Psoriasis

At 6 months, quality of life is largely the same whether psoriasis patients stay on their initial etanercept (Enbrel) dose of 50 mg twice weekly or step down to 50 mg once weekly with topical corticosteroids, according to a Canadian trial published in the Journal of The European Academy of Dermatology and Venereology.

“The opportunity to use a topical agent seemed to improve [patients’] overall satisfaction,” and weekly “etanercept and topical may be a less costly option compared with” etanercept twice weekly, said the investigators, led by Dr. Kim Papp, of Probity Medical Research in Waterloo, Ont.

Previously, the investigators showed that the step-down strategy works as well as full-dose maintenance in clearing the skin. They wanted to check if that also held true for quality of life, as assessed by the Dermatology Life Quality Index (DLQI) and the Treatment Satisfaction Questionnaire for Medication (TSQM). (J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1555-61).

The 287 patients, all with moderate-to-severe plaque psoriasis for at least half a year, received etanercept 50 mg twice weekly for 12 weeks; 144 were then randomized to stay on that dose, and 143 others to drop to 50 mg weekly with the addition of topicals as required through week 24. The mean age of patients in the trial was 45 years; 88% of the subjects were white and 65% were men.

Topicals included hydrocortisone 2.5%, beta methasone valerate 0.1%, betamethasone dipropionate 0.05%, clobetasol 0.05%, calcitriol, or calcipotriol plus betamethasone dipropionate 0.05%; the topicals were selected by the researchers, who were allowed to change them as needed.

The mean change in DLQI from baseline to week 24 was 10.7 points in the etanercept group and 9.9 points in the etanercept-plus-topical group. Mean change in TSQM effectiveness, convenience, side-effects, and global satisfaction was 27.1, 14.8, -0.7 and 26.7 points in the etanercept group, and 32.5, 18.5, 1.3, and 28.4 points in the etanercept-plus-topical group. Healthcare visits, employment status, work productivity, and ability to perform daily activities were similar between the treatment arms.

The study was descriptive; the investigators didn’t run statistical analyses. Even so, measures of quality of life “were numerically similar in patients who stayed on etanercept 50 mg [twice weekly] and patients who received etanercept 50 mg [weekly] plus topical therapies. No notable differences between treatment arms ... were observed. Additionally, improvements in [Psoriasis Area and Severity Index] scores appeared to correlate with improvements in patient reported outcomes,” the investigators said.

“The duration of treatment with topical therapies was only 12 weeks; a longer duration may result in loss of efficacy as adherence to topical therapies may decrease with time,” they noted.

The work was funded by etanercept’s maker, Amgen. Dr. Papp reported consulting for the company. Two other investigators have been Amgen advisors and reported research grants, speakers fees, or other payments.

aotto@frontlinemedcom.com

At 6 months, quality of life is largely the same whether psoriasis patients stay on their initial etanercept (Enbrel) dose of 50 mg twice weekly or step down to 50 mg once weekly with topical corticosteroids, according to a Canadian trial published in the Journal of The European Academy of Dermatology and Venereology.

“The opportunity to use a topical agent seemed to improve [patients’] overall satisfaction,” and weekly “etanercept and topical may be a less costly option compared with” etanercept twice weekly, said the investigators, led by Dr. Kim Papp, of Probity Medical Research in Waterloo, Ont.

Previously, the investigators showed that the step-down strategy works as well as full-dose maintenance in clearing the skin. They wanted to check if that also held true for quality of life, as assessed by the Dermatology Life Quality Index (DLQI) and the Treatment Satisfaction Questionnaire for Medication (TSQM). (J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1555-61).

The 287 patients, all with moderate-to-severe plaque psoriasis for at least half a year, received etanercept 50 mg twice weekly for 12 weeks; 144 were then randomized to stay on that dose, and 143 others to drop to 50 mg weekly with the addition of topicals as required through week 24. The mean age of patients in the trial was 45 years; 88% of the subjects were white and 65% were men.

Topicals included hydrocortisone 2.5%, beta methasone valerate 0.1%, betamethasone dipropionate 0.05%, clobetasol 0.05%, calcitriol, or calcipotriol plus betamethasone dipropionate 0.05%; the topicals were selected by the researchers, who were allowed to change them as needed.

The mean change in DLQI from baseline to week 24 was 10.7 points in the etanercept group and 9.9 points in the etanercept-plus-topical group. Mean change in TSQM effectiveness, convenience, side-effects, and global satisfaction was 27.1, 14.8, -0.7 and 26.7 points in the etanercept group, and 32.5, 18.5, 1.3, and 28.4 points in the etanercept-plus-topical group. Healthcare visits, employment status, work productivity, and ability to perform daily activities were similar between the treatment arms.

The study was descriptive; the investigators didn’t run statistical analyses. Even so, measures of quality of life “were numerically similar in patients who stayed on etanercept 50 mg [twice weekly] and patients who received etanercept 50 mg [weekly] plus topical therapies. No notable differences between treatment arms ... were observed. Additionally, improvements in [Psoriasis Area and Severity Index] scores appeared to correlate with improvements in patient reported outcomes,” the investigators said.

“The duration of treatment with topical therapies was only 12 weeks; a longer duration may result in loss of efficacy as adherence to topical therapies may decrease with time,” they noted.

The work was funded by etanercept’s maker, Amgen. Dr. Papp reported consulting for the company. Two other investigators have been Amgen advisors and reported research grants, speakers fees, or other payments.

aotto@frontlinemedcom.com

At 6 months, quality of life is largely the same whether psoriasis patients stay on their initial etanercept (Enbrel) dose of 50 mg twice weekly or step down to 50 mg once weekly with topical corticosteroids, according to a Canadian trial published in the Journal of The European Academy of Dermatology and Venereology.

“The opportunity to use a topical agent seemed to improve [patients’] overall satisfaction,” and weekly “etanercept and topical may be a less costly option compared with” etanercept twice weekly, said the investigators, led by Dr. Kim Papp, of Probity Medical Research in Waterloo, Ont.

Previously, the investigators showed that the step-down strategy works as well as full-dose maintenance in clearing the skin. They wanted to check if that also held true for quality of life, as assessed by the Dermatology Life Quality Index (DLQI) and the Treatment Satisfaction Questionnaire for Medication (TSQM). (J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1555-61).

The 287 patients, all with moderate-to-severe plaque psoriasis for at least half a year, received etanercept 50 mg twice weekly for 12 weeks; 144 were then randomized to stay on that dose, and 143 others to drop to 50 mg weekly with the addition of topicals as required through week 24. The mean age of patients in the trial was 45 years; 88% of the subjects were white and 65% were men.

Topicals included hydrocortisone 2.5%, beta methasone valerate 0.1%, betamethasone dipropionate 0.05%, clobetasol 0.05%, calcitriol, or calcipotriol plus betamethasone dipropionate 0.05%; the topicals were selected by the researchers, who were allowed to change them as needed.

The mean change in DLQI from baseline to week 24 was 10.7 points in the etanercept group and 9.9 points in the etanercept-plus-topical group. Mean change in TSQM effectiveness, convenience, side-effects, and global satisfaction was 27.1, 14.8, -0.7 and 26.7 points in the etanercept group, and 32.5, 18.5, 1.3, and 28.4 points in the etanercept-plus-topical group. Healthcare visits, employment status, work productivity, and ability to perform daily activities were similar between the treatment arms.

The study was descriptive; the investigators didn’t run statistical analyses. Even so, measures of quality of life “were numerically similar in patients who stayed on etanercept 50 mg [twice weekly] and patients who received etanercept 50 mg [weekly] plus topical therapies. No notable differences between treatment arms ... were observed. Additionally, improvements in [Psoriasis Area and Severity Index] scores appeared to correlate with improvements in patient reported outcomes,” the investigators said.

“The duration of treatment with topical therapies was only 12 weeks; a longer duration may result in loss of efficacy as adherence to topical therapies may decrease with time,” they noted.

The work was funded by etanercept’s maker, Amgen. Dr. Papp reported consulting for the company. Two other investigators have been Amgen advisors and reported research grants, speakers fees, or other payments.

aotto@frontlinemedcom.com

PARK CITY, UTAH – Evidence is mounting that the use of biologic therapies is associated with certain cardiovascular benefits in patients with psoriasis.

However, until the strength of the evidence becomes more robust, Dr. Jashin J. Wu does not recommend that patients are prescribed tumor necrosis factor (TNF) inhibitors specifically to reduce the risk of cardiovascular disease. “If systemic therapy is a consideration in the setting of CVD [cardiovascular disease] risk, it would appear that TNF inhibitors and methotrexate offer the best evidence of benefit,” Dr. Wu, director of the psoriasis clinic and director of dermatology research in the department of dermatology at Kaiser Permanente Los Angeles Medical Center, said at the annual meeting of the Pacific Dermatologic Association.

The National Psoriasis Foundation recently published a consensus statement about the potential impact of current therapies on cardiovascular disease, including the risk of diabetes (J Am Acad Dermatol. 2014;70[1]:168-77). In a retrospective study of 121,280 patients with rheumatoid arthritis (RA) or psoriasis, drug regimens were categorized into four mutually exclusive groups: TNF inhibitors with or without other disease-modifying antirheumatic drugs (DMARDs), methotrexate without TNF inhibitors or hydroxychloroquine, hydroxychloroquine without TNF inhibitors or methotrexate; and other nonbiologic DMARDs without TNF inhibitors, methotrexate or hydroxychloroquine (referent group). The researchers found that adjusted Cox proportional hazards for the risk of diabetes were lower among those on TNF inhibitors (hazard ratio, 0.62; 95% confidence interval, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80), compared with those on methotrexate (HR, 0.77, 95% CI, 0.53-1.13) (JAMA. 2011 Jun 22;305[24]:2525-31).

Increased carotid intimal media thickness (IMT) is also an independent predictor of CVD. In a prospective, observational study, 20 psoriasis patients received a 12-week treatment of TNF inhibitors (Ann Rheum Dis. 2011 Apr;70[4]:705-6). After 12 weeks, 9 patients continued on their TNF-inhibitor regimen (group 1), while 11 discontinued treatment because of financial constraints (group 2). Another 20 psoriasis patients who did not receive biologic therapy served as controls (group 3). The researchers measured IMT by carotid ultrasound at baseline, week 12 and at 2 years. They found that between baseline and 2 years, IMT decreased from 0.70 mm to 0.63 mm in group 1, from 0.71 to 0.67 in group 2, and increased from 0.79 to 0.82 in group 3. “This seems to suggest that the use of TNF inhibitors may improve atherosclerosis,” said Dr. Wu, who is currently running seven clinical trials of psoriasis patients. Similar findings were seen in a larger study that examined 224 patients with psoriatic arthritis and followed them for a mean of 55 months: 124 on TNF inhibitors, 104 on DMARDs, and 305 matched controls (Arterioscler Thromb Vasc Biol. 2011 Mar;31[3]:705-120).

In a separate study of 16 psoriasis patients treated with TNF inhibitors, researchers used ultrasound to measure IMT of carotid and brachial arteries after 6 months of therapy (J Am Acad Dermatol. 2013 Oct;69[4]:523-9). At baseline, all 16 patients had an IMT greater than normal. In those without initial calcified atherosclerotic plaques, 13 of 16 had a significant decrease of IMT (P = .0002). In those with initial calcified atherosclerotic plaques, 3 of 16 patients had a nonsignificant increase in IMT.

Increased arterial stiffness is another independent predictor of CVD. In a controlled study of 55 patients with psoriatic arthritis, RA, or ankylosing spondylitis, researchers used aortic pulse-wave velocity to measure aortic stiffness. Almost 35% of the patients (36) received TNF inhibitors while the remaining 19 did not receive treatment (Am J Hypertens. 2012 Jun;25[6]:644-50). After 1 year of follow-up, use of TNF inhibitors was associated with a significant improvement in aortic pulse-wave velocity (P = .02) and reduced carotid IMT progression (P = .04).

Other evidence suggests that systemic therapy with TNF inhibitors is associated with the reduction of cardiovascular events, including myocardial infarction. In a study led by Dr. Wu, 8,845 Kaiser Permanente patients with psoriasis were evaluated between Jan. 1, 2004, and Nov. 30, 2010, and placed into one of three groups: treatment with a TNF inhibitor, treatment with oral therapy or phototherapy, or treatment with a topical agent (referent group) (Arch Dermatol. 2012 Nov;148[11]:1244-50). On multivariate analysis, the investigators found that the use of TNF inhibitors was associated with a significant reduction in the rate of incident MI (HR, 0.50; P = .003), compared with the use of topical agents.

Dr. Wu went on to note that C-reactive protein (CRP) is a predictor of CVD such as MI, peripheral arterial disease, and sudden cardiac death. In a retrospective cohort study, Dr. Wu and his associates evaluated Kaiser Permanente patients with psoriasis, psoriatic arthritis, or RA who were treated with a combination of TNF plus methotrexate, or with methotrexate alone from Jan. 1, 2002, to July 31, 2011 (J. Am. Acad. Dermatol. 2015;72[5]:917-9). Only patients in the combination therapy group had a clinically and statistically significant decrease in CRP, compared with baseline (a mean decrease of 5.18 mg/dL). No significant changes between the two groups were observed in terms of BMI, blood pressure, fasting glucose, hemoglobin A_1C, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, or alanine aminotransferase.

HDL cholesterol composition and function have also been studied in psoriasis patients. In one trial, HDL cholesterol was isolated from 15 psoriasis patients at baseline and after effective topical and/or systemic psoriasis therapy, and from 15 healthy controls matched for age and sex (J. Invest. Dermatol. 2014;134[3]:635-42). The researchers found that HDL cholesterol from psoriasis patients showed a significantly impaired capability to mobilize cholesterol from macrophages. However, psoriasis therapy recovered HDL cholesterol composition and function, but had no effect on serum HDL cholesterol levels.

A better understanding of the cardiovascular effects of biologic therapy should be gleaned from the Vascular Inflammation in Psoriasis Trial, which includes $3.8 million in funding from the National Institutes of Health, to prospectively study the effect of therapy on biomarkers and on positron emission tomography with ¹⁸fluorodeoxyglucose (FDG-PET)/CT scan. The 1-year study just completed enrolling patients into one of three treatment groups: adalimumab, UVB phototherapy, or placebo. Biomarkers such as CRP, lipids, and imaging will be assessed at baseline, weeks 4, 8, 12, and then every 12 weeks. “The theory is that adalimumab, but not UVB phototherapy, will improve biomarkers and reduce vascular inflammation as measured by FDG-PET/CT scan,” Dr. Wu said. “Aggressive systemic therapy may alter the natural history of cardiovascular disease.”

Current recommendations from the National Psoriasis Foundation call for an assessment of blood pressure, pulse, and body mass index every 2 years, and an assessment of fasting blood glucose and lipid levels every 5 years, or every 2 years if the patient has additional risk factors.

Dr. Wu reported that he has received research and consulting fees from numerous pharmaceutical companies, including AbbVie and Amgen. These go to his employer.

dbrunk@frontlinemedcom.com

PARK CITY, UTAH – Evidence is mounting that the use of biologic therapies is associated with certain cardiovascular benefits in patients with psoriasis.

However, until the strength of the evidence becomes more robust, Dr. Jashin J. Wu does not recommend that patients are prescribed tumor necrosis factor (TNF) inhibitors specifically to reduce the risk of cardiovascular disease. “If systemic therapy is a consideration in the setting of CVD [cardiovascular disease] risk, it would appear that TNF inhibitors and methotrexate offer the best evidence of benefit,” Dr. Wu, director of the psoriasis clinic and director of dermatology research in the department of dermatology at Kaiser Permanente Los Angeles Medical Center, said at the annual meeting of the Pacific Dermatologic Association.

The National Psoriasis Foundation recently published a consensus statement about the potential impact of current therapies on cardiovascular disease, including the risk of diabetes (J Am Acad Dermatol. 2014;70[1]:168-77). In a retrospective study of 121,280 patients with rheumatoid arthritis (RA) or psoriasis, drug regimens were categorized into four mutually exclusive groups: TNF inhibitors with or without other disease-modifying antirheumatic drugs (DMARDs), methotrexate without TNF inhibitors or hydroxychloroquine, hydroxychloroquine without TNF inhibitors or methotrexate; and other nonbiologic DMARDs without TNF inhibitors, methotrexate or hydroxychloroquine (referent group). The researchers found that adjusted Cox proportional hazards for the risk of diabetes were lower among those on TNF inhibitors (hazard ratio, 0.62; 95% confidence interval, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80), compared with those on methotrexate (HR, 0.77, 95% CI, 0.53-1.13) (JAMA. 2011 Jun 22;305[24]:2525-31).

Increased carotid intimal media thickness (IMT) is also an independent predictor of CVD. In a prospective, observational study, 20 psoriasis patients received a 12-week treatment of TNF inhibitors (Ann Rheum Dis. 2011 Apr;70[4]:705-6). After 12 weeks, 9 patients continued on their TNF-inhibitor regimen (group 1), while 11 discontinued treatment because of financial constraints (group 2). Another 20 psoriasis patients who did not receive biologic therapy served as controls (group 3). The researchers measured IMT by carotid ultrasound at baseline, week 12 and at 2 years. They found that between baseline and 2 years, IMT decreased from 0.70 mm to 0.63 mm in group 1, from 0.71 to 0.67 in group 2, and increased from 0.79 to 0.82 in group 3. “This seems to suggest that the use of TNF inhibitors may improve atherosclerosis,” said Dr. Wu, who is currently running seven clinical trials of psoriasis patients. Similar findings were seen in a larger study that examined 224 patients with psoriatic arthritis and followed them for a mean of 55 months: 124 on TNF inhibitors, 104 on DMARDs, and 305 matched controls (Arterioscler Thromb Vasc Biol. 2011 Mar;31[3]:705-120).

In a separate study of 16 psoriasis patients treated with TNF inhibitors, researchers used ultrasound to measure IMT of carotid and brachial arteries after 6 months of therapy (J Am Acad Dermatol. 2013 Oct;69[4]:523-9). At baseline, all 16 patients had an IMT greater than normal. In those without initial calcified atherosclerotic plaques, 13 of 16 had a significant decrease of IMT (P = .0002). In those with initial calcified atherosclerotic plaques, 3 of 16 patients had a nonsignificant increase in IMT.

Increased arterial stiffness is another independent predictor of CVD. In a controlled study of 55 patients with psoriatic arthritis, RA, or ankylosing spondylitis, researchers used aortic pulse-wave velocity to measure aortic stiffness. Almost 35% of the patients (36) received TNF inhibitors while the remaining 19 did not receive treatment (Am J Hypertens. 2012 Jun;25[6]:644-50). After 1 year of follow-up, use of TNF inhibitors was associated with a significant improvement in aortic pulse-wave velocity (P = .02) and reduced carotid IMT progression (P = .04).

Other evidence suggests that systemic therapy with TNF inhibitors is associated with the reduction of cardiovascular events, including myocardial infarction. In a study led by Dr. Wu, 8,845 Kaiser Permanente patients with psoriasis were evaluated between Jan. 1, 2004, and Nov. 30, 2010, and placed into one of three groups: treatment with a TNF inhibitor, treatment with oral therapy or phototherapy, or treatment with a topical agent (referent group) (Arch Dermatol. 2012 Nov;148[11]:1244-50). On multivariate analysis, the investigators found that the use of TNF inhibitors was associated with a significant reduction in the rate of incident MI (HR, 0.50; P = .003), compared with the use of topical agents.

Dr. Wu went on to note that C-reactive protein (CRP) is a predictor of CVD such as MI, peripheral arterial disease, and sudden cardiac death. In a retrospective cohort study, Dr. Wu and his associates evaluated Kaiser Permanente patients with psoriasis, psoriatic arthritis, or RA who were treated with a combination of TNF plus methotrexate, or with methotrexate alone from Jan. 1, 2002, to July 31, 2011 (J. Am. Acad. Dermatol. 2015;72[5]:917-9). Only patients in the combination therapy group had a clinically and statistically significant decrease in CRP, compared with baseline (a mean decrease of 5.18 mg/dL). No significant changes between the two groups were observed in terms of BMI, blood pressure, fasting glucose, hemoglobin A_1C, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, or alanine aminotransferase.

HDL cholesterol composition and function have also been studied in psoriasis patients. In one trial, HDL cholesterol was isolated from 15 psoriasis patients at baseline and after effective topical and/or systemic psoriasis therapy, and from 15 healthy controls matched for age and sex (J. Invest. Dermatol. 2014;134[3]:635-42). The researchers found that HDL cholesterol from psoriasis patients showed a significantly impaired capability to mobilize cholesterol from macrophages. However, psoriasis therapy recovered HDL cholesterol composition and function, but had no effect on serum HDL cholesterol levels.

A better understanding of the cardiovascular effects of biologic therapy should be gleaned from the Vascular Inflammation in Psoriasis Trial, which includes $3.8 million in funding from the National Institutes of Health, to prospectively study the effect of therapy on biomarkers and on positron emission tomography with ¹⁸fluorodeoxyglucose (FDG-PET)/CT scan. The 1-year study just completed enrolling patients into one of three treatment groups: adalimumab, UVB phototherapy, or placebo. Biomarkers such as CRP, lipids, and imaging will be assessed at baseline, weeks 4, 8, 12, and then every 12 weeks. “The theory is that adalimumab, but not UVB phototherapy, will improve biomarkers and reduce vascular inflammation as measured by FDG-PET/CT scan,” Dr. Wu said. “Aggressive systemic therapy may alter the natural history of cardiovascular disease.”

Current recommendations from the National Psoriasis Foundation call for an assessment of blood pressure, pulse, and body mass index every 2 years, and an assessment of fasting blood glucose and lipid levels every 5 years, or every 2 years if the patient has additional risk factors.

Dr. Wu reported that he has received research and consulting fees from numerous pharmaceutical companies, including AbbVie and Amgen. These go to his employer.

dbrunk@frontlinemedcom.com

PARK CITY, UTAH – Evidence is mounting that the use of biologic therapies is associated with certain cardiovascular benefits in patients with psoriasis.

However, until the strength of the evidence becomes more robust, Dr. Jashin J. Wu does not recommend that patients are prescribed tumor necrosis factor (TNF) inhibitors specifically to reduce the risk of cardiovascular disease. “If systemic therapy is a consideration in the setting of CVD [cardiovascular disease] risk, it would appear that TNF inhibitors and methotrexate offer the best evidence of benefit,” Dr. Wu, director of the psoriasis clinic and director of dermatology research in the department of dermatology at Kaiser Permanente Los Angeles Medical Center, said at the annual meeting of the Pacific Dermatologic Association.

The National Psoriasis Foundation recently published a consensus statement about the potential impact of current therapies on cardiovascular disease, including the risk of diabetes (J Am Acad Dermatol. 2014;70[1]:168-77). In a retrospective study of 121,280 patients with rheumatoid arthritis (RA) or psoriasis, drug regimens were categorized into four mutually exclusive groups: TNF inhibitors with or without other disease-modifying antirheumatic drugs (DMARDs), methotrexate without TNF inhibitors or hydroxychloroquine, hydroxychloroquine without TNF inhibitors or methotrexate; and other nonbiologic DMARDs without TNF inhibitors, methotrexate or hydroxychloroquine (referent group). The researchers found that adjusted Cox proportional hazards for the risk of diabetes were lower among those on TNF inhibitors (hazard ratio, 0.62; 95% confidence interval, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80), compared with those on methotrexate (HR, 0.77, 95% CI, 0.53-1.13) (JAMA. 2011 Jun 22;305[24]:2525-31).

Increased carotid intimal media thickness (IMT) is also an independent predictor of CVD. In a prospective, observational study, 20 psoriasis patients received a 12-week treatment of TNF inhibitors (Ann Rheum Dis. 2011 Apr;70[4]:705-6). After 12 weeks, 9 patients continued on their TNF-inhibitor regimen (group 1), while 11 discontinued treatment because of financial constraints (group 2). Another 20 psoriasis patients who did not receive biologic therapy served as controls (group 3). The researchers measured IMT by carotid ultrasound at baseline, week 12 and at 2 years. They found that between baseline and 2 years, IMT decreased from 0.70 mm to 0.63 mm in group 1, from 0.71 to 0.67 in group 2, and increased from 0.79 to 0.82 in group 3. “This seems to suggest that the use of TNF inhibitors may improve atherosclerosis,” said Dr. Wu, who is currently running seven clinical trials of psoriasis patients. Similar findings were seen in a larger study that examined 224 patients with psoriatic arthritis and followed them for a mean of 55 months: 124 on TNF inhibitors, 104 on DMARDs, and 305 matched controls (Arterioscler Thromb Vasc Biol. 2011 Mar;31[3]:705-120).

In a separate study of 16 psoriasis patients treated with TNF inhibitors, researchers used ultrasound to measure IMT of carotid and brachial arteries after 6 months of therapy (J Am Acad Dermatol. 2013 Oct;69[4]:523-9). At baseline, all 16 patients had an IMT greater than normal. In those without initial calcified atherosclerotic plaques, 13 of 16 had a significant decrease of IMT (P = .0002). In those with initial calcified atherosclerotic plaques, 3 of 16 patients had a nonsignificant increase in IMT.

Increased arterial stiffness is another independent predictor of CVD. In a controlled study of 55 patients with psoriatic arthritis, RA, or ankylosing spondylitis, researchers used aortic pulse-wave velocity to measure aortic stiffness. Almost 35% of the patients (36) received TNF inhibitors while the remaining 19 did not receive treatment (Am J Hypertens. 2012 Jun;25[6]:644-50). After 1 year of follow-up, use of TNF inhibitors was associated with a significant improvement in aortic pulse-wave velocity (P = .02) and reduced carotid IMT progression (P = .04).

Other evidence suggests that systemic therapy with TNF inhibitors is associated with the reduction of cardiovascular events, including myocardial infarction. In a study led by Dr. Wu, 8,845 Kaiser Permanente patients with psoriasis were evaluated between Jan. 1, 2004, and Nov. 30, 2010, and placed into one of three groups: treatment with a TNF inhibitor, treatment with oral therapy or phototherapy, or treatment with a topical agent (referent group) (Arch Dermatol. 2012 Nov;148[11]:1244-50). On multivariate analysis, the investigators found that the use of TNF inhibitors was associated with a significant reduction in the rate of incident MI (HR, 0.50; P = .003), compared with the use of topical agents.

Dr. Wu went on to note that C-reactive protein (CRP) is a predictor of CVD such as MI, peripheral arterial disease, and sudden cardiac death. In a retrospective cohort study, Dr. Wu and his associates evaluated Kaiser Permanente patients with psoriasis, psoriatic arthritis, or RA who were treated with a combination of TNF plus methotrexate, or with methotrexate alone from Jan. 1, 2002, to July 31, 2011 (J. Am. Acad. Dermatol. 2015;72[5]:917-9). Only patients in the combination therapy group had a clinically and statistically significant decrease in CRP, compared with baseline (a mean decrease of 5.18 mg/dL). No significant changes between the two groups were observed in terms of BMI, blood pressure, fasting glucose, hemoglobin A_1C, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, or alanine aminotransferase.

HDL cholesterol composition and function have also been studied in psoriasis patients. In one trial, HDL cholesterol was isolated from 15 psoriasis patients at baseline and after effective topical and/or systemic psoriasis therapy, and from 15 healthy controls matched for age and sex (J. Invest. Dermatol. 2014;134[3]:635-42). The researchers found that HDL cholesterol from psoriasis patients showed a significantly impaired capability to mobilize cholesterol from macrophages. However, psoriasis therapy recovered HDL cholesterol composition and function, but had no effect on serum HDL cholesterol levels.

A better understanding of the cardiovascular effects of biologic therapy should be gleaned from the Vascular Inflammation in Psoriasis Trial, which includes $3.8 million in funding from the National Institutes of Health, to prospectively study the effect of therapy on biomarkers and on positron emission tomography with ¹⁸fluorodeoxyglucose (FDG-PET)/CT scan. The 1-year study just completed enrolling patients into one of three treatment groups: adalimumab, UVB phototherapy, or placebo. Biomarkers such as CRP, lipids, and imaging will be assessed at baseline, weeks 4, 8, 12, and then every 12 weeks. “The theory is that adalimumab, but not UVB phototherapy, will improve biomarkers and reduce vascular inflammation as measured by FDG-PET/CT scan,” Dr. Wu said. “Aggressive systemic therapy may alter the natural history of cardiovascular disease.”

Current recommendations from the National Psoriasis Foundation call for an assessment of blood pressure, pulse, and body mass index every 2 years, and an assessment of fasting blood glucose and lipid levels every 5 years, or every 2 years if the patient has additional risk factors.

Dr. Wu reported that he has received research and consulting fees from numerous pharmaceutical companies, including AbbVie and Amgen. These go to his employer.

dbrunk@frontlinemedcom.com

Tuberculosis is the only condition in patients with psoriasis or psoriatic arthritis who are being treated with systemic biologic agents for which there is strong evidence in favor of baseline screening, according to a literature review.

Analysis of 26 studies of systemic biologic treatments and screening tests – 13 of which included patients with hepatitis C, hepatitis B, or congestive heart failure – found the highest level evidence (grade B) in favor of tuberculin skin testing or interferon-gamma release assay, with the latter being preferred for its higher sensitivity and specificity.

CDC/James Archer

“Based on the [U.S. Preventive Services Task Force] grading system, it is recommended this screen be provided because there is high certainty that the net benefit is moderate, or medium certainty that the net benefit is moderate to substantial,” wrote Dr. Christine S. Ahn of Wake Forest University, Winston-Salem, N.C., and coauthors in the Journal of the American Academy of Dermatology.

Screening for hepatitis B or C infection only was supported by grade-C evidence, and there was insufficient evidence for HIV screening, with the authors suggesting that selective screening should be performed based on professional judgment, clinical context, or patient preference (J Am Acad Dermatol. 2015 July 14 doi: 10.1016/j.jaad.2015.06.004).

Similarly, there was insufficient evidence to support complete blood cell count screening, and, given the low grade evidence on monitoring hepatic function, the authors suggested this should be performed at the clinician’s discretion, particularly among patients treated with infliximab.

Tuberculosis is the only condition in patients with psoriasis or psoriatic arthritis who are being treated with systemic biologic agents for which there is strong evidence in favor of baseline screening, according to a literature review.

Analysis of 26 studies of systemic biologic treatments and screening tests – 13 of which included patients with hepatitis C, hepatitis B, or congestive heart failure – found the highest level evidence (grade B) in favor of tuberculin skin testing or interferon-gamma release assay, with the latter being preferred for its higher sensitivity and specificity.

CDC/James Archer

“Based on the [U.S. Preventive Services Task Force] grading system, it is recommended this screen be provided because there is high certainty that the net benefit is moderate, or medium certainty that the net benefit is moderate to substantial,” wrote Dr. Christine S. Ahn of Wake Forest University, Winston-Salem, N.C., and coauthors in the Journal of the American Academy of Dermatology.

Screening for hepatitis B or C infection only was supported by grade-C evidence, and there was insufficient evidence for HIV screening, with the authors suggesting that selective screening should be performed based on professional judgment, clinical context, or patient preference (J Am Acad Dermatol. 2015 July 14 doi: 10.1016/j.jaad.2015.06.004).

Similarly, there was insufficient evidence to support complete blood cell count screening, and, given the low grade evidence on monitoring hepatic function, the authors suggested this should be performed at the clinician’s discretion, particularly among patients treated with infliximab.

Tuberculosis is the only condition in patients with psoriasis or psoriatic arthritis who are being treated with systemic biologic agents for which there is strong evidence in favor of baseline screening, according to a literature review.

Analysis of 26 studies of systemic biologic treatments and screening tests – 13 of which included patients with hepatitis C, hepatitis B, or congestive heart failure – found the highest level evidence (grade B) in favor of tuberculin skin testing or interferon-gamma release assay, with the latter being preferred for its higher sensitivity and specificity.

CDC/James Archer

“Based on the [U.S. Preventive Services Task Force] grading system, it is recommended this screen be provided because there is high certainty that the net benefit is moderate, or medium certainty that the net benefit is moderate to substantial,” wrote Dr. Christine S. Ahn of Wake Forest University, Winston-Salem, N.C., and coauthors in the Journal of the American Academy of Dermatology.

Screening for hepatitis B or C infection only was supported by grade-C evidence, and there was insufficient evidence for HIV screening, with the authors suggesting that selective screening should be performed based on professional judgment, clinical context, or patient preference (J Am Acad Dermatol. 2015 July 14 doi: 10.1016/j.jaad.2015.06.004).

Similarly, there was insufficient evidence to support complete blood cell count screening, and, given the low grade evidence on monitoring hepatic function, the authors suggested this should be performed at the clinician’s discretion, particularly among patients treated with infliximab.

Researchers have uncovered a bidirectional relationship between psoriatic disease – psoriasis and psoriatic arthritis – and uveitis, with either condition significantly increasing the risk of the other.

A Danish nationwide cohort study of 74,129 individuals with psoriasis, including 6,735 with psoriatic arthritis, showed that patients with mild psoriasis had a 38% increased risk of uveitis, while those with psoriatic arthritis had a 2.5-fold increase in risk and those with psoriatic spondylitis had a greater than eight-fold increased risk, according to a paper published online in JAMA Dermatology.

Elsevier 2009

There was a nonsignificant increase in the risk of uveitis in patients with severe psoriasis, but this failed to reach significance because of the small number of patients.

Similarly, patients with uveitis had a 59% greater risk of mild psoriasis, a twofold greater risk of severe psoriasis, a nearly fourfold increase in the risk of psoriatic arthritis, and an eightfold increase in the risk of psoriatic spondylitis (JAMA Dermatol. 2015 July 29 doi: 10.1001/jamadermatol.2015.1986).

The authors suggested that an increased focus on eye symptoms in patients with psoriasis and psoriatic arthritis and on skin and joint symptoms in patients with uveitis may be appropriate.

“The bidirectional relationship between psoriasis and psoriatic arthritis and uveitis suggests a shared pathogenic pathway, and increased systemic inflammation may contribute to the observed relationship,” wrote Dr. Alexander Egeberg of Pfizer and his coauthors. Dr. Egeberg was at the University of Copenhagen, Hellerup, when the study was conducted.

The study was supported by Pfizer, the LEO Foundation, and the Novo Nordisk Foundation. One author is employed by Eli Lilly. No other conflicts of interest were declared.

Researchers have uncovered a bidirectional relationship between psoriatic disease – psoriasis and psoriatic arthritis – and uveitis, with either condition significantly increasing the risk of the other.

A Danish nationwide cohort study of 74,129 individuals with psoriasis, including 6,735 with psoriatic arthritis, showed that patients with mild psoriasis had a 38% increased risk of uveitis, while those with psoriatic arthritis had a 2.5-fold increase in risk and those with psoriatic spondylitis had a greater than eight-fold increased risk, according to a paper published online in JAMA Dermatology.

Elsevier 2009

There was a nonsignificant increase in the risk of uveitis in patients with severe psoriasis, but this failed to reach significance because of the small number of patients.

Similarly, patients with uveitis had a 59% greater risk of mild psoriasis, a twofold greater risk of severe psoriasis, a nearly fourfold increase in the risk of psoriatic arthritis, and an eightfold increase in the risk of psoriatic spondylitis (JAMA Dermatol. 2015 July 29 doi: 10.1001/jamadermatol.2015.1986).

The authors suggested that an increased focus on eye symptoms in patients with psoriasis and psoriatic arthritis and on skin and joint symptoms in patients with uveitis may be appropriate.

“The bidirectional relationship between psoriasis and psoriatic arthritis and uveitis suggests a shared pathogenic pathway, and increased systemic inflammation may contribute to the observed relationship,” wrote Dr. Alexander Egeberg of Pfizer and his coauthors. Dr. Egeberg was at the University of Copenhagen, Hellerup, when the study was conducted.

The study was supported by Pfizer, the LEO Foundation, and the Novo Nordisk Foundation. One author is employed by Eli Lilly. No other conflicts of interest were declared.

Researchers have uncovered a bidirectional relationship between psoriatic disease – psoriasis and psoriatic arthritis – and uveitis, with either condition significantly increasing the risk of the other.

A Danish nationwide cohort study of 74,129 individuals with psoriasis, including 6,735 with psoriatic arthritis, showed that patients with mild psoriasis had a 38% increased risk of uveitis, while those with psoriatic arthritis had a 2.5-fold increase in risk and those with psoriatic spondylitis had a greater than eight-fold increased risk, according to a paper published online in JAMA Dermatology.

Elsevier 2009

There was a nonsignificant increase in the risk of uveitis in patients with severe psoriasis, but this failed to reach significance because of the small number of patients.

Similarly, patients with uveitis had a 59% greater risk of mild psoriasis, a twofold greater risk of severe psoriasis, a nearly fourfold increase in the risk of psoriatic arthritis, and an eightfold increase in the risk of psoriatic spondylitis (JAMA Dermatol. 2015 July 29 doi: 10.1001/jamadermatol.2015.1986).

The authors suggested that an increased focus on eye symptoms in patients with psoriasis and psoriatic arthritis and on skin and joint symptoms in patients with uveitis may be appropriate.

“The bidirectional relationship between psoriasis and psoriatic arthritis and uveitis suggests a shared pathogenic pathway, and increased systemic inflammation may contribute to the observed relationship,” wrote Dr. Alexander Egeberg of Pfizer and his coauthors. Dr. Egeberg was at the University of Copenhagen, Hellerup, when the study was conducted.

The study was supported by Pfizer, the LEO Foundation, and the Novo Nordisk Foundation. One author is employed by Eli Lilly. No other conflicts of interest were declared.

New criteria that define psoriatic arthritis disease activity and treatment response establish cutpoints and percentage changes on the Disease Activity Index for Psoriatic Arthritis scores, Dr. Monika M. Schoels of the Second Department of Internal Medicine at Hietzing Hospital, Vienna, and her coauthors reported.

Dr. Schoels and her colleagues collected 30 patient profiles from an observational data set and then surveyed 44 rheumatology experts (getting 33 responses) to assess the patients’ disease activity based on swollen joint count, tender joint count, global activity, C-reactive protein, and pain ratings. Based on the distribution of Disease Activity Index for Psoriatic Arthritis (DAPSA) scores in the patient population, the investigators then calculated the 25th and 75th percentiles to determine the thresholds for different disease states.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Based on the results, the investigators suggested cutoff values of 4 or less for remission, more than 4 and up to 14 for low disease activity, more than 14 and up to 28 for moderate disease activity, and greater than 28 for high disease activity.

They also found that percentage changes of 50%, 75%, and 85% on the DAPSA corresponded to minor, moderate, and major treatment responses based on American College of Rheumatology 20, 50, and 70 responses observed in three randomized trials.

The study findings provide a “definition of treatment targets … as well as the definition of inclusion criteria for clinical trials for patients in” moderate and high disease activity, Dr. Schoels and her colleagues wrote. “The new response levels will help assess treatment in many settings.”

Read the full study in Annals of the Rheumatic Diseases.

mrajaraman@frontlinemedcom.com

New criteria that define psoriatic arthritis disease activity and treatment response establish cutpoints and percentage changes on the Disease Activity Index for Psoriatic Arthritis scores, Dr. Monika M. Schoels of the Second Department of Internal Medicine at Hietzing Hospital, Vienna, and her coauthors reported.

Dr. Schoels and her colleagues collected 30 patient profiles from an observational data set and then surveyed 44 rheumatology experts (getting 33 responses) to assess the patients’ disease activity based on swollen joint count, tender joint count, global activity, C-reactive protein, and pain ratings. Based on the distribution of Disease Activity Index for Psoriatic Arthritis (DAPSA) scores in the patient population, the investigators then calculated the 25th and 75th percentiles to determine the thresholds for different disease states.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Based on the results, the investigators suggested cutoff values of 4 or less for remission, more than 4 and up to 14 for low disease activity, more than 14 and up to 28 for moderate disease activity, and greater than 28 for high disease activity.

They also found that percentage changes of 50%, 75%, and 85% on the DAPSA corresponded to minor, moderate, and major treatment responses based on American College of Rheumatology 20, 50, and 70 responses observed in three randomized trials.

The study findings provide a “definition of treatment targets … as well as the definition of inclusion criteria for clinical trials for patients in” moderate and high disease activity, Dr. Schoels and her colleagues wrote. “The new response levels will help assess treatment in many settings.”

Read the full study in Annals of the Rheumatic Diseases.

mrajaraman@frontlinemedcom.com

New criteria that define psoriatic arthritis disease activity and treatment response establish cutpoints and percentage changes on the Disease Activity Index for Psoriatic Arthritis scores, Dr. Monika M. Schoels of the Second Department of Internal Medicine at Hietzing Hospital, Vienna, and her coauthors reported.

Dr. Schoels and her colleagues collected 30 patient profiles from an observational data set and then surveyed 44 rheumatology experts (getting 33 responses) to assess the patients’ disease activity based on swollen joint count, tender joint count, global activity, C-reactive protein, and pain ratings. Based on the distribution of Disease Activity Index for Psoriatic Arthritis (DAPSA) scores in the patient population, the investigators then calculated the 25th and 75th percentiles to determine the thresholds for different disease states.

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Based on the results, the investigators suggested cutoff values of 4 or less for remission, more than 4 and up to 14 for low disease activity, more than 14 and up to 28 for moderate disease activity, and greater than 28 for high disease activity.

They also found that percentage changes of 50%, 75%, and 85% on the DAPSA corresponded to minor, moderate, and major treatment responses based on American College of Rheumatology 20, 50, and 70 responses observed in three randomized trials.

The study findings provide a “definition of treatment targets … as well as the definition of inclusion criteria for clinical trials for patients in” moderate and high disease activity, Dr. Schoels and her colleagues wrote. “The new response levels will help assess treatment in many settings.”

Read the full study in Annals of the Rheumatic Diseases.

mrajaraman@frontlinemedcom.com

What do your patients need to know at the first visit?

Pregnant patients need to know that it is important to carefully monitor them throughout their pregnancy. Although many drugs are not contraindicated, it is still important for the dermatologist to consult with the patient’s obstetrician to discuss risks and benefits of different therapies. Some women see an improvement in the severity of their psoriasis during pregnancy, while others report their condition gets worse. Changes in severity of psoriasis vary by individual and from pregnancy to pregnancy.

What are your go-to treatments? What are the side effects?

UV therapy, particularly narrowband UVB, is a good choice during pregnancy. Excimer laser is another good choice. Topical therapies are standardly employed. Although many of these topical therapies are pregnancy category C, we still employ them regularly in consultation with the patient’s obstetrician. Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry (http: //www.pregnancystudies.org) would be good options. This registry is analyzing whether medications that are used to treat autoimmune diseases are safe to take during pregnancy. Specifically, the investigators are looking at medications used to treat Crohn disease, rheumatoid arthritis, psoriasis, psoriatic arthritis, and multiple sclerosis. Generally speaking, systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Women of childbearing potential should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects with each of those treatments.

How do you keep patients compliant with treatment?

We see the patients regularly, and I am always available to take telephone calls if any questions arise.

What do you do if patients refuse treatment?

We keep the dialogue ongoing and monitor their condition. They may change their attitude if their condition worsens.

What resources do you recommend to patients for more information?

Patients should consult the National Psoriasis Foundation (http://www.psoriasis.org).

Quick access to more resources on our PSORIASIS page

What do your patients need to know at the first visit?

Pregnant patients need to know that it is important to carefully monitor them throughout their pregnancy. Although many drugs are not contraindicated, it is still important for the dermatologist to consult with the patient’s obstetrician to discuss risks and benefits of different therapies. Some women see an improvement in the severity of their psoriasis during pregnancy, while others report their condition gets worse. Changes in severity of psoriasis vary by individual and from pregnancy to pregnancy.

What are your go-to treatments? What are the side effects?

UV therapy, particularly narrowband UVB, is a good choice during pregnancy. Excimer laser is another good choice. Topical therapies are standardly employed. Although many of these topical therapies are pregnancy category C, we still employ them regularly in consultation with the patient’s obstetrician. Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry (http: //www.pregnancystudies.org) would be good options. This registry is analyzing whether medications that are used to treat autoimmune diseases are safe to take during pregnancy. Specifically, the investigators are looking at medications used to treat Crohn disease, rheumatoid arthritis, psoriasis, psoriatic arthritis, and multiple sclerosis. Generally speaking, systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Women of childbearing potential should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects with each of those treatments.

How do you keep patients compliant with treatment?

We see the patients regularly, and I am always available to take telephone calls if any questions arise.

What do you do if patients refuse treatment?

We keep the dialogue ongoing and monitor their condition. They may change their attitude if their condition worsens.

What resources do you recommend to patients for more information?

Patients should consult the National Psoriasis Foundation (http://www.psoriasis.org).

Quick access to more resources on our PSORIASIS page

What do your patients need to know at the first visit?

Pregnant patients need to know that it is important to carefully monitor them throughout their pregnancy. Although many drugs are not contraindicated, it is still important for the dermatologist to consult with the patient’s obstetrician to discuss risks and benefits of different therapies. Some women see an improvement in the severity of their psoriasis during pregnancy, while others report their condition gets worse. Changes in severity of psoriasis vary by individual and from pregnancy to pregnancy.

What are your go-to treatments? What are the side effects?

UV therapy, particularly narrowband UVB, is a good choice during pregnancy. Excimer laser is another good choice. Topical therapies are standardly employed. Although many of these topical therapies are pregnancy category C, we still employ them regularly in consultation with the patient’s obstetrician. Most biologic therapies are pregnancy category B. We still use these drugs with caution in the setting of pregnancy. If a pregnant patient does wish to continue a biologic therapy, close monitoring and enrollment in a pregnancy registry (http: //www.pregnancystudies.org) would be good options. This registry is analyzing whether medications that are used to treat autoimmune diseases are safe to take during pregnancy. Specifically, the investigators are looking at medications used to treat Crohn disease, rheumatoid arthritis, psoriasis, psoriatic arthritis, and multiple sclerosis. Generally speaking, systemic and biologic drugs should be avoided while pregnant or breastfeeding unless there is a clear medical need. Women of childbearing potential should avoid oral retinoids, methotrexate, and cyclosporine due to a link to birth defects with each of those treatments.

How do you keep patients compliant with treatment?

We see the patients regularly, and I am always available to take telephone calls if any questions arise.

What do you do if patients refuse treatment?

We keep the dialogue ongoing and monitor their condition. They may change their attitude if their condition worsens.

What resources do you recommend to patients for more information?

Patients should consult the National Psoriasis Foundation (http://www.psoriasis.org).

Quick access to more resources on our PSORIASIS page

If apremilast (Otezla) works initially for psoriasis, it’s likely to keep on helping for at least a year, according to phase III results published by the drug’s maker, Celgene, in the Journal of the American Academy of Dermatology.

The trial randomized 562 patients with moderate to severe plaque psoriasis to apremilast 30 mg twice daily, and 282 to placebo (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

At week 16, 33% of apremilast patients, but only 5.3% of placebo patients, achieved a 75% or greater reduction from their baseline Psoriasis Area and Severity Index (PASI-75) scores (P less than .0001).

The placebo group was next switched to apremilast so that all the subjects were on the drug from weeks 16 to 32. By week 32, patients switched from placebo caught up with their apremilast peers on PASI-75 response rates and improved pruritus scores.

The study continued past week 32 with 154 patients who had been on apremilast since baseline and had reached PASI-75; half were rerandomized to placebo, half to the drug. At week 52, 47 (61%) of apremilast patients had maintained their PASI-75 response, versus 9 (12%) of placebo patients.

“PASI response was maintained over 52 weeks with continued apremilast treatment. In addition, apremilast demonstrated improvements in nail and scalp psoriasis, both difficult-to-treat forms of psoriasis. Most patients rerandomized to placebo who lost PASI-75 response regained it after apremilast reinitiation,” said the authors, led by Dr. Kim Papp of Probity Medical Research in Waterloo, Ont.

Apremilast, an oral phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in 2014 for moderate to severe plaque psoriasis and psoriatic arthritis. The 16-week results are included in the drug’s label.

The label warns of weight loss and depression with apremilast. The new report doesn’t mention depression but does note a mean weight loss of 2.08 kg with the drug, and that 19% of patients lost more than 5% of their body weight. However, no one left the study because of it.

During the first 16 weeks of the trial, the most common side effects were diarrhea (7.1% placebo versus 19% apremilast); nausea (6.7% placebo versus 16% apremilast); upper respiratory tract infection (7.4% versus 10%); nasopharyngitis (8.2% versus 7.3%); and tension headache (4.3% versus 7.3%).

Side effects tended to present early with apremilast, and the incidence didn’t increase as treatment continued. To minimize side effects, the investigators titrated the drug in 10-mg increments over the first week of treatment. Discontinuations due to side effects were low.

Serious adverse events occurred in 2.8% of placebo and 2.1% of apremilast subjects. In the apremilast group, they included three cases of coronary artery disease and three cases of nephrolithiasis, plus two cases each of urinary tract infections, acute myocardial infarctions, and chronic obstructive pulmonary disease.

The investigators excluded patients with major uncontrolled comorbidities, significant infections, active or incompletely treated tuberculosis, biologic use within 12-24 months, use of active topical agents within 2 weeks, and prolonged sun or ultraviolet exposure. Most of the subjects were white, two-thirds were men, and the average age in the study was 45 years. Weak or low-potency topical corticosteroids, coal tar shampoo and salicylic acid for scalp lesions, and unmedicated moisturizers were allowed in the study.

Celgene Corporation, the maker of apremilast, funded the work. Three investigators are employees, and most of the rest reported financial relationships with the company.

aotto@frontlinemedcom.com

If apremilast (Otezla) works initially for psoriasis, it’s likely to keep on helping for at least a year, according to phase III results published by the drug’s maker, Celgene, in the Journal of the American Academy of Dermatology.

The trial randomized 562 patients with moderate to severe plaque psoriasis to apremilast 30 mg twice daily, and 282 to placebo (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

At week 16, 33% of apremilast patients, but only 5.3% of placebo patients, achieved a 75% or greater reduction from their baseline Psoriasis Area and Severity Index (PASI-75) scores (P less than .0001).

The placebo group was next switched to apremilast so that all the subjects were on the drug from weeks 16 to 32. By week 32, patients switched from placebo caught up with their apremilast peers on PASI-75 response rates and improved pruritus scores.

The study continued past week 32 with 154 patients who had been on apremilast since baseline and had reached PASI-75; half were rerandomized to placebo, half to the drug. At week 52, 47 (61%) of apremilast patients had maintained their PASI-75 response, versus 9 (12%) of placebo patients.

“PASI response was maintained over 52 weeks with continued apremilast treatment. In addition, apremilast demonstrated improvements in nail and scalp psoriasis, both difficult-to-treat forms of psoriasis. Most patients rerandomized to placebo who lost PASI-75 response regained it after apremilast reinitiation,” said the authors, led by Dr. Kim Papp of Probity Medical Research in Waterloo, Ont.

Apremilast, an oral phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in 2014 for moderate to severe plaque psoriasis and psoriatic arthritis. The 16-week results are included in the drug’s label.

The label warns of weight loss and depression with apremilast. The new report doesn’t mention depression but does note a mean weight loss of 2.08 kg with the drug, and that 19% of patients lost more than 5% of their body weight. However, no one left the study because of it.

During the first 16 weeks of the trial, the most common side effects were diarrhea (7.1% placebo versus 19% apremilast); nausea (6.7% placebo versus 16% apremilast); upper respiratory tract infection (7.4% versus 10%); nasopharyngitis (8.2% versus 7.3%); and tension headache (4.3% versus 7.3%).

Side effects tended to present early with apremilast, and the incidence didn’t increase as treatment continued. To minimize side effects, the investigators titrated the drug in 10-mg increments over the first week of treatment. Discontinuations due to side effects were low.

Serious adverse events occurred in 2.8% of placebo and 2.1% of apremilast subjects. In the apremilast group, they included three cases of coronary artery disease and three cases of nephrolithiasis, plus two cases each of urinary tract infections, acute myocardial infarctions, and chronic obstructive pulmonary disease.

The investigators excluded patients with major uncontrolled comorbidities, significant infections, active or incompletely treated tuberculosis, biologic use within 12-24 months, use of active topical agents within 2 weeks, and prolonged sun or ultraviolet exposure. Most of the subjects were white, two-thirds were men, and the average age in the study was 45 years. Weak or low-potency topical corticosteroids, coal tar shampoo and salicylic acid for scalp lesions, and unmedicated moisturizers were allowed in the study.

Celgene Corporation, the maker of apremilast, funded the work. Three investigators are employees, and most of the rest reported financial relationships with the company.

aotto@frontlinemedcom.com

If apremilast (Otezla) works initially for psoriasis, it’s likely to keep on helping for at least a year, according to phase III results published by the drug’s maker, Celgene, in the Journal of the American Academy of Dermatology.

The trial randomized 562 patients with moderate to severe plaque psoriasis to apremilast 30 mg twice daily, and 282 to placebo (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

At week 16, 33% of apremilast patients, but only 5.3% of placebo patients, achieved a 75% or greater reduction from their baseline Psoriasis Area and Severity Index (PASI-75) scores (P less than .0001).

The placebo group was next switched to apremilast so that all the subjects were on the drug from weeks 16 to 32. By week 32, patients switched from placebo caught up with their apremilast peers on PASI-75 response rates and improved pruritus scores.

The study continued past week 32 with 154 patients who had been on apremilast since baseline and had reached PASI-75; half were rerandomized to placebo, half to the drug. At week 52, 47 (61%) of apremilast patients had maintained their PASI-75 response, versus 9 (12%) of placebo patients.

“PASI response was maintained over 52 weeks with continued apremilast treatment. In addition, apremilast demonstrated improvements in nail and scalp psoriasis, both difficult-to-treat forms of psoriasis. Most patients rerandomized to placebo who lost PASI-75 response regained it after apremilast reinitiation,” said the authors, led by Dr. Kim Papp of Probity Medical Research in Waterloo, Ont.

Apremilast, an oral phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in 2014 for moderate to severe plaque psoriasis and psoriatic arthritis. The 16-week results are included in the drug’s label.

The label warns of weight loss and depression with apremilast. The new report doesn’t mention depression but does note a mean weight loss of 2.08 kg with the drug, and that 19% of patients lost more than 5% of their body weight. However, no one left the study because of it.

During the first 16 weeks of the trial, the most common side effects were diarrhea (7.1% placebo versus 19% apremilast); nausea (6.7% placebo versus 16% apremilast); upper respiratory tract infection (7.4% versus 10%); nasopharyngitis (8.2% versus 7.3%); and tension headache (4.3% versus 7.3%).

Side effects tended to present early with apremilast, and the incidence didn’t increase as treatment continued. To minimize side effects, the investigators titrated the drug in 10-mg increments over the first week of treatment. Discontinuations due to side effects were low.

Serious adverse events occurred in 2.8% of placebo and 2.1% of apremilast subjects. In the apremilast group, they included three cases of coronary artery disease and three cases of nephrolithiasis, plus two cases each of urinary tract infections, acute myocardial infarctions, and chronic obstructive pulmonary disease.

The investigators excluded patients with major uncontrolled comorbidities, significant infections, active or incompletely treated tuberculosis, biologic use within 12-24 months, use of active topical agents within 2 weeks, and prolonged sun or ultraviolet exposure. Most of the subjects were white, two-thirds were men, and the average age in the study was 45 years. Weak or low-potency topical corticosteroids, coal tar shampoo and salicylic acid for scalp lesions, and unmedicated moisturizers were allowed in the study.

Celgene Corporation, the maker of apremilast, funded the work. Three investigators are employees, and most of the rest reported financial relationships with the company.

aotto@frontlinemedcom.com

Low cholesterol efflux capacity may be an important biomarker for subclinical coronary atherosclerosis in patients with psoriasis, based on findings from a prospective cohort study.

High-density lipoprotein cholesterol efflux capacity (CEC) was inversely correlated with the noncalcified burden (NCB) of coronary atherosclerosis in baseline data from the first 101 patients enrolled in the 4-year study, Dr. Taufiq Salahuddin of the National Heart, Lung, and Blood Institute and colleagues reported online in the European Heart Journal.

The relationship between CEC and NCB “suggests that higher CEC may promote reverse cholesterol transport from earlier, more lipid-rich plaques. … Others have found this noncalcified plaque to be the culprit lesion in acute coronary syndromes. Therefore, in the context of our study, there is strong biological plausibility for observing a relationship between CEC and NCB; psoriasis is associated with both increased future cardiovascular events and impaired HDL function, and our findings suggest that this may be due to predisposition toward formation of noncalcified plaque,” the researchers wrote.

The relationship between CEC (quantified using a cell-based ex vivo assay), and NCB plaque indexes (assessed by quantitative coronary computed tomography angiography) persisted after adjustment for cardiovascular risk factors, high-density lipoprotein cholesterol levels, and apolipoprotein A₁ levels.

Of note, the relationship between CEC and NCB was stronger in women than in men, with a statistically significant gender interaction, the investigators found (Eur Heart J. 2015 Jul 18. doi.org/10.1093/eurheartj/ehv339).

Cholesterol efflux capacity has been shown in prior studies to predict future cardiovascular events, and since psoriasis both increases cardiovascular risk and impairs CEC, the investigators sought to assess the cross-sectional relationship between coronary plaque burden and CEC.

Study subjects were adults over age 18 years with moderate skin disease severity (median psoriasis area severity index [PASI] score, 6.2), and a low 10-year pooled cohort equation risk score (median, 2.7%). Traditional lipid profiles were within normal limits, and the median CEC was 0.94.

In addition to the inverse correlation between CEC and NCB at baseline, significant relationships were seen between CEC and PASI score, body surface area affected by psoriasis, and HDL cholesterol level, and between noncalcified burden and CEC, psoriasis severity, body surface area affected by psoriasis, and HDL cholesterol.

“Stratified by the sample’s median CEC value, patients with low CEC had greater total burden of coronary plaque and greater NCB than did patients with high CEC (0.0131 and 0.0127 mm² in low CEC vs. 0.0106 and 0.0103 mm² with high CEC),” they wrote.

No differences were seen based on psoriasis treatment status or statin use, although systemic/biologic therapy was associated with a reduction in noncalcified burden.

The findings with respect to gender differences may suggest that greater CEC is more protective against noncalcified plaque in women than it is in men, the investigators added, concluding that “ongoing follow-up of these patients will inform whether aggressive treatment of psoriasis and lifestyle measures improve CEC and ultimately noncalcified burden within the coronary arteries in psoriasis.”

This study was supported by a National Institutes of Health intramural grant, and the NIH Medical Research Scholars Program. The investigators reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

Low cholesterol efflux capacity may be an important biomarker for subclinical coronary atherosclerosis in patients with psoriasis, based on findings from a prospective cohort study.

High-density lipoprotein cholesterol efflux capacity (CEC) was inversely correlated with the noncalcified burden (NCB) of coronary atherosclerosis in baseline data from the first 101 patients enrolled in the 4-year study, Dr. Taufiq Salahuddin of the National Heart, Lung, and Blood Institute and colleagues reported online in the European Heart Journal.

The relationship between CEC and NCB “suggests that higher CEC may promote reverse cholesterol transport from earlier, more lipid-rich plaques. … Others have found this noncalcified plaque to be the culprit lesion in acute coronary syndromes. Therefore, in the context of our study, there is strong biological plausibility for observing a relationship between CEC and NCB; psoriasis is associated with both increased future cardiovascular events and impaired HDL function, and our findings suggest that this may be due to predisposition toward formation of noncalcified plaque,” the researchers wrote.

The relationship between CEC (quantified using a cell-based ex vivo assay), and NCB plaque indexes (assessed by quantitative coronary computed tomography angiography) persisted after adjustment for cardiovascular risk factors, high-density lipoprotein cholesterol levels, and apolipoprotein A₁ levels.

Of note, the relationship between CEC and NCB was stronger in women than in men, with a statistically significant gender interaction, the investigators found (Eur Heart J. 2015 Jul 18. doi.org/10.1093/eurheartj/ehv339).

Cholesterol efflux capacity has been shown in prior studies to predict future cardiovascular events, and since psoriasis both increases cardiovascular risk and impairs CEC, the investigators sought to assess the cross-sectional relationship between coronary plaque burden and CEC.

Study subjects were adults over age 18 years with moderate skin disease severity (median psoriasis area severity index [PASI] score, 6.2), and a low 10-year pooled cohort equation risk score (median, 2.7%). Traditional lipid profiles were within normal limits, and the median CEC was 0.94.

In addition to the inverse correlation between CEC and NCB at baseline, significant relationships were seen between CEC and PASI score, body surface area affected by psoriasis, and HDL cholesterol level, and between noncalcified burden and CEC, psoriasis severity, body surface area affected by psoriasis, and HDL cholesterol.

“Stratified by the sample’s median CEC value, patients with low CEC had greater total burden of coronary plaque and greater NCB than did patients with high CEC (0.0131 and 0.0127 mm² in low CEC vs. 0.0106 and 0.0103 mm² with high CEC),” they wrote.

No differences were seen based on psoriasis treatment status or statin use, although systemic/biologic therapy was associated with a reduction in noncalcified burden.

The findings with respect to gender differences may suggest that greater CEC is more protective against noncalcified plaque in women than it is in men, the investigators added, concluding that “ongoing follow-up of these patients will inform whether aggressive treatment of psoriasis and lifestyle measures improve CEC and ultimately noncalcified burden within the coronary arteries in psoriasis.”

This study was supported by a National Institutes of Health intramural grant, and the NIH Medical Research Scholars Program. The investigators reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

Low cholesterol efflux capacity may be an important biomarker for subclinical coronary atherosclerosis in patients with psoriasis, based on findings from a prospective cohort study.

High-density lipoprotein cholesterol efflux capacity (CEC) was inversely correlated with the noncalcified burden (NCB) of coronary atherosclerosis in baseline data from the first 101 patients enrolled in the 4-year study, Dr. Taufiq Salahuddin of the National Heart, Lung, and Blood Institute and colleagues reported online in the European Heart Journal.

The relationship between CEC and NCB “suggests that higher CEC may promote reverse cholesterol transport from earlier, more lipid-rich plaques. … Others have found this noncalcified plaque to be the culprit lesion in acute coronary syndromes. Therefore, in the context of our study, there is strong biological plausibility for observing a relationship between CEC and NCB; psoriasis is associated with both increased future cardiovascular events and impaired HDL function, and our findings suggest that this may be due to predisposition toward formation of noncalcified plaque,” the researchers wrote.

The relationship between CEC (quantified using a cell-based ex vivo assay), and NCB plaque indexes (assessed by quantitative coronary computed tomography angiography) persisted after adjustment for cardiovascular risk factors, high-density lipoprotein cholesterol levels, and apolipoprotein A₁ levels.

Of note, the relationship between CEC and NCB was stronger in women than in men, with a statistically significant gender interaction, the investigators found (Eur Heart J. 2015 Jul 18. doi.org/10.1093/eurheartj/ehv339).

Cholesterol efflux capacity has been shown in prior studies to predict future cardiovascular events, and since psoriasis both increases cardiovascular risk and impairs CEC, the investigators sought to assess the cross-sectional relationship between coronary plaque burden and CEC.

Study subjects were adults over age 18 years with moderate skin disease severity (median psoriasis area severity index [PASI] score, 6.2), and a low 10-year pooled cohort equation risk score (median, 2.7%). Traditional lipid profiles were within normal limits, and the median CEC was 0.94.

In addition to the inverse correlation between CEC and NCB at baseline, significant relationships were seen between CEC and PASI score, body surface area affected by psoriasis, and HDL cholesterol level, and between noncalcified burden and CEC, psoriasis severity, body surface area affected by psoriasis, and HDL cholesterol.

“Stratified by the sample’s median CEC value, patients with low CEC had greater total burden of coronary plaque and greater NCB than did patients with high CEC (0.0131 and 0.0127 mm² in low CEC vs. 0.0106 and 0.0103 mm² with high CEC),” they wrote.

No differences were seen based on psoriasis treatment status or statin use, although systemic/biologic therapy was associated with a reduction in noncalcified burden.

The findings with respect to gender differences may suggest that greater CEC is more protective against noncalcified plaque in women than it is in men, the investigators added, concluding that “ongoing follow-up of these patients will inform whether aggressive treatment of psoriasis and lifestyle measures improve CEC and ultimately noncalcified burden within the coronary arteries in psoriasis.”

This study was supported by a National Institutes of Health intramural grant, and the NIH Medical Research Scholars Program. The investigators reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com