Psoriasis

Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.

There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.

The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.

The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).

The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.

Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.

There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.

The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.

The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).

The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.

Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.

There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.

The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.

The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).

The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.

Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.

Lori Farmer/MDedge News

In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.

All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.

Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.

Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.

Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.

The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.

AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.

SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.

As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.¹With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.² The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.² In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.

METHODS

A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.³ Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.⁴

We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).

Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.

RESULTS

The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).

Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).

Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.

COMMENT

Patient Apps

The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness^5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.⁶ Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.

Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al⁷ demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.

Teledermatology
Teledermatology apps are the most common dermatology apps,² allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.⁸ Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.

The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.⁹ The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.

For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.¹⁰ The app also met the American Telemedicine Association standard for teledermatology apps.⁹ The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.

Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.

Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.

Physician Apps

After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,¹¹ our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.

General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.

Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.

Limitations

Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.

CONCLUSION

There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.

As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.¹With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.² The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.² In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.

METHODS

A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.³ Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.⁴

We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).

Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.

RESULTS

The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).

Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).

Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.

COMMENT

Patient Apps

The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness^5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.⁶ Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.

Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al⁷ demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.

Teledermatology
Teledermatology apps are the most common dermatology apps,² allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.⁸ Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.

The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.⁹ The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.

For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.¹⁰ The app also met the American Telemedicine Association standard for teledermatology apps.⁹ The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.

Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.

Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.

Physician Apps

After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,¹¹ our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.

General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.

Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.

Limitations

Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.

CONCLUSION

There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.

As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.¹With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.² The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.² In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.

METHODS

A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.³ Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.⁴

We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).

Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.

RESULTS

The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).

Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).

Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.

COMMENT

Patient Apps

The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness^5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.⁶ Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.

Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al⁷ demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.

Teledermatology
Teledermatology apps are the most common dermatology apps,² allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.⁸ Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.

The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.⁹ The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.

For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.¹⁰ The app also met the American Telemedicine Association standard for teledermatology apps.⁹ The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.

Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.

Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.

Physician Apps

After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,¹¹ our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.

General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.

Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.

Limitations

Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.

CONCLUSION

There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.

A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.

Courtesy Centers for Disease Control and Prevention

The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.

On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.

Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.

They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.

“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.

The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.

“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”

The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.

SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.

A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.

Courtesy Centers for Disease Control and Prevention

The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.

On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.

Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.

They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.

“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.

The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.

“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”

The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.

SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.

A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.

Courtesy Centers for Disease Control and Prevention

The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.

On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.

Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.

They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.

“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.

The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.

“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”

The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.

SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.

Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

Antonio_Diaz/Thinkstock

The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.

For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.

MotherToBaby

A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.

For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).

For the asthma group, the drug being investigated is mepolizumab (Nucala).

Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.

The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).

Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

Antonio_Diaz/Thinkstock

The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.

For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.

MotherToBaby

A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.

For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).

For the asthma group, the drug being investigated is mepolizumab (Nucala).

Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.

The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).

Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.

Antonio_Diaz/Thinkstock

The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.

For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.

MotherToBaby

A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.

For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).

For the asthma group, the drug being investigated is mepolizumab (Nucala).

Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.

The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).

PARIS – A novel oral small molecule that selectively targets tyrosine kinase 2 signaling pathways critical in the pathogenesis of psoriasis performed impressively in a phase 2 clinical trial including 267 adults with moderate to severe disease, James G. Krueger, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“I would say the clinical response here is almost dead-on as a copy for ustekinumab, which is an [injectable interleukin] IL-23/IL-12 blocker. And we’re only at 12 weeks here; some of the curves look like they’re on a trajectory to go up further in terms of improvement. So I’m getting a performance with an oral drug that is just so much better than the approved alternatives that we have,” said Dr. Krueger, head of the laboratory of investigative dermatology and professor in clinical investigation at Rockefeller University in New York.

Oral apremilast (Otezla), for example, can’t touch those PASI 75 response rates in patients with moderate to severe psoriasis. Indeed, many psoriasis experts favor reserving apremilast for patients with moderate disease.

The 12-week, double-blind, placebo-controlled study was conducted at 82 sites in the United States and seven other countries. In this dose-ranging study, participants were randomized to the oral selective tyrosine kinase 2 (TYK2) inhibitor, known for the time being as BMS-986165, at 3 mg every other day, 3 mg daily, 3 mg twice a day, 6 mg twice a day, 12 mg daily, or to placebo.

The primary outcome was a 75% or greater reduction from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 12. The TYK2 inhibitor outperformed placebo in dose-dependent fashion starting at the 3 mg/day dose. The PASI 75 rate was 7% with placebo, 9% with 3 mg of BMS-986165 every other day, 39% with 3 mg daily, 69% with 3 mg BID, 67% with 6 mg BID, and 75% with 12 mg/day. All secondary endpoints followed suit.

A striking finding in the phase 2 study was that when the drug was stopped for a month at the end of the 12-week treatment period, for the most part, the PASI 75 response and other clinical benefits were retained.

“I would contrast this to experiments that I have personally done with cyclosporine, where I have cleared people with cyclosporine, stopped it, and a month later every single patient has rip-roaring disease back. So I think this TYK2 inhibitor has some different performance features than just blocking a downstream T-cell transduction molecule,” observed the dermatologist, who is credited as the discoverer of the importance of the T cell in psoriasis pathogenesis.

The strong multidimensional evidence of clinical efficacy in the phase 2 study was supported mechanistically by analysis of skin biopsies obtained on study days 1, 15, and 85. The laboratory studies showed that the oral drug improved molecular, cellular, and clinical biomarkers associated with treatment efficacy. For example, at doses of 3 mg twice a day or higher, the TYK2 inhibitor reduced expression of IL-19 and IL-36A, which are key drivers of keratinocyte activation and epidermal hyperplasia. The drug also markedly decreased expression of genes in the Th17 pathway and essentially normalized expression of the proinflammatory genes beta defensin and S100A9.

In contrast to the Janus kinase (JAK) 1/3 and JAK 2 inhibitors in development for treatment of psoriasis, which paint with a much broader brush, the TYK2 inhibitor is highly selective for IL-23, IL-12, and interferon alpha.

“Previous studies have shown pan-JAK inhibition can be very effective in remitting psoriasis. The problem is that if one inhibits JAK1 and JAK3, one blocks the transduction of effector cytokines that are essentially there for protective immunity. That could lead to undesirable levels of immunosuppression,” Dr. Krueger explained.

The most important cytokine in the pathogenesis of psoriasis is clearly IL-23, he continued. In cell-based assays, the TYK2 inhibitor has been shown to be 100 times more selective in inhibiting IL-23 , IL-12, and interferon-alpha than JAK 1/3 inhibitors and 3,000 times more selective than JAK 2 inhibitors. This high degree of selectivity makes for fewer off-target effects and for a favorable safety profile.

“There were no major safety signals that would lead you to be concerned,” Dr. Krueger said. Indeed, based upon the encouraging safety and efficacy demonstrated this phase 2 study, a phase 3 program known as POETYK-PSO is underway (POETYK-PSO-1 and POETYK-PSO-2).

The phase 2 clinical trial results were published online in conjunction with the EADV congress.

The TYK2 inhibitor is being developed by Bristol-Myers Squibb. Dr. Krueger reported receiving personal fees as well as research grants paid directly to Rockefeller University from that pharmaceutical company and numerous others.

[email protected]
 

Source: Papp K et al. N Engl J Med. 2018 Sep 11. doi: 10.1056/NEJMoa1806382.


 

PARIS – A novel oral small molecule that selectively targets tyrosine kinase 2 signaling pathways critical in the pathogenesis of psoriasis performed impressively in a phase 2 clinical trial including 267 adults with moderate to severe disease, James G. Krueger, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“I would say the clinical response here is almost dead-on as a copy for ustekinumab, which is an [injectable interleukin] IL-23/IL-12 blocker. And we’re only at 12 weeks here; some of the curves look like they’re on a trajectory to go up further in terms of improvement. So I’m getting a performance with an oral drug that is just so much better than the approved alternatives that we have,” said Dr. Krueger, head of the laboratory of investigative dermatology and professor in clinical investigation at Rockefeller University in New York.

Oral apremilast (Otezla), for example, can’t touch those PASI 75 response rates in patients with moderate to severe psoriasis. Indeed, many psoriasis experts favor reserving apremilast for patients with moderate disease.

The 12-week, double-blind, placebo-controlled study was conducted at 82 sites in the United States and seven other countries. In this dose-ranging study, participants were randomized to the oral selective tyrosine kinase 2 (TYK2) inhibitor, known for the time being as BMS-986165, at 3 mg every other day, 3 mg daily, 3 mg twice a day, 6 mg twice a day, 12 mg daily, or to placebo.

The primary outcome was a 75% or greater reduction from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 12. The TYK2 inhibitor outperformed placebo in dose-dependent fashion starting at the 3 mg/day dose. The PASI 75 rate was 7% with placebo, 9% with 3 mg of BMS-986165 every other day, 39% with 3 mg daily, 69% with 3 mg BID, 67% with 6 mg BID, and 75% with 12 mg/day. All secondary endpoints followed suit.

A striking finding in the phase 2 study was that when the drug was stopped for a month at the end of the 12-week treatment period, for the most part, the PASI 75 response and other clinical benefits were retained.

“I would contrast this to experiments that I have personally done with cyclosporine, where I have cleared people with cyclosporine, stopped it, and a month later every single patient has rip-roaring disease back. So I think this TYK2 inhibitor has some different performance features than just blocking a downstream T-cell transduction molecule,” observed the dermatologist, who is credited as the discoverer of the importance of the T cell in psoriasis pathogenesis.

The strong multidimensional evidence of clinical efficacy in the phase 2 study was supported mechanistically by analysis of skin biopsies obtained on study days 1, 15, and 85. The laboratory studies showed that the oral drug improved molecular, cellular, and clinical biomarkers associated with treatment efficacy. For example, at doses of 3 mg twice a day or higher, the TYK2 inhibitor reduced expression of IL-19 and IL-36A, which are key drivers of keratinocyte activation and epidermal hyperplasia. The drug also markedly decreased expression of genes in the Th17 pathway and essentially normalized expression of the proinflammatory genes beta defensin and S100A9.

In contrast to the Janus kinase (JAK) 1/3 and JAK 2 inhibitors in development for treatment of psoriasis, which paint with a much broader brush, the TYK2 inhibitor is highly selective for IL-23, IL-12, and interferon alpha.

“Previous studies have shown pan-JAK inhibition can be very effective in remitting psoriasis. The problem is that if one inhibits JAK1 and JAK3, one blocks the transduction of effector cytokines that are essentially there for protective immunity. That could lead to undesirable levels of immunosuppression,” Dr. Krueger explained.

The most important cytokine in the pathogenesis of psoriasis is clearly IL-23, he continued. In cell-based assays, the TYK2 inhibitor has been shown to be 100 times more selective in inhibiting IL-23 , IL-12, and interferon-alpha than JAK 1/3 inhibitors and 3,000 times more selective than JAK 2 inhibitors. This high degree of selectivity makes for fewer off-target effects and for a favorable safety profile.

“There were no major safety signals that would lead you to be concerned,” Dr. Krueger said. Indeed, based upon the encouraging safety and efficacy demonstrated this phase 2 study, a phase 3 program known as POETYK-PSO is underway (POETYK-PSO-1 and POETYK-PSO-2).

The phase 2 clinical trial results were published online in conjunction with the EADV congress.

The TYK2 inhibitor is being developed by Bristol-Myers Squibb. Dr. Krueger reported receiving personal fees as well as research grants paid directly to Rockefeller University from that pharmaceutical company and numerous others.

[email protected]
 

Source: Papp K et al. N Engl J Med. 2018 Sep 11. doi: 10.1056/NEJMoa1806382.


 

PARIS – A novel oral small molecule that selectively targets tyrosine kinase 2 signaling pathways critical in the pathogenesis of psoriasis performed impressively in a phase 2 clinical trial including 267 adults with moderate to severe disease, James G. Krueger, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“I would say the clinical response here is almost dead-on as a copy for ustekinumab, which is an [injectable interleukin] IL-23/IL-12 blocker. And we’re only at 12 weeks here; some of the curves look like they’re on a trajectory to go up further in terms of improvement. So I’m getting a performance with an oral drug that is just so much better than the approved alternatives that we have,” said Dr. Krueger, head of the laboratory of investigative dermatology and professor in clinical investigation at Rockefeller University in New York.

Oral apremilast (Otezla), for example, can’t touch those PASI 75 response rates in patients with moderate to severe psoriasis. Indeed, many psoriasis experts favor reserving apremilast for patients with moderate disease.

The 12-week, double-blind, placebo-controlled study was conducted at 82 sites in the United States and seven other countries. In this dose-ranging study, participants were randomized to the oral selective tyrosine kinase 2 (TYK2) inhibitor, known for the time being as BMS-986165, at 3 mg every other day, 3 mg daily, 3 mg twice a day, 6 mg twice a day, 12 mg daily, or to placebo.

The primary outcome was a 75% or greater reduction from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 12. The TYK2 inhibitor outperformed placebo in dose-dependent fashion starting at the 3 mg/day dose. The PASI 75 rate was 7% with placebo, 9% with 3 mg of BMS-986165 every other day, 39% with 3 mg daily, 69% with 3 mg BID, 67% with 6 mg BID, and 75% with 12 mg/day. All secondary endpoints followed suit.

A striking finding in the phase 2 study was that when the drug was stopped for a month at the end of the 12-week treatment period, for the most part, the PASI 75 response and other clinical benefits were retained.

“I would contrast this to experiments that I have personally done with cyclosporine, where I have cleared people with cyclosporine, stopped it, and a month later every single patient has rip-roaring disease back. So I think this TYK2 inhibitor has some different performance features than just blocking a downstream T-cell transduction molecule,” observed the dermatologist, who is credited as the discoverer of the importance of the T cell in psoriasis pathogenesis.

The strong multidimensional evidence of clinical efficacy in the phase 2 study was supported mechanistically by analysis of skin biopsies obtained on study days 1, 15, and 85. The laboratory studies showed that the oral drug improved molecular, cellular, and clinical biomarkers associated with treatment efficacy. For example, at doses of 3 mg twice a day or higher, the TYK2 inhibitor reduced expression of IL-19 and IL-36A, which are key drivers of keratinocyte activation and epidermal hyperplasia. The drug also markedly decreased expression of genes in the Th17 pathway and essentially normalized expression of the proinflammatory genes beta defensin and S100A9.

In contrast to the Janus kinase (JAK) 1/3 and JAK 2 inhibitors in development for treatment of psoriasis, which paint with a much broader brush, the TYK2 inhibitor is highly selective for IL-23, IL-12, and interferon alpha.

“Previous studies have shown pan-JAK inhibition can be very effective in remitting psoriasis. The problem is that if one inhibits JAK1 and JAK3, one blocks the transduction of effector cytokines that are essentially there for protective immunity. That could lead to undesirable levels of immunosuppression,” Dr. Krueger explained.

The most important cytokine in the pathogenesis of psoriasis is clearly IL-23, he continued. In cell-based assays, the TYK2 inhibitor has been shown to be 100 times more selective in inhibiting IL-23 , IL-12, and interferon-alpha than JAK 1/3 inhibitors and 3,000 times more selective than JAK 2 inhibitors. This high degree of selectivity makes for fewer off-target effects and for a favorable safety profile.

“There were no major safety signals that would lead you to be concerned,” Dr. Krueger said. Indeed, based upon the encouraging safety and efficacy demonstrated this phase 2 study, a phase 3 program known as POETYK-PSO is underway (POETYK-PSO-1 and POETYK-PSO-2).

The phase 2 clinical trial results were published online in conjunction with the EADV congress.

The TYK2 inhibitor is being developed by Bristol-Myers Squibb. Dr. Krueger reported receiving personal fees as well as research grants paid directly to Rockefeller University from that pharmaceutical company and numerous others.

[email protected]
 

Source: Papp K et al. N Engl J Med. 2018 Sep 11. doi: 10.1056/NEJMoa1806382.


 

Patients with incident psoriatic arthritis are at a significantly increased risk of developing type 2 diabetes when compared against patients with psoriasis alone and with the general population, according to recent research published in Rheumatology.

Tashatuvango/Thinkstock

Rachel Charlton, PhD, of the department of pharmacy and pharmacology at the University of Bath (England), and her colleagues performed an analysis of 6,783 incident cases of psoriatic arthritis (PsA) from the U.K. Clinical Practice Research Datalink who were diagnosed during 1998-2014. Patients were between 18 years and 89 years old with a median age of 49 years at PsA diagnosis.

In the study, the researchers randomly matched PsA cases at a 1:4 ratio to either a cohort of general population patients with no PsA, psoriasis, or inflammatory arthritis or a cohort of patients with psoriasis but no PsA or inflammatory arthritis. Patients were followed from match to the point where they either no longer met inclusion criteria for the cohort or received a diagnosis of type 2 diabetes, cerebrovascular disease (CVD), ischemic heart disease (IHD), or peripheral vascular disease (PVD) with a mean follow-up duration of approximately 5.5 years across all patient groups.

Patients in the PsA group had a significantly higher incidence of type 2 diabetes, compared with the general population (adjusted relative risk, 1.40; 95% confidence interval, 1.15-1.70; P = .0007) and psoriasis groups (adjusted RR, 1.53; 95% CI, 1.19-1.97; P = .0009). In the PsA group, risk of CVD (adjusted RR, 1.24; 95% CI, 0.99-1.56; P = .06), IHD (adjusted RR, 1.27; 95% CI, 1.05-1.54; P = .02), and PVD (adjusted RR, 1.40; 95% CI, 1.02-1.92; P = .04) were significantly higher than in the general population but not when compared with the psoriasis group. The overall risk of cardiovascular disease (including CVD, IHD, and PVD) for the PsA group was significantly higher (adjusted RR, 1.29; 95% CI, 1.12-1.48; P = .0005), compared with the general population.

“These results support the proposal in existing clinical guidelines that, in order to reduce cardiovascular risk in patients with PsA, it is important to treat inflammatory disease as well as to screen and treat traditional risk factors early in the disease course,” Ms. Charlton and her colleagues wrote in their study.

This study was funded by a grant from the National Institute for Health Research in the United Kingdom. The authors reported no relevant conflicts of interest.

SOURCE: Charlton RA et al. Rheumatology. 2018 Sep 6. doi: 10.1093/rheumatology/key286.

Patients with incident psoriatic arthritis are at a significantly increased risk of developing type 2 diabetes when compared against patients with psoriasis alone and with the general population, according to recent research published in Rheumatology.

Tashatuvango/Thinkstock

Rachel Charlton, PhD, of the department of pharmacy and pharmacology at the University of Bath (England), and her colleagues performed an analysis of 6,783 incident cases of psoriatic arthritis (PsA) from the U.K. Clinical Practice Research Datalink who were diagnosed during 1998-2014. Patients were between 18 years and 89 years old with a median age of 49 years at PsA diagnosis.

In the study, the researchers randomly matched PsA cases at a 1:4 ratio to either a cohort of general population patients with no PsA, psoriasis, or inflammatory arthritis or a cohort of patients with psoriasis but no PsA or inflammatory arthritis. Patients were followed from match to the point where they either no longer met inclusion criteria for the cohort or received a diagnosis of type 2 diabetes, cerebrovascular disease (CVD), ischemic heart disease (IHD), or peripheral vascular disease (PVD) with a mean follow-up duration of approximately 5.5 years across all patient groups.

Patients in the PsA group had a significantly higher incidence of type 2 diabetes, compared with the general population (adjusted relative risk, 1.40; 95% confidence interval, 1.15-1.70; P = .0007) and psoriasis groups (adjusted RR, 1.53; 95% CI, 1.19-1.97; P = .0009). In the PsA group, risk of CVD (adjusted RR, 1.24; 95% CI, 0.99-1.56; P = .06), IHD (adjusted RR, 1.27; 95% CI, 1.05-1.54; P = .02), and PVD (adjusted RR, 1.40; 95% CI, 1.02-1.92; P = .04) were significantly higher than in the general population but not when compared with the psoriasis group. The overall risk of cardiovascular disease (including CVD, IHD, and PVD) for the PsA group was significantly higher (adjusted RR, 1.29; 95% CI, 1.12-1.48; P = .0005), compared with the general population.

“These results support the proposal in existing clinical guidelines that, in order to reduce cardiovascular risk in patients with PsA, it is important to treat inflammatory disease as well as to screen and treat traditional risk factors early in the disease course,” Ms. Charlton and her colleagues wrote in their study.

This study was funded by a grant from the National Institute for Health Research in the United Kingdom. The authors reported no relevant conflicts of interest.

SOURCE: Charlton RA et al. Rheumatology. 2018 Sep 6. doi: 10.1093/rheumatology/key286.

Patients with incident psoriatic arthritis are at a significantly increased risk of developing type 2 diabetes when compared against patients with psoriasis alone and with the general population, according to recent research published in Rheumatology.

Tashatuvango/Thinkstock

Rachel Charlton, PhD, of the department of pharmacy and pharmacology at the University of Bath (England), and her colleagues performed an analysis of 6,783 incident cases of psoriatic arthritis (PsA) from the U.K. Clinical Practice Research Datalink who were diagnosed during 1998-2014. Patients were between 18 years and 89 years old with a median age of 49 years at PsA diagnosis.

In the study, the researchers randomly matched PsA cases at a 1:4 ratio to either a cohort of general population patients with no PsA, psoriasis, or inflammatory arthritis or a cohort of patients with psoriasis but no PsA or inflammatory arthritis. Patients were followed from match to the point where they either no longer met inclusion criteria for the cohort or received a diagnosis of type 2 diabetes, cerebrovascular disease (CVD), ischemic heart disease (IHD), or peripheral vascular disease (PVD) with a mean follow-up duration of approximately 5.5 years across all patient groups.

Patients in the PsA group had a significantly higher incidence of type 2 diabetes, compared with the general population (adjusted relative risk, 1.40; 95% confidence interval, 1.15-1.70; P = .0007) and psoriasis groups (adjusted RR, 1.53; 95% CI, 1.19-1.97; P = .0009). In the PsA group, risk of CVD (adjusted RR, 1.24; 95% CI, 0.99-1.56; P = .06), IHD (adjusted RR, 1.27; 95% CI, 1.05-1.54; P = .02), and PVD (adjusted RR, 1.40; 95% CI, 1.02-1.92; P = .04) were significantly higher than in the general population but not when compared with the psoriasis group. The overall risk of cardiovascular disease (including CVD, IHD, and PVD) for the PsA group was significantly higher (adjusted RR, 1.29; 95% CI, 1.12-1.48; P = .0005), compared with the general population.

“These results support the proposal in existing clinical guidelines that, in order to reduce cardiovascular risk in patients with PsA, it is important to treat inflammatory disease as well as to screen and treat traditional risk factors early in the disease course,” Ms. Charlton and her colleagues wrote in their study.

This study was funded by a grant from the National Institute for Health Research in the United Kingdom. The authors reported no relevant conflicts of interest.

SOURCE: Charlton RA et al. Rheumatology. 2018 Sep 6. doi: 10.1093/rheumatology/key286.

The infliximab-dyyb biosimilar was only moderately less expensive than the originator infliximab product Remicade in the United States in 2017 under Medicare Part D, an analysis shows.

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Infliximab-dyyb (Inflectra) cost 18% less than infliximab, with an annual cost exceeding $14,000 in an analysis published online Sept. 4 in JAMA by Jinoos Yazdany, MD, of the division of rheumatology at the University of California, San Francisco, and her coauthors.

However, “without biosimilar gap discounts in 2017, beneficiaries would have paid more than $5,100 for infliximab-dyyb, or nearly $1,700 more in projected out-of-pocket costs than infliximab,” Dr. Yazdany and her coauthors wrote.

Biologics represent only 2% of U.S. prescriptions but made up 38% of drug spending in 2015 and accounted for 70% of growth in drug spending from 2010 to 2015, according to Dr. Yazdany and her colleagues.

Biologics for rheumatoid arthritis (RA) cost more than $14,000 per year, and in 2015, 3 were among the top 15 drugs in terms of Medicare expenditures, they added.

While biosimilars are supposed to increase competition and lower prices, it’s an open question whether they actually reduce out-of-pocket expenditures for the 43 million individuals with drug benefits under Medicare Part D.

That uncertainty is due in part to the complex cost-sharing design of Part D, which includes an initial deductible, a coverage phase, a coverage gap, and catastrophic coverage.

In 2017, the plan included an initial $400 deductible, followed by the coverage phase, in which the patient paid 25% of drug costs. In the coverage gap, which started at $3,700 in total drug costs, the patient’s share of drug costs increased to 40% for biologics, and 51% for biosimilars. In the catastrophic coverage phase, triggered when out-of-pocket costs exceeded $4,950, the patient was responsible for 5% of drug costs.

“Currently, beneficiaries receive a 50% manufacturer discount during the gap for brand-name drugs and biologics, but not for biosimilars,” Dr. Yazdany and her coauthors said in the report.

To evaluate cost-sharing for infliximab-dyyb, which in 2016 became the first available RA biosimilar, the authors analyzed data for all Part D plans in the June 2017 Medicare Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files.

Out of 2,547 plans, only 10% covered the biosimilar, while 96% covered infliximab, the authors found.

The mean total cost of infliximab-dyyb was “modestly lower,” they reported. Eight-week prescription costs were $2,185 for infliximab-dyyb versus $2,667 for infliximab, while annual costs were $14,202 for the biosimilar and $17,335 for infliximab.

However, all plans required coinsurance cost-sharing for the biosimilar, they said. The mean coinsurance rate was 26.6% of the total drug cost for the biosimilar and 28.4% for infliximab.

For beneficiaries, projected annual out-of-pocket costs without the gap discount were $5,118 for infliximab-dyyb and $3,432 for infliximab, the researchers said.

Biosimilar gap discounts are set to start in 2019, according to the authors. However, they said those discounts may not substantially reduce out-of-pocket costs for Part D beneficiaries because of the high price of infliximab-dyyb and a coinsurance cost-sharing rate similar to that of infliximab.

“Further policies are needed to address affordability and access to specialty drugs,” Dr. Yazdany and her coauthors concluded.

The study was funded in part by grants from the Agency for Healthcare Research and Quality, the Robert L. Kroc Endowed Chair in Rheumatic and Connective Tissue Diseases, and other sources. Dr. Yazdany reported receiving an independent investigator award from Pfizer. Her coauthors reported no conflict of interest disclosures.

SOURCE: Yazdany J et al. JAMA. 2018;320(9):931-3.

The infliximab-dyyb biosimilar was only moderately less expensive than the originator infliximab product Remicade in the United States in 2017 under Medicare Part D, an analysis shows.

Thinkstock Photos

Infliximab-dyyb (Inflectra) cost 18% less than infliximab, with an annual cost exceeding $14,000 in an analysis published online Sept. 4 in JAMA by Jinoos Yazdany, MD, of the division of rheumatology at the University of California, San Francisco, and her coauthors.

However, “without biosimilar gap discounts in 2017, beneficiaries would have paid more than $5,100 for infliximab-dyyb, or nearly $1,700 more in projected out-of-pocket costs than infliximab,” Dr. Yazdany and her coauthors wrote.

Biologics represent only 2% of U.S. prescriptions but made up 38% of drug spending in 2015 and accounted for 70% of growth in drug spending from 2010 to 2015, according to Dr. Yazdany and her colleagues.

Biologics for rheumatoid arthritis (RA) cost more than $14,000 per year, and in 2015, 3 were among the top 15 drugs in terms of Medicare expenditures, they added.

While biosimilars are supposed to increase competition and lower prices, it’s an open question whether they actually reduce out-of-pocket expenditures for the 43 million individuals with drug benefits under Medicare Part D.

That uncertainty is due in part to the complex cost-sharing design of Part D, which includes an initial deductible, a coverage phase, a coverage gap, and catastrophic coverage.

In 2017, the plan included an initial $400 deductible, followed by the coverage phase, in which the patient paid 25% of drug costs. In the coverage gap, which started at $3,700 in total drug costs, the patient’s share of drug costs increased to 40% for biologics, and 51% for biosimilars. In the catastrophic coverage phase, triggered when out-of-pocket costs exceeded $4,950, the patient was responsible for 5% of drug costs.

“Currently, beneficiaries receive a 50% manufacturer discount during the gap for brand-name drugs and biologics, but not for biosimilars,” Dr. Yazdany and her coauthors said in the report.

To evaluate cost-sharing for infliximab-dyyb, which in 2016 became the first available RA biosimilar, the authors analyzed data for all Part D plans in the June 2017 Medicare Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files.

Out of 2,547 plans, only 10% covered the biosimilar, while 96% covered infliximab, the authors found.

The mean total cost of infliximab-dyyb was “modestly lower,” they reported. Eight-week prescription costs were $2,185 for infliximab-dyyb versus $2,667 for infliximab, while annual costs were $14,202 for the biosimilar and $17,335 for infliximab.

However, all plans required coinsurance cost-sharing for the biosimilar, they said. The mean coinsurance rate was 26.6% of the total drug cost for the biosimilar and 28.4% for infliximab.

For beneficiaries, projected annual out-of-pocket costs without the gap discount were $5,118 for infliximab-dyyb and $3,432 for infliximab, the researchers said.

Biosimilar gap discounts are set to start in 2019, according to the authors. However, they said those discounts may not substantially reduce out-of-pocket costs for Part D beneficiaries because of the high price of infliximab-dyyb and a coinsurance cost-sharing rate similar to that of infliximab.

“Further policies are needed to address affordability and access to specialty drugs,” Dr. Yazdany and her coauthors concluded.

The study was funded in part by grants from the Agency for Healthcare Research and Quality, the Robert L. Kroc Endowed Chair in Rheumatic and Connective Tissue Diseases, and other sources. Dr. Yazdany reported receiving an independent investigator award from Pfizer. Her coauthors reported no conflict of interest disclosures.

SOURCE: Yazdany J et al. JAMA. 2018;320(9):931-3.

The infliximab-dyyb biosimilar was only moderately less expensive than the originator infliximab product Remicade in the United States in 2017 under Medicare Part D, an analysis shows.

Thinkstock Photos

Infliximab-dyyb (Inflectra) cost 18% less than infliximab, with an annual cost exceeding $14,000 in an analysis published online Sept. 4 in JAMA by Jinoos Yazdany, MD, of the division of rheumatology at the University of California, San Francisco, and her coauthors.

However, “without biosimilar gap discounts in 2017, beneficiaries would have paid more than $5,100 for infliximab-dyyb, or nearly $1,700 more in projected out-of-pocket costs than infliximab,” Dr. Yazdany and her coauthors wrote.

Biologics represent only 2% of U.S. prescriptions but made up 38% of drug spending in 2015 and accounted for 70% of growth in drug spending from 2010 to 2015, according to Dr. Yazdany and her colleagues.

Biologics for rheumatoid arthritis (RA) cost more than $14,000 per year, and in 2015, 3 were among the top 15 drugs in terms of Medicare expenditures, they added.

While biosimilars are supposed to increase competition and lower prices, it’s an open question whether they actually reduce out-of-pocket expenditures for the 43 million individuals with drug benefits under Medicare Part D.

That uncertainty is due in part to the complex cost-sharing design of Part D, which includes an initial deductible, a coverage phase, a coverage gap, and catastrophic coverage.

In 2017, the plan included an initial $400 deductible, followed by the coverage phase, in which the patient paid 25% of drug costs. In the coverage gap, which started at $3,700 in total drug costs, the patient’s share of drug costs increased to 40% for biologics, and 51% for biosimilars. In the catastrophic coverage phase, triggered when out-of-pocket costs exceeded $4,950, the patient was responsible for 5% of drug costs.

“Currently, beneficiaries receive a 50% manufacturer discount during the gap for brand-name drugs and biologics, but not for biosimilars,” Dr. Yazdany and her coauthors said in the report.

To evaluate cost-sharing for infliximab-dyyb, which in 2016 became the first available RA biosimilar, the authors analyzed data for all Part D plans in the June 2017 Medicare Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files.

Out of 2,547 plans, only 10% covered the biosimilar, while 96% covered infliximab, the authors found.

The mean total cost of infliximab-dyyb was “modestly lower,” they reported. Eight-week prescription costs were $2,185 for infliximab-dyyb versus $2,667 for infliximab, while annual costs were $14,202 for the biosimilar and $17,335 for infliximab.

However, all plans required coinsurance cost-sharing for the biosimilar, they said. The mean coinsurance rate was 26.6% of the total drug cost for the biosimilar and 28.4% for infliximab.

For beneficiaries, projected annual out-of-pocket costs without the gap discount were $5,118 for infliximab-dyyb and $3,432 for infliximab, the researchers said.

Biosimilar gap discounts are set to start in 2019, according to the authors. However, they said those discounts may not substantially reduce out-of-pocket costs for Part D beneficiaries because of the high price of infliximab-dyyb and a coinsurance cost-sharing rate similar to that of infliximab.

“Further policies are needed to address affordability and access to specialty drugs,” Dr. Yazdany and her coauthors concluded.

The study was funded in part by grants from the Agency for Healthcare Research and Quality, the Robert L. Kroc Endowed Chair in Rheumatic and Connective Tissue Diseases, and other sources. Dr. Yazdany reported receiving an independent investigator award from Pfizer. Her coauthors reported no conflict of interest disclosures.

SOURCE: Yazdany J et al. JAMA. 2018;320(9):931-3.

Use of a smartphone application that provided daily reminders about topical treatment significantly improved adherence for patients with psoriasis, compared with those who did not use the app.

Milan_Zokic/thinkstockphotos.com

Treatment adherence remains a challenge in psoriasis, and although the field of electronic health interventions is growing, data on the effectiveness of such interventions are limited, wrote Mathias T. Svendsen, MD, of Odense University Hospital in Denmark, and his colleagues.

In a study published in the British Journal of Dermatology, 134 adults with psoriasis were randomized to use a smartphone app (68) or not (66) that provided daily medication reminders and daily information about the amount of treatment and number of product applications.

The primary outcome measure of treatment adherence was defined as once-daily application of topical medication – calcipotriol/betamethasone dipropionate cutaneous foam – for at least 80% of the days during the treatment period. A computer chip on the medication dispenser tracked patient use of the product and sent usage information to the patient’s smartphone via Bluetooth.

At 4 weeks, 65% of patients who used the app were adherent to treatment, versus 38% of those who didn’t use the app (P = .004).

In addition, patients who used the app showed significant improvement in disease severity, based on the secondary outcome measure of the Lattice System Physician’s Global Assessment (LS-PGA) at 4 weeks, with a mean change in score from baseline of 1.86 in the app group and 1.46 in the non-app group (P = .047). The LS-PGA and the Dermatology Life Quality Index (DLQI) were measured at all visits. No significant differences on the DLQI appeared between the groups.

During a 22-week follow-up completed by 122 patients, the effects were similar, but the differences were not statistically significant at weeks 8 and 26.

The study findings were limited by several factors, including the lack of knowledge of the correct amount of medication needed for the full benefit of the topical treatment and a lack of data on patient satisfaction with the app, the researchers noted. However, the results suggest that a medication reminder app improved disease severity as well as patient adherence rates in the short term, and that “there is potential for implementing patient-supporting apps in the dermatology clinic.”

The study was supported by LEO Pharma and by the Kirsten and Volmer Rask Nielsen’s Foundation; part of Dr. Svendsen’s salary during the study was paid by LEO Pharma, and several coauthors reported relationships with LEO Pharma.

SOURCE: Svendsen MT et al. Br J Dermatol. 2018 Apr 14. doi: 10.1111/bjd.16667.

Use of a smartphone application that provided daily reminders about topical treatment significantly improved adherence for patients with psoriasis, compared with those who did not use the app.

Milan_Zokic/thinkstockphotos.com

Treatment adherence remains a challenge in psoriasis, and although the field of electronic health interventions is growing, data on the effectiveness of such interventions are limited, wrote Mathias T. Svendsen, MD, of Odense University Hospital in Denmark, and his colleagues.

In a study published in the British Journal of Dermatology, 134 adults with psoriasis were randomized to use a smartphone app (68) or not (66) that provided daily medication reminders and daily information about the amount of treatment and number of product applications.

The primary outcome measure of treatment adherence was defined as once-daily application of topical medication – calcipotriol/betamethasone dipropionate cutaneous foam – for at least 80% of the days during the treatment period. A computer chip on the medication dispenser tracked patient use of the product and sent usage information to the patient’s smartphone via Bluetooth.

At 4 weeks, 65% of patients who used the app were adherent to treatment, versus 38% of those who didn’t use the app (P = .004).

In addition, patients who used the app showed significant improvement in disease severity, based on the secondary outcome measure of the Lattice System Physician’s Global Assessment (LS-PGA) at 4 weeks, with a mean change in score from baseline of 1.86 in the app group and 1.46 in the non-app group (P = .047). The LS-PGA and the Dermatology Life Quality Index (DLQI) were measured at all visits. No significant differences on the DLQI appeared between the groups.

During a 22-week follow-up completed by 122 patients, the effects were similar, but the differences were not statistically significant at weeks 8 and 26.

The study findings were limited by several factors, including the lack of knowledge of the correct amount of medication needed for the full benefit of the topical treatment and a lack of data on patient satisfaction with the app, the researchers noted. However, the results suggest that a medication reminder app improved disease severity as well as patient adherence rates in the short term, and that “there is potential for implementing patient-supporting apps in the dermatology clinic.”

The study was supported by LEO Pharma and by the Kirsten and Volmer Rask Nielsen’s Foundation; part of Dr. Svendsen’s salary during the study was paid by LEO Pharma, and several coauthors reported relationships with LEO Pharma.

SOURCE: Svendsen MT et al. Br J Dermatol. 2018 Apr 14. doi: 10.1111/bjd.16667.

Use of a smartphone application that provided daily reminders about topical treatment significantly improved adherence for patients with psoriasis, compared with those who did not use the app.

Milan_Zokic/thinkstockphotos.com

Treatment adherence remains a challenge in psoriasis, and although the field of electronic health interventions is growing, data on the effectiveness of such interventions are limited, wrote Mathias T. Svendsen, MD, of Odense University Hospital in Denmark, and his colleagues.

In a study published in the British Journal of Dermatology, 134 adults with psoriasis were randomized to use a smartphone app (68) or not (66) that provided daily medication reminders and daily information about the amount of treatment and number of product applications.

The primary outcome measure of treatment adherence was defined as once-daily application of topical medication – calcipotriol/betamethasone dipropionate cutaneous foam – for at least 80% of the days during the treatment period. A computer chip on the medication dispenser tracked patient use of the product and sent usage information to the patient’s smartphone via Bluetooth.

At 4 weeks, 65% of patients who used the app were adherent to treatment, versus 38% of those who didn’t use the app (P = .004).

In addition, patients who used the app showed significant improvement in disease severity, based on the secondary outcome measure of the Lattice System Physician’s Global Assessment (LS-PGA) at 4 weeks, with a mean change in score from baseline of 1.86 in the app group and 1.46 in the non-app group (P = .047). The LS-PGA and the Dermatology Life Quality Index (DLQI) were measured at all visits. No significant differences on the DLQI appeared between the groups.

During a 22-week follow-up completed by 122 patients, the effects were similar, but the differences were not statistically significant at weeks 8 and 26.

The study findings were limited by several factors, including the lack of knowledge of the correct amount of medication needed for the full benefit of the topical treatment and a lack of data on patient satisfaction with the app, the researchers noted. However, the results suggest that a medication reminder app improved disease severity as well as patient adherence rates in the short term, and that “there is potential for implementing patient-supporting apps in the dermatology clinic.”

The study was supported by LEO Pharma and by the Kirsten and Volmer Rask Nielsen’s Foundation; part of Dr. Svendsen’s salary during the study was paid by LEO Pharma, and several coauthors reported relationships with LEO Pharma.

SOURCE: Svendsen MT et al. Br J Dermatol. 2018 Apr 14. doi: 10.1111/bjd.16667.