Doug Brunk

PARK CITY, UTAH – Dr. Glen M. Bowen has been working to improve the surgical treatment of lentigo maligna ever since he joined the Huntsman Cancer Institute at the University of Utah 16 years ago. A retrospective review from Memorial Sloan-Kettering Cancer Center found that on average, 7.1-mm margins are required to remove lentigo maligna (LM) (J. Am. Acad. Dermatol. 2008;58[1]:142-8).

“If you have an LM with a 10-mm diameter to begin with, 7.1-mm margins give you a final surgical diameter of 24.2 mm,” Dr. Bowen said at the annual meeting of the Pacific Dermatologic Association. “These are very morbid surgeries in cosmetically sensitive areas for a relatively low-risk tumor.”

Dr. Glen M. Bowen

The risk of LM progressing to an invasive melanoma is not known, but is estimated to range between 5% and 33%. Of 2,016 patients treated for LM at the Huntsman Cancer Institute, 522 have been treated with neo-adjuvant topical imiquimod 5% cream followed by a conservative staged excision with 2-mm margins with a recurrence rate of 2.3% during median follow-up of 5 years. Of their recurrences, about 20% recurred with invasion. All recurrences to date have been less than 1 mm in depth (stage IA), which has an estimated mortality risk of 5% at 5 years. “A 5% mortality rate of the 20% that recur with invasion of the 2.3% that recur after surgery yields a mortality risk of 0.023%,” Dr. Bowen said. “Due to the very low risk of actually dying from a recurrent LM, very large and morbid surgical defects strike me as a punishment that doesn’t fit the crime in terms of the cost-benefit ratio.”

He and his associates at the Huntsman Cancer Institute have observed some deaths in patients who presented with LM melanoma (invasive melanoma) but have not observed a single death in patients who presented with LM in situ that subsequently recurred. For these reasons, Dr. Bowen favors pretreating LM with imiquimod 5% cream followed by a conservative staged excision, a process that substantially decreases the size of the surgical defects.

His current treatment protocol involves a five-step process that begins with removing all of the visible lentigo maligna to rule out invasion, since 16% of LMs referred to him have harbored invasion when removed and are upgraded from stage 0 to IA. “I am not going to use a topical cream on an invasive melanoma,” he said. “After an excisional biopsy with minimal margins, I usually close the defect with a purse-string suture because it avoids removing standing cones and consequently enlarging the treatment area.”

Second, he traces a template of the LM border on transparent plastic and places a tiny tattoo in the center of the biopsy site to enable pinpoint placement of the template at the time of surgery.

Third, he treats the site with imiquimod 5% cream Monday through Friday for 2-3 months and sees the patient monthly for dosage adjustments when needed. The fourth step involves enabling the site to recover for 2-6 months to allow for resolution of the inflammatory infiltrate. The final step involves re-excising around the original template with 2-mm margins for confirmation with the use of a negative control taken from an equally sun-exposed site taken some distance away from the LM. “Caucasians will have atypical junctional melanocytic hyperplasia (AJMH), which must be subtracted out as background,” he said. “Otherwise, if you hold a non–sun-exposed site as your standard for a negative margin, you will never stop cutting.”

Dr. Bowen likes to use frozen radial sections with routine staining with H and E and immunostaining with MART-1 (Melan-A) and SOX-10. Processing takes 2 hours, he continued, “so I put in relaxing sutures, which will stretch out nicely over 2 hours so I can usually close the defects primarily.”

In Dr. Bowen’s opinion, topical imiquimod as monotherapy for LM is not safe, since about 30% of patients treated with imiquimod will still harbor residual LM. “In our dataset, about 70% have no residual LM, 20% have residual LM in the center but negative perimeter margins, and 10% have LM touching a perimeter margin and require a second stage,” he said. “Taken together, 90% of patients pretreated with imiquimod will be cleared in one stage of surgery with 2 mm margins.”

Making the distinction between LM and AJMH common to chronically sun-damaged skin is no easy task. Dr. Bowen cited a concordance study between dermatopathologists interpreting staged excisional margins on permanent sections for LM where the concordance was only moderate at best. In this study, the use of a negative control improved the concordance rate on “difficult” cases from 46% to 76%; P = .001 (Arch Dermatol. 2003 May;139(5):595-604). “What we really need is a molecular marker that will tell us if a melanocyte is malignant or not,” he said. “All we have now are immunostains that tell you if it’s melanocyte but nothing more.” He went on to say that in multivariate analysis in two studies of the histologic features of LM, the only feature that consistently predicted the difference between LM and AJMH was the melanocyte density and its ratio to the negative control (Dermatol Surg. 2011;37(5):657-63 and J. Plast. Reconstr. Aesthet. Surg. 2014;67(10):1322-32). “The MART-1 immunostain is extremely sensitive, but it makes the slide somewhat muddy, so it’s hard to do an accurate cell count,” he said. “For that reason, we also use a SOX-10 immunostain which is very specific but not as sensitive. I believe that the truth lies somewhere in between those two immunostains in light of a positive control from our lab and a negative control from the patient.”

He concluded that the neoadjuvant use of imiquimod followed by a conservative staged excision “allows me to clear 90% of LM with a 2 mm margin with a recurrence rate of 2.3% in patients with a mean follow-up of 5-years or greater.”

Dr. Bowen reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – Dr. Glen M. Bowen has been working to improve the surgical treatment of lentigo maligna ever since he joined the Huntsman Cancer Institute at the University of Utah 16 years ago. A retrospective review from Memorial Sloan-Kettering Cancer Center found that on average, 7.1-mm margins are required to remove lentigo maligna (LM) (J. Am. Acad. Dermatol. 2008;58[1]:142-8).

“If you have an LM with a 10-mm diameter to begin with, 7.1-mm margins give you a final surgical diameter of 24.2 mm,” Dr. Bowen said at the annual meeting of the Pacific Dermatologic Association. “These are very morbid surgeries in cosmetically sensitive areas for a relatively low-risk tumor.”

Dr. Glen M. Bowen

The risk of LM progressing to an invasive melanoma is not known, but is estimated to range between 5% and 33%. Of 2,016 patients treated for LM at the Huntsman Cancer Institute, 522 have been treated with neo-adjuvant topical imiquimod 5% cream followed by a conservative staged excision with 2-mm margins with a recurrence rate of 2.3% during median follow-up of 5 years. Of their recurrences, about 20% recurred with invasion. All recurrences to date have been less than 1 mm in depth (stage IA), which has an estimated mortality risk of 5% at 5 years. “A 5% mortality rate of the 20% that recur with invasion of the 2.3% that recur after surgery yields a mortality risk of 0.023%,” Dr. Bowen said. “Due to the very low risk of actually dying from a recurrent LM, very large and morbid surgical defects strike me as a punishment that doesn’t fit the crime in terms of the cost-benefit ratio.”

He and his associates at the Huntsman Cancer Institute have observed some deaths in patients who presented with LM melanoma (invasive melanoma) but have not observed a single death in patients who presented with LM in situ that subsequently recurred. For these reasons, Dr. Bowen favors pretreating LM with imiquimod 5% cream followed by a conservative staged excision, a process that substantially decreases the size of the surgical defects.

His current treatment protocol involves a five-step process that begins with removing all of the visible lentigo maligna to rule out invasion, since 16% of LMs referred to him have harbored invasion when removed and are upgraded from stage 0 to IA. “I am not going to use a topical cream on an invasive melanoma,” he said. “After an excisional biopsy with minimal margins, I usually close the defect with a purse-string suture because it avoids removing standing cones and consequently enlarging the treatment area.”

Second, he traces a template of the LM border on transparent plastic and places a tiny tattoo in the center of the biopsy site to enable pinpoint placement of the template at the time of surgery.

Third, he treats the site with imiquimod 5% cream Monday through Friday for 2-3 months and sees the patient monthly for dosage adjustments when needed. The fourth step involves enabling the site to recover for 2-6 months to allow for resolution of the inflammatory infiltrate. The final step involves re-excising around the original template with 2-mm margins for confirmation with the use of a negative control taken from an equally sun-exposed site taken some distance away from the LM. “Caucasians will have atypical junctional melanocytic hyperplasia (AJMH), which must be subtracted out as background,” he said. “Otherwise, if you hold a non–sun-exposed site as your standard for a negative margin, you will never stop cutting.”

Dr. Bowen likes to use frozen radial sections with routine staining with H and E and immunostaining with MART-1 (Melan-A) and SOX-10. Processing takes 2 hours, he continued, “so I put in relaxing sutures, which will stretch out nicely over 2 hours so I can usually close the defects primarily.”

In Dr. Bowen’s opinion, topical imiquimod as monotherapy for LM is not safe, since about 30% of patients treated with imiquimod will still harbor residual LM. “In our dataset, about 70% have no residual LM, 20% have residual LM in the center but negative perimeter margins, and 10% have LM touching a perimeter margin and require a second stage,” he said. “Taken together, 90% of patients pretreated with imiquimod will be cleared in one stage of surgery with 2 mm margins.”

Making the distinction between LM and AJMH common to chronically sun-damaged skin is no easy task. Dr. Bowen cited a concordance study between dermatopathologists interpreting staged excisional margins on permanent sections for LM where the concordance was only moderate at best. In this study, the use of a negative control improved the concordance rate on “difficult” cases from 46% to 76%; P = .001 (Arch Dermatol. 2003 May;139(5):595-604). “What we really need is a molecular marker that will tell us if a melanocyte is malignant or not,” he said. “All we have now are immunostains that tell you if it’s melanocyte but nothing more.” He went on to say that in multivariate analysis in two studies of the histologic features of LM, the only feature that consistently predicted the difference between LM and AJMH was the melanocyte density and its ratio to the negative control (Dermatol Surg. 2011;37(5):657-63 and J. Plast. Reconstr. Aesthet. Surg. 2014;67(10):1322-32). “The MART-1 immunostain is extremely sensitive, but it makes the slide somewhat muddy, so it’s hard to do an accurate cell count,” he said. “For that reason, we also use a SOX-10 immunostain which is very specific but not as sensitive. I believe that the truth lies somewhere in between those two immunostains in light of a positive control from our lab and a negative control from the patient.”

He concluded that the neoadjuvant use of imiquimod followed by a conservative staged excision “allows me to clear 90% of LM with a 2 mm margin with a recurrence rate of 2.3% in patients with a mean follow-up of 5-years or greater.”

Dr. Bowen reported having no financial disclosures.

[email protected]

PARK CITY, UTAH – Dr. Glen M. Bowen has been working to improve the surgical treatment of lentigo maligna ever since he joined the Huntsman Cancer Institute at the University of Utah 16 years ago. A retrospective review from Memorial Sloan-Kettering Cancer Center found that on average, 7.1-mm margins are required to remove lentigo maligna (LM) (J. Am. Acad. Dermatol. 2008;58[1]:142-8).

“If you have an LM with a 10-mm diameter to begin with, 7.1-mm margins give you a final surgical diameter of 24.2 mm,” Dr. Bowen said at the annual meeting of the Pacific Dermatologic Association. “These are very morbid surgeries in cosmetically sensitive areas for a relatively low-risk tumor.”

Dr. Glen M. Bowen

The risk of LM progressing to an invasive melanoma is not known, but is estimated to range between 5% and 33%. Of 2,016 patients treated for LM at the Huntsman Cancer Institute, 522 have been treated with neo-adjuvant topical imiquimod 5% cream followed by a conservative staged excision with 2-mm margins with a recurrence rate of 2.3% during median follow-up of 5 years. Of their recurrences, about 20% recurred with invasion. All recurrences to date have been less than 1 mm in depth (stage IA), which has an estimated mortality risk of 5% at 5 years. “A 5% mortality rate of the 20% that recur with invasion of the 2.3% that recur after surgery yields a mortality risk of 0.023%,” Dr. Bowen said. “Due to the very low risk of actually dying from a recurrent LM, very large and morbid surgical defects strike me as a punishment that doesn’t fit the crime in terms of the cost-benefit ratio.”

He and his associates at the Huntsman Cancer Institute have observed some deaths in patients who presented with LM melanoma (invasive melanoma) but have not observed a single death in patients who presented with LM in situ that subsequently recurred. For these reasons, Dr. Bowen favors pretreating LM with imiquimod 5% cream followed by a conservative staged excision, a process that substantially decreases the size of the surgical defects.

His current treatment protocol involves a five-step process that begins with removing all of the visible lentigo maligna to rule out invasion, since 16% of LMs referred to him have harbored invasion when removed and are upgraded from stage 0 to IA. “I am not going to use a topical cream on an invasive melanoma,” he said. “After an excisional biopsy with minimal margins, I usually close the defect with a purse-string suture because it avoids removing standing cones and consequently enlarging the treatment area.”

Second, he traces a template of the LM border on transparent plastic and places a tiny tattoo in the center of the biopsy site to enable pinpoint placement of the template at the time of surgery.

Third, he treats the site with imiquimod 5% cream Monday through Friday for 2-3 months and sees the patient monthly for dosage adjustments when needed. The fourth step involves enabling the site to recover for 2-6 months to allow for resolution of the inflammatory infiltrate. The final step involves re-excising around the original template with 2-mm margins for confirmation with the use of a negative control taken from an equally sun-exposed site taken some distance away from the LM. “Caucasians will have atypical junctional melanocytic hyperplasia (AJMH), which must be subtracted out as background,” he said. “Otherwise, if you hold a non–sun-exposed site as your standard for a negative margin, you will never stop cutting.”

Dr. Bowen likes to use frozen radial sections with routine staining with H and E and immunostaining with MART-1 (Melan-A) and SOX-10. Processing takes 2 hours, he continued, “so I put in relaxing sutures, which will stretch out nicely over 2 hours so I can usually close the defects primarily.”

In Dr. Bowen’s opinion, topical imiquimod as monotherapy for LM is not safe, since about 30% of patients treated with imiquimod will still harbor residual LM. “In our dataset, about 70% have no residual LM, 20% have residual LM in the center but negative perimeter margins, and 10% have LM touching a perimeter margin and require a second stage,” he said. “Taken together, 90% of patients pretreated with imiquimod will be cleared in one stage of surgery with 2 mm margins.”

Making the distinction between LM and AJMH common to chronically sun-damaged skin is no easy task. Dr. Bowen cited a concordance study between dermatopathologists interpreting staged excisional margins on permanent sections for LM where the concordance was only moderate at best. In this study, the use of a negative control improved the concordance rate on “difficult” cases from 46% to 76%; P = .001 (Arch Dermatol. 2003 May;139(5):595-604). “What we really need is a molecular marker that will tell us if a melanocyte is malignant or not,” he said. “All we have now are immunostains that tell you if it’s melanocyte but nothing more.” He went on to say that in multivariate analysis in two studies of the histologic features of LM, the only feature that consistently predicted the difference between LM and AJMH was the melanocyte density and its ratio to the negative control (Dermatol Surg. 2011;37(5):657-63 and J. Plast. Reconstr. Aesthet. Surg. 2014;67(10):1322-32). “The MART-1 immunostain is extremely sensitive, but it makes the slide somewhat muddy, so it’s hard to do an accurate cell count,” he said. “For that reason, we also use a SOX-10 immunostain which is very specific but not as sensitive. I believe that the truth lies somewhere in between those two immunostains in light of a positive control from our lab and a negative control from the patient.”

He concluded that the neoadjuvant use of imiquimod followed by a conservative staged excision “allows me to clear 90% of LM with a 2 mm margin with a recurrence rate of 2.3% in patients with a mean follow-up of 5-years or greater.”

Dr. Bowen reported having no financial disclosures.

[email protected]

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.

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.

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.

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.

[email protected]

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.

[email protected]

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.

[email protected]

Eradicating Helicobacter pylori bacteria with a short course of antibiotics and proton pump inhibitors helped reduce the risk of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults by 34%, according to a review published online July 22.

However, because all but one of the six studies included in the analysis were conducted in Asian populations, it is not known whether the results would be the same in Western populations.

© NDDIC.NIH.gov

“Gastric cancer is the third most common cause of cancer death worldwide,” wrote the researchers, who are members of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group. “Individuals infected with H. pylori have a higher likelihood of developing gastric cancer than individuals who are not infected. Eradication of H. pylori in healthy asymptomatic individuals in the general population may reduce the incidence of gastric cancer, but the magnitude of this effect is unclear.”

For the review, the researchers searched the Cochrane Central Register of Controlled Trials and other major databases for randomized, controlled trials that compared at least 1 week of H. pylori therapy with placebo or no treatment in preventing subsequent development of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD005583.pub2]. To be included, trials had to follow up participants for at least 2 years and needed to have at least two participants with gastric cancer as an outcome. The researchers defined gastric cancer as any gastric adenocarcinoma, including intestinal (differentiated) or diffuse (undifferentiated) type, with or without specified histology.

In all, six studies with a total of 6,497 participants met eligibility criteria. The studies primarily used a combination of antibiotics and proton pump inhibitors. Five of the six studies were conducted in Asian populations. Of 3,294 participants assigned to eradication therapy, 51 (1.6%) subsequently developed gastric cancer, compared with 76 (2.4%) of 3,203 participants who received placebo or no treatment. “There was no statistically significant heterogeneity between individual trial results,” the researchers wrote. “Therefore there was a small, but statistically significant benefit of H. pylori eradication therapy in preventing gastric cancer in healthy asymptomatic infected individuals (risk ratio, 0.66).”

They pointed out that the effect of H. pylori eradication on preventing death from gastric cancer, compared with placebo or no treatment “was uncertain due to wide confidence intervals” and there was “no evidence of an effect on all-cause mortality. Adverse events data were poorly reported.”

The researchers acknowledged certain limitations of the review, including that fact that only three of the trials were considered to be at low risk of bias. In addition, the design of some trials made it “difficult to ascertain whether the significant reduction in the risk of subsequent gastric cancer was due to H. pylori eradication therapy alone, or to the antioxidants or vitamins that were coadministered in some of the trials.”

In terms of implication for clinical practice, “the findings of this systematic review and meta-analysis add to the increasing evidence that eradicating H. pylori in the general population has the potential to prevent gastric cancer,” they concluded. “International guidelines for the management of H. pylori infection may change as a result.”

The researchers reported having no relevant financial conflicts.

[email protected]

Eradicating Helicobacter pylori bacteria with a short course of antibiotics and proton pump inhibitors helped reduce the risk of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults by 34%, according to a review published online July 22.

However, because all but one of the six studies included in the analysis were conducted in Asian populations, it is not known whether the results would be the same in Western populations.

© NDDIC.NIH.gov

“Gastric cancer is the third most common cause of cancer death worldwide,” wrote the researchers, who are members of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group. “Individuals infected with H. pylori have a higher likelihood of developing gastric cancer than individuals who are not infected. Eradication of H. pylori in healthy asymptomatic individuals in the general population may reduce the incidence of gastric cancer, but the magnitude of this effect is unclear.”

For the review, the researchers searched the Cochrane Central Register of Controlled Trials and other major databases for randomized, controlled trials that compared at least 1 week of H. pylori therapy with placebo or no treatment in preventing subsequent development of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD005583.pub2]. To be included, trials had to follow up participants for at least 2 years and needed to have at least two participants with gastric cancer as an outcome. The researchers defined gastric cancer as any gastric adenocarcinoma, including intestinal (differentiated) or diffuse (undifferentiated) type, with or without specified histology.

In all, six studies with a total of 6,497 participants met eligibility criteria. The studies primarily used a combination of antibiotics and proton pump inhibitors. Five of the six studies were conducted in Asian populations. Of 3,294 participants assigned to eradication therapy, 51 (1.6%) subsequently developed gastric cancer, compared with 76 (2.4%) of 3,203 participants who received placebo or no treatment. “There was no statistically significant heterogeneity between individual trial results,” the researchers wrote. “Therefore there was a small, but statistically significant benefit of H. pylori eradication therapy in preventing gastric cancer in healthy asymptomatic infected individuals (risk ratio, 0.66).”

They pointed out that the effect of H. pylori eradication on preventing death from gastric cancer, compared with placebo or no treatment “was uncertain due to wide confidence intervals” and there was “no evidence of an effect on all-cause mortality. Adverse events data were poorly reported.”

The researchers acknowledged certain limitations of the review, including that fact that only three of the trials were considered to be at low risk of bias. In addition, the design of some trials made it “difficult to ascertain whether the significant reduction in the risk of subsequent gastric cancer was due to H. pylori eradication therapy alone, or to the antioxidants or vitamins that were coadministered in some of the trials.”

In terms of implication for clinical practice, “the findings of this systematic review and meta-analysis add to the increasing evidence that eradicating H. pylori in the general population has the potential to prevent gastric cancer,” they concluded. “International guidelines for the management of H. pylori infection may change as a result.”

The researchers reported having no relevant financial conflicts.

[email protected]

Eradicating Helicobacter pylori bacteria with a short course of antibiotics and proton pump inhibitors helped reduce the risk of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults by 34%, according to a review published online July 22.

However, because all but one of the six studies included in the analysis were conducted in Asian populations, it is not known whether the results would be the same in Western populations.

© NDDIC.NIH.gov

“Gastric cancer is the third most common cause of cancer death worldwide,” wrote the researchers, who are members of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group. “Individuals infected with H. pylori have a higher likelihood of developing gastric cancer than individuals who are not infected. Eradication of H. pylori in healthy asymptomatic individuals in the general population may reduce the incidence of gastric cancer, but the magnitude of this effect is unclear.”

For the review, the researchers searched the Cochrane Central Register of Controlled Trials and other major databases for randomized, controlled trials that compared at least 1 week of H. pylori therapy with placebo or no treatment in preventing subsequent development of gastric cancer in otherwise healthy and asymptomatic H. pylori–positive adults (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD005583.pub2]. To be included, trials had to follow up participants for at least 2 years and needed to have at least two participants with gastric cancer as an outcome. The researchers defined gastric cancer as any gastric adenocarcinoma, including intestinal (differentiated) or diffuse (undifferentiated) type, with or without specified histology.

In all, six studies with a total of 6,497 participants met eligibility criteria. The studies primarily used a combination of antibiotics and proton pump inhibitors. Five of the six studies were conducted in Asian populations. Of 3,294 participants assigned to eradication therapy, 51 (1.6%) subsequently developed gastric cancer, compared with 76 (2.4%) of 3,203 participants who received placebo or no treatment. “There was no statistically significant heterogeneity between individual trial results,” the researchers wrote. “Therefore there was a small, but statistically significant benefit of H. pylori eradication therapy in preventing gastric cancer in healthy asymptomatic infected individuals (risk ratio, 0.66).”

They pointed out that the effect of H. pylori eradication on preventing death from gastric cancer, compared with placebo or no treatment “was uncertain due to wide confidence intervals” and there was “no evidence of an effect on all-cause mortality. Adverse events data were poorly reported.”

The researchers acknowledged certain limitations of the review, including that fact that only three of the trials were considered to be at low risk of bias. In addition, the design of some trials made it “difficult to ascertain whether the significant reduction in the risk of subsequent gastric cancer was due to H. pylori eradication therapy alone, or to the antioxidants or vitamins that were coadministered in some of the trials.”

In terms of implication for clinical practice, “the findings of this systematic review and meta-analysis add to the increasing evidence that eradicating H. pylori in the general population has the potential to prevent gastric cancer,” they concluded. “International guidelines for the management of H. pylori infection may change as a result.”

The researchers reported having no relevant financial conflicts.

[email protected]

There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Fuse/ThinkStockPhotos.com

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Fuse/ThinkStockPhotos.com

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Fuse/ThinkStockPhotos.com

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Fuse/ThinkStockPhotos.com

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

[email protected]

There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Fuse/ThinkStockPhotos.com

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

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There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act (S. 1438) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

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Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act (S. 1532), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation (House Bill 3343) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879, which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

[email protected]