Psoriasis

Topical medication is a mainstay in the treatment of dermatologic conditions. Adherence to medication regimens can be challenging in patients requiring long-term topical treatment, and nonadherence is multifactorial. A major modifiable contributing factor is patient dissatisfaction with the vehicle used. Medications often have options for different topical preparations. Therefore, it is important to consider patient preference when prescribing topical treatments to maximize adherence, ensure patient satisfaction, and optimize outcomes.

We hypothesized that notable differences exist among demographic groups regarding preference for topical vehicles. Little research has been conducted to delineate trends. This study aimed to identify variations in preference for creams, lotions, and ointments by age, gender, and ethnicity.

Methods

Data were collected through surveys distributed to all patients seen at the Truman Medical Center University Health Dermatology Clinic in Kansas City, Missouri, between September 2018 and June 2019. The study was approved by the University of Missouri Kansas City institutional review board. An estimated response rate of 95% was achieved. Each patient was informed that the survey was voluntary and anonymous, and declining to complete the survey had no effect on the care provided. Each patient completed only 1 survey and returned it to a collection box before departing from clinic.

In the survey, patients provided demographic information, including age, gender, and ethnicity. Age groups included patients younger than 40 years, 40 to 60 years, and older than 60 years. Gender groups included male and female. Ethnicity included white, black, Hispanic/Latino, and Asian/Pacific Islander or other. Patients then chose 1 of 3 options for topical vehicle preference: cream, lotion, or ointment. Each of these options was accompanied by a brief description of the vehicle, a photograph, and examples of common commercial products to aid in decision-making. The expected values were calculated based on a probability distribution under the assumption that variables have no association. Therefore, the discrepancy between the expected value and the observed value was used to describe the significance of the association between variables. 

Data were analyzed using χ² tests with the aid of a statistician. P<.05 was considered statistically significant.

Results

A total of 404 surveys were collected and recorded. Data showed statistically significant trends in each demographic parameter.

Age
First, we analyzed differences in preference based on age (Table 1). Of 404 patients, 163 were younger than 40 years, 171 were aged 40 to 60 years, and 70 were older than 60 years. Patients younger than 40 years preferred lotion (68 vs 46.0 expected). Patients aged 40 to 60 years showed preference for cream (83 vs 76.6 expected) and ointment (56 vs 46.1 expected). Patients older than 60 years preferred cream (41 vs 31.4 expected). These findings were statistically significant (P<.0001).

Comment

Topical medication is a mainstay of dermatologic therapy. Many topical preparations (or vehicles) exist, including ointments, creams, lotions, gels, solutions, and foams. Vehicle type not only influences bioavailability of the prepared medication but also has a notable impact on adherence and subsequent efficacy of the topical therapy.

Medication adherence is especially challenging in dermatology, as topical medications play a central role in treatment. Compliance with the medication regimen is paramount in treatment efficacy.¹ In dermatology, adherence with oral medications is higher than it is for topical medications²; various factors contribute to this difference. Compliance may decline with topical treatment due to time-consuming application, misunderstanding about the disease or the treatment regimen, frequency of administration, dissatisfaction with efficacy or appearance, and other variables.³

Other factors have been found to be important to topical medication adherence; younger age, female gender, marriage, employment, nonsmoking, nondrinking, and higher cognitive ability were associated with higher topical medication adherence.⁴ Our study focused on one factor: identification of demographic-specific preferences that might have implications on adherence within the studied demographic groups.

It is known that individual preferences exist when patients are choosing a topical preparation. However, a PubMed search of articles indexed for MEDLINE using the terms topical, vehicle, preparation, adherence, and preference revealed few studies that examined the preference for topical vehicle by age, gender, or ethnicity.

Existing studies have examined preferences for topical preparations based on specific disease states; this literature, albeit limited, demonstrates that preferences for topical product formulations vary among acne, atopic dermatitis, and plaque psoriasis patients.⁵ Other studies focus on specific patient populations or medications. For example, one study found that preference for corticosteroid vehicles among psoriasis patients was highly variable and choice of vehicle was critical to adherence.⁶ Another study highlighted differences in vehicle choice between younger and older age groups with psoriasis.⁷

Given the limited data overall, it was our goal to determine if any patterns of preference existed by age, gender, or ethnicity, regardless of disease state or indication for topical product. Importantly, over-the-counter products—cosmetic or otherwise—were not differentiated from prescribed topical medications. Our survey elucidated significant differences in preference by age, gender, and ethnicity.

Notable Findings
Regarding age, patients younger than 40 years preferred lotion, patients aged 40 to 60 years preferred cream, and patients older than 60 years preferred cream. Analysis based on gender showed that females preferred cream, and males preferred lotion and ointment. Analysis based on ethnicity most notably demonstrated a strong preference for ointment in black patients while showing preference for cream in white patients.

Potential Biases and Pitfalls
Limitations of this study included the small Hispanic/Latino and Asian/Pacific Islander populations surveyed, possible misunderstanding of the survey by respondents, and the potential for surveys being filled out twice by the same patient. Future surveys could be conducted over a longer period to increase the total sample size and to better characterize less-represented populations, such as Hispanic and Asian patients. To avoid repeat participation, the first question of the survey asked patients to indicate if they had previously completed the survey and instructed patients who had to return the repeat survey to the front desk.

To limit other errors, our survey included concise accessible descriptions of each preparation along with clear representative photographs and examples of common brands. Still, it is possible that some mistakes could have been made while patients filled out the survey based on comprehension deficits, oversight, or other reasons. It also is possible that preference might vary individually depending on the indication of the topical product—cosmetic or therapeutic—or even by anatomic site of application. Neither of these considerations was assessed specifically in our survey.

Conclusion

Our hope is that this study helps practitioners better anticipate topical preferences among patients with the ultimate goal of increasing medication adherence and patient outcomes. Nevertheless, although these general trends can provide helpful guidance, we acknowledge that individual preferences vary, and care should always be patient centered.

Acknowledgment
We thank An-Lin Cheng, PhD (Kansas City, Missouri), for assistance with the statistical analysis.

Topical medication is a mainstay in the treatment of dermatologic conditions. Adherence to medication regimens can be challenging in patients requiring long-term topical treatment, and nonadherence is multifactorial. A major modifiable contributing factor is patient dissatisfaction with the vehicle used. Medications often have options for different topical preparations. Therefore, it is important to consider patient preference when prescribing topical treatments to maximize adherence, ensure patient satisfaction, and optimize outcomes.

We hypothesized that notable differences exist among demographic groups regarding preference for topical vehicles. Little research has been conducted to delineate trends. This study aimed to identify variations in preference for creams, lotions, and ointments by age, gender, and ethnicity.

Methods

Data were collected through surveys distributed to all patients seen at the Truman Medical Center University Health Dermatology Clinic in Kansas City, Missouri, between September 2018 and June 2019. The study was approved by the University of Missouri Kansas City institutional review board. An estimated response rate of 95% was achieved. Each patient was informed that the survey was voluntary and anonymous, and declining to complete the survey had no effect on the care provided. Each patient completed only 1 survey and returned it to a collection box before departing from clinic.

In the survey, patients provided demographic information, including age, gender, and ethnicity. Age groups included patients younger than 40 years, 40 to 60 years, and older than 60 years. Gender groups included male and female. Ethnicity included white, black, Hispanic/Latino, and Asian/Pacific Islander or other. Patients then chose 1 of 3 options for topical vehicle preference: cream, lotion, or ointment. Each of these options was accompanied by a brief description of the vehicle, a photograph, and examples of common commercial products to aid in decision-making. The expected values were calculated based on a probability distribution under the assumption that variables have no association. Therefore, the discrepancy between the expected value and the observed value was used to describe the significance of the association between variables. 

Data were analyzed using χ² tests with the aid of a statistician. P<.05 was considered statistically significant.

Results

A total of 404 surveys were collected and recorded. Data showed statistically significant trends in each demographic parameter.

Age
First, we analyzed differences in preference based on age (Table 1). Of 404 patients, 163 were younger than 40 years, 171 were aged 40 to 60 years, and 70 were older than 60 years. Patients younger than 40 years preferred lotion (68 vs 46.0 expected). Patients aged 40 to 60 years showed preference for cream (83 vs 76.6 expected) and ointment (56 vs 46.1 expected). Patients older than 60 years preferred cream (41 vs 31.4 expected). These findings were statistically significant (P<.0001).

Comment

Topical medication is a mainstay of dermatologic therapy. Many topical preparations (or vehicles) exist, including ointments, creams, lotions, gels, solutions, and foams. Vehicle type not only influences bioavailability of the prepared medication but also has a notable impact on adherence and subsequent efficacy of the topical therapy.

Medication adherence is especially challenging in dermatology, as topical medications play a central role in treatment. Compliance with the medication regimen is paramount in treatment efficacy.¹ In dermatology, adherence with oral medications is higher than it is for topical medications²; various factors contribute to this difference. Compliance may decline with topical treatment due to time-consuming application, misunderstanding about the disease or the treatment regimen, frequency of administration, dissatisfaction with efficacy or appearance, and other variables.³

Other factors have been found to be important to topical medication adherence; younger age, female gender, marriage, employment, nonsmoking, nondrinking, and higher cognitive ability were associated with higher topical medication adherence.⁴ Our study focused on one factor: identification of demographic-specific preferences that might have implications on adherence within the studied demographic groups.

It is known that individual preferences exist when patients are choosing a topical preparation. However, a PubMed search of articles indexed for MEDLINE using the terms topical, vehicle, preparation, adherence, and preference revealed few studies that examined the preference for topical vehicle by age, gender, or ethnicity.

Existing studies have examined preferences for topical preparations based on specific disease states; this literature, albeit limited, demonstrates that preferences for topical product formulations vary among acne, atopic dermatitis, and plaque psoriasis patients.⁵ Other studies focus on specific patient populations or medications. For example, one study found that preference for corticosteroid vehicles among psoriasis patients was highly variable and choice of vehicle was critical to adherence.⁶ Another study highlighted differences in vehicle choice between younger and older age groups with psoriasis.⁷

Given the limited data overall, it was our goal to determine if any patterns of preference existed by age, gender, or ethnicity, regardless of disease state or indication for topical product. Importantly, over-the-counter products—cosmetic or otherwise—were not differentiated from prescribed topical medications. Our survey elucidated significant differences in preference by age, gender, and ethnicity.

Notable Findings
Regarding age, patients younger than 40 years preferred lotion, patients aged 40 to 60 years preferred cream, and patients older than 60 years preferred cream. Analysis based on gender showed that females preferred cream, and males preferred lotion and ointment. Analysis based on ethnicity most notably demonstrated a strong preference for ointment in black patients while showing preference for cream in white patients.

Potential Biases and Pitfalls
Limitations of this study included the small Hispanic/Latino and Asian/Pacific Islander populations surveyed, possible misunderstanding of the survey by respondents, and the potential for surveys being filled out twice by the same patient. Future surveys could be conducted over a longer period to increase the total sample size and to better characterize less-represented populations, such as Hispanic and Asian patients. To avoid repeat participation, the first question of the survey asked patients to indicate if they had previously completed the survey and instructed patients who had to return the repeat survey to the front desk.

To limit other errors, our survey included concise accessible descriptions of each preparation along with clear representative photographs and examples of common brands. Still, it is possible that some mistakes could have been made while patients filled out the survey based on comprehension deficits, oversight, or other reasons. It also is possible that preference might vary individually depending on the indication of the topical product—cosmetic or therapeutic—or even by anatomic site of application. Neither of these considerations was assessed specifically in our survey.

Conclusion

Our hope is that this study helps practitioners better anticipate topical preferences among patients with the ultimate goal of increasing medication adherence and patient outcomes. Nevertheless, although these general trends can provide helpful guidance, we acknowledge that individual preferences vary, and care should always be patient centered.

Acknowledgment
We thank An-Lin Cheng, PhD (Kansas City, Missouri), for assistance with the statistical analysis.

Topical medication is a mainstay in the treatment of dermatologic conditions. Adherence to medication regimens can be challenging in patients requiring long-term topical treatment, and nonadherence is multifactorial. A major modifiable contributing factor is patient dissatisfaction with the vehicle used. Medications often have options for different topical preparations. Therefore, it is important to consider patient preference when prescribing topical treatments to maximize adherence, ensure patient satisfaction, and optimize outcomes.

We hypothesized that notable differences exist among demographic groups regarding preference for topical vehicles. Little research has been conducted to delineate trends. This study aimed to identify variations in preference for creams, lotions, and ointments by age, gender, and ethnicity.

Methods

Data were collected through surveys distributed to all patients seen at the Truman Medical Center University Health Dermatology Clinic in Kansas City, Missouri, between September 2018 and June 2019. The study was approved by the University of Missouri Kansas City institutional review board. An estimated response rate of 95% was achieved. Each patient was informed that the survey was voluntary and anonymous, and declining to complete the survey had no effect on the care provided. Each patient completed only 1 survey and returned it to a collection box before departing from clinic.

In the survey, patients provided demographic information, including age, gender, and ethnicity. Age groups included patients younger than 40 years, 40 to 60 years, and older than 60 years. Gender groups included male and female. Ethnicity included white, black, Hispanic/Latino, and Asian/Pacific Islander or other. Patients then chose 1 of 3 options for topical vehicle preference: cream, lotion, or ointment. Each of these options was accompanied by a brief description of the vehicle, a photograph, and examples of common commercial products to aid in decision-making. The expected values were calculated based on a probability distribution under the assumption that variables have no association. Therefore, the discrepancy between the expected value and the observed value was used to describe the significance of the association between variables. 

Data were analyzed using χ² tests with the aid of a statistician. P<.05 was considered statistically significant.

Results

A total of 404 surveys were collected and recorded. Data showed statistically significant trends in each demographic parameter.

Age
First, we analyzed differences in preference based on age (Table 1). Of 404 patients, 163 were younger than 40 years, 171 were aged 40 to 60 years, and 70 were older than 60 years. Patients younger than 40 years preferred lotion (68 vs 46.0 expected). Patients aged 40 to 60 years showed preference for cream (83 vs 76.6 expected) and ointment (56 vs 46.1 expected). Patients older than 60 years preferred cream (41 vs 31.4 expected). These findings were statistically significant (P<.0001).

Comment

Topical medication is a mainstay of dermatologic therapy. Many topical preparations (or vehicles) exist, including ointments, creams, lotions, gels, solutions, and foams. Vehicle type not only influences bioavailability of the prepared medication but also has a notable impact on adherence and subsequent efficacy of the topical therapy.

Medication adherence is especially challenging in dermatology, as topical medications play a central role in treatment. Compliance with the medication regimen is paramount in treatment efficacy.¹ In dermatology, adherence with oral medications is higher than it is for topical medications²; various factors contribute to this difference. Compliance may decline with topical treatment due to time-consuming application, misunderstanding about the disease or the treatment regimen, frequency of administration, dissatisfaction with efficacy or appearance, and other variables.³

Other factors have been found to be important to topical medication adherence; younger age, female gender, marriage, employment, nonsmoking, nondrinking, and higher cognitive ability were associated with higher topical medication adherence.⁴ Our study focused on one factor: identification of demographic-specific preferences that might have implications on adherence within the studied demographic groups.

It is known that individual preferences exist when patients are choosing a topical preparation. However, a PubMed search of articles indexed for MEDLINE using the terms topical, vehicle, preparation, adherence, and preference revealed few studies that examined the preference for topical vehicle by age, gender, or ethnicity.

Existing studies have examined preferences for topical preparations based on specific disease states; this literature, albeit limited, demonstrates that preferences for topical product formulations vary among acne, atopic dermatitis, and plaque psoriasis patients.⁵ Other studies focus on specific patient populations or medications. For example, one study found that preference for corticosteroid vehicles among psoriasis patients was highly variable and choice of vehicle was critical to adherence.⁶ Another study highlighted differences in vehicle choice between younger and older age groups with psoriasis.⁷

Given the limited data overall, it was our goal to determine if any patterns of preference existed by age, gender, or ethnicity, regardless of disease state or indication for topical product. Importantly, over-the-counter products—cosmetic or otherwise—were not differentiated from prescribed topical medications. Our survey elucidated significant differences in preference by age, gender, and ethnicity.

Notable Findings
Regarding age, patients younger than 40 years preferred lotion, patients aged 40 to 60 years preferred cream, and patients older than 60 years preferred cream. Analysis based on gender showed that females preferred cream, and males preferred lotion and ointment. Analysis based on ethnicity most notably demonstrated a strong preference for ointment in black patients while showing preference for cream in white patients.

Potential Biases and Pitfalls
Limitations of this study included the small Hispanic/Latino and Asian/Pacific Islander populations surveyed, possible misunderstanding of the survey by respondents, and the potential for surveys being filled out twice by the same patient. Future surveys could be conducted over a longer period to increase the total sample size and to better characterize less-represented populations, such as Hispanic and Asian patients. To avoid repeat participation, the first question of the survey asked patients to indicate if they had previously completed the survey and instructed patients who had to return the repeat survey to the front desk.

To limit other errors, our survey included concise accessible descriptions of each preparation along with clear representative photographs and examples of common brands. Still, it is possible that some mistakes could have been made while patients filled out the survey based on comprehension deficits, oversight, or other reasons. It also is possible that preference might vary individually depending on the indication of the topical product—cosmetic or therapeutic—or even by anatomic site of application. Neither of these considerations was assessed specifically in our survey.

Conclusion

Our hope is that this study helps practitioners better anticipate topical preferences among patients with the ultimate goal of increasing medication adherence and patient outcomes. Nevertheless, although these general trends can provide helpful guidance, we acknowledge that individual preferences vary, and care should always be patient centered.

Acknowledgment
We thank An-Lin Cheng, PhD (Kansas City, Missouri), for assistance with the statistical analysis.

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

[email protected]

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

[email protected]

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

[email protected]

The interleukin (IL)-23 inhibitor risankizumab was decisively more effective than the IL-17A inhibitor secukinumab at 52 weeks in a multinational randomized head-to-head trial in patients with moderate to severe psoriasis.

Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.

In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.

The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.

The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.

The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.

Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.

He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.

[email protected]

The interleukin (IL)-23 inhibitor risankizumab was decisively more effective than the IL-17A inhibitor secukinumab at 52 weeks in a multinational randomized head-to-head trial in patients with moderate to severe psoriasis.

Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.

In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.

The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.

The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.

The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.

Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.

He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.

[email protected]

The interleukin (IL)-23 inhibitor risankizumab was decisively more effective than the IL-17A inhibitor secukinumab at 52 weeks in a multinational randomized head-to-head trial in patients with moderate to severe psoriasis.

Risankizumab was better tolerated, with a significantly lower rate of treatment-emergent adverse events and a lower study dropout rate, Richard B. Warren, MBChB, PhD, reported at the virtual annual meeting of the American Academy of Dermatology.

In addition, the dosing schedule for risankizumab (Skyrizi) is more convenient, with maintenance dosing by subcutaneous injection once every 12 weeks, compared with monthly for secukinumab (Cosentyx), a biologic for psoriasis considered state-of-the-art not long ago, noted Dr. Warren, a dermatologist at the Salford (England) Royal NHS Foundation Trust and the Manchester NIHR Biomedical Research Center as well as professor of dermatology at the University of Manchester.

The phase 3 IMMERGE trial included 327 patients with moderate to severe psoriasis randomized to risankizumab or secukinumab for 52 weeks at their approved dosing. The trial, conducted mainly in the United States, Canada, and Europe, was open label, but evaluator blinded.

The coprimary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index scores (PASI 90) at weeks 16 and 52. The week 52 PASI 90 response rates were 87% in the risankizumab group and 57% with secukinumab, for a highly significant absolute 30% difference. The week 16 result was a prespecified noninferiority analysis, and here again risankizumab met its mark, with a PASI 90 rate of 74%, statistically noninferior to the 66% rate with secukinumab, even though at that point patients had received only two doses of risankizumab, versus seven doses of secukinumab.

The PASI 100 response rate at 52 weeks, a key secondary endpoint, was 66% with risankizumab and 40% with secukinumab. Another secondary endpoint was achievement of a static Physician Global Assessment score of 0 or 1 – clear or almost clear – at week 52; the rates were 88% with risankizumab, 58% with secukinumab.

Ninety-two percent of participants randomized to risankizumab completed the full 52-week study, as did 82.8% of the secukinumab group. The nearly 10% absolute lower completion rate in the secukinumab group was driven by a higher rate of lack of efficacy – 4.3%, compared to 0.6% for risankizumab – and a greater incidence of adverse events. Indeed, treatment-emergent adverse events were fourfold more common in the secukinumab arm, with a rate of 4.9%, versus 1.2% with risankizumab, according to Dr. Warren.

He reported receiving research grants from and serving as a consultant to the study sponsor, AbbVie, as well as roughly a dozen other pharmaceutical companies.

[email protected]

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

[email protected]

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

[email protected]

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

[email protected]

Here are the stories our MDedge editors across specialties think you need to know about today:

It’s official: COVID-19 is bad for your health care business

For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.

Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.

“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.

 

FDA revokes emergency use of hydroxychloroquine

The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.

"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.

Secondary infections common in COVID-19, implications unclear

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."

An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.

Automated insulin delivery system ‘getting better and better’

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest. 

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. 

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.

Access more top news from the ADA virtual meeting.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

It’s official: COVID-19 is bad for your health care business

For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.

Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.

“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.

 

FDA revokes emergency use of hydroxychloroquine

The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.

"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.

Secondary infections common in COVID-19, implications unclear

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."

An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.

Automated insulin delivery system ‘getting better and better’

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest. 

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. 

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.

Access more top news from the ADA virtual meeting.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

It’s official: COVID-19 is bad for your health care business

For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.

Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.

“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.

 

FDA revokes emergency use of hydroxychloroquine

The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.

"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.

Secondary infections common in COVID-19, implications unclear

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."

An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.

Automated insulin delivery system ‘getting better and better’

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest. 

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. 

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.

Access more top news from the ADA virtual meeting.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Results from two late-breaking phase 3 trials of bimekizumab, an investigational interleukin-17A and IL-17F inhibitor, showed that most patients with moderate to severe psoriasis achieved clearance at week 16 and maintained their clinical response at 1 year.

“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.

Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)

The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.

At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).

“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”

In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.

The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.

“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”

As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.

“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”

Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..

[email protected]

Results from two late-breaking phase 3 trials of bimekizumab, an investigational interleukin-17A and IL-17F inhibitor, showed that most patients with moderate to severe psoriasis achieved clearance at week 16 and maintained their clinical response at 1 year.

“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.

Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)

The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.

At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).

“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”

In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.

The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.

“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”

As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.

“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”

Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..

[email protected]

Results from two late-breaking phase 3 trials of bimekizumab, an investigational interleukin-17A and IL-17F inhibitor, showed that most patients with moderate to severe psoriasis achieved clearance at week 16 and maintained their clinical response at 1 year.

“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.

Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)

The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.

At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).

“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”

In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.

The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.

“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”

As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.

“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”

Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..

[email protected]

The risk of melanoma was increased among patients taking biologics for immune-mediated inflammatory diseases, compared with biologic-naive patients on conventional systemic therapy, but the association was not statistically significant in a systematic review and meta-analysis published in JAMA Dermatology.

The studies included in the analysis, however, had limitations, including a lack of those comparing biologic and conventional systemic therapy in psoriasis and inflammatory bowel disease (IBD), according to Shamarke Esse, MRes, of the division of musculoskeletal and dermatological sciences at the University of Manchester (England) and colleagues. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty” regarding this association, they wrote.

Previous studies that have found an increased risk of melanoma in patients on biologics for psoriasis, rheumatoid arthritis, and IBD have “typically used the general population as the comparator,” they noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. Moreover, they added, “melanoma is a highly immunogenic skin cancer and therefore of concern to patients treated with TNFIs [tumor necrosis factor inhibitors] because melanoma risk increases with suppression of the immune system and TNF-alpha plays an important role in the immune surveillance of tumors.12,13

In their review, the researchers identified seven cohort studies from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases published between January 1995 and February 2019 that evaluated melanoma risk in about 34,000 patients receiving biologics and 135,370 patients who had never been treated with biologics, and were receiving conventional systemic therapy for psoriasis, RA, or IBD. Of these, four studies were in patients with RA, two studies were in patients with IBD, and a single study was in patients with psoriasis. Six studies examined patients taking TNF inhibitors, but only one of six studies had information on specific TNF inhibitors (adalimumab, etanercept, and infliximab) in patients with RA. One study evaluated abatacept and rituximab in RA patients.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57; 95% confidence interval, 0.61-4.09), RA (pooled relative risk, 1.20; 95% CI, 0.83-1.74), and IBD (pRR, 1.20; 95% CI, 0.60-2.40).

Among RA patients who received TNF inhibitors only, there was a slightly elevated nonsignificant risk of melanoma (pRR, 1.08; 95% CI, 0.81-1.43). Patients receiving rituximab had a pRR of 0.73 (95% CI, 0.38-1.39), and patients taking abatacept had a pRR of 1.43 (95% CI, 0.66-3.09), compared with RA patients receiving conventional systemic therapy. When excluding two major studies in the RA subgroup of patients in a sensitivity analysis, pooled risk estimates varied from 0.91 (95% CI, 0.69-1.18) to 1.95 (95% CI, 1.16- 3.30). There were no significant between-study heterogeneity or publication bias among the IBD and RA studies.

Mr. Esse and colleagues acknowledged the small number of IBD and psoriasis studies in the meta-analysis, which could affect pooled risk estimates. “Any future update of our study through the inclusion of newly published studies may produce significantly different pooled risk estimates than those reported in our meta-analysis,” they said. In addition, the use of health insurance databases, lack of risk factors for melanoma, and inconsistent information about treatment duration for patients receiving conventional systemic therapy were also limitations.

“Prospective cohort studies using an active comparator, new-user study design providing detailed information on treatment history, concomitant treatments, biologic and conventional systemic treatment duration, recreational and treatment-related UV exposure, skin color, and date of melanoma diagnosis are required to help improve certainty. These studies would also need to account for key risk factors and the latency period of melanoma,” the researchers said.

Mr. Esse disclosed being funded by a PhD studentship from the Psoriasis Association. One author disclosed receiving personal fees from Janssen, LEO Pharma, Lilly, and Novartis outside the study; another disclosed receiving grants and personal fees from those and several other pharmaceutical companies during the study, and personal fees from several pharmaceutical companies outside of the submitted work; the fourth author had no disclosures.

SOURCE: Esse S et al. JAMA Dermatol. 2020 May 20;e201300.

The risk of melanoma was increased among patients taking biologics for immune-mediated inflammatory diseases, compared with biologic-naive patients on conventional systemic therapy, but the association was not statistically significant in a systematic review and meta-analysis published in JAMA Dermatology.

The studies included in the analysis, however, had limitations, including a lack of those comparing biologic and conventional systemic therapy in psoriasis and inflammatory bowel disease (IBD), according to Shamarke Esse, MRes, of the division of musculoskeletal and dermatological sciences at the University of Manchester (England) and colleagues. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty” regarding this association, they wrote.

Previous studies that have found an increased risk of melanoma in patients on biologics for psoriasis, rheumatoid arthritis, and IBD have “typically used the general population as the comparator,” they noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. Moreover, they added, “melanoma is a highly immunogenic skin cancer and therefore of concern to patients treated with TNFIs [tumor necrosis factor inhibitors] because melanoma risk increases with suppression of the immune system and TNF-alpha plays an important role in the immune surveillance of tumors.12,13

In their review, the researchers identified seven cohort studies from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases published between January 1995 and February 2019 that evaluated melanoma risk in about 34,000 patients receiving biologics and 135,370 patients who had never been treated with biologics, and were receiving conventional systemic therapy for psoriasis, RA, or IBD. Of these, four studies were in patients with RA, two studies were in patients with IBD, and a single study was in patients with psoriasis. Six studies examined patients taking TNF inhibitors, but only one of six studies had information on specific TNF inhibitors (adalimumab, etanercept, and infliximab) in patients with RA. One study evaluated abatacept and rituximab in RA patients.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57; 95% confidence interval, 0.61-4.09), RA (pooled relative risk, 1.20; 95% CI, 0.83-1.74), and IBD (pRR, 1.20; 95% CI, 0.60-2.40).

Among RA patients who received TNF inhibitors only, there was a slightly elevated nonsignificant risk of melanoma (pRR, 1.08; 95% CI, 0.81-1.43). Patients receiving rituximab had a pRR of 0.73 (95% CI, 0.38-1.39), and patients taking abatacept had a pRR of 1.43 (95% CI, 0.66-3.09), compared with RA patients receiving conventional systemic therapy. When excluding two major studies in the RA subgroup of patients in a sensitivity analysis, pooled risk estimates varied from 0.91 (95% CI, 0.69-1.18) to 1.95 (95% CI, 1.16- 3.30). There were no significant between-study heterogeneity or publication bias among the IBD and RA studies.

Mr. Esse and colleagues acknowledged the small number of IBD and psoriasis studies in the meta-analysis, which could affect pooled risk estimates. “Any future update of our study through the inclusion of newly published studies may produce significantly different pooled risk estimates than those reported in our meta-analysis,” they said. In addition, the use of health insurance databases, lack of risk factors for melanoma, and inconsistent information about treatment duration for patients receiving conventional systemic therapy were also limitations.

“Prospective cohort studies using an active comparator, new-user study design providing detailed information on treatment history, concomitant treatments, biologic and conventional systemic treatment duration, recreational and treatment-related UV exposure, skin color, and date of melanoma diagnosis are required to help improve certainty. These studies would also need to account for key risk factors and the latency period of melanoma,” the researchers said.

Mr. Esse disclosed being funded by a PhD studentship from the Psoriasis Association. One author disclosed receiving personal fees from Janssen, LEO Pharma, Lilly, and Novartis outside the study; another disclosed receiving grants and personal fees from those and several other pharmaceutical companies during the study, and personal fees from several pharmaceutical companies outside of the submitted work; the fourth author had no disclosures.

SOURCE: Esse S et al. JAMA Dermatol. 2020 May 20;e201300.

The risk of melanoma was increased among patients taking biologics for immune-mediated inflammatory diseases, compared with biologic-naive patients on conventional systemic therapy, but the association was not statistically significant in a systematic review and meta-analysis published in JAMA Dermatology.

The studies included in the analysis, however, had limitations, including a lack of those comparing biologic and conventional systemic therapy in psoriasis and inflammatory bowel disease (IBD), according to Shamarke Esse, MRes, of the division of musculoskeletal and dermatological sciences at the University of Manchester (England) and colleagues. “We advocate for more large, well-designed studies of this issue to be performed to help improve certainty” regarding this association, they wrote.

Previous studies that have found an increased risk of melanoma in patients on biologics for psoriasis, rheumatoid arthritis, and IBD have “typically used the general population as the comparator,” they noted. There is a large amount of evidence that has established short-term efficacy and safety of biologics, compared with conventional systemic treatments, but concerns about longer-term cancer risk associated with biologics remains a concern. Moreover, they added, “melanoma is a highly immunogenic skin cancer and therefore of concern to patients treated with TNFIs [tumor necrosis factor inhibitors] because melanoma risk increases with suppression of the immune system and TNF-alpha plays an important role in the immune surveillance of tumors.12,13

In their review, the researchers identified seven cohort studies from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases published between January 1995 and February 2019 that evaluated melanoma risk in about 34,000 patients receiving biologics and 135,370 patients who had never been treated with biologics, and were receiving conventional systemic therapy for psoriasis, RA, or IBD. Of these, four studies were in patients with RA, two studies were in patients with IBD, and a single study was in patients with psoriasis. Six studies examined patients taking TNF inhibitors, but only one of six studies had information on specific TNF inhibitors (adalimumab, etanercept, and infliximab) in patients with RA. One study evaluated abatacept and rituximab in RA patients.

The researchers analyzed the pooled relative risk across all studies. Compared with patients who received conventional systemic therapy, there was a nonsignificant association with risk of melanoma in patients with psoriasis (hazard ratio, 1.57; 95% confidence interval, 0.61-4.09), RA (pooled relative risk, 1.20; 95% CI, 0.83-1.74), and IBD (pRR, 1.20; 95% CI, 0.60-2.40).

Among RA patients who received TNF inhibitors only, there was a slightly elevated nonsignificant risk of melanoma (pRR, 1.08; 95% CI, 0.81-1.43). Patients receiving rituximab had a pRR of 0.73 (95% CI, 0.38-1.39), and patients taking abatacept had a pRR of 1.43 (95% CI, 0.66-3.09), compared with RA patients receiving conventional systemic therapy. When excluding two major studies in the RA subgroup of patients in a sensitivity analysis, pooled risk estimates varied from 0.91 (95% CI, 0.69-1.18) to 1.95 (95% CI, 1.16- 3.30). There were no significant between-study heterogeneity or publication bias among the IBD and RA studies.

Mr. Esse and colleagues acknowledged the small number of IBD and psoriasis studies in the meta-analysis, which could affect pooled risk estimates. “Any future update of our study through the inclusion of newly published studies may produce significantly different pooled risk estimates than those reported in our meta-analysis,” they said. In addition, the use of health insurance databases, lack of risk factors for melanoma, and inconsistent information about treatment duration for patients receiving conventional systemic therapy were also limitations.

“Prospective cohort studies using an active comparator, new-user study design providing detailed information on treatment history, concomitant treatments, biologic and conventional systemic treatment duration, recreational and treatment-related UV exposure, skin color, and date of melanoma diagnosis are required to help improve certainty. These studies would also need to account for key risk factors and the latency period of melanoma,” the researchers said.

Mr. Esse disclosed being funded by a PhD studentship from the Psoriasis Association. One author disclosed receiving personal fees from Janssen, LEO Pharma, Lilly, and Novartis outside the study; another disclosed receiving grants and personal fees from those and several other pharmaceutical companies during the study, and personal fees from several pharmaceutical companies outside of the submitted work; the fourth author had no disclosures.

SOURCE: Esse S et al. JAMA Dermatol. 2020 May 20;e201300.

Psoriasis Area and Severity Index (PASI 100) scores were reached by one in four patients after 6 months of therapy in a study that examined six different biologic treatments in biologic-naive and biologic-experienced patients.

The study was published in May in the Journal of the European Academy of Dermatology and Venereology.

High efficacy rates, which include PASI 100 scores, have been reported in randomized trials of biologics that include anti–interleukin (IL)–17A therapies (secukinumab and ixekizumab), anti–IL-17A–receptor therapies (brodalumab), and anti–IL-23 therapies (guselkumab and risankizumab), but information on rates in real-world cohorts has been limited. “Real-world evidence provided by registries is only beginning to emerge, and efficacy data have mostly been derived from clinical trials,” senior author Kristian Reich, MD, PhD, professor for translational research in inflammatory skin diseases at the Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf (Germany), said in an interview.

He and his coinvestigators conducted the PSO-BIO-REAL (Plaque Psoriasis Treated With Biologics in a Real World Setting) prospective trial in five countries, to evaluate the effectiveness of treatments in patients with moderate to severe plaque psoriasis over a year’s time following administration of a biologic therapy. Patients were 18 years of age or older and had either started a biologic for the first time (biologic-naive) or were transitioning to another biologic (biologic-experienced).

Among 846 participants, 32% were in the United States, followed by France (28%), Italy (22%), the United Kingdom (11%), and Germany (8%). Investigators estimated the proportion of patients achieving a PASI 100 (complete skin clearance) 6 months after starting a biologic as a primary objective, and as secondary objectives, PASI 100 scores at 1 year and PASI 100 maintenance from 6 to 12 months.

Nearly 200 patients withdrew during the course of the study, and 108 switched treatments. Therapies varied among patients: 61% received an anti–tumor necrosis factor agent such as etanercept, infliximab, adalimumab, or certolizumab pegol as an initial biologic treatment, 30% received an anti–IL-12/-23 agent (ustekinumab), and 9% received an anti-IL-17 agent (secukinumab). Additionally, 23% received a concomitant psoriasis medication.

PASI assessments were completed in 603 patients at 6 months, and 522 patients at 12 months. At 6 and 12 months respectively, 23% and 26% of the patients had achieved a PASI 100 score. Investigators noted that the rate of complete skin clearance declined as the number of baseline comorbidities and the number of prior biologics increased.

Biologic-experienced patients at study entry had lower PASI 100 response rates (about 20% at 6 and 12 months) than the biologic-naive patients (25% at 6 months, 30% at 12 months). Dr. Reich pointed out that many biologic-experienced patients often have active disease, despite previous use of biologics, and “they’re likely to represent a more difficult-to-treat population.” Factors such as convenience, safety, and the fact that more complicated patients – those with weight issues, more comorbidities and pretreatments, and lower compliance – are treated in real life than in clinical trials, are likely to influence lack of response in real-world data, Dr. Reich said.

The study’s enrollment period took place from 2014 to 2015, so it did not include patients on newer biologics such as brodalumab, guselkumab, ixekizumab, and tildrakizumab. “Some of these newer therapies have shown greater efficacy than drugs such as ustekinumab and etanercept in clinical trials, and patients are more likely to achieve complete skin clearance. Therefore, real-world rates of complete clearance may have improved since this study concluded,” the investigators pointed out.

Possible limitations of the study include selection bias and possible confounders, they noted.

The study was sponsored by Amgen/AstraZeneca; the manuscript was sponsored by LEO Pharma. One author was an AstraZeneca employee, two are LEO pharma employees, one author had no disclosures, and the remaining authors, including Dr. Reich, disclosed serving as an adviser, paid speaker, consultant, and/or investigator for multiple pharmaceutical companies.

SOURCE: Seneschal J et al. J Eur Acad Dermatol Venereol. 2020 May 4. doi: 10.1111/jdv.16568.

Psoriasis Area and Severity Index (PASI 100) scores were reached by one in four patients after 6 months of therapy in a study that examined six different biologic treatments in biologic-naive and biologic-experienced patients.

The study was published in May in the Journal of the European Academy of Dermatology and Venereology.

High efficacy rates, which include PASI 100 scores, have been reported in randomized trials of biologics that include anti–interleukin (IL)–17A therapies (secukinumab and ixekizumab), anti–IL-17A–receptor therapies (brodalumab), and anti–IL-23 therapies (guselkumab and risankizumab), but information on rates in real-world cohorts has been limited. “Real-world evidence provided by registries is only beginning to emerge, and efficacy data have mostly been derived from clinical trials,” senior author Kristian Reich, MD, PhD, professor for translational research in inflammatory skin diseases at the Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf (Germany), said in an interview.

He and his coinvestigators conducted the PSO-BIO-REAL (Plaque Psoriasis Treated With Biologics in a Real World Setting) prospective trial in five countries, to evaluate the effectiveness of treatments in patients with moderate to severe plaque psoriasis over a year’s time following administration of a biologic therapy. Patients were 18 years of age or older and had either started a biologic for the first time (biologic-naive) or were transitioning to another biologic (biologic-experienced).

Among 846 participants, 32% were in the United States, followed by France (28%), Italy (22%), the United Kingdom (11%), and Germany (8%). Investigators estimated the proportion of patients achieving a PASI 100 (complete skin clearance) 6 months after starting a biologic as a primary objective, and as secondary objectives, PASI 100 scores at 1 year and PASI 100 maintenance from 6 to 12 months.

Nearly 200 patients withdrew during the course of the study, and 108 switched treatments. Therapies varied among patients: 61% received an anti–tumor necrosis factor agent such as etanercept, infliximab, adalimumab, or certolizumab pegol as an initial biologic treatment, 30% received an anti–IL-12/-23 agent (ustekinumab), and 9% received an anti-IL-17 agent (secukinumab). Additionally, 23% received a concomitant psoriasis medication.

PASI assessments were completed in 603 patients at 6 months, and 522 patients at 12 months. At 6 and 12 months respectively, 23% and 26% of the patients had achieved a PASI 100 score. Investigators noted that the rate of complete skin clearance declined as the number of baseline comorbidities and the number of prior biologics increased.

Biologic-experienced patients at study entry had lower PASI 100 response rates (about 20% at 6 and 12 months) than the biologic-naive patients (25% at 6 months, 30% at 12 months). Dr. Reich pointed out that many biologic-experienced patients often have active disease, despite previous use of biologics, and “they’re likely to represent a more difficult-to-treat population.” Factors such as convenience, safety, and the fact that more complicated patients – those with weight issues, more comorbidities and pretreatments, and lower compliance – are treated in real life than in clinical trials, are likely to influence lack of response in real-world data, Dr. Reich said.

The study’s enrollment period took place from 2014 to 2015, so it did not include patients on newer biologics such as brodalumab, guselkumab, ixekizumab, and tildrakizumab. “Some of these newer therapies have shown greater efficacy than drugs such as ustekinumab and etanercept in clinical trials, and patients are more likely to achieve complete skin clearance. Therefore, real-world rates of complete clearance may have improved since this study concluded,” the investigators pointed out.

Possible limitations of the study include selection bias and possible confounders, they noted.

The study was sponsored by Amgen/AstraZeneca; the manuscript was sponsored by LEO Pharma. One author was an AstraZeneca employee, two are LEO pharma employees, one author had no disclosures, and the remaining authors, including Dr. Reich, disclosed serving as an adviser, paid speaker, consultant, and/or investigator for multiple pharmaceutical companies.

SOURCE: Seneschal J et al. J Eur Acad Dermatol Venereol. 2020 May 4. doi: 10.1111/jdv.16568.

Psoriasis Area and Severity Index (PASI 100) scores were reached by one in four patients after 6 months of therapy in a study that examined six different biologic treatments in biologic-naive and biologic-experienced patients.

The study was published in May in the Journal of the European Academy of Dermatology and Venereology.

High efficacy rates, which include PASI 100 scores, have been reported in randomized trials of biologics that include anti–interleukin (IL)–17A therapies (secukinumab and ixekizumab), anti–IL-17A–receptor therapies (brodalumab), and anti–IL-23 therapies (guselkumab and risankizumab), but information on rates in real-world cohorts has been limited. “Real-world evidence provided by registries is only beginning to emerge, and efficacy data have mostly been derived from clinical trials,” senior author Kristian Reich, MD, PhD, professor for translational research in inflammatory skin diseases at the Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf (Germany), said in an interview.

He and his coinvestigators conducted the PSO-BIO-REAL (Plaque Psoriasis Treated With Biologics in a Real World Setting) prospective trial in five countries, to evaluate the effectiveness of treatments in patients with moderate to severe plaque psoriasis over a year’s time following administration of a biologic therapy. Patients were 18 years of age or older and had either started a biologic for the first time (biologic-naive) or were transitioning to another biologic (biologic-experienced).

Among 846 participants, 32% were in the United States, followed by France (28%), Italy (22%), the United Kingdom (11%), and Germany (8%). Investigators estimated the proportion of patients achieving a PASI 100 (complete skin clearance) 6 months after starting a biologic as a primary objective, and as secondary objectives, PASI 100 scores at 1 year and PASI 100 maintenance from 6 to 12 months.

Nearly 200 patients withdrew during the course of the study, and 108 switched treatments. Therapies varied among patients: 61% received an anti–tumor necrosis factor agent such as etanercept, infliximab, adalimumab, or certolizumab pegol as an initial biologic treatment, 30% received an anti–IL-12/-23 agent (ustekinumab), and 9% received an anti-IL-17 agent (secukinumab). Additionally, 23% received a concomitant psoriasis medication.

PASI assessments were completed in 603 patients at 6 months, and 522 patients at 12 months. At 6 and 12 months respectively, 23% and 26% of the patients had achieved a PASI 100 score. Investigators noted that the rate of complete skin clearance declined as the number of baseline comorbidities and the number of prior biologics increased.

Biologic-experienced patients at study entry had lower PASI 100 response rates (about 20% at 6 and 12 months) than the biologic-naive patients (25% at 6 months, 30% at 12 months). Dr. Reich pointed out that many biologic-experienced patients often have active disease, despite previous use of biologics, and “they’re likely to represent a more difficult-to-treat population.” Factors such as convenience, safety, and the fact that more complicated patients – those with weight issues, more comorbidities and pretreatments, and lower compliance – are treated in real life than in clinical trials, are likely to influence lack of response in real-world data, Dr. Reich said.

The study’s enrollment period took place from 2014 to 2015, so it did not include patients on newer biologics such as brodalumab, guselkumab, ixekizumab, and tildrakizumab. “Some of these newer therapies have shown greater efficacy than drugs such as ustekinumab and etanercept in clinical trials, and patients are more likely to achieve complete skin clearance. Therefore, real-world rates of complete clearance may have improved since this study concluded,” the investigators pointed out.

Possible limitations of the study include selection bias and possible confounders, they noted.

The study was sponsored by Amgen/AstraZeneca; the manuscript was sponsored by LEO Pharma. One author was an AstraZeneca employee, two are LEO pharma employees, one author had no disclosures, and the remaining authors, including Dr. Reich, disclosed serving as an adviser, paid speaker, consultant, and/or investigator for multiple pharmaceutical companies.

SOURCE: Seneschal J et al. J Eur Acad Dermatol Venereol. 2020 May 4. doi: 10.1111/jdv.16568.

The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.

The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.

Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).

Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.

[email protected]

The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.

The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.

Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).

Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.

[email protected]

The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.

The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.

Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).

Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.

[email protected]

Emphasizing the potential harms of not taking a psoriasis treatment may make patients more likely to agree to start that therapy, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”

In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).

He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.

In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).

The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.

Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.

Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.

“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”

Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.

SOURCE: Kassardjian A. SID 2020, Abstract 489.

Emphasizing the potential harms of not taking a psoriasis treatment may make patients more likely to agree to start that therapy, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”

In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).

He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.

In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).

The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.

Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.

Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.

“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”

Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.

SOURCE: Kassardjian A. SID 2020, Abstract 489.

Emphasizing the potential harms of not taking a psoriasis treatment may make patients more likely to agree to start that therapy, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

“We typically explain to patients the benefits of treatment,” Ari A. Kassardjian, BS, of the University of Southern California, Los Angeles, said in his presentation. “However, explaining to them the harmful effects on their skin and joint diseases, such as exacerbation of psoriasis and/or psoriatic arthritis, could offer some patients a new perspective that may influence their treatment preferences; and ultimately, better communication may lead to better medication adherence in patients.”

In the study he presented, explaining to patients possible outcomes without treatment was more effective in getting them to agree to treatment than was messaging that focused on the positive effects of a therapy (reducing disease severity and pain, and improved health).

He noted that the impact of framing choices in terms of gain or loss on decision-making has been measured in other areas of medicine, including in patients with multiple sclerosis where medication adherence is an issue (J Health Commun. 2017 Jun;22[6]:523-31). “Gain-framed” messages focus on the benefits of taking a medication, while “loss-framed” messages highlight the potential consequences of not agreeing or adhering to treatment.

In the study, Mr. Kassardjian and coinvestigators evaluated 90 patients with psoriasis who were randomized to receive a gain-framed or loss-framed message about a hypothetical new biologic injectable medication for psoriasis and psoriatic arthritis (PsA). More than half were male (64.4%), white (53.3%), and non-Hispanic or Latino (55.6%); and about one-fourth of the participants (27.8%) also had psoriatic arthritis (PsA).

The gain-framed message emphasized “the chance to reduce psoriasis severity, reduce joint pain, and improve how you feel overall,” while the loss-framed message described the downsides of not taking medication – missing out “on the chance to improve your skin, your joints, and your overall health,” with the possibility that psoriasis may get worse, “with worsening pain in your joints from psoriatic arthritis,” and feeling “worse overall.” Both messages included the side effects of the theoretical injectable, a small risk of injection-site pain and skin infections. After receiving the message, participants ranked their likelihood of taking the medication on an 11-point Likert scale, with a score of 0 indicating that they would “definitely” not use the medication and a score of 10 indicating that they would “definitely” use the medication.

Scores among those who received the loss-framed message were a mean of 8.84, compared with 7.11 among patients who received the gain-framed message (between-group difference; 1.73; P less than .0001). When comparing patients with and without PsA, the between-group difference was 1.90 for patients with PsA (P less than .0001) and 1.08 for patients who did not have PsA (P = .002). Comparing the responses of those with PsA and those without PsA, the between-group difference was 1.08 (P = .03). While PsA and non-PsA patients favored the loss-framed messages, “regardless of the framing type, PsA patients always responded with a greater preference for the therapy,” Mr. Kassardjian said.

Gender also had an effect on responsiveness to gain-framed or loss-framed messaging. Both men and women ranked the loss-framed messaging as making them more likely to use the medication, but the between-group difference for women (2.00; P = .008) was higher than in men (1.49; P = .003). However, the total men compared with total women between-group differences were not significant.

“In clinical practice, physicians regularly weigh the benefits and risks of treatment. In order to communicate this information to patients, it is important to understand how framing these benefits and risks impacts patient preferences for therapy,” Mr. Kassardjian said. “While most available biologics are effective and have tolerable safety profiles, many psoriasis patients may be hesitant to initiate these therapies. Thus, it is important to convey the benefits and risks of these systemic agents in ways that resonate with patients.”

Mr. Kassardjian reports receiving the Dean’s Research Scholarship at the University of Southern California, funded by the Wright Foundation at the time of the study. Senior author April Armstrong, MD, disclosed serving as an investigator and/or consultant for AbbVie, BMS, Dermavant, Dermira, Eli Lilly, Janssen, Leo Pharma, Kyowa Hakko Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.

SOURCE: Kassardjian A. SID 2020, Abstract 489.