Psoriasis Collection

The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”¹ However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?

Psoriasis is associated with an increased risk for cardiovascular disease.^2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.^5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and T_H17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.⁶ Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.⁶ Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.^7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.⁹

Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.¹⁰ Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.¹¹

Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.¹² Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.⁹ Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).¹³ Patients also may experience physical discomfort from pain and itching.¹⁴ Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.¹⁵ The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.¹⁵ Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.¹⁶ Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.¹⁷

Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.¹⁶ The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.

The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”¹ However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?

Psoriasis is associated with an increased risk for cardiovascular disease.^2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.^5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and T_H17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.⁶ Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.⁶ Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.^7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.⁹

Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.¹⁰ Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.¹¹

Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.¹² Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.⁹ Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).¹³ Patients also may experience physical discomfort from pain and itching.¹⁴ Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.¹⁵ The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.¹⁵ Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.¹⁶ Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.¹⁷

Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.¹⁶ The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.

The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”¹ However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?

Psoriasis is associated with an increased risk for cardiovascular disease.^2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.^5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and T_H17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.⁶ Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.⁶ Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.^7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.⁹

Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.¹⁰ Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.¹¹

Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.¹² Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.⁹ Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).¹³ Patients also may experience physical discomfort from pain and itching.¹⁴ Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.¹⁵ The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.¹⁵ Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.¹⁶ Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.¹⁷

Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.¹⁶ The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.

Psoriasis patients may have more success with a second tumor necrosis factor (TNF) antagonist after failure with a first, report Paul S. Yamauchi, MD, PhD, and coauthors.

Investigators analyzed 15 studies evaluating the efficacy of switching TNF antagonists after primary or secondary failure. Response rates at 24 weeks for a second antagonist were 30%-74% for a 75% improvement in Psoriasis Area and Severity Index score, and 20%-70% for achieving a Physician Global Assessment score of 0/1. Mean improvements in Dermatology Life Quality Index ranged from –3.5 to –13, Dr. Yamauchi and colleagues reported.

©AzriSuratmin/Thinkstock

Patients who experienced secondary failure with initial treatment generally achieved better responses than those with primary failure, the authors said.

Though response rates to a second anti-TNF agent were lower than for a first, “a substantial proportion of patients in every study achieved treatment success,” they added.

Read the full article in the Journal of the American Academy of Dermatology.

[email protected]

Psoriasis patients may have more success with a second tumor necrosis factor (TNF) antagonist after failure with a first, report Paul S. Yamauchi, MD, PhD, and coauthors.

Investigators analyzed 15 studies evaluating the efficacy of switching TNF antagonists after primary or secondary failure. Response rates at 24 weeks for a second antagonist were 30%-74% for a 75% improvement in Psoriasis Area and Severity Index score, and 20%-70% for achieving a Physician Global Assessment score of 0/1. Mean improvements in Dermatology Life Quality Index ranged from –3.5 to –13, Dr. Yamauchi and colleagues reported.

©AzriSuratmin/Thinkstock

Patients who experienced secondary failure with initial treatment generally achieved better responses than those with primary failure, the authors said.

Though response rates to a second anti-TNF agent were lower than for a first, “a substantial proportion of patients in every study achieved treatment success,” they added.

Read the full article in the Journal of the American Academy of Dermatology.

[email protected]

Psoriasis patients may have more success with a second tumor necrosis factor (TNF) antagonist after failure with a first, report Paul S. Yamauchi, MD, PhD, and coauthors.

Investigators analyzed 15 studies evaluating the efficacy of switching TNF antagonists after primary or secondary failure. Response rates at 24 weeks for a second antagonist were 30%-74% for a 75% improvement in Psoriasis Area and Severity Index score, and 20%-70% for achieving a Physician Global Assessment score of 0/1. Mean improvements in Dermatology Life Quality Index ranged from –3.5 to –13, Dr. Yamauchi and colleagues reported.

©AzriSuratmin/Thinkstock

Patients who experienced secondary failure with initial treatment generally achieved better responses than those with primary failure, the authors said.

Though response rates to a second anti-TNF agent were lower than for a first, “a substantial proportion of patients in every study achieved treatment success,” they added.

Read the full article in the Journal of the American Academy of Dermatology.

[email protected]

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

Two different doses of the humanized monoclonal antibody ixekizumab improved signs and symptoms of active psoriatic arthritis in a phase III manufacturer-sponsored trial of patients who had not taken a biologic drug before.

The agent selectively binds and neutralizes interleukin (IL)-17A, which promotes joint inflammation and damage via several mechanisms. So the study findings support the view that IL-17A is a key cytokine in the pathogenesis of psoriatic arthritis and an appropriate therapeutic target, said Philip J. Mease, MD, of the department of rheumatology at Swedish Medical Center and the University of Washington, Seattle, and his associates.

They are performing the ongoing, 3-year, randomized, double-blind trial (SPIRIT-P1) comparing responses with an 80-mg dose of ixekizumab every 2 weeks (103 patients), an 80-mg dose every 4 weeks (107 patients), a 40-mg dose of adalimumab (Humira) every 2 weeks (101 patients, active control group), and matching placebo (106 patients, placebo-control group). Each of the two ixekizumab arms received a starting dose of 160 mg given as two injections at week 0. This report presented the findings after the initial 24-week, double-blind treatment period of the trial.

The study participants are adults with active psoriatic arthritis who had never been treated with biologic agents and who continued taking their usual doses of conventional disease-modifying antirheumatic drugs, oral corticosteroids, opiates, and/or nonsteroidal anti-inflammatory drugs/Cox-2 inhibitors during the study. The mean patient age was 49.5 years. Of the 382 who completed this portion of the study, 57 showed an inadequate response and required rescue medication, including 10 on the lower dose of ixekizumab, 11 on the higher dose of ixekizumab, 9 taking adalimumab, and 27 taking placebo.

The primary efficacy endpoint, ACR20 response at week 24, was met by 62.1% of the higher-dose ixekizumab group, 57.9% of the lower-dose ixekizumab group, and 57.4% of the adalimumab group, all of which were significantly greater than the 30.2% rate in the placebo group. Both doses of the study drug as well as the active control drug also improved secondary endpoints: reducing mean levels of disease activity as measured by the 28-joint Disease Activity Score using on C-reactive protein, improving patient-reported physical function on the Health Assessment Questionnaire–Disability Index, and improving disease-related physical health as measured by the SF-36, the investigators said (Ann Rheum Dis. 2016 Aug 23. doi: 10.1136/annrheumdis-2016-209709).

In addition, the progression of structural joint damage, as assessed on radiographs of bone erosions and joint-space narrowing in the hands and feet, was significantly less with the three active treatments than with placebo. Among patients with the most extensive disease, a significantly greater percentage achieved Psoriasis Area and Severity Index 75 level of improvement with the three active treatments than with placebo. And among patients with nail involvement, mean improvements in Nail Psoriasis Severity Index scores were significantly higher with the three active treatments than with placebo.

Adverse effects included grade 1 and 2 neutropenia, herpes zoster involving the eyelid, gastroenteritis, esophageal candidiasis, and depression-related symptoms. All infections resolved with treatment, and none required discontinuation of the study drug.

This study was funded and sponsored by Eli Lilly, maker of ixekizumab. Dr. Mease reported receiving grants, personal fees, and other support from Eli Lilly, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo, Genentech, Janssen, Pfizer, UCB Pharma, Merck, Novartis, and Corrona. His associates reported ties to numerous industry sources.

Two different doses of the humanized monoclonal antibody ixekizumab improved signs and symptoms of active psoriatic arthritis in a phase III manufacturer-sponsored trial of patients who had not taken a biologic drug before.

The agent selectively binds and neutralizes interleukin (IL)-17A, which promotes joint inflammation and damage via several mechanisms. So the study findings support the view that IL-17A is a key cytokine in the pathogenesis of psoriatic arthritis and an appropriate therapeutic target, said Philip J. Mease, MD, of the department of rheumatology at Swedish Medical Center and the University of Washington, Seattle, and his associates.

They are performing the ongoing, 3-year, randomized, double-blind trial (SPIRIT-P1) comparing responses with an 80-mg dose of ixekizumab every 2 weeks (103 patients), an 80-mg dose every 4 weeks (107 patients), a 40-mg dose of adalimumab (Humira) every 2 weeks (101 patients, active control group), and matching placebo (106 patients, placebo-control group). Each of the two ixekizumab arms received a starting dose of 160 mg given as two injections at week 0. This report presented the findings after the initial 24-week, double-blind treatment period of the trial.

The study participants are adults with active psoriatic arthritis who had never been treated with biologic agents and who continued taking their usual doses of conventional disease-modifying antirheumatic drugs, oral corticosteroids, opiates, and/or nonsteroidal anti-inflammatory drugs/Cox-2 inhibitors during the study. The mean patient age was 49.5 years. Of the 382 who completed this portion of the study, 57 showed an inadequate response and required rescue medication, including 10 on the lower dose of ixekizumab, 11 on the higher dose of ixekizumab, 9 taking adalimumab, and 27 taking placebo.

The primary efficacy endpoint, ACR20 response at week 24, was met by 62.1% of the higher-dose ixekizumab group, 57.9% of the lower-dose ixekizumab group, and 57.4% of the adalimumab group, all of which were significantly greater than the 30.2% rate in the placebo group. Both doses of the study drug as well as the active control drug also improved secondary endpoints: reducing mean levels of disease activity as measured by the 28-joint Disease Activity Score using on C-reactive protein, improving patient-reported physical function on the Health Assessment Questionnaire–Disability Index, and improving disease-related physical health as measured by the SF-36, the investigators said (Ann Rheum Dis. 2016 Aug 23. doi: 10.1136/annrheumdis-2016-209709).

In addition, the progression of structural joint damage, as assessed on radiographs of bone erosions and joint-space narrowing in the hands and feet, was significantly less with the three active treatments than with placebo. Among patients with the most extensive disease, a significantly greater percentage achieved Psoriasis Area and Severity Index 75 level of improvement with the three active treatments than with placebo. And among patients with nail involvement, mean improvements in Nail Psoriasis Severity Index scores were significantly higher with the three active treatments than with placebo.

Adverse effects included grade 1 and 2 neutropenia, herpes zoster involving the eyelid, gastroenteritis, esophageal candidiasis, and depression-related symptoms. All infections resolved with treatment, and none required discontinuation of the study drug.

This study was funded and sponsored by Eli Lilly, maker of ixekizumab. Dr. Mease reported receiving grants, personal fees, and other support from Eli Lilly, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo, Genentech, Janssen, Pfizer, UCB Pharma, Merck, Novartis, and Corrona. His associates reported ties to numerous industry sources.

Two different doses of the humanized monoclonal antibody ixekizumab improved signs and symptoms of active psoriatic arthritis in a phase III manufacturer-sponsored trial of patients who had not taken a biologic drug before.

The agent selectively binds and neutralizes interleukin (IL)-17A, which promotes joint inflammation and damage via several mechanisms. So the study findings support the view that IL-17A is a key cytokine in the pathogenesis of psoriatic arthritis and an appropriate therapeutic target, said Philip J. Mease, MD, of the department of rheumatology at Swedish Medical Center and the University of Washington, Seattle, and his associates.

They are performing the ongoing, 3-year, randomized, double-blind trial (SPIRIT-P1) comparing responses with an 80-mg dose of ixekizumab every 2 weeks (103 patients), an 80-mg dose every 4 weeks (107 patients), a 40-mg dose of adalimumab (Humira) every 2 weeks (101 patients, active control group), and matching placebo (106 patients, placebo-control group). Each of the two ixekizumab arms received a starting dose of 160 mg given as two injections at week 0. This report presented the findings after the initial 24-week, double-blind treatment period of the trial.

The study participants are adults with active psoriatic arthritis who had never been treated with biologic agents and who continued taking their usual doses of conventional disease-modifying antirheumatic drugs, oral corticosteroids, opiates, and/or nonsteroidal anti-inflammatory drugs/Cox-2 inhibitors during the study. The mean patient age was 49.5 years. Of the 382 who completed this portion of the study, 57 showed an inadequate response and required rescue medication, including 10 on the lower dose of ixekizumab, 11 on the higher dose of ixekizumab, 9 taking adalimumab, and 27 taking placebo.

The primary efficacy endpoint, ACR20 response at week 24, was met by 62.1% of the higher-dose ixekizumab group, 57.9% of the lower-dose ixekizumab group, and 57.4% of the adalimumab group, all of which were significantly greater than the 30.2% rate in the placebo group. Both doses of the study drug as well as the active control drug also improved secondary endpoints: reducing mean levels of disease activity as measured by the 28-joint Disease Activity Score using on C-reactive protein, improving patient-reported physical function on the Health Assessment Questionnaire–Disability Index, and improving disease-related physical health as measured by the SF-36, the investigators said (Ann Rheum Dis. 2016 Aug 23. doi: 10.1136/annrheumdis-2016-209709).

In addition, the progression of structural joint damage, as assessed on radiographs of bone erosions and joint-space narrowing in the hands and feet, was significantly less with the three active treatments than with placebo. Among patients with the most extensive disease, a significantly greater percentage achieved Psoriasis Area and Severity Index 75 level of improvement with the three active treatments than with placebo. And among patients with nail involvement, mean improvements in Nail Psoriasis Severity Index scores were significantly higher with the three active treatments than with placebo.

Adverse effects included grade 1 and 2 neutropenia, herpes zoster involving the eyelid, gastroenteritis, esophageal candidiasis, and depression-related symptoms. All infections resolved with treatment, and none required discontinuation of the study drug.

This study was funded and sponsored by Eli Lilly, maker of ixekizumab. Dr. Mease reported receiving grants, personal fees, and other support from Eli Lilly, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo, Genentech, Janssen, Pfizer, UCB Pharma, Merck, Novartis, and Corrona. His associates reported ties to numerous industry sources.

Psoriasis increased the measures of coronary artery calcium at a level similar to that seen in type 2 diabetes mellitus, independent of cardiovascular disease risk factors, based on data from a trio of cross-sectional studies including 387 adults. .

“Psoriasis and type 2 diabetes share similar cardiovascular risk profiles, which may predispose patients to developing coronary atherosclerosis at a relatively young age,” wrote Bobbak Mansouri, MD, of Baylor University Medical Center in Dallas and his associates (JAMA Dermatol. 2016. [doi: 10.1001/jamadermatol.2016.2907]).

©eenevski/thinkstockphotos

The researchers compared coronary artery calcium (CAC) levels in patients with psoriasis, patients with type 2 diabetes, and healthy controls. CAC has become an accepted measure of atherosclerosis and “the cornerstone for screening the risk of future cardiac events and improving cardiovascular risk stratification beyond traditional risk factors, especially in higher-risk groups,” according to the investigators. The average age of the patients was 52 years, 50% were female, and at least 92% were white.

The researchers used a hierarchical Tobit regression analysis to determine the association between disease and CAC level, as measured by the Agatston score. After controlling for confounding variables, including cardiovascular risk factors (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, fasting blood glucose, systolic blood pressure, and tobacco use), the association with CAC was similar in psoriasis patients and type 2 diabetes patients (Tobit regression ratio [TRR], 0.89 and 0.79, respectively).

In a logistic multivariate regression analysis, patients with either psoriasis or type 2 diabetes were approximately twice as likely to have evidence of CAC as were healthy controls (odds ratio, 2.35 and 2.18, respectively), and psoriasis remained independently associated with the presence of CAC.

“When we added use of systemic or biological therapy to the models, the TRR and OR increased; however, these analyses were exploratory,” wrote Dr. Mansouri and his associates.

The study was limited by factors including the cross-sectional design and lack of diversity in the patient population, the investigators noted. However, the results suggest that “CAC assessment may be considered in patients with psoriasis who have two or more traditional cardiovascular risk factors given the high prevalence of CAC observed in this study,” they said.

Dr. Mansouri disclosed serving on an advisory board and receiving an honorarium from Celgene, maker of the psoriasis drug apremilast (Otezl). Study coauthors disclosed financial relationships with multiple pharmaceutical companies.

Psoriasis increased the measures of coronary artery calcium at a level similar to that seen in type 2 diabetes mellitus, independent of cardiovascular disease risk factors, based on data from a trio of cross-sectional studies including 387 adults. .

“Psoriasis and type 2 diabetes share similar cardiovascular risk profiles, which may predispose patients to developing coronary atherosclerosis at a relatively young age,” wrote Bobbak Mansouri, MD, of Baylor University Medical Center in Dallas and his associates (JAMA Dermatol. 2016. [doi: 10.1001/jamadermatol.2016.2907]).

©eenevski/thinkstockphotos

The researchers compared coronary artery calcium (CAC) levels in patients with psoriasis, patients with type 2 diabetes, and healthy controls. CAC has become an accepted measure of atherosclerosis and “the cornerstone for screening the risk of future cardiac events and improving cardiovascular risk stratification beyond traditional risk factors, especially in higher-risk groups,” according to the investigators. The average age of the patients was 52 years, 50% were female, and at least 92% were white.

The researchers used a hierarchical Tobit regression analysis to determine the association between disease and CAC level, as measured by the Agatston score. After controlling for confounding variables, including cardiovascular risk factors (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, fasting blood glucose, systolic blood pressure, and tobacco use), the association with CAC was similar in psoriasis patients and type 2 diabetes patients (Tobit regression ratio [TRR], 0.89 and 0.79, respectively).

In a logistic multivariate regression analysis, patients with either psoriasis or type 2 diabetes were approximately twice as likely to have evidence of CAC as were healthy controls (odds ratio, 2.35 and 2.18, respectively), and psoriasis remained independently associated with the presence of CAC.

“When we added use of systemic or biological therapy to the models, the TRR and OR increased; however, these analyses were exploratory,” wrote Dr. Mansouri and his associates.

The study was limited by factors including the cross-sectional design and lack of diversity in the patient population, the investigators noted. However, the results suggest that “CAC assessment may be considered in patients with psoriasis who have two or more traditional cardiovascular risk factors given the high prevalence of CAC observed in this study,” they said.

Dr. Mansouri disclosed serving on an advisory board and receiving an honorarium from Celgene, maker of the psoriasis drug apremilast (Otezl). Study coauthors disclosed financial relationships with multiple pharmaceutical companies.

Psoriasis increased the measures of coronary artery calcium at a level similar to that seen in type 2 diabetes mellitus, independent of cardiovascular disease risk factors, based on data from a trio of cross-sectional studies including 387 adults. .

“Psoriasis and type 2 diabetes share similar cardiovascular risk profiles, which may predispose patients to developing coronary atherosclerosis at a relatively young age,” wrote Bobbak Mansouri, MD, of Baylor University Medical Center in Dallas and his associates (JAMA Dermatol. 2016. [doi: 10.1001/jamadermatol.2016.2907]).

©eenevski/thinkstockphotos

The researchers compared coronary artery calcium (CAC) levels in patients with psoriasis, patients with type 2 diabetes, and healthy controls. CAC has become an accepted measure of atherosclerosis and “the cornerstone for screening the risk of future cardiac events and improving cardiovascular risk stratification beyond traditional risk factors, especially in higher-risk groups,” according to the investigators. The average age of the patients was 52 years, 50% were female, and at least 92% were white.

The researchers used a hierarchical Tobit regression analysis to determine the association between disease and CAC level, as measured by the Agatston score. After controlling for confounding variables, including cardiovascular risk factors (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, fasting blood glucose, systolic blood pressure, and tobacco use), the association with CAC was similar in psoriasis patients and type 2 diabetes patients (Tobit regression ratio [TRR], 0.89 and 0.79, respectively).

In a logistic multivariate regression analysis, patients with either psoriasis or type 2 diabetes were approximately twice as likely to have evidence of CAC as were healthy controls (odds ratio, 2.35 and 2.18, respectively), and psoriasis remained independently associated with the presence of CAC.

“When we added use of systemic or biological therapy to the models, the TRR and OR increased; however, these analyses were exploratory,” wrote Dr. Mansouri and his associates.

The study was limited by factors including the cross-sectional design and lack of diversity in the patient population, the investigators noted. However, the results suggest that “CAC assessment may be considered in patients with psoriasis who have two or more traditional cardiovascular risk factors given the high prevalence of CAC observed in this study,” they said.

Dr. Mansouri disclosed serving on an advisory board and receiving an honorarium from Celgene, maker of the psoriasis drug apremilast (Otezl). Study coauthors disclosed financial relationships with multiple pharmaceutical companies.

Myth: Psoriasis Cannot Be Treated

At the Summer Meeting of the American Academy of Dermatology in Boston, Massachusetts (July 28-31, 2016), Dr. Alexa Kimball presented on dermatology research advances at the plenary session and referenced the revolution in psoriasis treatment that has been experienced in the last several years, noting that dermatologists previously were relegated to treating patients with tar treatments. Today, many options for the treatment of psoriasis exist, though the disease is not curable.

According to the Mayo Clinic, psoriasis treatment is aimed at stopping the skin cells from growing so quickly, which reduces inflammation and plaque formation, and removing scales and smoothing skin. It is important for patients to understand the different treatment options so that they are aware that a variety of therapies may be tried until the right regimen with the fewest potential side effects is found. Options include:

• Biologics: given by injection or intravenous infusion for moderate to severe psoriasis that has not responded to other treatments

• Experimental medications: new medications undergoing clinical trials

• Oral treatments: inhibit specific molecules associated with inflammation and can be taken by mouth rather than injection or infusion (eg, retinoids, methotrexate, cyclosporine)

• Phototherapy or other light therapy: involves exposing the skin to UV light on a regular basis and under medical supervision (eg, UVB phototherapy, narrowband UVB therapy, psoralen plus UVA, excimer laser)

• Systemics: given orally or by injection and work throughout the body for moderate to severe psoriasis

• Topicals: applied to the skin and typically used for mild to moderate psoriasis (eg, topical corticosteroids, vitamin D analogues, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, moisturizers)

In a 2014 analysis of data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey of the National Center for Health Statistics, the frequency of phototherapy treatments for psoriasis significantly decreased from 1993 to 2010 (P<.001), while the frequency of biologics significantly increased, becoming the most frequently used treatment from 2008 to 2010 (P<.0001).

However, psoriasis has been noted to be undertreated. A 2007 survey of 1657 psoriasis patients (28% with severe disease and 41% with moderate disease) from the National Psoriasis Foundation contact database indicated that 39% of respondents with severe psoriasis and 37% with moderate psoriasis were not currently receiving any treatment. Among those receiving treatment, only 43% with severe psoriasis received either traditional systemic therapy, biologic therapy, or phototherapy.

Access to care and cost of treatment are some of the reasons why psoriasis may go untreated. In 2013 the National Psoriasis Foundation reported results of a survey of 5600 patients with psoriasis and psoriatic arthritis, which revealed that patients did not see a specialist (ie, dermatologist, rheumatologist) to treat their disease because they had given up on treatment (28%), it was too expensive (21%), or it was too much of a hassle (11%). Although approximately 91% of patients were covered by medical insurance, the majority spent more than $2500 per year in out-of-pocket costs for their disease.

Patient satisfaction with treatment also is a concern. A 2002 National Psoriasis Foundation survey reported that 33% of patients are unsatisfied with current treatments and 78% do not use more aggressive therapies to treat their disease because of their side effects and lack of effectiveness. The advent of biologic therapies and new oral treatments has afforded psoriasis patients the opportunity to have a frank discussion with their health care provider if they are not satisfied with treatment or are not seeing the type of improvement that would make a substantial impact on their quality of life. Additionally, over time skin may become resistant to various treatments. Therefore, open communication with psoriasis patients is key.

Expert Commentary

We are in the midst of a second revolution in the treatment of psoriasis. We have multiple new biologic and oral agents available for the treatment of this condition. In addition, there are a large number of treatments currently in development. Not only can psoriasis be treated, it can be treated highly effectively and safely.

—Jeffrey M. Weinberg, MD (New York, New York)

Myth: Psoriasis Cannot Be Treated

At the Summer Meeting of the American Academy of Dermatology in Boston, Massachusetts (July 28-31, 2016), Dr. Alexa Kimball presented on dermatology research advances at the plenary session and referenced the revolution in psoriasis treatment that has been experienced in the last several years, noting that dermatologists previously were relegated to treating patients with tar treatments. Today, many options for the treatment of psoriasis exist, though the disease is not curable.

According to the Mayo Clinic, psoriasis treatment is aimed at stopping the skin cells from growing so quickly, which reduces inflammation and plaque formation, and removing scales and smoothing skin. It is important for patients to understand the different treatment options so that they are aware that a variety of therapies may be tried until the right regimen with the fewest potential side effects is found. Options include:

• Biologics: given by injection or intravenous infusion for moderate to severe psoriasis that has not responded to other treatments

• Experimental medications: new medications undergoing clinical trials

• Oral treatments: inhibit specific molecules associated with inflammation and can be taken by mouth rather than injection or infusion (eg, retinoids, methotrexate, cyclosporine)

• Phototherapy or other light therapy: involves exposing the skin to UV light on a regular basis and under medical supervision (eg, UVB phototherapy, narrowband UVB therapy, psoralen plus UVA, excimer laser)

• Systemics: given orally or by injection and work throughout the body for moderate to severe psoriasis

• Topicals: applied to the skin and typically used for mild to moderate psoriasis (eg, topical corticosteroids, vitamin D analogues, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, moisturizers)

In a 2014 analysis of data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey of the National Center for Health Statistics, the frequency of phototherapy treatments for psoriasis significantly decreased from 1993 to 2010 (P<.001), while the frequency of biologics significantly increased, becoming the most frequently used treatment from 2008 to 2010 (P<.0001).

However, psoriasis has been noted to be undertreated. A 2007 survey of 1657 psoriasis patients (28% with severe disease and 41% with moderate disease) from the National Psoriasis Foundation contact database indicated that 39% of respondents with severe psoriasis and 37% with moderate psoriasis were not currently receiving any treatment. Among those receiving treatment, only 43% with severe psoriasis received either traditional systemic therapy, biologic therapy, or phototherapy.

Access to care and cost of treatment are some of the reasons why psoriasis may go untreated. In 2013 the National Psoriasis Foundation reported results of a survey of 5600 patients with psoriasis and psoriatic arthritis, which revealed that patients did not see a specialist (ie, dermatologist, rheumatologist) to treat their disease because they had given up on treatment (28%), it was too expensive (21%), or it was too much of a hassle (11%). Although approximately 91% of patients were covered by medical insurance, the majority spent more than $2500 per year in out-of-pocket costs for their disease.

Patient satisfaction with treatment also is a concern. A 2002 National Psoriasis Foundation survey reported that 33% of patients are unsatisfied with current treatments and 78% do not use more aggressive therapies to treat their disease because of their side effects and lack of effectiveness. The advent of biologic therapies and new oral treatments has afforded psoriasis patients the opportunity to have a frank discussion with their health care provider if they are not satisfied with treatment or are not seeing the type of improvement that would make a substantial impact on their quality of life. Additionally, over time skin may become resistant to various treatments. Therefore, open communication with psoriasis patients is key.

Expert Commentary

We are in the midst of a second revolution in the treatment of psoriasis. We have multiple new biologic and oral agents available for the treatment of this condition. In addition, there are a large number of treatments currently in development. Not only can psoriasis be treated, it can be treated highly effectively and safely.

—Jeffrey M. Weinberg, MD (New York, New York)

Myth: Psoriasis Cannot Be Treated

At the Summer Meeting of the American Academy of Dermatology in Boston, Massachusetts (July 28-31, 2016), Dr. Alexa Kimball presented on dermatology research advances at the plenary session and referenced the revolution in psoriasis treatment that has been experienced in the last several years, noting that dermatologists previously were relegated to treating patients with tar treatments. Today, many options for the treatment of psoriasis exist, though the disease is not curable.

According to the Mayo Clinic, psoriasis treatment is aimed at stopping the skin cells from growing so quickly, which reduces inflammation and plaque formation, and removing scales and smoothing skin. It is important for patients to understand the different treatment options so that they are aware that a variety of therapies may be tried until the right regimen with the fewest potential side effects is found. Options include:

• Biologics: given by injection or intravenous infusion for moderate to severe psoriasis that has not responded to other treatments

• Experimental medications: new medications undergoing clinical trials

• Oral treatments: inhibit specific molecules associated with inflammation and can be taken by mouth rather than injection or infusion (eg, retinoids, methotrexate, cyclosporine)

• Phototherapy or other light therapy: involves exposing the skin to UV light on a regular basis and under medical supervision (eg, UVB phototherapy, narrowband UVB therapy, psoralen plus UVA, excimer laser)

• Systemics: given orally or by injection and work throughout the body for moderate to severe psoriasis

• Topicals: applied to the skin and typically used for mild to moderate psoriasis (eg, topical corticosteroids, vitamin D analogues, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, moisturizers)

In a 2014 analysis of data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey of the National Center for Health Statistics, the frequency of phototherapy treatments for psoriasis significantly decreased from 1993 to 2010 (P<.001), while the frequency of biologics significantly increased, becoming the most frequently used treatment from 2008 to 2010 (P<.0001).

However, psoriasis has been noted to be undertreated. A 2007 survey of 1657 psoriasis patients (28% with severe disease and 41% with moderate disease) from the National Psoriasis Foundation contact database indicated that 39% of respondents with severe psoriasis and 37% with moderate psoriasis were not currently receiving any treatment. Among those receiving treatment, only 43% with severe psoriasis received either traditional systemic therapy, biologic therapy, or phototherapy.

Access to care and cost of treatment are some of the reasons why psoriasis may go untreated. In 2013 the National Psoriasis Foundation reported results of a survey of 5600 patients with psoriasis and psoriatic arthritis, which revealed that patients did not see a specialist (ie, dermatologist, rheumatologist) to treat their disease because they had given up on treatment (28%), it was too expensive (21%), or it was too much of a hassle (11%). Although approximately 91% of patients were covered by medical insurance, the majority spent more than $2500 per year in out-of-pocket costs for their disease.

Patient satisfaction with treatment also is a concern. A 2002 National Psoriasis Foundation survey reported that 33% of patients are unsatisfied with current treatments and 78% do not use more aggressive therapies to treat their disease because of their side effects and lack of effectiveness. The advent of biologic therapies and new oral treatments has afforded psoriasis patients the opportunity to have a frank discussion with their health care provider if they are not satisfied with treatment or are not seeing the type of improvement that would make a substantial impact on their quality of life. Additionally, over time skin may become resistant to various treatments. Therefore, open communication with psoriasis patients is key.

Expert Commentary

We are in the midst of a second revolution in the treatment of psoriasis. We have multiple new biologic and oral agents available for the treatment of this condition. In addition, there are a large number of treatments currently in development. Not only can psoriasis be treated, it can be treated highly effectively and safely.

—Jeffrey M. Weinberg, MD (New York, New York)

For the last decade, we have considered the cardioprotective benefit of biologics, especially in patients with chronic inflammatory diseases. Due to accelerated coronary artery disease, inflammatory pathways of psoriasis share connections with the mechanisms of atherosclerosis.

In a July 7 article published online in JAMA Dermatology, Hjuler et al investigated the association of biological therapy with changes in coronary artery disease progression, measured by serial coronary computed tomography (CT). Patients with severe psoriasis were enrolled in a single-center, prospective, controlled, observer-blinded clinical study. Between April 2011 and June 2014, biologic therapy (intervention group) and a matched control that did not receive the same therapy (control group) were initiated. Biological therapies included adalimumab, etanercept, infliximab, and ustekinumab, along with the possibility to switch between treatments to ensure inflammation control.

At baseline and 13-month follow-up, 28 treated patients (mean age [SD], 49.2 [10.2] years; 71% men; mean psoriasis area severity index [PASI][SD], 15.4 [4.3]) and 28 controls (mean age [SD], 52.8 [10.6] years; 71% men; mean PASI [SD], 12.4 [3.9]) underwent noncontrast coronary artery calcium (CAC) CT and contrast-enhanced coronary CT angiography. Changes in CAC score, number of coronary plaques, severity of luminal narrowing, composition, and vessel wall volume were measured.

In the intervention group, the CAC scores remained stable (mean yearly CAC change [SD], -16 [56]; P=.15) and progressed in the control group (14 [29]; P=.02). The severity of luminal narrowing in the diseased segments remained unchanged in the intervention group (Wilcoxon W=76; n=483; P=.39) but increased at follow-up in the control group (Wilcoxon W=281; n=414; P=.02). Luminal abnormalities remained unchanged in both groups.

The authors concluded that clinically effective treatment with biologic agents is associated with reduced coronary artery diseases in patients with severe psoriasis. These findings support a beneficial effect of biologic anti-inflammatory agents in preventing cardiovascular disease progression in addition to disease control in inflammatory diseases.

What’s the issue?

These findings give continued support to the cardioprotective effects of biologics in inflammatory diseases. How will these data change your prescribing habits?

We want to know your views! Tell us what you think.

For the last decade, we have considered the cardioprotective benefit of biologics, especially in patients with chronic inflammatory diseases. Due to accelerated coronary artery disease, inflammatory pathways of psoriasis share connections with the mechanisms of atherosclerosis.

In a July 7 article published online in JAMA Dermatology, Hjuler et al investigated the association of biological therapy with changes in coronary artery disease progression, measured by serial coronary computed tomography (CT). Patients with severe psoriasis were enrolled in a single-center, prospective, controlled, observer-blinded clinical study. Between April 2011 and June 2014, biologic therapy (intervention group) and a matched control that did not receive the same therapy (control group) were initiated. Biological therapies included adalimumab, etanercept, infliximab, and ustekinumab, along with the possibility to switch between treatments to ensure inflammation control.

At baseline and 13-month follow-up, 28 treated patients (mean age [SD], 49.2 [10.2] years; 71% men; mean psoriasis area severity index [PASI][SD], 15.4 [4.3]) and 28 controls (mean age [SD], 52.8 [10.6] years; 71% men; mean PASI [SD], 12.4 [3.9]) underwent noncontrast coronary artery calcium (CAC) CT and contrast-enhanced coronary CT angiography. Changes in CAC score, number of coronary plaques, severity of luminal narrowing, composition, and vessel wall volume were measured.

In the intervention group, the CAC scores remained stable (mean yearly CAC change [SD], -16 [56]; P=.15) and progressed in the control group (14 [29]; P=.02). The severity of luminal narrowing in the diseased segments remained unchanged in the intervention group (Wilcoxon W=76; n=483; P=.39) but increased at follow-up in the control group (Wilcoxon W=281; n=414; P=.02). Luminal abnormalities remained unchanged in both groups.

The authors concluded that clinically effective treatment with biologic agents is associated with reduced coronary artery diseases in patients with severe psoriasis. These findings support a beneficial effect of biologic anti-inflammatory agents in preventing cardiovascular disease progression in addition to disease control in inflammatory diseases.

What’s the issue?

These findings give continued support to the cardioprotective effects of biologics in inflammatory diseases. How will these data change your prescribing habits?

We want to know your views! Tell us what you think.

For the last decade, we have considered the cardioprotective benefit of biologics, especially in patients with chronic inflammatory diseases. Due to accelerated coronary artery disease, inflammatory pathways of psoriasis share connections with the mechanisms of atherosclerosis.

In a July 7 article published online in JAMA Dermatology, Hjuler et al investigated the association of biological therapy with changes in coronary artery disease progression, measured by serial coronary computed tomography (CT). Patients with severe psoriasis were enrolled in a single-center, prospective, controlled, observer-blinded clinical study. Between April 2011 and June 2014, biologic therapy (intervention group) and a matched control that did not receive the same therapy (control group) were initiated. Biological therapies included adalimumab, etanercept, infliximab, and ustekinumab, along with the possibility to switch between treatments to ensure inflammation control.

At baseline and 13-month follow-up, 28 treated patients (mean age [SD], 49.2 [10.2] years; 71% men; mean psoriasis area severity index [PASI][SD], 15.4 [4.3]) and 28 controls (mean age [SD], 52.8 [10.6] years; 71% men; mean PASI [SD], 12.4 [3.9]) underwent noncontrast coronary artery calcium (CAC) CT and contrast-enhanced coronary CT angiography. Changes in CAC score, number of coronary plaques, severity of luminal narrowing, composition, and vessel wall volume were measured.

In the intervention group, the CAC scores remained stable (mean yearly CAC change [SD], -16 [56]; P=.15) and progressed in the control group (14 [29]; P=.02). The severity of luminal narrowing in the diseased segments remained unchanged in the intervention group (Wilcoxon W=76; n=483; P=.39) but increased at follow-up in the control group (Wilcoxon W=281; n=414; P=.02). Luminal abnormalities remained unchanged in both groups.

The authors concluded that clinically effective treatment with biologic agents is associated with reduced coronary artery diseases in patients with severe psoriasis. These findings support a beneficial effect of biologic anti-inflammatory agents in preventing cardiovascular disease progression in addition to disease control in inflammatory diseases.

What’s the issue?

These findings give continued support to the cardioprotective effects of biologics in inflammatory diseases. How will these data change your prescribing habits?

We want to know your views! Tell us what you think.

Patients with psoriasis now have several treatment options to help control their disease. Among them are oral therapies. Dr. Gary Goldenberg reviews clearance data on approved therapies and ones on the horizon.

Patients with psoriasis now have several treatment options to help control their disease. Among them are oral therapies. Dr. Gary Goldenberg reviews clearance data on approved therapies and ones on the horizon.

Patients with psoriasis now have several treatment options to help control their disease. Among them are oral therapies. Dr. Gary Goldenberg reviews clearance data on approved therapies and ones on the horizon.

MIAMI – People with nonplaque psoriasis could soon have their day. Some patients with nail, inverse, and genital psoriasis, for example, fail to meet traditional criteria for moderate to severe disease and therefore do not meet label indications for treatment.

That could soon change if dermatologist Abrar A. Qureshi, MD, and rheumatologist-dermatologist Joseph F. Merola, MD, have their way, according to their dual presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“What we’re trying to do really is go into redefining moderate to severe psoriasis. The current definition is moderate to severe plaque psoriasis,” said Dr. Qureshi, chief of dermatology at Rhode Island Hospital in Providence. “If you look at all the labels out there, it’s plaque disease.”

However, “psoriasis is poly phenotype,” Dr. Qureshi said. “This paradigm needs to change in the next few years to redefine what moderate to severe psoriasis is.” A patient with limited, nonplaque psoriasis on their elbows, one knee, or who presents only with perianal disease, for example, might not meet the traditional definition of moderate to severe psoriasis. Another patient might just have scalp disease or inverse psoriasis on a limited body area.

Currently, the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) and Body Surface Area (BSA) assessments classify mild, moderate, and severe psoriasis, “with the majority of people out there in the world with mild psoriasis,” Dr. Qureshi said. A new measure called the Comprehensive Assessment of the Psoriasis Patient (CAPP) “captures more people with moderate to severe disease.”

CAPP includes a measure of plaque disease, palmoplantar, nail, scale, inverse, and genital psoriasis. “Where PASI fails, we hope the CAPP meets this unmet need,” said Dr. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. The two highest phenotypic scores are added to the plaque score for a final CAPP score. “It’s easy to use.”

A newly announced genital psoriasis component of CAPP measures any suprapubic, perineal, and genital involvement. Thickness, scale, and severity are included in CAPP, as well as secondary skin changes like fissuring or erosion. Then the score is equally weighted with the patient reported outcomes of pain and effect on intimacy rated on a simple visual analog scale.

Dr. Merola, Dr. Qureshi, and their colleagues collaborated on a study looking at the prevalence of nonplaque psoriasis among almost 4,000 patients (Clin Exp Dermatol. 2016;41:486-9).

“It surprised us to see such a high prevalence of inverse disease, almost 24%,” Dr. Merola said. “Many of these patients have two nonplaque phenotypes. It’s also important because it seems like there is an increased psoriatic arthritis risk.”

“The nail story and the scalp story have been out there a while, but looking at inverse disease there was a fairly high hazard ratio [2.07] for development of psoriatic arthritis.”

Proposing a polyphenotype psoriasis clinical trial

“I will end with a recommendation for a polyphenotype psoriasis clinical trial, to be really controversial,” Dr. Qureshi said. “We want to capture only the people who qualify as moderate to severe with the new measure and look at them before and after therapy.” He added participants would be “people out there in clinic who are currently not receiving treatment.”

During the Q&A, a meeting attendee asked if the investigators could recruit enough patients with nonplaque psoriasis. “We think it’s about 15%-23%,” Dr. Qureshi said. “The only type we cannot capture well is the palmoplantar phenotype because of its really low prevalence.”

MIAMI – People with nonplaque psoriasis could soon have their day. Some patients with nail, inverse, and genital psoriasis, for example, fail to meet traditional criteria for moderate to severe disease and therefore do not meet label indications for treatment.

That could soon change if dermatologist Abrar A. Qureshi, MD, and rheumatologist-dermatologist Joseph F. Merola, MD, have their way, according to their dual presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“What we’re trying to do really is go into redefining moderate to severe psoriasis. The current definition is moderate to severe plaque psoriasis,” said Dr. Qureshi, chief of dermatology at Rhode Island Hospital in Providence. “If you look at all the labels out there, it’s plaque disease.”

However, “psoriasis is poly phenotype,” Dr. Qureshi said. “This paradigm needs to change in the next few years to redefine what moderate to severe psoriasis is.” A patient with limited, nonplaque psoriasis on their elbows, one knee, or who presents only with perianal disease, for example, might not meet the traditional definition of moderate to severe psoriasis. Another patient might just have scalp disease or inverse psoriasis on a limited body area.

Currently, the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) and Body Surface Area (BSA) assessments classify mild, moderate, and severe psoriasis, “with the majority of people out there in the world with mild psoriasis,” Dr. Qureshi said. A new measure called the Comprehensive Assessment of the Psoriasis Patient (CAPP) “captures more people with moderate to severe disease.”

CAPP includes a measure of plaque disease, palmoplantar, nail, scale, inverse, and genital psoriasis. “Where PASI fails, we hope the CAPP meets this unmet need,” said Dr. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. The two highest phenotypic scores are added to the plaque score for a final CAPP score. “It’s easy to use.”

A newly announced genital psoriasis component of CAPP measures any suprapubic, perineal, and genital involvement. Thickness, scale, and severity are included in CAPP, as well as secondary skin changes like fissuring or erosion. Then the score is equally weighted with the patient reported outcomes of pain and effect on intimacy rated on a simple visual analog scale.

Dr. Merola, Dr. Qureshi, and their colleagues collaborated on a study looking at the prevalence of nonplaque psoriasis among almost 4,000 patients (Clin Exp Dermatol. 2016;41:486-9).

“It surprised us to see such a high prevalence of inverse disease, almost 24%,” Dr. Merola said. “Many of these patients have two nonplaque phenotypes. It’s also important because it seems like there is an increased psoriatic arthritis risk.”

“The nail story and the scalp story have been out there a while, but looking at inverse disease there was a fairly high hazard ratio [2.07] for development of psoriatic arthritis.”

Proposing a polyphenotype psoriasis clinical trial

“I will end with a recommendation for a polyphenotype psoriasis clinical trial, to be really controversial,” Dr. Qureshi said. “We want to capture only the people who qualify as moderate to severe with the new measure and look at them before and after therapy.” He added participants would be “people out there in clinic who are currently not receiving treatment.”

During the Q&A, a meeting attendee asked if the investigators could recruit enough patients with nonplaque psoriasis. “We think it’s about 15%-23%,” Dr. Qureshi said. “The only type we cannot capture well is the palmoplantar phenotype because of its really low prevalence.”

MIAMI – People with nonplaque psoriasis could soon have their day. Some patients with nail, inverse, and genital psoriasis, for example, fail to meet traditional criteria for moderate to severe disease and therefore do not meet label indications for treatment.

That could soon change if dermatologist Abrar A. Qureshi, MD, and rheumatologist-dermatologist Joseph F. Merola, MD, have their way, according to their dual presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“What we’re trying to do really is go into redefining moderate to severe psoriasis. The current definition is moderate to severe plaque psoriasis,” said Dr. Qureshi, chief of dermatology at Rhode Island Hospital in Providence. “If you look at all the labels out there, it’s plaque disease.”

However, “psoriasis is poly phenotype,” Dr. Qureshi said. “This paradigm needs to change in the next few years to redefine what moderate to severe psoriasis is.” A patient with limited, nonplaque psoriasis on their elbows, one knee, or who presents only with perianal disease, for example, might not meet the traditional definition of moderate to severe psoriasis. Another patient might just have scalp disease or inverse psoriasis on a limited body area.

Currently, the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) and Body Surface Area (BSA) assessments classify mild, moderate, and severe psoriasis, “with the majority of people out there in the world with mild psoriasis,” Dr. Qureshi said. A new measure called the Comprehensive Assessment of the Psoriasis Patient (CAPP) “captures more people with moderate to severe disease.”

CAPP includes a measure of plaque disease, palmoplantar, nail, scale, inverse, and genital psoriasis. “Where PASI fails, we hope the CAPP meets this unmet need,” said Dr. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. The two highest phenotypic scores are added to the plaque score for a final CAPP score. “It’s easy to use.”

A newly announced genital psoriasis component of CAPP measures any suprapubic, perineal, and genital involvement. Thickness, scale, and severity are included in CAPP, as well as secondary skin changes like fissuring or erosion. Then the score is equally weighted with the patient reported outcomes of pain and effect on intimacy rated on a simple visual analog scale.

Dr. Merola, Dr. Qureshi, and their colleagues collaborated on a study looking at the prevalence of nonplaque psoriasis among almost 4,000 patients (Clin Exp Dermatol. 2016;41:486-9).

“It surprised us to see such a high prevalence of inverse disease, almost 24%,” Dr. Merola said. “Many of these patients have two nonplaque phenotypes. It’s also important because it seems like there is an increased psoriatic arthritis risk.”

“The nail story and the scalp story have been out there a while, but looking at inverse disease there was a fairly high hazard ratio [2.07] for development of psoriatic arthritis.”

Proposing a polyphenotype psoriasis clinical trial

“I will end with a recommendation for a polyphenotype psoriasis clinical trial, to be really controversial,” Dr. Qureshi said. “We want to capture only the people who qualify as moderate to severe with the new measure and look at them before and after therapy.” He added participants would be “people out there in clinic who are currently not receiving treatment.”

During the Q&A, a meeting attendee asked if the investigators could recruit enough patients with nonplaque psoriasis. “We think it’s about 15%-23%,” Dr. Qureshi said. “The only type we cannot capture well is the palmoplantar phenotype because of its really low prevalence.”

MIAMI – As patients with psoriasis develop psoriatic arthritis, the abundance of particular genera in the skin microbiome decreases, according to a preliminary study characterizing cutaneous microbiota in these populations.

“The big overall message is there might be a decrease in microbiota diversity as you progress through the disease spectrum,” Julia Manasson, MD, a fellow in the division of rheumatology at New York University said. “This is the first study characterizing the cutaneous microbial compositions of subjects with psoriasis and psoriatic arthritis in both psoriatic lesions and unaffected skin.”

Damian McNamara/Frontline Medical News

A previous study that revealed changes in gut microbiome between psoriasis and psoriatic arthritis patient stool samples (Arthritis Rheumatol. 2015;67:128-39) prompted the current research, which is “trying to see if the skin has a similar manifestation,” Dr. Manasson said during an oral presentation of her poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“The microbiome has been implicated as a potential trigger for inflammation and autoimmune disease,” Dr. Manasson noted.

To investigate a potential role of the skin microbiome, the investigators swabbed lesions and unaffected skin (on a contralateral site) in 29 people with psoriasis and 62 others with psoriatic arthritis. They extracted, amplified, and sequenced DNA from the samples. No participants in the study were on treatment with biologics, disease-modifying antirheumatic drugs, or steroids at the time of assessment. The psoriasis group was 66% men and had an average age of 45 years; the psoriatic arthritis group was 55% men and the average age was 42.

Dr. Manasson and her colleagues calculated the taxonomic relative abundance and contrasted their prevalence among the four skin phenotypes examined: lesions and unaffected skin of psoriasis patients and lesions and unaffected skin of psoriatic arthritis patients. Alpha diversity plots revealed a similar number of operational taxonomic units (OTUs) between psoriasis and psoriatic arthritis samples. Beta diversity analysis showed no distinct clustering or significant difference in microbiota communities among different phenotypes.

“We saw more of a decrease in nonlesional skin and across clinical severity, too,” Dr. Manasson said. “Globally, we didn’t see significant differences [in microbiota present].”

Staphylococcus and Corynebacterium were the predominant bacteria in all samples, but there were also specific genera that were less common in psoriatic arthritis patients and in lesional skin. These less abundant genera included unclassified Bradyrhizobiaceae, Rahnella, unclassified Prevotellaceae, and Parvibaculum.

“It looks like you had some differences between lesion and nonlesional skin,” Alice Gottlieb, MD, chair and dermatologist in chief at Tufts Medical Center in Boston. “In psoriasis, the barrier function is not normal. You may want to look at atopic dermatitis where you clearly have altered barrier function.”

Dr. Manasson said they used a skin swab, so they did not assess barrier function.

“The nonlesional skin may be more interesting to look at,” Dr. Gottlieb added. “If you see a difference in nonlesional skin, it could be more [conclusive].”

Microbiome stability often changes in individuals from week to week, commented Philip Helliwell, DM, PhD, a rheumatologist at the University of Leeds in England and president of GRAPPA. Dr. Manasson said she could assess variability over time in the future. She also would like to evaluate how therapies, including antibiotics, alter the skin microbiome.

Lack of a healthy control group is a potential limitation of the study. Some unanswered questions remain, Dr. Manasson said, such as what are the regional differences in skin microbiota, for example, between a patient’s scalp and forearm? She added, “The most interesting question is what does this actually mean? What are the downstream effects?”

If a decrease in skin microbiome flora diversity is verified in future research as a sign that a patient with psoriasis is at elevated risk for developing psoriatic arthritis, it could help physicians predict who will progress. Currently, about 30% of psoriatic patients go on to develop joint disease, but methods to identify this subpopulation remain elusive.

Dr. Manasson, Dr. Gottlieb, and Dr. Helliwell had no relevant financial disclosures.

MIAMI – As patients with psoriasis develop psoriatic arthritis, the abundance of particular genera in the skin microbiome decreases, according to a preliminary study characterizing cutaneous microbiota in these populations.

“The big overall message is there might be a decrease in microbiota diversity as you progress through the disease spectrum,” Julia Manasson, MD, a fellow in the division of rheumatology at New York University said. “This is the first study characterizing the cutaneous microbial compositions of subjects with psoriasis and psoriatic arthritis in both psoriatic lesions and unaffected skin.”

Damian McNamara/Frontline Medical News

A previous study that revealed changes in gut microbiome between psoriasis and psoriatic arthritis patient stool samples (Arthritis Rheumatol. 2015;67:128-39) prompted the current research, which is “trying to see if the skin has a similar manifestation,” Dr. Manasson said during an oral presentation of her poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“The microbiome has been implicated as a potential trigger for inflammation and autoimmune disease,” Dr. Manasson noted.

To investigate a potential role of the skin microbiome, the investigators swabbed lesions and unaffected skin (on a contralateral site) in 29 people with psoriasis and 62 others with psoriatic arthritis. They extracted, amplified, and sequenced DNA from the samples. No participants in the study were on treatment with biologics, disease-modifying antirheumatic drugs, or steroids at the time of assessment. The psoriasis group was 66% men and had an average age of 45 years; the psoriatic arthritis group was 55% men and the average age was 42.

Dr. Manasson and her colleagues calculated the taxonomic relative abundance and contrasted their prevalence among the four skin phenotypes examined: lesions and unaffected skin of psoriasis patients and lesions and unaffected skin of psoriatic arthritis patients. Alpha diversity plots revealed a similar number of operational taxonomic units (OTUs) between psoriasis and psoriatic arthritis samples. Beta diversity analysis showed no distinct clustering or significant difference in microbiota communities among different phenotypes.

“We saw more of a decrease in nonlesional skin and across clinical severity, too,” Dr. Manasson said. “Globally, we didn’t see significant differences [in microbiota present].”

Staphylococcus and Corynebacterium were the predominant bacteria in all samples, but there were also specific genera that were less common in psoriatic arthritis patients and in lesional skin. These less abundant genera included unclassified Bradyrhizobiaceae, Rahnella, unclassified Prevotellaceae, and Parvibaculum.

“It looks like you had some differences between lesion and nonlesional skin,” Alice Gottlieb, MD, chair and dermatologist in chief at Tufts Medical Center in Boston. “In psoriasis, the barrier function is not normal. You may want to look at atopic dermatitis where you clearly have altered barrier function.”

Dr. Manasson said they used a skin swab, so they did not assess barrier function.

“The nonlesional skin may be more interesting to look at,” Dr. Gottlieb added. “If you see a difference in nonlesional skin, it could be more [conclusive].”

Microbiome stability often changes in individuals from week to week, commented Philip Helliwell, DM, PhD, a rheumatologist at the University of Leeds in England and president of GRAPPA. Dr. Manasson said she could assess variability over time in the future. She also would like to evaluate how therapies, including antibiotics, alter the skin microbiome.

Lack of a healthy control group is a potential limitation of the study. Some unanswered questions remain, Dr. Manasson said, such as what are the regional differences in skin microbiota, for example, between a patient’s scalp and forearm? She added, “The most interesting question is what does this actually mean? What are the downstream effects?”

If a decrease in skin microbiome flora diversity is verified in future research as a sign that a patient with psoriasis is at elevated risk for developing psoriatic arthritis, it could help physicians predict who will progress. Currently, about 30% of psoriatic patients go on to develop joint disease, but methods to identify this subpopulation remain elusive.

Dr. Manasson, Dr. Gottlieb, and Dr. Helliwell had no relevant financial disclosures.

MIAMI – As patients with psoriasis develop psoriatic arthritis, the abundance of particular genera in the skin microbiome decreases, according to a preliminary study characterizing cutaneous microbiota in these populations.

“The big overall message is there might be a decrease in microbiota diversity as you progress through the disease spectrum,” Julia Manasson, MD, a fellow in the division of rheumatology at New York University said. “This is the first study characterizing the cutaneous microbial compositions of subjects with psoriasis and psoriatic arthritis in both psoriatic lesions and unaffected skin.”

Damian McNamara/Frontline Medical News

A previous study that revealed changes in gut microbiome between psoriasis and psoriatic arthritis patient stool samples (Arthritis Rheumatol. 2015;67:128-39) prompted the current research, which is “trying to see if the skin has a similar manifestation,” Dr. Manasson said during an oral presentation of her poster at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“The microbiome has been implicated as a potential trigger for inflammation and autoimmune disease,” Dr. Manasson noted.

To investigate a potential role of the skin microbiome, the investigators swabbed lesions and unaffected skin (on a contralateral site) in 29 people with psoriasis and 62 others with psoriatic arthritis. They extracted, amplified, and sequenced DNA from the samples. No participants in the study were on treatment with biologics, disease-modifying antirheumatic drugs, or steroids at the time of assessment. The psoriasis group was 66% men and had an average age of 45 years; the psoriatic arthritis group was 55% men and the average age was 42.

Dr. Manasson and her colleagues calculated the taxonomic relative abundance and contrasted their prevalence among the four skin phenotypes examined: lesions and unaffected skin of psoriasis patients and lesions and unaffected skin of psoriatic arthritis patients. Alpha diversity plots revealed a similar number of operational taxonomic units (OTUs) between psoriasis and psoriatic arthritis samples. Beta diversity analysis showed no distinct clustering or significant difference in microbiota communities among different phenotypes.

“We saw more of a decrease in nonlesional skin and across clinical severity, too,” Dr. Manasson said. “Globally, we didn’t see significant differences [in microbiota present].”

Staphylococcus and Corynebacterium were the predominant bacteria in all samples, but there were also specific genera that were less common in psoriatic arthritis patients and in lesional skin. These less abundant genera included unclassified Bradyrhizobiaceae, Rahnella, unclassified Prevotellaceae, and Parvibaculum.

“It looks like you had some differences between lesion and nonlesional skin,” Alice Gottlieb, MD, chair and dermatologist in chief at Tufts Medical Center in Boston. “In psoriasis, the barrier function is not normal. You may want to look at atopic dermatitis where you clearly have altered barrier function.”

Dr. Manasson said they used a skin swab, so they did not assess barrier function.

“The nonlesional skin may be more interesting to look at,” Dr. Gottlieb added. “If you see a difference in nonlesional skin, it could be more [conclusive].”

Microbiome stability often changes in individuals from week to week, commented Philip Helliwell, DM, PhD, a rheumatologist at the University of Leeds in England and president of GRAPPA. Dr. Manasson said she could assess variability over time in the future. She also would like to evaluate how therapies, including antibiotics, alter the skin microbiome.

Lack of a healthy control group is a potential limitation of the study. Some unanswered questions remain, Dr. Manasson said, such as what are the regional differences in skin microbiota, for example, between a patient’s scalp and forearm? She added, “The most interesting question is what does this actually mean? What are the downstream effects?”

If a decrease in skin microbiome flora diversity is verified in future research as a sign that a patient with psoriasis is at elevated risk for developing psoriatic arthritis, it could help physicians predict who will progress. Currently, about 30% of psoriatic patients go on to develop joint disease, but methods to identify this subpopulation remain elusive.

Dr. Manasson, Dr. Gottlieb, and Dr. Helliwell had no relevant financial disclosures.