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Enlarging lesion on temple
A shave biopsy revealed acanthosis, papillomatosis, hyperkeratosis, hypergranulosis, parakeratosis, and cytoplasmic viral-like inclusions without atypia, consistent with a diagnosis of a common wart. The biopsy ruled out other possible diagnoses, which included keratoacanthoma, seborrheic keratosis, and squamous cell carcinoma.
Cutaneous warts can manifest as common warts (verruca vulgaris), plantar warts (verruca plantaris), or plane warts (verruca plana). These benign skin lesions are caused by human papillomavirus and can manifest in areas of skin trauma; this is known as the Koebner phenomenon. Most warts can be diagnosed through clinical history and examination. Dermoscopy, if performed, may reveal thrombosed capillaries as dotted structures, but there is an increased risk of cross-contamination.1 That said, some dermatoscopes have disposable covers or can be cleaned with antiviral, antibacterial wipes. If the diagnosis is unclear or the exam is clinically suspicious, a biopsy may be required.
Cases with progressive enlargement and extensive involvement of the skin (as was seen here) are generally associated with certain predisposing conditions, such as atopic dermatitis and immunosuppression.2 Our patient screened negative for HIV infection, and further evaluation did not reveal any concerns for immunosuppression.
Treatment for a common wart depends on patient characteristics, preferences, cost, and possible adverse effects. Standard treatment options are topical salicylic acid and cryotherapy with liquid nitrogen. Depending on the location and type of the wart, multiple treatments may be required, and recurrences are common. Intralesional injection with bleomycin, 5‐fluorouracil, or cidofovir is often used for recurrent and refractory warts.
Patients unable to tolerate cryotherapy or local injections may benefit from thermotherapy by heating the wart with a pulsed dye laser.3 Observation is also a reasonable course of action for new warts, as they may spontaneously resolve within a year.
In this case, the patient opted for over-the-counter salicylic acid 17% to be applied nightly until resolution. Cryosurgery would be a next step for him if the lesion does not resolve after 3 months of treatment.
Image courtesy of Faryal Tahir, MD. Text courtesy of Faryal Tahir, MD, Assistant Professor, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Mun JH, Park SM, Ko HC, et al. Prevention of possible cross-infection among patients by dermoscopy: a brief review of the literature and our suggestion. Dermatol Pract Concept. 2013;3:33-34. doi: 10.5826/dpc.0304a07
2. Leiding JW, Holland SM. Warts and all: human papillomavirus in primary immunodeficiencies. J Allergy Clin Immunol. 2012;130:1030-1048. doi: 10.1016/j.jaci.2012.07.049
3. Zhu P, Qi RQ, Yang Y, et al. Clinical guideline for the diagnosis and treatment of cutaneous warts (2022). J Evid Based Med. 2022;15:284-301. doi: 10.1111/jebm.12494
A shave biopsy revealed acanthosis, papillomatosis, hyperkeratosis, hypergranulosis, parakeratosis, and cytoplasmic viral-like inclusions without atypia, consistent with a diagnosis of a common wart. The biopsy ruled out other possible diagnoses, which included keratoacanthoma, seborrheic keratosis, and squamous cell carcinoma.
Cutaneous warts can manifest as common warts (verruca vulgaris), plantar warts (verruca plantaris), or plane warts (verruca plana). These benign skin lesions are caused by human papillomavirus and can manifest in areas of skin trauma; this is known as the Koebner phenomenon. Most warts can be diagnosed through clinical history and examination. Dermoscopy, if performed, may reveal thrombosed capillaries as dotted structures, but there is an increased risk of cross-contamination.1 That said, some dermatoscopes have disposable covers or can be cleaned with antiviral, antibacterial wipes. If the diagnosis is unclear or the exam is clinically suspicious, a biopsy may be required.
Cases with progressive enlargement and extensive involvement of the skin (as was seen here) are generally associated with certain predisposing conditions, such as atopic dermatitis and immunosuppression.2 Our patient screened negative for HIV infection, and further evaluation did not reveal any concerns for immunosuppression.
Treatment for a common wart depends on patient characteristics, preferences, cost, and possible adverse effects. Standard treatment options are topical salicylic acid and cryotherapy with liquid nitrogen. Depending on the location and type of the wart, multiple treatments may be required, and recurrences are common. Intralesional injection with bleomycin, 5‐fluorouracil, or cidofovir is often used for recurrent and refractory warts.
Patients unable to tolerate cryotherapy or local injections may benefit from thermotherapy by heating the wart with a pulsed dye laser.3 Observation is also a reasonable course of action for new warts, as they may spontaneously resolve within a year.
In this case, the patient opted for over-the-counter salicylic acid 17% to be applied nightly until resolution. Cryosurgery would be a next step for him if the lesion does not resolve after 3 months of treatment.
Image courtesy of Faryal Tahir, MD. Text courtesy of Faryal Tahir, MD, Assistant Professor, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
A shave biopsy revealed acanthosis, papillomatosis, hyperkeratosis, hypergranulosis, parakeratosis, and cytoplasmic viral-like inclusions without atypia, consistent with a diagnosis of a common wart. The biopsy ruled out other possible diagnoses, which included keratoacanthoma, seborrheic keratosis, and squamous cell carcinoma.
Cutaneous warts can manifest as common warts (verruca vulgaris), plantar warts (verruca plantaris), or plane warts (verruca plana). These benign skin lesions are caused by human papillomavirus and can manifest in areas of skin trauma; this is known as the Koebner phenomenon. Most warts can be diagnosed through clinical history and examination. Dermoscopy, if performed, may reveal thrombosed capillaries as dotted structures, but there is an increased risk of cross-contamination.1 That said, some dermatoscopes have disposable covers or can be cleaned with antiviral, antibacterial wipes. If the diagnosis is unclear or the exam is clinically suspicious, a biopsy may be required.
Cases with progressive enlargement and extensive involvement of the skin (as was seen here) are generally associated with certain predisposing conditions, such as atopic dermatitis and immunosuppression.2 Our patient screened negative for HIV infection, and further evaluation did not reveal any concerns for immunosuppression.
Treatment for a common wart depends on patient characteristics, preferences, cost, and possible adverse effects. Standard treatment options are topical salicylic acid and cryotherapy with liquid nitrogen. Depending on the location and type of the wart, multiple treatments may be required, and recurrences are common. Intralesional injection with bleomycin, 5‐fluorouracil, or cidofovir is often used for recurrent and refractory warts.
Patients unable to tolerate cryotherapy or local injections may benefit from thermotherapy by heating the wart with a pulsed dye laser.3 Observation is also a reasonable course of action for new warts, as they may spontaneously resolve within a year.
In this case, the patient opted for over-the-counter salicylic acid 17% to be applied nightly until resolution. Cryosurgery would be a next step for him if the lesion does not resolve after 3 months of treatment.
Image courtesy of Faryal Tahir, MD. Text courtesy of Faryal Tahir, MD, Assistant Professor, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Mun JH, Park SM, Ko HC, et al. Prevention of possible cross-infection among patients by dermoscopy: a brief review of the literature and our suggestion. Dermatol Pract Concept. 2013;3:33-34. doi: 10.5826/dpc.0304a07
2. Leiding JW, Holland SM. Warts and all: human papillomavirus in primary immunodeficiencies. J Allergy Clin Immunol. 2012;130:1030-1048. doi: 10.1016/j.jaci.2012.07.049
3. Zhu P, Qi RQ, Yang Y, et al. Clinical guideline for the diagnosis and treatment of cutaneous warts (2022). J Evid Based Med. 2022;15:284-301. doi: 10.1111/jebm.12494
1. Mun JH, Park SM, Ko HC, et al. Prevention of possible cross-infection among patients by dermoscopy: a brief review of the literature and our suggestion. Dermatol Pract Concept. 2013;3:33-34. doi: 10.5826/dpc.0304a07
2. Leiding JW, Holland SM. Warts and all: human papillomavirus in primary immunodeficiencies. J Allergy Clin Immunol. 2012;130:1030-1048. doi: 10.1016/j.jaci.2012.07.049
3. Zhu P, Qi RQ, Yang Y, et al. Clinical guideline for the diagnosis and treatment of cutaneous warts (2022). J Evid Based Med. 2022;15:284-301. doi: 10.1111/jebm.12494
More evidence shows COVID-19’s link to risk for autoimmune disease
TOPLINE:
Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.
METHODOLOGY:
- In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
- Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
- Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).
TAKEAWAY:
- Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
- Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
IN PRACTICE:
“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.
SOURCE:
Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.
LIMITATIONS:
The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.
DISCLOSURES:
The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.
METHODOLOGY:
- In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
- Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
- Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).
TAKEAWAY:
- Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
- Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
IN PRACTICE:
“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.
SOURCE:
Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.
LIMITATIONS:
The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.
DISCLOSURES:
The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.
METHODOLOGY:
- In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
- Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
- Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).
TAKEAWAY:
- Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
- Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
IN PRACTICE:
“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.
SOURCE:
Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.
LIMITATIONS:
The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.
DISCLOSURES:
The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Choosing which biologic to prescribe for psoriasis
CARLSBAD, CALIF. –
“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.
In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).
In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).
In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”
Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.
Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.
The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.
She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”
She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”
If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”
Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.
CARLSBAD, CALIF. –
“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.
In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).
In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).
In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”
Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.
Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.
The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.
She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”
She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”
If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”
Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.
CARLSBAD, CALIF. –
“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.
In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).
In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).
In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”
Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.
Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.
The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.
She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”
She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”
If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”
Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.
AT CALDERM 2023
FDA approves topical roflumilast for psoriasis in children aged 6-11
On Oct. 6, the first approved for the same indication in July, 2022, for individuals aged 12 and older.
This marks an expanded indication for the drug, which wasRoflumilast cream 0.3% is a phosphodiesterase-4 inhibitor approved for once-daily topical treatment of mild, moderate, and severe plaque psoriasis. According to a press release from the manufacturer, Arcutis Biotherapeutics, approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6-11 years with plaque psoriasis. It stated that pharmacokinetic, safety, tolerability, and efficacy data from this study were “generally consistent” with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults.
According to the press release, a future FDA review is planned for the results from a second MUSE study in children ages 2-5 years, as well as data from an ongoing open-label extension study evaluating the long-term safety of roflumilast cream in individuals with plaque psoriasis aged 2 years and older. The company markets topical roflumilast as Zoryve.
On Oct. 6, the first approved for the same indication in July, 2022, for individuals aged 12 and older.
This marks an expanded indication for the drug, which wasRoflumilast cream 0.3% is a phosphodiesterase-4 inhibitor approved for once-daily topical treatment of mild, moderate, and severe plaque psoriasis. According to a press release from the manufacturer, Arcutis Biotherapeutics, approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6-11 years with plaque psoriasis. It stated that pharmacokinetic, safety, tolerability, and efficacy data from this study were “generally consistent” with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults.
According to the press release, a future FDA review is planned for the results from a second MUSE study in children ages 2-5 years, as well as data from an ongoing open-label extension study evaluating the long-term safety of roflumilast cream in individuals with plaque psoriasis aged 2 years and older. The company markets topical roflumilast as Zoryve.
On Oct. 6, the first approved for the same indication in July, 2022, for individuals aged 12 and older.
This marks an expanded indication for the drug, which wasRoflumilast cream 0.3% is a phosphodiesterase-4 inhibitor approved for once-daily topical treatment of mild, moderate, and severe plaque psoriasis. According to a press release from the manufacturer, Arcutis Biotherapeutics, approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6-11 years with plaque psoriasis. It stated that pharmacokinetic, safety, tolerability, and efficacy data from this study were “generally consistent” with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults.
According to the press release, a future FDA review is planned for the results from a second MUSE study in children ages 2-5 years, as well as data from an ongoing open-label extension study evaluating the long-term safety of roflumilast cream in individuals with plaque psoriasis aged 2 years and older. The company markets topical roflumilast as Zoryve.
Enlarging pink patches after traveling
The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.
While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.
Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.
If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.
The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1
This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.
Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1
The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.
While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.
Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.
If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.
The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1
This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.
Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.
While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.
Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.
If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.
The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1
This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.
Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.
1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1
1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1
Spironolactone safe, effective option for women with hidradenitis suppurativa
CARLSBAD, CALIF. –
Those are the key findings from a single-center retrospective study that Jennifer L. Hsiao, MD, and colleagues presented during a poster session at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
In an interview after the meeting, Dr. Hsiao, a dermatologist who directs the hidradenitis suppurativa clinic at the University of Southern California, Los Angeles, said that hormones are thought to play a role in HS pathogenesis given the typical HS symptom onset around puberty and fluctuations in disease activity with menses (typically premenstrual flares) and pregnancy. “Spironolactone, an anti-androgenic agent, is used to treat HS in women; however, there is a paucity of data on the efficacy of spironolactone for HS and whether certain patient characteristics may influence treatment response,” she told this news organization. “This study is unique in that we contribute to existing literature regarding spironolactone efficacy in HS and we also investigate whether the presence of menstrual HS flares or polycystic ovarian syndrome influences the likelihood of response to spironolactone.”
For the analysis, Dr. Hsiao and colleagues retrospectively reviewed the medical records of 53 adult women with HS who were prescribed spironolactone and who received care at USC’s HS clinic between January 2015 and December 2021. They collected data on demographics, comorbidities, HS medications, treatment response at 3 and 6 months, as well as adverse events. They also evaluated physician-assessed response to treatment when available.
The mean age of patients was 31 years, 37% were White, 30.4% were Black, 21.7% were Hispanic, 6.5% were Asian, and the remainder were biracial. The mean age at HS diagnosis was 25.1 years and the three most common comorbidities were acne (50.9%), obesity (45.3%), and anemia (37.7%). As for menstrual history, 56.6% had perimenstrual HS flares and 37.7% had irregular menstrual cycles. The top three classes of concomitant medications were antibiotics (58.5%), oral contraceptives (50.9%), and other birth control methods (18.9%).
The mean spironolactone dose was 104 mg/day; 84.1% of the women experienced improvement of HS 3 months after starting the drug, while 81.8% had improvement of their HS 6 months after starting the drug. The researchers also found that 56.6% of women had documented perimenstrual HS flares and 7.5% had PCOS.
“Spironolactone is often thought of as a helpful medication to consider if a patient reports having HS flares around menses or features of PCOS,” Dr. Hsiao said. However, she added, “our study found that there was no statistically significant difference in the response to spironolactone based on the presence of premenstrual flares or concomitant PCOS.” She said that spironolactone may be used as an adjunct therapeutic option in patients with more severe disease in addition to other medical and surgical therapies for HS. “Combining different treatment options that target different pathophysiologic factors is usually required to achieve adequate disease control in HS,” she said.
Dr. Hsiao acknowledged certain limitations of the study, including its single-center design and small sample size. “A confounding variable is that some patients were on other medications in addition to spironolactone, which may have influenced treatment outcomes,” she noted. “Larger prospective studies are needed to identify optimal dosing for spironolactone therapy in HS as well as predictors of treatment response.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that with only one FDA-approved systemic medication for the management of HS (adalimumab), “we off-label bandits must be creative to curtail the incredibly painful impact this chronic, destructive inflammatory disease can have on our patients.”
“The evidence supporting our approaches, whether it be antibiotics, immunomodulators, or in this case, antihormonal therapies, is limited, so more data is always welcome,” said Dr. Friedman, who was not involved with the study. “One very interesting point raised by the authors, one I share with my trainees frequently from my own experience, is that regardless of menstrual cycle abnormalities, spironolactone can be impactful. This is important to remember, in that overt signs of hormonal influences is not a requisite for the use or effectiveness of antihormonal therapy.”
Dr. Hsiao disclosed that she is a member of board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Novartis, UCB, as a speaker for AbbVie, and as an investigator for Amgen, Boehringer Ingelheim, and Incyte. Dr. Friedman reported having no relevant financial disclosures.
CARLSBAD, CALIF. –
Those are the key findings from a single-center retrospective study that Jennifer L. Hsiao, MD, and colleagues presented during a poster session at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
In an interview after the meeting, Dr. Hsiao, a dermatologist who directs the hidradenitis suppurativa clinic at the University of Southern California, Los Angeles, said that hormones are thought to play a role in HS pathogenesis given the typical HS symptom onset around puberty and fluctuations in disease activity with menses (typically premenstrual flares) and pregnancy. “Spironolactone, an anti-androgenic agent, is used to treat HS in women; however, there is a paucity of data on the efficacy of spironolactone for HS and whether certain patient characteristics may influence treatment response,” she told this news organization. “This study is unique in that we contribute to existing literature regarding spironolactone efficacy in HS and we also investigate whether the presence of menstrual HS flares or polycystic ovarian syndrome influences the likelihood of response to spironolactone.”
For the analysis, Dr. Hsiao and colleagues retrospectively reviewed the medical records of 53 adult women with HS who were prescribed spironolactone and who received care at USC’s HS clinic between January 2015 and December 2021. They collected data on demographics, comorbidities, HS medications, treatment response at 3 and 6 months, as well as adverse events. They also evaluated physician-assessed response to treatment when available.
The mean age of patients was 31 years, 37% were White, 30.4% were Black, 21.7% were Hispanic, 6.5% were Asian, and the remainder were biracial. The mean age at HS diagnosis was 25.1 years and the three most common comorbidities were acne (50.9%), obesity (45.3%), and anemia (37.7%). As for menstrual history, 56.6% had perimenstrual HS flares and 37.7% had irregular menstrual cycles. The top three classes of concomitant medications were antibiotics (58.5%), oral contraceptives (50.9%), and other birth control methods (18.9%).
The mean spironolactone dose was 104 mg/day; 84.1% of the women experienced improvement of HS 3 months after starting the drug, while 81.8% had improvement of their HS 6 months after starting the drug. The researchers also found that 56.6% of women had documented perimenstrual HS flares and 7.5% had PCOS.
“Spironolactone is often thought of as a helpful medication to consider if a patient reports having HS flares around menses or features of PCOS,” Dr. Hsiao said. However, she added, “our study found that there was no statistically significant difference in the response to spironolactone based on the presence of premenstrual flares or concomitant PCOS.” She said that spironolactone may be used as an adjunct therapeutic option in patients with more severe disease in addition to other medical and surgical therapies for HS. “Combining different treatment options that target different pathophysiologic factors is usually required to achieve adequate disease control in HS,” she said.
Dr. Hsiao acknowledged certain limitations of the study, including its single-center design and small sample size. “A confounding variable is that some patients were on other medications in addition to spironolactone, which may have influenced treatment outcomes,” she noted. “Larger prospective studies are needed to identify optimal dosing for spironolactone therapy in HS as well as predictors of treatment response.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that with only one FDA-approved systemic medication for the management of HS (adalimumab), “we off-label bandits must be creative to curtail the incredibly painful impact this chronic, destructive inflammatory disease can have on our patients.”
“The evidence supporting our approaches, whether it be antibiotics, immunomodulators, or in this case, antihormonal therapies, is limited, so more data is always welcome,” said Dr. Friedman, who was not involved with the study. “One very interesting point raised by the authors, one I share with my trainees frequently from my own experience, is that regardless of menstrual cycle abnormalities, spironolactone can be impactful. This is important to remember, in that overt signs of hormonal influences is not a requisite for the use or effectiveness of antihormonal therapy.”
Dr. Hsiao disclosed that she is a member of board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Novartis, UCB, as a speaker for AbbVie, and as an investigator for Amgen, Boehringer Ingelheim, and Incyte. Dr. Friedman reported having no relevant financial disclosures.
CARLSBAD, CALIF. –
Those are the key findings from a single-center retrospective study that Jennifer L. Hsiao, MD, and colleagues presented during a poster session at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.
In an interview after the meeting, Dr. Hsiao, a dermatologist who directs the hidradenitis suppurativa clinic at the University of Southern California, Los Angeles, said that hormones are thought to play a role in HS pathogenesis given the typical HS symptom onset around puberty and fluctuations in disease activity with menses (typically premenstrual flares) and pregnancy. “Spironolactone, an anti-androgenic agent, is used to treat HS in women; however, there is a paucity of data on the efficacy of spironolactone for HS and whether certain patient characteristics may influence treatment response,” she told this news organization. “This study is unique in that we contribute to existing literature regarding spironolactone efficacy in HS and we also investigate whether the presence of menstrual HS flares or polycystic ovarian syndrome influences the likelihood of response to spironolactone.”
For the analysis, Dr. Hsiao and colleagues retrospectively reviewed the medical records of 53 adult women with HS who were prescribed spironolactone and who received care at USC’s HS clinic between January 2015 and December 2021. They collected data on demographics, comorbidities, HS medications, treatment response at 3 and 6 months, as well as adverse events. They also evaluated physician-assessed response to treatment when available.
The mean age of patients was 31 years, 37% were White, 30.4% were Black, 21.7% were Hispanic, 6.5% were Asian, and the remainder were biracial. The mean age at HS diagnosis was 25.1 years and the three most common comorbidities were acne (50.9%), obesity (45.3%), and anemia (37.7%). As for menstrual history, 56.6% had perimenstrual HS flares and 37.7% had irregular menstrual cycles. The top three classes of concomitant medications were antibiotics (58.5%), oral contraceptives (50.9%), and other birth control methods (18.9%).
The mean spironolactone dose was 104 mg/day; 84.1% of the women experienced improvement of HS 3 months after starting the drug, while 81.8% had improvement of their HS 6 months after starting the drug. The researchers also found that 56.6% of women had documented perimenstrual HS flares and 7.5% had PCOS.
“Spironolactone is often thought of as a helpful medication to consider if a patient reports having HS flares around menses or features of PCOS,” Dr. Hsiao said. However, she added, “our study found that there was no statistically significant difference in the response to spironolactone based on the presence of premenstrual flares or concomitant PCOS.” She said that spironolactone may be used as an adjunct therapeutic option in patients with more severe disease in addition to other medical and surgical therapies for HS. “Combining different treatment options that target different pathophysiologic factors is usually required to achieve adequate disease control in HS,” she said.
Dr. Hsiao acknowledged certain limitations of the study, including its single-center design and small sample size. “A confounding variable is that some patients were on other medications in addition to spironolactone, which may have influenced treatment outcomes,” she noted. “Larger prospective studies are needed to identify optimal dosing for spironolactone therapy in HS as well as predictors of treatment response.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, said that with only one FDA-approved systemic medication for the management of HS (adalimumab), “we off-label bandits must be creative to curtail the incredibly painful impact this chronic, destructive inflammatory disease can have on our patients.”
“The evidence supporting our approaches, whether it be antibiotics, immunomodulators, or in this case, antihormonal therapies, is limited, so more data is always welcome,” said Dr. Friedman, who was not involved with the study. “One very interesting point raised by the authors, one I share with my trainees frequently from my own experience, is that regardless of menstrual cycle abnormalities, spironolactone can be impactful. This is important to remember, in that overt signs of hormonal influences is not a requisite for the use or effectiveness of antihormonal therapy.”
Dr. Hsiao disclosed that she is a member of board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Novartis, UCB, as a speaker for AbbVie, and as an investigator for Amgen, Boehringer Ingelheim, and Incyte. Dr. Friedman reported having no relevant financial disclosures.
AT CALDERM 2023
Can zoo poo help manage diabetic foot ulcers?
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FDA issues letter regarding lebrikizumab review for atopic dermatitis
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
Study finds inflammatory bowel disease risk higher in children, adults with atopic dermatitis
The published recently in JAMA Dermatology.
The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.
“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.
“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”
The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.
“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.
UK general practice cohort
AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.
To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.
The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.
In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
AD severity linked with IBD risk
The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.
Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.
AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).
Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.
Robust data with cautionary note
“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”
However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.
But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”
For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.
“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.
“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”
The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”
Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.
“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”
The authors recommend future related studies in more diverse populations.
Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
The published recently in JAMA Dermatology.
The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.
“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.
“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”
The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.
“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.
UK general practice cohort
AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.
To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.
The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.
In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
AD severity linked with IBD risk
The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.
Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.
AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).
Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.
Robust data with cautionary note
“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”
However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.
But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”
For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.
“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.
“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”
The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”
Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.
“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”
The authors recommend future related studies in more diverse populations.
Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
The published recently in JAMA Dermatology.
The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.
“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.
“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”
The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.
“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.
UK general practice cohort
AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.
To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.
The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.
In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
AD severity linked with IBD risk
The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.
Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.
AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).
Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.
Robust data with cautionary note
“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”
However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.
But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”
For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.
“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.
“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”
The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”
Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.
“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”
The authors recommend future related studies in more diverse populations.
Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM JAMA DERMATOLOGY
These adverse events linked to improved cancer prognosis
TOPLINE:
.
METHODOLOGY:
- Emerging evidence suggests that the presence of cutaneous immune-related adverse events may be linked with favorable outcomes among patients with cancer who receive ICIs.
- Researchers conducted a systematic review and meta-analysis that included 23 studies and a total of 22,749 patients with cancer who received ICI treatment; studies compared outcomes among patients with and those without cutaneous immune-related adverse events.
- The major outcomes evaluated in the analysis were overall survival and progression-free survival (PFS); subgroup analyses assessed cutaneous immune-related adverse event type, cancer type, and other factors.
TAKEAWAY:
- The occurrence of cutaneous immune-related adverse events was associated with improved PFS (hazard ratio, 0.52; P < .001) and overall survival (HR, 0.61; P < .001).
- In the subgroup analysis, patients with eczematous (HR, 0.69), lichenoid or lichen planus–like skin lesions (HR, 0.51), pruritus without rash (HR, 0.70), psoriasis (HR, 0.63), or vitiligo (HR, 0.30) demonstrated a significant overall survival advantage. Vitiligo was the only adverse event associated with a PFS advantage (HR, 0.28).
- Among patients with melanoma, analyses revealed a significant association between the incidence of cutaneous immune-related adverse events and improved overall survival (HR, 0.51) and PFS (HR, 0.45). The authors highlighted similar findings among patients with non–small cell lung cancer (HR, 0.50 for overall survival and 0.61 for PFS).
IN PRACTICE:
“These data suggest that [cutaneous immune-related adverse events] may have useful prognostic value in ICI treatment,” the authors concluded.
SOURCE:
The analysis, led by Fei Wang, MD, Zhong Da Hospital, School of Medicine, Southeast University, Nanjing, China, was published online in JAMA Dermatology.
LIMITATIONS:
Most of the data came from retrospective studies, and there were limited data on specific patient subgroups. The Egger tests, used to assess potential publication bias in meta-analyses, revealed publication bias.
DISCLOSURES:
No disclosures were reported. The study was supported by a grant from the Postgraduate Research and Practice Innovation Program of Jiangsu Province.
A version of this article first appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Emerging evidence suggests that the presence of cutaneous immune-related adverse events may be linked with favorable outcomes among patients with cancer who receive ICIs.
- Researchers conducted a systematic review and meta-analysis that included 23 studies and a total of 22,749 patients with cancer who received ICI treatment; studies compared outcomes among patients with and those without cutaneous immune-related adverse events.
- The major outcomes evaluated in the analysis were overall survival and progression-free survival (PFS); subgroup analyses assessed cutaneous immune-related adverse event type, cancer type, and other factors.
TAKEAWAY:
- The occurrence of cutaneous immune-related adverse events was associated with improved PFS (hazard ratio, 0.52; P < .001) and overall survival (HR, 0.61; P < .001).
- In the subgroup analysis, patients with eczematous (HR, 0.69), lichenoid or lichen planus–like skin lesions (HR, 0.51), pruritus without rash (HR, 0.70), psoriasis (HR, 0.63), or vitiligo (HR, 0.30) demonstrated a significant overall survival advantage. Vitiligo was the only adverse event associated with a PFS advantage (HR, 0.28).
- Among patients with melanoma, analyses revealed a significant association between the incidence of cutaneous immune-related adverse events and improved overall survival (HR, 0.51) and PFS (HR, 0.45). The authors highlighted similar findings among patients with non–small cell lung cancer (HR, 0.50 for overall survival and 0.61 for PFS).
IN PRACTICE:
“These data suggest that [cutaneous immune-related adverse events] may have useful prognostic value in ICI treatment,” the authors concluded.
SOURCE:
The analysis, led by Fei Wang, MD, Zhong Da Hospital, School of Medicine, Southeast University, Nanjing, China, was published online in JAMA Dermatology.
LIMITATIONS:
Most of the data came from retrospective studies, and there were limited data on specific patient subgroups. The Egger tests, used to assess potential publication bias in meta-analyses, revealed publication bias.
DISCLOSURES:
No disclosures were reported. The study was supported by a grant from the Postgraduate Research and Practice Innovation Program of Jiangsu Province.
A version of this article first appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Emerging evidence suggests that the presence of cutaneous immune-related adverse events may be linked with favorable outcomes among patients with cancer who receive ICIs.
- Researchers conducted a systematic review and meta-analysis that included 23 studies and a total of 22,749 patients with cancer who received ICI treatment; studies compared outcomes among patients with and those without cutaneous immune-related adverse events.
- The major outcomes evaluated in the analysis were overall survival and progression-free survival (PFS); subgroup analyses assessed cutaneous immune-related adverse event type, cancer type, and other factors.
TAKEAWAY:
- The occurrence of cutaneous immune-related adverse events was associated with improved PFS (hazard ratio, 0.52; P < .001) and overall survival (HR, 0.61; P < .001).
- In the subgroup analysis, patients with eczematous (HR, 0.69), lichenoid or lichen planus–like skin lesions (HR, 0.51), pruritus without rash (HR, 0.70), psoriasis (HR, 0.63), or vitiligo (HR, 0.30) demonstrated a significant overall survival advantage. Vitiligo was the only adverse event associated with a PFS advantage (HR, 0.28).
- Among patients with melanoma, analyses revealed a significant association between the incidence of cutaneous immune-related adverse events and improved overall survival (HR, 0.51) and PFS (HR, 0.45). The authors highlighted similar findings among patients with non–small cell lung cancer (HR, 0.50 for overall survival and 0.61 for PFS).
IN PRACTICE:
“These data suggest that [cutaneous immune-related adverse events] may have useful prognostic value in ICI treatment,” the authors concluded.
SOURCE:
The analysis, led by Fei Wang, MD, Zhong Da Hospital, School of Medicine, Southeast University, Nanjing, China, was published online in JAMA Dermatology.
LIMITATIONS:
Most of the data came from retrospective studies, and there were limited data on specific patient subgroups. The Egger tests, used to assess potential publication bias in meta-analyses, revealed publication bias.
DISCLOSURES:
No disclosures were reported. The study was supported by a grant from the Postgraduate Research and Practice Innovation Program of Jiangsu Province.
A version of this article first appeared on Medscape.com.