness, specifically depression. Many chronic diseases are known to be associated with depression. As more and more evidence supports the relationship between psoriasis and cardiovascular disease, it is important to examine the relationship between psoriasis and depression, while controlling for cardiovascular comorbidity.

In our study of a nationally-representative population of US patients, we found that patients with psoriasis had twice the odds of having depression than patients without psoriasis, even after adjusting for major confounders including a history of myocardial infarction, stroke, and diabetes that may independently be associated with depression. The risk of depression did not depend on extent or severity of psoriatic disease.

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How Many Screening Tests Are Needed For Psoriasis Patients on Biologics?

William W. Huang, MD, MPH Assistant Professor and Program Director Wake Forest School of Medicine Department of Dermatology Winston-Salem, NC 27104MedicalResearch.com Interview with:
William W. Huang, MD, MPH
Assistant Professor and Program Director
Wake Forest School of Medicine
Department of Dermatology
Winston-Salem, NC 27104

Medical Research: What is the background for this study? What are the main findings?
Dr. Huang: This particular study was an update of a previous study our group had published in 2008 (JAAD, 6/08). As the use of biologics in dermatology has increased dramatically in recent years, we wanted to evaluate the evidence for the screening and monitoring tests that are routinely performed for patients with psoriasis and psoriatic arthritis on biologic agents.

We found that current guidelines for screening and monitoring tests varied among various national organizations (Table 1) including the American Academy of Dermatology, Japanese Dermatology Association, European Academy of Dermatology and Venerology, and the British Association of Dermatologists. Using evidence grading based on methods developed by the US Preventative Services Task Force (USPSTF), we found that the evidence was strongest (Grade B) for tuberculosis screening. High level evidence was in general lacking for other routine screening and monitoring tests except in select populations (Table 2, Table 3).

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New Generation Biologic Markedly Improved Psoriasis

Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich,  Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung] MedicalResearch.com Interview with:
Prof. Dr. med. Kristian Reich
DERMATOLOGIKUM HAMBURG
Hamburg

Medical Research: What is the background for this study? What are the main findings?

Prof. Reich: The Phase 2b X-PLORE study compared a new generation biologic therapy, guselkumab – an inhibitor of IL–23, with the anti–tumor necrosis factor (TNF)–alpha agent adalimumab (Humira®) and placebo in the treatment of moderate-to-severe plaque-type psoriasis. It showed that up to 86 percent of patients treated with guselkumab achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary endpoint.  Interestingly, levels of efficacy were higher for several guselkumab doses through week 16 when compared to adalimumab. Improvements with guselkumab continued through week 40 with every eight- or twelve-week maintenance treatment.   Continue reading

Not All Biologics For Psoriasis Carry Same Risk Of Serious Infections

MedicalResearch.com Interview with: Robert E Kalb, M.D. Clinical Professor of Dermatology State University of New York at Buffalo School of Medicine and Biomedical Sciences Buffalo Medical Group, P.C. Buffalo, NY 14221MedicalResearch.com Interview with:
Robert E Kalb, M.D.

Clinical Professor of Dermatology
State University of New York at Buffalo School of Medicine and Biomedical Sciences
Buffalo Medical Group, P.C.
Buffalo, NY 14221

Medical Research: What is the background for this study? What are the main findings?

Dr. Kalb: It’s important to evaluate the safety of biologics in the real world post-marketing setting, and in particular with respect to serious infections. We studied patients with psoriasis in the PSOLAR registry and evaluated the risk of various biologic therapies. We found that infliximab and adalimumab were associated with increased risk of serious infections when compared with non-biologic/non-methotrexate therapies, while ustekinumab and etanercept were not associated with increased risk. Continue reading

Genital Psoriasis Negatively Impacts Quality of Life and Sexual Function

MedicalResearch.com Interview with: Caitriona Ryan, MD Baylor University Medical Center, DallasMedicalResearch.com Interview with:
Caitriona Ryan, MD

Baylor University Medical Center, Dallas

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Ryan: Psoriasis is a common, chronic, inflammatory disorder of the skin which has a considerable impact on social functioning and personal relationships. Genital involvement can have devastating psychosexual implications for psoriasis patients. In a study examining the stigmatization experience in psoriasis patients, involvement of the genitalia was found to be the most relevant, regardless of the overall psoriasis severity. Although sexual function is an integral component of quality of life, dermatology-specific and psoriasis-specific scales largely neglect the impact of disease on sexual health. Despite major advances in other aspects of psoriasis research, there has been little emphasis in recent times on the identification and treatment of genital psoriasis and few studies have examined predisposing risk factors, phenotypical associations or its impact on quality of life and sexual functioning.

This study was designed to examine the prevalence and nature of genital involvement in patients with psoriasis, to ascertain risk factors for the development of genital psoriasis, to determine the impact of genital disease on quality of life and sexual functioning, and to assess patient satisfaction with current topical treatments for genital psoriasis.

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Psoriasis: Effective Two Year Response to IL-17A Antagonist Cosentyx

Andrew Blauvelt, M.D., M.B.A. President and Investigator Research Excellence & Personalized Patient Care Portland, OR 97223MedicalResearch.com Interview with:
Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Research Excellence & Personalized Patient Care
Portland, OR 97223

Medical Research: What is the background for this study? What are the main findings?

Dr. Blauvelt: A2303E1 is a multicenter, double-blind, randomized withdrawal extension to the FIXTURE and ERASURE pivotal phase III studies.  The purpose of this extension study was to collect additional long term efficacy, safety, and tolerability data on secukinumab (i.e., Cosentyx) in patients who demonstrated a PASI 75 response to Cosentyx at Week 52 of these core studies in moderate-to-severe plaque psoriasis.

In the extension phase, 995 patients who achieved Psoriasis Area Severity Index (PASI) 75 responses after 52 weeks of therapy received either Cosentyx 300 mg, Cosentyx 150 mg, or placebo for an additional year (Week 104).  After two full years of therapy in patients treated with Cosentyx 300 mg, almost 9 out of 10 (88.2%) patients maintained their PASI 75 response, 7 out of 10 (70.6%) had clear or almost clear skin (PASI 90), and 4 out of 10 (43.9) had clear skin (PASI 100) at Week 104.  For patients treated with Cosentyx 150 mg, 75.5% maintained their PASI 75 response, 44.6% had clear or almost clear skin (PASI 90), and 23.5% had clear skin (PASI 100) at Week 104.  In addition, 94.8% of patients who initially received placebo (at the start of the extension), and were switched to receive Cosentyx 300 mg after relapse, were able to achieve PASI 75 and 70.3% achieved PASI 90 within 12 weeks of re-starting Cosentyx. Continue reading

Apremilast -Otezla -May Be Cost Effective For Psoriasis Treatment

MedicalResearch.com Interview with:
Steven R. Feldman, M.D., Ph.D.

Professor of Dermatology
Wake Forest Baptist Medical Center
Winston-Salem, NC

Medical Research: What is the background for this study? What are the main findings?

Response: Results show that introducing apremilast into the treatment pathway prior to biologics is cost-saving and confers a cost and quality of life benefit. Over 10 years, apremilast was estimated to provide an additional 0.74 years (5.00 vs. 4.26 years) in which patients achieved a 75% reduction from baseline in PASI score, compared to a pathway of biologics only. It was also found to be less costly, mainly due to less time spent on more expensive biologic therapy (costs reduced by $9,072.39 over 10 years).
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Bacterial DNA Detected In Blood Of Patients With Active Psoriasis

MedicalResearch.com Interview with:
Dr. Ana Ramírez-Boscá, MD Department of Dermatology and Clinical Research Unit
Dr. Ana Ramírez-Boscá, MD
Department of Dermatology and Clinical Research Unit and

Vicente Navarro-López, MD Clinical Research Unit and Infectious Diseases Unit Centro Dermatológico Estético, Alicante, SpainVicente Navarro-López, MD
Clinical Research Unit and Infectious Diseases Unit
Centro Dermatológico Estético, Alicante, Spain

 

MedicalResearch: What is the background for this study? What are the main findings?

Response: Infections have been related with the pathogenesis of guttate psoriasis, however antibiotic treatment does not improve prognosis nor does it affect the evolution of the disease. The association between psoriasis and other infectious diseases has been reported as well, although in these cases there is scarce information on the causative microbial likely involved and the role of these bacteria in the pathogenesis of this skin disease.

MedicalResearch: What are the main findings? 

Response: Bacterial DNA may be detected in bloodstream of a significant proportion of patients with active plaque psoriasis. Increased levels of pro-inflammatory cytokines in patients with presence of bacterial DNA but not in patients without presence of bacterial genomic fragments suggest a role of bacterial DNA translocation in inducing an inflammatory response.

"Guttate psoriasis" by Bobjgalindo - Own work. Licensed under GFDL via Wikimedia Commons - http://commons.wikimedia.org/wiki/File:Guttate_psoriasis.jpg#/media/File:Guttate_psoriasis.jpg

Guttate Psoriasis
from Wikipedia

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Genetic Predisposition to Psoriatic Arthritis Localized To Chromosome 5

psoriasis_kneesMedicalResearch.com Interview with:
Professor Anne Barton FRCP PhD and
Dr John Bowes PhD

Centre for Musculoskeletal Research and
Centre for Genetics and Genomics,
The University of Manchester, Manchester UK

Medical Research: What is the background for this study?

Response: Psoriatic arthritis (PsA) is an inflammatory condition causing pain and stiffness in joints and tendons. Approximately one third of patients with psoriasis will go on to develop PsA resulting in a reduction in their quality of life caused by increasing disability and additional health complications. A key area of research within the Arthritis Research UK Centre for Genetics and Genomics in the Centre for Musculoskeletal Research is the identification of risk factors for the development of Psoriatic arthritis; this will allow us to understand the underlying cause of disease and ultimately help identify psoriasis patients at high risk of PsA, allowing early treatment to be introduced to reduce the impact of PsA.

Our study focuses on the identification of genetic risk factors for Psoriatic arthritis; we compared the frequency of genetic variants, referred to as single nucleotide polymorphisms (SNPs), between large numbers of DNA samples from patients with PsA and healthy control samples. When the frequency of the SNP is significantly different between cases and controls, the SNP is said to be associated with risk of developing Psoriatic arthritis and this association is interpreted as being important in the disease process.

Medical Research: What are the main findings?

Response: When we analysed the data from the study we found a new association to SNPs on chromosome 5, and when we investigated these SNPs for association with skin-only psoriasis, we did not find any evidence for association. In addition, we also found SNPs that were specifically associated with Psoriatic arthritis at a gene on chromosome 1. This gene is known to be associated with psoriasis, but our results show that there are different SNPs associated with PsA and psoriasis at this gene. Hence, our results identify new SNPs that are specifically associated with PsA.

In addition, identifying which cells are the key drivers of inflammation in Psoriatic arthritis will help us to focus on how the genetic changes act in those cells to cause disease. Our results show that many of the PsA associated SNPs occur in regions of the genome that are important in the function of CD8+ cells,  an important cell type in the immune system.
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Psoriasis Linked To Insulin Resistance and Increased Risk of Diabetes

MedicalResearch.com Interview with:
Mette Gyldenløve MD
Gentofte Hospital, University of Copenhagen
Denmark

MedicalResearch: What is the background for this study?

Dr. Gyldenløve: Epidemiological studies have shown that patients with psoriasis have increased risk of type 2 diabetes. The pathophysiology is largely unknown, but it is hypothesised that systemic inflammation causes insulin resistance, which is an early feature of type 2 diabetes. Insulin sensitivity has only been sparsely investigated in patients with psoriasis, and previous studies have used suboptimal methodology. The objective of the present study was to investigate, if patients with psoriasis exhibit impaired insulin sensitivity when assessed by the hyperinsulinaemic euglycaemic clamp technique (gold standard).

MedicalResearch: What are the main findings?

Dr. Gyldenløve: In this study we found that normal glucose-tolerant patients with moderate-to-severe psoriasis (n=16) had significantly reduced insulin sensitivity compared to age, gender, and body mass index (BMI)-matched, healthy control subjects (n=16). The two groups were similar with regard to age, gender, BMI, body composition, physical activity, fasting plasma glucose, and glycosylated haemoglobin.

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Performance Improvement CME Improved Psoriasis Care By Dermatologists

Robert S. Kirsner, MD, PhD, FAAD Interim Chairman and Harvey Blank Professor in Dermatology, Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine Director, University of Miami Hospital Wound Center Chief of Dermatology, University of Miami HospitalMedicalResearch.com Interview with:
Robert S. Kirsner, MD, PhD, FAAD

Interim Chairman and Harvey Blank Professor in Dermatology, Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine
Director, University of Miami Hospital Wound Center
Chief of Dermatology, University of Miami Hospital

Medical Research: What is the background for this study? What are the main findings?

Dr. Kirsner: Psoriasis is common, affecting 7.5 million Americans. The major indication of psoriasis is chronic inflammation of the skin. It is characterized by disfiguring, scaling and erythematous plaques that may be painful or pruritic and may cause significant quality of life issues. Psoriasis may also cause joint pain and more recently has been associated with metabolic syndrome, diabetes, cardiovascular disease, dyslipidemia, hypertension and nonalcoholic fatty liver disease. Thus, patients may be physically and emotionally impacted by psoriasis.

The American Academy of Dermatology (Academy) developed a Performance Improvement (PI) CME activity to enhance dermatologists’ care of psoriasis patients by allowing them to evaluate their practice using patient charts, utilize evidence-based strategies to overcome self-identified gaps, and then re-measure their performance using charts for patients seen after practice changes were implemented.

It was found that the PI CME activity significantly improved dermatologists’ overall documentation of patient history, patient counseling for lifestyle behaviors and shared decision-making ability. For example, dermatologists who participated in and completed this PI CME activity improved practice performance by either inquiring about or documenting to a greater extent comorbidities (particularly cardiovascular disease), drug costs and interactions, patient preference, other medical problems, and severity of disease, resulting in an overall improvement in documented clinical behaviors.

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Psoriasis Linked To Increased Risk of Atherosclerosis

psoriasisMedicalResearch.com Interview with:
Ellen Slevolden, MD  and Kristin Evensen,MD
Department of Dermatology
Oslo University Hospital Rikshospitalet,
Oslo, Norway


Medical Research
: What are the main findings of the study?

Response: The main finding of our study is that psoriasis may be associated with an increased risk of atherosclerosis and subsequent cardiovascular disease. We found that carotid intima-media thickness was increased in patients with psoriasis compared to healthy controls. Psoriasis patients also had a higher prevalence of carotid plaques.
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Psoriasis May Increase Risk of Atherosclerosis

Reza Robati, MD Associate Professor of Dermatology Deputy editor, Iranian Journal of Dermatology Skin Research Center, Shahid Beheshti University of Medical Sciences Tehran, IranMedicalResearch.com Interview with:
Reza Robati, MD
Associate Professor of Dermatology
Deputy editor, Iranian Journal of Dermatology
Skin Research Center, Shahid Beheshti University of Medical Sciences
Tehran, Iran

Medical Research: What are the main findings of the study?

Dr. Robati: In our study, increased levels of serum leptin and resistin and increased intima-media wall thickness of common carotid artery were observed in 60 psoriasis patients in comparison with 60 healthy controls. Moreover, we found positive correlation between these variables in psoriasis patients.
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Psoriatic Arthritis: Tight Control Improves Arthritis, Skin Disease

Dr. Laura Coates Division of Rheumatic and Musculoskeletal Disease Chapel Allerton Hospital Chapeltown Road Leeds NIHR Clinical Lecturer at the University of LeedsMedicalResearch.com Interview with:
Dr. Laura Coates
Division of Rheumatic and Musculoskeletal Disease
Chapel Allerton Hospital Chapeltown Road Leeds
NIHR Clinical Lecturer at the University of Leeds


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

Answer: The TICOPA study showed that treating patients with early psoriatic
arthritis to an objective target with regular review improved
patient’s clinical outcome both in terms of arthritis and skin
psoriasis.  There was an increase in adverse events in the tight
control arm but only 4 serious infections seen in the tight control
arm that were thought to be related to treatment (2 cases of
cellulitis, 2 cases of chest infection).
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