Dermatology

Pediatric dermatology hospitalizations accounted for 4% of all pediatric admissions and 1.9% of total hospital costs for children in 2012, according to data from the Agency for Healthcare Research and Quality.

There were 74,229 such admissions in the United States that year – all others totaled 1.77 million – and the children at the highest risk for dermatology hospitalization were those living in communities with the lowest household incomes, the uninsured and those on Medicaid, and those living in the South, Justin D. Arnold of George Washington University, Washington, and his associates said in Pediatric Dermatology.

“Individuals from communities of low socioeconomic status may be more likely to be hospitalized because of gaps in insurance coverage, difficulty with transportation, or inconsistent access to preventative medical care, which for skin disease, would include access to an outpatient pediatric dermatologist,” they wrote.

All those admissions for skin diseases cost the health care system $379.8 million in 2012, or 1.9% of the $20.3 billion spent on all pediatric hospitalizations, excluding those related to pregnancy or childbirth. The mean cost of a skin disease admission was $5,211 for a child aged less than 18 years, compared with $11,409 for nondermatology admissions, according to data from the 2012 Kids’ Inpatient Database, which includes records of pediatric discharges from 44 states.

Cutaneous lymphoma was the most expensive skin disease per admission at a mean cost of $58,294, with congenital skin abnormalities second at $24,186, and ulcers third at $17,064. Bacterial skin infections and infestations were only the 19th most expensive admission at $4,135, but it was by far the most common (59,115 admissions) and the most expensive overall, with a total cost of $240 million. The second most common condition was viral diseases with 3,812 admissions and the next most expensive total was $33.5 million for connective tissue disorders, Mr. Arnold and his associates said.

Multivariate models that adjusted for such factors as age, sex, and race revealed that “the risk of hospitalization for skin disease increased as the median income of one’s zip code declined,” the investigators noted. The adjusted odds ratio for hospitalization in the lowest-income quartile (less than $39,000) was 1.22, compared with the highest-income quartile.

Insurance status also affected hospitalization, putting children from families with no insurance (aOR, 1.35) and those on Medicaid (aOR, 1.17) at a disadvantage, compared with those who had private insurance. “Policy makers should consider increasing Medicaid reimbursement rates to outpatient dermatologists, which might encourage more clinicians to accept this form of insurance and thereby expand access to preventative skin care,” they said.

Regional differences also were observed, which put children from the southern states at the highest risk (aOR, 1.32), compared with those in the West, which could be related to access issues. “In 2016, 4 of the 10 communities in the United States with the lowest density of dermatologists were in the South, suggesting that the high rate of hospitalizations there may also be partially attributed to lack of access to dermatologists,” Mr. Arnold and his associates wrote.

The investigators did not report funding or disclose conflicts of interest.

[email protected]

SOURCE: Arnold JD et al. Pediatr Dermatol. 2018 Jul 1. doi: 10.1111/pde.13549.

Pediatric dermatology hospitalizations accounted for 4% of all pediatric admissions and 1.9% of total hospital costs for children in 2012, according to data from the Agency for Healthcare Research and Quality.

There were 74,229 such admissions in the United States that year – all others totaled 1.77 million – and the children at the highest risk for dermatology hospitalization were those living in communities with the lowest household incomes, the uninsured and those on Medicaid, and those living in the South, Justin D. Arnold of George Washington University, Washington, and his associates said in Pediatric Dermatology.

“Individuals from communities of low socioeconomic status may be more likely to be hospitalized because of gaps in insurance coverage, difficulty with transportation, or inconsistent access to preventative medical care, which for skin disease, would include access to an outpatient pediatric dermatologist,” they wrote.

All those admissions for skin diseases cost the health care system $379.8 million in 2012, or 1.9% of the $20.3 billion spent on all pediatric hospitalizations, excluding those related to pregnancy or childbirth. The mean cost of a skin disease admission was $5,211 for a child aged less than 18 years, compared with $11,409 for nondermatology admissions, according to data from the 2012 Kids’ Inpatient Database, which includes records of pediatric discharges from 44 states.

Cutaneous lymphoma was the most expensive skin disease per admission at a mean cost of $58,294, with congenital skin abnormalities second at $24,186, and ulcers third at $17,064. Bacterial skin infections and infestations were only the 19th most expensive admission at $4,135, but it was by far the most common (59,115 admissions) and the most expensive overall, with a total cost of $240 million. The second most common condition was viral diseases with 3,812 admissions and the next most expensive total was $33.5 million for connective tissue disorders, Mr. Arnold and his associates said.

Multivariate models that adjusted for such factors as age, sex, and race revealed that “the risk of hospitalization for skin disease increased as the median income of one’s zip code declined,” the investigators noted. The adjusted odds ratio for hospitalization in the lowest-income quartile (less than $39,000) was 1.22, compared with the highest-income quartile.

Insurance status also affected hospitalization, putting children from families with no insurance (aOR, 1.35) and those on Medicaid (aOR, 1.17) at a disadvantage, compared with those who had private insurance. “Policy makers should consider increasing Medicaid reimbursement rates to outpatient dermatologists, which might encourage more clinicians to accept this form of insurance and thereby expand access to preventative skin care,” they said.

Regional differences also were observed, which put children from the southern states at the highest risk (aOR, 1.32), compared with those in the West, which could be related to access issues. “In 2016, 4 of the 10 communities in the United States with the lowest density of dermatologists were in the South, suggesting that the high rate of hospitalizations there may also be partially attributed to lack of access to dermatologists,” Mr. Arnold and his associates wrote.

The investigators did not report funding or disclose conflicts of interest.

[email protected]

SOURCE: Arnold JD et al. Pediatr Dermatol. 2018 Jul 1. doi: 10.1111/pde.13549.

Pediatric dermatology hospitalizations accounted for 4% of all pediatric admissions and 1.9% of total hospital costs for children in 2012, according to data from the Agency for Healthcare Research and Quality.

There were 74,229 such admissions in the United States that year – all others totaled 1.77 million – and the children at the highest risk for dermatology hospitalization were those living in communities with the lowest household incomes, the uninsured and those on Medicaid, and those living in the South, Justin D. Arnold of George Washington University, Washington, and his associates said in Pediatric Dermatology.

“Individuals from communities of low socioeconomic status may be more likely to be hospitalized because of gaps in insurance coverage, difficulty with transportation, or inconsistent access to preventative medical care, which for skin disease, would include access to an outpatient pediatric dermatologist,” they wrote.

All those admissions for skin diseases cost the health care system $379.8 million in 2012, or 1.9% of the $20.3 billion spent on all pediatric hospitalizations, excluding those related to pregnancy or childbirth. The mean cost of a skin disease admission was $5,211 for a child aged less than 18 years, compared with $11,409 for nondermatology admissions, according to data from the 2012 Kids’ Inpatient Database, which includes records of pediatric discharges from 44 states.

Cutaneous lymphoma was the most expensive skin disease per admission at a mean cost of $58,294, with congenital skin abnormalities second at $24,186, and ulcers third at $17,064. Bacterial skin infections and infestations were only the 19th most expensive admission at $4,135, but it was by far the most common (59,115 admissions) and the most expensive overall, with a total cost of $240 million. The second most common condition was viral diseases with 3,812 admissions and the next most expensive total was $33.5 million for connective tissue disorders, Mr. Arnold and his associates said.

Multivariate models that adjusted for such factors as age, sex, and race revealed that “the risk of hospitalization for skin disease increased as the median income of one’s zip code declined,” the investigators noted. The adjusted odds ratio for hospitalization in the lowest-income quartile (less than $39,000) was 1.22, compared with the highest-income quartile.

Insurance status also affected hospitalization, putting children from families with no insurance (aOR, 1.35) and those on Medicaid (aOR, 1.17) at a disadvantage, compared with those who had private insurance. “Policy makers should consider increasing Medicaid reimbursement rates to outpatient dermatologists, which might encourage more clinicians to accept this form of insurance and thereby expand access to preventative skin care,” they said.

Regional differences also were observed, which put children from the southern states at the highest risk (aOR, 1.32), compared with those in the West, which could be related to access issues. “In 2016, 4 of the 10 communities in the United States with the lowest density of dermatologists were in the South, suggesting that the high rate of hospitalizations there may also be partially attributed to lack of access to dermatologists,” Mr. Arnold and his associates wrote.

The investigators did not report funding or disclose conflicts of interest.

[email protected]

SOURCE: Arnold JD et al. Pediatr Dermatol. 2018 Jul 1. doi: 10.1111/pde.13549.

When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

• Becker nevus (BN) is far more common in males than females.
• BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
• Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
• The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.

When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

• Becker nevus (BN) is far more common in males than females.
• BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
• Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
• The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.

When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

• Becker nevus (BN) is far more common in males than females.
• BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
• Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
• The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.

The FP diagnosed syringomas in this patient.

He explained that the bumps are benign tumors that occur frequently on the lower eyelids and upper cheeks. They are completely unrelated to the birth control pill and can develop in men, and run in families, too. While syringomas appear to occur more often in women than men, there are no known causative agents. These are benign growths of the eccrine sweat glands.

Treatment options include cryosurgery, electrosurgery, or chemical destruction with trichloroacetic acid. All of these approaches need to be performed carefully, as the syringomas are so close to the eye. Also, these treatments are only modestly effective; new syringomas can form. And there are no preventive treatments.

In this case, the patient had light brown skin, so there was a risk of causing permanent hypopigmentation with any of these destructive methods. The patient was reassured about the benign nature of the condition; she decided not to seek therapy.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP diagnosed syringomas in this patient.

He explained that the bumps are benign tumors that occur frequently on the lower eyelids and upper cheeks. They are completely unrelated to the birth control pill and can develop in men, and run in families, too. While syringomas appear to occur more often in women than men, there are no known causative agents. These are benign growths of the eccrine sweat glands.

Treatment options include cryosurgery, electrosurgery, or chemical destruction with trichloroacetic acid. All of these approaches need to be performed carefully, as the syringomas are so close to the eye. Also, these treatments are only modestly effective; new syringomas can form. And there are no preventive treatments.

In this case, the patient had light brown skin, so there was a risk of causing permanent hypopigmentation with any of these destructive methods. The patient was reassured about the benign nature of the condition; she decided not to seek therapy.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP diagnosed syringomas in this patient.

He explained that the bumps are benign tumors that occur frequently on the lower eyelids and upper cheeks. They are completely unrelated to the birth control pill and can develop in men, and run in families, too. While syringomas appear to occur more often in women than men, there are no known causative agents. These are benign growths of the eccrine sweat glands.

Treatment options include cryosurgery, electrosurgery, or chemical destruction with trichloroacetic acid. All of these approaches need to be performed carefully, as the syringomas are so close to the eye. Also, these treatments are only modestly effective; new syringomas can form. And there are no preventive treatments.

In this case, the patient had light brown skin, so there was a risk of causing permanent hypopigmentation with any of these destructive methods. The patient was reassured about the benign nature of the condition; she decided not to seek therapy.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

More than half of the patients with moderate to severe atopic dermatitis (AD) had inadequately controlled disease, which was associated with a higher patient-reported disease burden compared with those who had adequately controlled disease, in a cross-sectional study of adults with AD.

Disease control aside, patient-reported burden was generally higher in those with moderate to severe AD versus patients with mild AD, according to Eric L. Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, and his coauthors.

“These results highlight the need for more effective therapies to better control AD, and support the importance of incorporating the patient perspective into assessment of AD beyond using measures of disease activity,” the researchers wrote. The study, published in JAMA Dermatology, was conducted before the introduction of dupilumab (Dupixent), the first biologic approved by the Food and Drug Administration for treatment of moderate to severe AD, the authors noted. (The study was supported by the manufacturers of dupilumab.)

The patients were in the Adults With Atopic Dermatitis Reporting on Their Experience (AD-AWARE) study, a cross-sectional analysis of burden of illness in adults with AD in clinical practices at six U.S. academic medical centers. The 1,519 patients completed a self-administered, Internet-based questionnaire during 2013-2014. Among these patients, 830 (54.6%) had moderate to severe AD.

A total of 185 patients with moderate to severe disease received systemic immunomodulators or phototherapy, and of those, more than half (103, or 55.7%) reported inadequate disease control, according to the survey results.

Regardless of disease control, the patients with moderate to severe AD had a greater burden of disease compared with patients with mild AD, according to the investigators. Those burdens included more severe pain and itching, sleep effects, anxiety and depression, and impairment of health-related quality of life, they reported.

Those with moderate to severe disease had a mean of 5.7 days per week with itchy skin, and 22.8% reported itch lasting for more than half a day, compared with a mean of 2.7 days and 2.9%, respectively, for those with mild disease, all significant differences.

Those with moderate to severe disease also reported more trouble sleeping, along with more frequent sleep disturbances, longer time transitioning into sleep, and more use of nonprescription sleep medications than those with mild disease.

Among those with moderate to severe disease, those who were inadequately controlled had a higher level of itch intensity and more frequent itching (a mean of 6.3 days per week), compared with those who were controlled (a mean of 5.7 days per week).

In a previous study looking at patient burden in a phase 2b clinical trial of dupilumab, Dr. Simpson and his coinvestigators found that adults with moderate to severe AD reported a “multidimensional burden” of disease that included disease activity, patient-reported symptoms, quality-of-life impact, and comorbidities (J Am Acad Dermatol. 2016 Mar;74[3]:491-8).

The current analysis based on the AD-AWARE study was supported by dupilumab manufacturers Regeneron Pharmaceuticals and Sanofi. Dr. Simpson reported disclosures related to Amgen, Anacor, Asubio, Celgene, Chugai, Galderma, Genentech, Medicis, Merck, and Regeneron; five of the 15 authors were employees of Sanofi or Regeneron. Other authors reported disclosures related to these and other companies.

SOURCE: Simpson EL et al. JAMA Dermatol. 2018 Jul 3. doi: 10.1001/jamadermatol.2018.1572.

More than half of the patients with moderate to severe atopic dermatitis (AD) had inadequately controlled disease, which was associated with a higher patient-reported disease burden compared with those who had adequately controlled disease, in a cross-sectional study of adults with AD.

Disease control aside, patient-reported burden was generally higher in those with moderate to severe AD versus patients with mild AD, according to Eric L. Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, and his coauthors.

“These results highlight the need for more effective therapies to better control AD, and support the importance of incorporating the patient perspective into assessment of AD beyond using measures of disease activity,” the researchers wrote. The study, published in JAMA Dermatology, was conducted before the introduction of dupilumab (Dupixent), the first biologic approved by the Food and Drug Administration for treatment of moderate to severe AD, the authors noted. (The study was supported by the manufacturers of dupilumab.)

The patients were in the Adults With Atopic Dermatitis Reporting on Their Experience (AD-AWARE) study, a cross-sectional analysis of burden of illness in adults with AD in clinical practices at six U.S. academic medical centers. The 1,519 patients completed a self-administered, Internet-based questionnaire during 2013-2014. Among these patients, 830 (54.6%) had moderate to severe AD.

A total of 185 patients with moderate to severe disease received systemic immunomodulators or phototherapy, and of those, more than half (103, or 55.7%) reported inadequate disease control, according to the survey results.

Regardless of disease control, the patients with moderate to severe AD had a greater burden of disease compared with patients with mild AD, according to the investigators. Those burdens included more severe pain and itching, sleep effects, anxiety and depression, and impairment of health-related quality of life, they reported.

Those with moderate to severe disease had a mean of 5.7 days per week with itchy skin, and 22.8% reported itch lasting for more than half a day, compared with a mean of 2.7 days and 2.9%, respectively, for those with mild disease, all significant differences.

Those with moderate to severe disease also reported more trouble sleeping, along with more frequent sleep disturbances, longer time transitioning into sleep, and more use of nonprescription sleep medications than those with mild disease.

Among those with moderate to severe disease, those who were inadequately controlled had a higher level of itch intensity and more frequent itching (a mean of 6.3 days per week), compared with those who were controlled (a mean of 5.7 days per week).

In a previous study looking at patient burden in a phase 2b clinical trial of dupilumab, Dr. Simpson and his coinvestigators found that adults with moderate to severe AD reported a “multidimensional burden” of disease that included disease activity, patient-reported symptoms, quality-of-life impact, and comorbidities (J Am Acad Dermatol. 2016 Mar;74[3]:491-8).

The current analysis based on the AD-AWARE study was supported by dupilumab manufacturers Regeneron Pharmaceuticals and Sanofi. Dr. Simpson reported disclosures related to Amgen, Anacor, Asubio, Celgene, Chugai, Galderma, Genentech, Medicis, Merck, and Regeneron; five of the 15 authors were employees of Sanofi or Regeneron. Other authors reported disclosures related to these and other companies.

SOURCE: Simpson EL et al. JAMA Dermatol. 2018 Jul 3. doi: 10.1001/jamadermatol.2018.1572.

More than half of the patients with moderate to severe atopic dermatitis (AD) had inadequately controlled disease, which was associated with a higher patient-reported disease burden compared with those who had adequately controlled disease, in a cross-sectional study of adults with AD.

Disease control aside, patient-reported burden was generally higher in those with moderate to severe AD versus patients with mild AD, according to Eric L. Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, and his coauthors.

“These results highlight the need for more effective therapies to better control AD, and support the importance of incorporating the patient perspective into assessment of AD beyond using measures of disease activity,” the researchers wrote. The study, published in JAMA Dermatology, was conducted before the introduction of dupilumab (Dupixent), the first biologic approved by the Food and Drug Administration for treatment of moderate to severe AD, the authors noted. (The study was supported by the manufacturers of dupilumab.)

The patients were in the Adults With Atopic Dermatitis Reporting on Their Experience (AD-AWARE) study, a cross-sectional analysis of burden of illness in adults with AD in clinical practices at six U.S. academic medical centers. The 1,519 patients completed a self-administered, Internet-based questionnaire during 2013-2014. Among these patients, 830 (54.6%) had moderate to severe AD.

A total of 185 patients with moderate to severe disease received systemic immunomodulators or phototherapy, and of those, more than half (103, or 55.7%) reported inadequate disease control, according to the survey results.

Regardless of disease control, the patients with moderate to severe AD had a greater burden of disease compared with patients with mild AD, according to the investigators. Those burdens included more severe pain and itching, sleep effects, anxiety and depression, and impairment of health-related quality of life, they reported.

Those with moderate to severe disease had a mean of 5.7 days per week with itchy skin, and 22.8% reported itch lasting for more than half a day, compared with a mean of 2.7 days and 2.9%, respectively, for those with mild disease, all significant differences.

Those with moderate to severe disease also reported more trouble sleeping, along with more frequent sleep disturbances, longer time transitioning into sleep, and more use of nonprescription sleep medications than those with mild disease.

Among those with moderate to severe disease, those who were inadequately controlled had a higher level of itch intensity and more frequent itching (a mean of 6.3 days per week), compared with those who were controlled (a mean of 5.7 days per week).

In a previous study looking at patient burden in a phase 2b clinical trial of dupilumab, Dr. Simpson and his coinvestigators found that adults with moderate to severe AD reported a “multidimensional burden” of disease that included disease activity, patient-reported symptoms, quality-of-life impact, and comorbidities (J Am Acad Dermatol. 2016 Mar;74[3]:491-8).

The current analysis based on the AD-AWARE study was supported by dupilumab manufacturers Regeneron Pharmaceuticals and Sanofi. Dr. Simpson reported disclosures related to Amgen, Anacor, Asubio, Celgene, Chugai, Galderma, Genentech, Medicis, Merck, and Regeneron; five of the 15 authors were employees of Sanofi or Regeneron. Other authors reported disclosures related to these and other companies.

SOURCE: Simpson EL et al. JAMA Dermatol. 2018 Jul 3. doi: 10.1001/jamadermatol.2018.1572.

THE CASE

A 7-year-old boy presented with a one-week history of a pruritic rash, which first appeared on his back and continued to spread across his entire body. The patient’s medical history was significant for a scalp lesion (FIGURE 1) that was being treated with oral griseofulvin (started 3 days earlier). He had no history of seasonal allergies, asthma, recent illness, or recent immunizations.

The physical exam was significant for a body-wide, nonerythematous, papular rash (FIGURE 2). There was evidence of excoriation due to itching. No mucosal involvement was appreciated. The remainder of the examination was unremarkable.

QUESTION

Based on the patient’s history and physical exam, which of the following is the most likely diagnosis?

A. Gianotti-Crosti syndrome

B. Atopic dermatitis

C. Dermatophytid reaction

D. Morbilliform drug eruption.

Continue to: THE DIAGNOSIS

 

 

THE DIAGNOSIS

The answer is C, dermatophytid reaction.

DISCUSSION

A dermatophytid reaction is a type of id reaction, or autoeczematization. An id reaction is when a localized dermatitis becomes a generalized pruritic eruption.¹ In this case, the patient’s dermatitis was the result of a dermatophyte infection (tinea capitis), but an id reaction can also occur in response to noninfectious dermatitides and may be of an atopic, contact, or seborrheic nature.¹

Dermatophytid reactions occur in up to 5% of all dermatophyte infections (most commonly tinea pedis) and are proposed to be type IV hypersensitivity reactions to the release of fungal antigens.¹ These reactions can occur either before or after the initiation of antifungal treatment. They manifest as symmetric, pruritic, papulovesicular eruptions with fine scaling and commonly affect the face, trunk, extremities, palms, and interdigital spaces.¹

What about other possible diagnoses?

Gianotti-Crosti syndrome is an asymptomatic, symmetric, papulovesicular dermatosis that involves the face, limbs, and buttocks of children 2 to 6 years of age.² The lesions develop in response to a respiratory or gastrointestinal illness.² They are typically associated with Epstein-Barr virus, hepatitis B, cytomegalovirus, respiratory syncytial virus, and coxsackievirus, but can occur with bacterial infections or following administration of routine immunizations.²

While the initial impulse may be to discontinue oral antifungals, these treatments help resolve the underlying dermatophyte infection and should be continued.

The lesions are self-limited and resolve within 2 months.² Symptomatic lesions may be treated with oral antihistamines or steroids (topical or systemic).²

Continue to: Atopic dermatitis

Atopic dermatitis is characterized by symmetric involvement of the flexural sur­faces of the body with a pruritic, erythematous rash that may have a fine scale.³ It usually manifests prior to 2 years of age, is recurrent, and is commonly associated with allergic rhinitis and asthma.³ Treatment involves trigger avoidance, topical emollients, topical corticosteroids, dilute bleach baths, and topical calcineurin inhibitors.^3,4 For patients with significant nocturnal symptoms and sleep loss, oral antihistamines may be helpful.⁴

Morbilliform drug eruptions are the most common type of dermatologic drug reaction.⁵ These rashes occur approximately one to 2 weeks after exposure to a causative drug; they consist of pruritic, erythematous papules or macules that start centrally and may spread to the proximal extremities.⁵ Treatment involves discontinuation of the offending agent. Symptomatic relief may be achieved with oral antihistamines or topical or systemic corticosteroids.⁵

Treatment of dermatophytid reactions

While the initial impulse in the treatment of a dermatophytid reaction may be to discon­tinue oral antifungals, these treatments actually help resolve the underlying dermatophyte infection and should be continued. For children with tinea capitis, at least 6 weeks of treatment with an oral antifungal agent is warranted. Medications approved by the US Food and Drug Administration include terbinafine (for patients >4 years of age) and griseofulvin (for patients >2 years of age). Dosages are weight-based. (Fluconazole and itraconazole are not approved for this indication.) Lubricants, topical corticosteroids, and oral antihistamines can be used for acute management of pruritus.¹

Our patient was treated successfully with griseofulvin and an oral antihistamine. However, he experienced headaches attrib­uted to griseofulvin and was switched to terbinafine 5 mg/kg/d for 4 weeks. His tinea capitis was resolved at 8 weeks.

CORRESPONDENCE
Richard Temple, MD, CAPT, MC, USN. Department of Family Medicine, Naval Medical Center Camp Lejeune, 100 Brewster Blvd, Camp Lejeune, NC 28547; [email protected].

THE CASE

A 7-year-old boy presented with a one-week history of a pruritic rash, which first appeared on his back and continued to spread across his entire body. The patient’s medical history was significant for a scalp lesion (FIGURE 1) that was being treated with oral griseofulvin (started 3 days earlier). He had no history of seasonal allergies, asthma, recent illness, or recent immunizations.

The physical exam was significant for a body-wide, nonerythematous, papular rash (FIGURE 2). There was evidence of excoriation due to itching. No mucosal involvement was appreciated. The remainder of the examination was unremarkable.

QUESTION

Based on the patient’s history and physical exam, which of the following is the most likely diagnosis?

A. Gianotti-Crosti syndrome

B. Atopic dermatitis

C. Dermatophytid reaction

D. Morbilliform drug eruption.

Continue to: THE DIAGNOSIS

 

 

THE DIAGNOSIS

The answer is C, dermatophytid reaction.

DISCUSSION

A dermatophytid reaction is a type of id reaction, or autoeczematization. An id reaction is when a localized dermatitis becomes a generalized pruritic eruption.¹ In this case, the patient’s dermatitis was the result of a dermatophyte infection (tinea capitis), but an id reaction can also occur in response to noninfectious dermatitides and may be of an atopic, contact, or seborrheic nature.¹

Dermatophytid reactions occur in up to 5% of all dermatophyte infections (most commonly tinea pedis) and are proposed to be type IV hypersensitivity reactions to the release of fungal antigens.¹ These reactions can occur either before or after the initiation of antifungal treatment. They manifest as symmetric, pruritic, papulovesicular eruptions with fine scaling and commonly affect the face, trunk, extremities, palms, and interdigital spaces.¹

What about other possible diagnoses?

Gianotti-Crosti syndrome is an asymptomatic, symmetric, papulovesicular dermatosis that involves the face, limbs, and buttocks of children 2 to 6 years of age.² The lesions develop in response to a respiratory or gastrointestinal illness.² They are typically associated with Epstein-Barr virus, hepatitis B, cytomegalovirus, respiratory syncytial virus, and coxsackievirus, but can occur with bacterial infections or following administration of routine immunizations.²

While the initial impulse may be to discontinue oral antifungals, these treatments help resolve the underlying dermatophyte infection and should be continued.

The lesions are self-limited and resolve within 2 months.² Symptomatic lesions may be treated with oral antihistamines or steroids (topical or systemic).²

Continue to: Atopic dermatitis

Atopic dermatitis is characterized by symmetric involvement of the flexural sur­faces of the body with a pruritic, erythematous rash that may have a fine scale.³ It usually manifests prior to 2 years of age, is recurrent, and is commonly associated with allergic rhinitis and asthma.³ Treatment involves trigger avoidance, topical emollients, topical corticosteroids, dilute bleach baths, and topical calcineurin inhibitors.^3,4 For patients with significant nocturnal symptoms and sleep loss, oral antihistamines may be helpful.⁴

Morbilliform drug eruptions are the most common type of dermatologic drug reaction.⁵ These rashes occur approximately one to 2 weeks after exposure to a causative drug; they consist of pruritic, erythematous papules or macules that start centrally and may spread to the proximal extremities.⁵ Treatment involves discontinuation of the offending agent. Symptomatic relief may be achieved with oral antihistamines or topical or systemic corticosteroids.⁵

Treatment of dermatophytid reactions

While the initial impulse in the treatment of a dermatophytid reaction may be to discon­tinue oral antifungals, these treatments actually help resolve the underlying dermatophyte infection and should be continued. For children with tinea capitis, at least 6 weeks of treatment with an oral antifungal agent is warranted. Medications approved by the US Food and Drug Administration include terbinafine (for patients >4 years of age) and griseofulvin (for patients >2 years of age). Dosages are weight-based. (Fluconazole and itraconazole are not approved for this indication.) Lubricants, topical corticosteroids, and oral antihistamines can be used for acute management of pruritus.¹

Our patient was treated successfully with griseofulvin and an oral antihistamine. However, he experienced headaches attrib­uted to griseofulvin and was switched to terbinafine 5 mg/kg/d for 4 weeks. His tinea capitis was resolved at 8 weeks.

CORRESPONDENCE
Richard Temple, MD, CAPT, MC, USN. Department of Family Medicine, Naval Medical Center Camp Lejeune, 100 Brewster Blvd, Camp Lejeune, NC 28547; [email protected].

THE CASE

A 7-year-old boy presented with a one-week history of a pruritic rash, which first appeared on his back and continued to spread across his entire body. The patient’s medical history was significant for a scalp lesion (FIGURE 1) that was being treated with oral griseofulvin (started 3 days earlier). He had no history of seasonal allergies, asthma, recent illness, or recent immunizations.

The physical exam was significant for a body-wide, nonerythematous, papular rash (FIGURE 2). There was evidence of excoriation due to itching. No mucosal involvement was appreciated. The remainder of the examination was unremarkable.

QUESTION

Based on the patient’s history and physical exam, which of the following is the most likely diagnosis?

A. Gianotti-Crosti syndrome

B. Atopic dermatitis

C. Dermatophytid reaction

D. Morbilliform drug eruption.

Continue to: THE DIAGNOSIS

 

 

THE DIAGNOSIS

The answer is C, dermatophytid reaction.

DISCUSSION

A dermatophytid reaction is a type of id reaction, or autoeczematization. An id reaction is when a localized dermatitis becomes a generalized pruritic eruption.¹ In this case, the patient’s dermatitis was the result of a dermatophyte infection (tinea capitis), but an id reaction can also occur in response to noninfectious dermatitides and may be of an atopic, contact, or seborrheic nature.¹

Dermatophytid reactions occur in up to 5% of all dermatophyte infections (most commonly tinea pedis) and are proposed to be type IV hypersensitivity reactions to the release of fungal antigens.¹ These reactions can occur either before or after the initiation of antifungal treatment. They manifest as symmetric, pruritic, papulovesicular eruptions with fine scaling and commonly affect the face, trunk, extremities, palms, and interdigital spaces.¹

What about other possible diagnoses?

Gianotti-Crosti syndrome is an asymptomatic, symmetric, papulovesicular dermatosis that involves the face, limbs, and buttocks of children 2 to 6 years of age.² The lesions develop in response to a respiratory or gastrointestinal illness.² They are typically associated with Epstein-Barr virus, hepatitis B, cytomegalovirus, respiratory syncytial virus, and coxsackievirus, but can occur with bacterial infections or following administration of routine immunizations.²

While the initial impulse may be to discontinue oral antifungals, these treatments help resolve the underlying dermatophyte infection and should be continued.

The lesions are self-limited and resolve within 2 months.² Symptomatic lesions may be treated with oral antihistamines or steroids (topical or systemic).²

Continue to: Atopic dermatitis

Atopic dermatitis is characterized by symmetric involvement of the flexural sur­faces of the body with a pruritic, erythematous rash that may have a fine scale.³ It usually manifests prior to 2 years of age, is recurrent, and is commonly associated with allergic rhinitis and asthma.³ Treatment involves trigger avoidance, topical emollients, topical corticosteroids, dilute bleach baths, and topical calcineurin inhibitors.^3,4 For patients with significant nocturnal symptoms and sleep loss, oral antihistamines may be helpful.⁴

Morbilliform drug eruptions are the most common type of dermatologic drug reaction.⁵ These rashes occur approximately one to 2 weeks after exposure to a causative drug; they consist of pruritic, erythematous papules or macules that start centrally and may spread to the proximal extremities.⁵ Treatment involves discontinuation of the offending agent. Symptomatic relief may be achieved with oral antihistamines or topical or systemic corticosteroids.⁵

Treatment of dermatophytid reactions

While the initial impulse in the treatment of a dermatophytid reaction may be to discon­tinue oral antifungals, these treatments actually help resolve the underlying dermatophyte infection and should be continued. For children with tinea capitis, at least 6 weeks of treatment with an oral antifungal agent is warranted. Medications approved by the US Food and Drug Administration include terbinafine (for patients >4 years of age) and griseofulvin (for patients >2 years of age). Dosages are weight-based. (Fluconazole and itraconazole are not approved for this indication.) Lubricants, topical corticosteroids, and oral antihistamines can be used for acute management of pruritus.¹

Our patient was treated successfully with griseofulvin and an oral antihistamine. However, he experienced headaches attrib­uted to griseofulvin and was switched to terbinafine 5 mg/kg/d for 4 weeks. His tinea capitis was resolved at 8 weeks.

CORRESPONDENCE
Richard Temple, MD, CAPT, MC, USN. Department of Family Medicine, Naval Medical Center Camp Lejeune, 100 Brewster Blvd, Camp Lejeune, NC 28547; [email protected].

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

[email protected]

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

[email protected]

The Food and Drug Administration has approved glycopyrronium tosylate, an anticholinergic for the topical treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older.

Glycopyrronium, which is formulated in a cloth wipe, will be marketed as Qbrexza and is expected to be available in October, according to the approval announcement June 29, which was made by Dermira, the manufacturer. The instructions for use section in the prescribing information states that patients are advised to use one cloth to apply the medication to both axillae, wiping the cloth across each underarm. Each cloth, intended for single use, is pre-moistened with 2.4% glycopyrronium solution.

Glycopyrronium blocks sweat production “by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation,” the company said in a February press release.

The approval was based on the results of two phase 3 clinical studies, ATMOS-1 and ATMOS-2, which were multicenter, randomized, double-blind, vehicle-controlled, 4-week studies in patients 9 years of age or older with primary axillary hyperhidrosis for 6 months or longer. Study subjects had production of at least 50 mg of underarm sweat over 5 minutes, and scores of four or higher on the 11-point Axillary Sweating Daily Diary (ASDD) or the Children’s ASDD (ASDD-C) – an instrument developed by the company in consultation with the FDA – and scores of three or four on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). In total, 463 patients were randomized to receive glycopyrronium and 234 to vehicle. Forty four of these patients were aged 9-16 years, with 25 receiving glycopyrronium and 19 receiving vehicle.

According to the February release, the ASDD/ASDD-C severity scale responder rates were about 60% in the pediatric and adult groups treated with glycopyrronium, compared with 13.0% and 28.8% for children and adults, respectively, in the vehicle group. At week 4, the median absolute change in sweat production was a reduction of 64.2 mg in children and a reduction of 80.6 mg among adults treated with glycopyrronium, compared with reductions of 53.7 mg and 62 mg among those in the vehicle group, respectively.

In the glycopyrronium-treated group, almost 80% of the pediatric patients and 74.3% of the adults experienced at least a 50% reduction in sweat production at week 4, compared with almost 55% and 53%, respectively, in the vehicle group.

Among pediatric patients, the mean decrease from baseline in the Children’s Dermatology Quality of Life Index was 8.1 in glycopyrronium-treated patients, compared with 1.9 in the vehicle group. In adults, scores on the Dermatology Life Quality Index measure were reduced by 8.4 and 4.7 in glycopyrronium- and vehicle-treated adult patients, respectively.

Nearly 57% of adults and 44% of pediatric patients treated with glycopyrronium experienced treatment-emergent adverse events, compared with 34.3% of adults and 10.5% of the pediatric patients in the vehicle group. The majority were related to anticholinergic activity and were mild, and rarely led to drug discontinuation, according to the company.

The press release announcing the approval stated that the most common adverse effects observed after application of glycopyrronium were dry mouth, mydriasis, sore throat, headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. Erythema, burning/stinging, and pruritus were the most common skin reactions.

The product is contraindicated in patients with glaucoma, paralytic ileus, and other medical conditions that can be exacerbated by its anticholinergic effects, according to the prescribing information. Patients should be advised that they should wash their hands thoroughly after application, and that it can cause temporary dilation of the pupils and blurred vision if glycopyrronium comes into contact with their eyes.

[email protected]

Elderly patients with psoriasis respond just as well to biologic treatments as do younger patients, with a low rate of serious adverse events, according to a new retrospective study.

Among 266 older patients, 65% achieved a 75% improvement in Psoriasis Area Severity Index score (PASI 75) after 1 year of therapy; 50% reached a PASI 90, and 40% a PASI 100, Francesca Prignano MD, PhD, and her colleagues reported in the Journal of the European Academy of Dermatology and Venereology. The rate of serious adverse events was less than 10%.

Elderly patients – those aged 65 years and older – are commonly excluded from studies on biologic treatments because they have more medical comorbidities and are thought to be more at risk for serious adverse events, like infections and malignancy, wrote Dr. Prignano of the dermatology unit, University of Florence, Italy, and her colleagues.

As a result, they noted, there is a “lack of information concerning safety and effectiveness of available treatments for psoriasis in the elderly, particularly about new biologic agents. Disease remission should be an objective for both younger patients and older patients, and biologic therapy should be considered a treatment option for all patients.”

To examine both the benefit and risk of biologics in this population, the team reviewed the records of 266 elderly psoriasis patients; everyone had been on a biologic treatment for at least 1 year.

The primary outcome was PASI score at weeks 8, 16, 28, and 52. The secondary outcomes were the rate and types of biologic-associated adverse events.

The study comprised 266 patients (mean age 72 years). Their mean psoriasis duration was 25.7 years. Comorbidities included psoriatic arthritis; hypertension and dyslipidemia; diabetes mellitus; cardiovascular, gastrointestinal and respiratory diseases; osteoporosis; thyroid dysfunction; depression; and cancer.

Adalimumab was the most commonly prescribed biologic (31%), followed by ustekinumab (28.9%), etanercept (20%), and secukinumab (15%). A smaller proportion of patients were taking infliximab, golimumab, or certolizumab pegol.

The mean baseline PASI was 16.5, although the range was wide (4-54). At the time of review, the average biologic treatment duration was 44 months. Almost half of the cohort (128) were on their second biologic, and 20 more had been on three biologics. A few patients were taking concomitant medications, including steroids, cyclosporine, and acitretin.

The mean PASI scores decreased to 3.7 at week 16, 1.6 at week 28, and 1.2 at week 52. The group exhibited a rapid response to biologic treatment. By 16 weeks, about 55% had achieved a PASI 75, about 28% a PASI 90, and about 20% a PASI 100. By 28 weeks, these numbers were about 64%, 45%, and 35%, respectively. At 1 year, they were about 65%, 50%, and 40%, respectively.

The rate of adverse events was 9.4%. There were 25 events in the cohort, the majority of which (48%) were infections; these included four respiratory infections, three urinary tract infections, two cases of mucocutaneous candidiasis, two cases of herpes zoster infection, and one case of erysipelas.

There were four malignancies: three nonmelanoma skin cancers and one vocal cord cancer.

Noting that, to date, their study represented “the broadest experience on the use of biological drugs” for elderly patients with psoriasis, they wrote that while “comorbidities should be taken into consideration when a long-term treatment is proposed, for the higher risk of side effects and drug interactions,” they wrote, noting that none of the 266 patients had a serious infection and the malignancy rate was low (1.5%).

None of the authors had financial disclosures, and the study had no funding source.

[email protected]

SOURCE: Ricceri F et al. J Eur Acad Dermatol Venereol. 2018 Jun 15. doi: 10.1111/jdv.15139.

Elderly patients with psoriasis respond just as well to biologic treatments as do younger patients, with a low rate of serious adverse events, according to a new retrospective study.

Among 266 older patients, 65% achieved a 75% improvement in Psoriasis Area Severity Index score (PASI 75) after 1 year of therapy; 50% reached a PASI 90, and 40% a PASI 100, Francesca Prignano MD, PhD, and her colleagues reported in the Journal of the European Academy of Dermatology and Venereology. The rate of serious adverse events was less than 10%.

Elderly patients – those aged 65 years and older – are commonly excluded from studies on biologic treatments because they have more medical comorbidities and are thought to be more at risk for serious adverse events, like infections and malignancy, wrote Dr. Prignano of the dermatology unit, University of Florence, Italy, and her colleagues.

As a result, they noted, there is a “lack of information concerning safety and effectiveness of available treatments for psoriasis in the elderly, particularly about new biologic agents. Disease remission should be an objective for both younger patients and older patients, and biologic therapy should be considered a treatment option for all patients.”

To examine both the benefit and risk of biologics in this population, the team reviewed the records of 266 elderly psoriasis patients; everyone had been on a biologic treatment for at least 1 year.

The primary outcome was PASI score at weeks 8, 16, 28, and 52. The secondary outcomes were the rate and types of biologic-associated adverse events.

The study comprised 266 patients (mean age 72 years). Their mean psoriasis duration was 25.7 years. Comorbidities included psoriatic arthritis; hypertension and dyslipidemia; diabetes mellitus; cardiovascular, gastrointestinal and respiratory diseases; osteoporosis; thyroid dysfunction; depression; and cancer.

Adalimumab was the most commonly prescribed biologic (31%), followed by ustekinumab (28.9%), etanercept (20%), and secukinumab (15%). A smaller proportion of patients were taking infliximab, golimumab, or certolizumab pegol.

The mean baseline PASI was 16.5, although the range was wide (4-54). At the time of review, the average biologic treatment duration was 44 months. Almost half of the cohort (128) were on their second biologic, and 20 more had been on three biologics. A few patients were taking concomitant medications, including steroids, cyclosporine, and acitretin.

The mean PASI scores decreased to 3.7 at week 16, 1.6 at week 28, and 1.2 at week 52. The group exhibited a rapid response to biologic treatment. By 16 weeks, about 55% had achieved a PASI 75, about 28% a PASI 90, and about 20% a PASI 100. By 28 weeks, these numbers were about 64%, 45%, and 35%, respectively. At 1 year, they were about 65%, 50%, and 40%, respectively.

The rate of adverse events was 9.4%. There were 25 events in the cohort, the majority of which (48%) were infections; these included four respiratory infections, three urinary tract infections, two cases of mucocutaneous candidiasis, two cases of herpes zoster infection, and one case of erysipelas.

There were four malignancies: three nonmelanoma skin cancers and one vocal cord cancer.

Noting that, to date, their study represented “the broadest experience on the use of biological drugs” for elderly patients with psoriasis, they wrote that while “comorbidities should be taken into consideration when a long-term treatment is proposed, for the higher risk of side effects and drug interactions,” they wrote, noting that none of the 266 patients had a serious infection and the malignancy rate was low (1.5%).

None of the authors had financial disclosures, and the study had no funding source.

[email protected]

SOURCE: Ricceri F et al. J Eur Acad Dermatol Venereol. 2018 Jun 15. doi: 10.1111/jdv.15139.

Elderly patients with psoriasis respond just as well to biologic treatments as do younger patients, with a low rate of serious adverse events, according to a new retrospective study.

Among 266 older patients, 65% achieved a 75% improvement in Psoriasis Area Severity Index score (PASI 75) after 1 year of therapy; 50% reached a PASI 90, and 40% a PASI 100, Francesca Prignano MD, PhD, and her colleagues reported in the Journal of the European Academy of Dermatology and Venereology. The rate of serious adverse events was less than 10%.

Elderly patients – those aged 65 years and older – are commonly excluded from studies on biologic treatments because they have more medical comorbidities and are thought to be more at risk for serious adverse events, like infections and malignancy, wrote Dr. Prignano of the dermatology unit, University of Florence, Italy, and her colleagues.

As a result, they noted, there is a “lack of information concerning safety and effectiveness of available treatments for psoriasis in the elderly, particularly about new biologic agents. Disease remission should be an objective for both younger patients and older patients, and biologic therapy should be considered a treatment option for all patients.”

To examine both the benefit and risk of biologics in this population, the team reviewed the records of 266 elderly psoriasis patients; everyone had been on a biologic treatment for at least 1 year.

The primary outcome was PASI score at weeks 8, 16, 28, and 52. The secondary outcomes were the rate and types of biologic-associated adverse events.

The study comprised 266 patients (mean age 72 years). Their mean psoriasis duration was 25.7 years. Comorbidities included psoriatic arthritis; hypertension and dyslipidemia; diabetes mellitus; cardiovascular, gastrointestinal and respiratory diseases; osteoporosis; thyroid dysfunction; depression; and cancer.

Adalimumab was the most commonly prescribed biologic (31%), followed by ustekinumab (28.9%), etanercept (20%), and secukinumab (15%). A smaller proportion of patients were taking infliximab, golimumab, or certolizumab pegol.

The mean baseline PASI was 16.5, although the range was wide (4-54). At the time of review, the average biologic treatment duration was 44 months. Almost half of the cohort (128) were on their second biologic, and 20 more had been on three biologics. A few patients were taking concomitant medications, including steroids, cyclosporine, and acitretin.

The mean PASI scores decreased to 3.7 at week 16, 1.6 at week 28, and 1.2 at week 52. The group exhibited a rapid response to biologic treatment. By 16 weeks, about 55% had achieved a PASI 75, about 28% a PASI 90, and about 20% a PASI 100. By 28 weeks, these numbers were about 64%, 45%, and 35%, respectively. At 1 year, they were about 65%, 50%, and 40%, respectively.

The rate of adverse events was 9.4%. There were 25 events in the cohort, the majority of which (48%) were infections; these included four respiratory infections, three urinary tract infections, two cases of mucocutaneous candidiasis, two cases of herpes zoster infection, and one case of erysipelas.

There were four malignancies: three nonmelanoma skin cancers and one vocal cord cancer.

Noting that, to date, their study represented “the broadest experience on the use of biological drugs” for elderly patients with psoriasis, they wrote that while “comorbidities should be taken into consideration when a long-term treatment is proposed, for the higher risk of side effects and drug interactions,” they wrote, noting that none of the 266 patients had a serious infection and the malignancy rate was low (1.5%).

None of the authors had financial disclosures, and the study had no funding source.

[email protected]

SOURCE: Ricceri F et al. J Eur Acad Dermatol Venereol. 2018 Jun 15. doi: 10.1111/jdv.15139.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Human parvovirus B19 can sometimes cause the appearance of multiple bullae alone, a pattern not typically seen with parvovirus B19 infections, reported Shoko Yoshii, MD, and his associates at the National Center for Child Health and Development in Tokyo.

In a case study, a 2-year-old boy was admitted to an ED with swelling of both lower limbs. In the 2 weeks previous, he had had a fever that lasted 3 days followed by erythema on the cheeks and limbs. A physical examination reveled edematous erythema on his lower limbs with a predominance of them on the left leg. Doctors analyzed his laboratory results and found that the boy’s white blood cell count was in the normal range, with C-reactive protein level of 3.2 mg/L. The boy was treated with cefazolin for suspected bacterial cellulitis, but this did little; erythema and edema progressed on the left leg and multiple bullae developed 2 days after admission. Within a week, the bullae spontaneously ruptured and resolved.

Parvovirus B19 infection was suspected, and parvovirus B19 IgM was positive on the first day of admission. The boy ultimately recovered and has had no further episodes within 1 year of follow-up.Bullae or vesicles are considered rare manifestations of parvovirus B19 infection, which more typically presents with a “slapped-cheek” appearance and lacy exanthema, sometimes called erythema infectiosum. In adults with parvovirus infection, bullae or vesicles develop at the same time as papular purpuric gloves-and-socks syndrome.

This case did not follow this pattern, with lesions appearing on the lower legs with no involvement of the hands or feet. The few cases of parvovirus infection that have been reported with bulbous skin lesions in children generally were not associated with papular purpuric gloves-and-socks syndrome, which is widely considered a textbook manifestation of parvovirus infection, the authors wrote.

This case study was supported by a grant from National Center for Child Health and Development. No disclosures were reported.

[email protected]

SOURCE: Yoshii S et al. J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.05.038.

Human parvovirus B19 can sometimes cause the appearance of multiple bullae alone, a pattern not typically seen with parvovirus B19 infections, reported Shoko Yoshii, MD, and his associates at the National Center for Child Health and Development in Tokyo.

In a case study, a 2-year-old boy was admitted to an ED with swelling of both lower limbs. In the 2 weeks previous, he had had a fever that lasted 3 days followed by erythema on the cheeks and limbs. A physical examination reveled edematous erythema on his lower limbs with a predominance of them on the left leg. Doctors analyzed his laboratory results and found that the boy’s white blood cell count was in the normal range, with C-reactive protein level of 3.2 mg/L. The boy was treated with cefazolin for suspected bacterial cellulitis, but this did little; erythema and edema progressed on the left leg and multiple bullae developed 2 days after admission. Within a week, the bullae spontaneously ruptured and resolved.

Parvovirus B19 infection was suspected, and parvovirus B19 IgM was positive on the first day of admission. The boy ultimately recovered and has had no further episodes within 1 year of follow-up.Bullae or vesicles are considered rare manifestations of parvovirus B19 infection, which more typically presents with a “slapped-cheek” appearance and lacy exanthema, sometimes called erythema infectiosum. In adults with parvovirus infection, bullae or vesicles develop at the same time as papular purpuric gloves-and-socks syndrome.

This case did not follow this pattern, with lesions appearing on the lower legs with no involvement of the hands or feet. The few cases of parvovirus infection that have been reported with bulbous skin lesions in children generally were not associated with papular purpuric gloves-and-socks syndrome, which is widely considered a textbook manifestation of parvovirus infection, the authors wrote.

This case study was supported by a grant from National Center for Child Health and Development. No disclosures were reported.

[email protected]

SOURCE: Yoshii S et al. J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.05.038.

Human parvovirus B19 can sometimes cause the appearance of multiple bullae alone, a pattern not typically seen with parvovirus B19 infections, reported Shoko Yoshii, MD, and his associates at the National Center for Child Health and Development in Tokyo.

In a case study, a 2-year-old boy was admitted to an ED with swelling of both lower limbs. In the 2 weeks previous, he had had a fever that lasted 3 days followed by erythema on the cheeks and limbs. A physical examination reveled edematous erythema on his lower limbs with a predominance of them on the left leg. Doctors analyzed his laboratory results and found that the boy’s white blood cell count was in the normal range, with C-reactive protein level of 3.2 mg/L. The boy was treated with cefazolin for suspected bacterial cellulitis, but this did little; erythema and edema progressed on the left leg and multiple bullae developed 2 days after admission. Within a week, the bullae spontaneously ruptured and resolved.

Parvovirus B19 infection was suspected, and parvovirus B19 IgM was positive on the first day of admission. The boy ultimately recovered and has had no further episodes within 1 year of follow-up.Bullae or vesicles are considered rare manifestations of parvovirus B19 infection, which more typically presents with a “slapped-cheek” appearance and lacy exanthema, sometimes called erythema infectiosum. In adults with parvovirus infection, bullae or vesicles develop at the same time as papular purpuric gloves-and-socks syndrome.

This case did not follow this pattern, with lesions appearing on the lower legs with no involvement of the hands or feet. The few cases of parvovirus infection that have been reported with bulbous skin lesions in children generally were not associated with papular purpuric gloves-and-socks syndrome, which is widely considered a textbook manifestation of parvovirus infection, the authors wrote.

This case study was supported by a grant from National Center for Child Health and Development. No disclosures were reported.

[email protected]

SOURCE: Yoshii S et al. J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.05.038.

ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.

M. Alexander Otto/MDedge News

“Now we have two trials that are definitively negative for TNF inhibitors” reducing aortic inflammation, a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.

The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).

Both studies used positron emission tomography/computed tomography to assess vascular inflammation.

“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).

Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.

In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”

Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.

Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.

At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.

Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.

About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.

[email protected]

SOURCE: Gelfand JM et al. IID 2018, Abstract 393.

ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.

M. Alexander Otto/MDedge News

“Now we have two trials that are definitively negative for TNF inhibitors” reducing aortic inflammation, a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.

The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).

Both studies used positron emission tomography/computed tomography to assess vascular inflammation.

“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).

Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.

In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”

Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.

Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.

At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.

Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.

About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.

[email protected]

SOURCE: Gelfand JM et al. IID 2018, Abstract 393.

ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.

M. Alexander Otto/MDedge News

“Now we have two trials that are definitively negative for TNF inhibitors” reducing aortic inflammation, a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.

The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).

Both studies used positron emission tomography/computed tomography to assess vascular inflammation.

“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).

Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.

In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”

Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.

Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.

At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.

Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.

About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.

[email protected]

SOURCE: Gelfand JM et al. IID 2018, Abstract 393.