Dermatology

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

SAN DIEGO – Combining topical tyrosinase inhibitors with either a nonablative fractional laser or a fractional picosecond laser was safe and effective for treating postinflammatory hyperpigmentation (PIH) in patients with Fitzpatrick skin phototypes V and VI, results from a small retrospective case series suggest.

“Postinflammatory hyperpigmentation is a leading chief of complaint of many skin of color persons seeking a dermatologist,” Elizabeth J. Kream, MD, told this news organization in advance of the annual conference of American Society for Laser Medicine and Surgery. “I describe PIH to patients as the ‘ashes after a fire is extinguished.’ It’s the stubborn brown to gray/black spots that persist after conditions like acne and folliculitis, but it can be caused by any insult to the skin including external injury. In fact, there’s a risk of inciting PIH with lasers and energy-based devices and this risk is greater in skin of color given the greater melanin content. Unfortunately, we see patients present after visiting a med spa who were treated with the wrong devices and/or the wrong settings and they have disfiguring scarring and/or dyspigmentation.”

During an abstract session at the meeting, Dr. Kream, a dermatology resident at the University of Illinois at Chicago, discussed three patients with recalcitrant PIH and Fitzpatrick skin phototype V and VI who were treated in San Diego with a combination of topical and laser therapies. She presented the case series on behalf of coauthors Monica Boen, MD and Douglas C. Wu, MD, dermatologists who practice in San Diego.

The first patient was a 37-year-old Black female who presented for evaluation of longstanding hyperpigmentation on the face and neck determined to be PIH secondary to folliculitis on the chin and neck. She was started on 8% hydroquinone with kojic acid daily and received four treatments spaced 4-8 weeks apart with the 1,927-nm fractional nonablative diode laser. Laser settings were 5 mJ pulse energy and 5% coverage after eight passes. Triamcinolone 0.1% ointment was applied immediately after treatment and for 3 days following treatment, and the “patient experienced near complete resolution of PIH with no unexpected adverse events,” Dr. Kream said.

The second patient was a 20-year-old Black male who presented with a 3-month history of facial hyperpigmentation after suffering a laser-induced injury. He was started on a non-hydroquinone topical lightening agent and received five treatments spaced 2 weeks apart with a 1,927-nm fractional nonablative diode laser. The laser settings were 5 mJ pulse energy and 5% coverage after eight passes. The patient experienced 80%-90% resolution of his PIH with no unexpected adverse reactions.

The third patient in the series was a 39-year-old Black male who presented with a 6-month history of hyperpigmentation on his right shin and calf, secondary to minor occupational-related trauma. Treatment was initiated with a fractional 1,064-nm picosecond laser. The laser settings were 2.1 mJ per microbeam microwave pulse energy and a 450 picosecond pulse duration delivered at 2 Hz through a holographic beam splitter with a 6 x 6–mm spot size containing 101 microbeams, for an estimated coverage of 4% per pulse. Four passes were performed for each area. The endpoint was a mild erythema to several treated areas a few minutes following laser treatment. Postoperative care consisted of applying a non-hydroquinone topical lightening agent twice daily to the affected area for 1 month. Near-complete resolution of the PIH was achieved, with no unexpected adverse reactions.

“In our clinical experience, PIH can be treated with the combination of topical skin lighteners and low density, low fluence laser therapy in almost all skin types,” Dr. Kream said. “The rationale behind this combination is to treat and remove existing pigment with the laser therapy while minimizing and preventing any pigmentary recurrence with diligent topical therapy and photoprotection.”

It is important to identify the cause of PIH “because some cases are trickier than others,” such as a lichenoid process that deposits pigment “a little bit deeper into the dermis,” she said. “When selecting an appropriate laser modality for the treatment of PIH in skin types V and VI, it’s especially important to consider the mechanism of action, depth of penetration, degree of tissue damage, and the extent of disruption to the dermal-epidermal junction.”

Following the presentation, one of the session moderators, Albert Wolkerstorfer, MD, PhD, a dermatologist at Amsterdam University Medical Center, the Netherlands, emphasized the importance of proper patient selection for laser treatment of PIH. “Not every patient with PIH is adapted to treatment with the laser,” Dr. Wolkerstorfer said. “I think it’s also important to choose stable PIH, meaning you often see patients with an underlying disorder who want to get rid of the pigment. They often believe that the laser is the solution, but it often isn’t.”

During a question-and-answer session, a meeting attendee pointed out that the study lacked a control area to compare the treatment results to. “This was a retrospective case series,” Dr. Kream replied. “I’d like to see more elegant studies in the future, with a control [area],” she said.

Dr. Kream reported having no financial disclosures, Dr. Boen has no disclosures, and Dr. Wu has conducted research for many pharmaceutical and device companies. Dr. Wolkerstorfer disclosed that he has received grant or research funding from Lumenis, Novartis, and Avita Medical, and is an advisory board member for Incyte.

SAN DIEGO – Combining topical tyrosinase inhibitors with either a nonablative fractional laser or a fractional picosecond laser was safe and effective for treating postinflammatory hyperpigmentation (PIH) in patients with Fitzpatrick skin phototypes V and VI, results from a small retrospective case series suggest.

“Postinflammatory hyperpigmentation is a leading chief of complaint of many skin of color persons seeking a dermatologist,” Elizabeth J. Kream, MD, told this news organization in advance of the annual conference of American Society for Laser Medicine and Surgery. “I describe PIH to patients as the ‘ashes after a fire is extinguished.’ It’s the stubborn brown to gray/black spots that persist after conditions like acne and folliculitis, but it can be caused by any insult to the skin including external injury. In fact, there’s a risk of inciting PIH with lasers and energy-based devices and this risk is greater in skin of color given the greater melanin content. Unfortunately, we see patients present after visiting a med spa who were treated with the wrong devices and/or the wrong settings and they have disfiguring scarring and/or dyspigmentation.”

During an abstract session at the meeting, Dr. Kream, a dermatology resident at the University of Illinois at Chicago, discussed three patients with recalcitrant PIH and Fitzpatrick skin phototype V and VI who were treated in San Diego with a combination of topical and laser therapies. She presented the case series on behalf of coauthors Monica Boen, MD and Douglas C. Wu, MD, dermatologists who practice in San Diego.

The first patient was a 37-year-old Black female who presented for evaluation of longstanding hyperpigmentation on the face and neck determined to be PIH secondary to folliculitis on the chin and neck. She was started on 8% hydroquinone with kojic acid daily and received four treatments spaced 4-8 weeks apart with the 1,927-nm fractional nonablative diode laser. Laser settings were 5 mJ pulse energy and 5% coverage after eight passes. Triamcinolone 0.1% ointment was applied immediately after treatment and for 3 days following treatment, and the “patient experienced near complete resolution of PIH with no unexpected adverse events,” Dr. Kream said.

The second patient was a 20-year-old Black male who presented with a 3-month history of facial hyperpigmentation after suffering a laser-induced injury. He was started on a non-hydroquinone topical lightening agent and received five treatments spaced 2 weeks apart with a 1,927-nm fractional nonablative diode laser. The laser settings were 5 mJ pulse energy and 5% coverage after eight passes. The patient experienced 80%-90% resolution of his PIH with no unexpected adverse reactions.

The third patient in the series was a 39-year-old Black male who presented with a 6-month history of hyperpigmentation on his right shin and calf, secondary to minor occupational-related trauma. Treatment was initiated with a fractional 1,064-nm picosecond laser. The laser settings were 2.1 mJ per microbeam microwave pulse energy and a 450 picosecond pulse duration delivered at 2 Hz through a holographic beam splitter with a 6 x 6–mm spot size containing 101 microbeams, for an estimated coverage of 4% per pulse. Four passes were performed for each area. The endpoint was a mild erythema to several treated areas a few minutes following laser treatment. Postoperative care consisted of applying a non-hydroquinone topical lightening agent twice daily to the affected area for 1 month. Near-complete resolution of the PIH was achieved, with no unexpected adverse reactions.

“In our clinical experience, PIH can be treated with the combination of topical skin lighteners and low density, low fluence laser therapy in almost all skin types,” Dr. Kream said. “The rationale behind this combination is to treat and remove existing pigment with the laser therapy while minimizing and preventing any pigmentary recurrence with diligent topical therapy and photoprotection.”

It is important to identify the cause of PIH “because some cases are trickier than others,” such as a lichenoid process that deposits pigment “a little bit deeper into the dermis,” she said. “When selecting an appropriate laser modality for the treatment of PIH in skin types V and VI, it’s especially important to consider the mechanism of action, depth of penetration, degree of tissue damage, and the extent of disruption to the dermal-epidermal junction.”

Following the presentation, one of the session moderators, Albert Wolkerstorfer, MD, PhD, a dermatologist at Amsterdam University Medical Center, the Netherlands, emphasized the importance of proper patient selection for laser treatment of PIH. “Not every patient with PIH is adapted to treatment with the laser,” Dr. Wolkerstorfer said. “I think it’s also important to choose stable PIH, meaning you often see patients with an underlying disorder who want to get rid of the pigment. They often believe that the laser is the solution, but it often isn’t.”

During a question-and-answer session, a meeting attendee pointed out that the study lacked a control area to compare the treatment results to. “This was a retrospective case series,” Dr. Kream replied. “I’d like to see more elegant studies in the future, with a control [area],” she said.

Dr. Kream reported having no financial disclosures, Dr. Boen has no disclosures, and Dr. Wu has conducted research for many pharmaceutical and device companies. Dr. Wolkerstorfer disclosed that he has received grant or research funding from Lumenis, Novartis, and Avita Medical, and is an advisory board member for Incyte.

SAN DIEGO – Combining topical tyrosinase inhibitors with either a nonablative fractional laser or a fractional picosecond laser was safe and effective for treating postinflammatory hyperpigmentation (PIH) in patients with Fitzpatrick skin phototypes V and VI, results from a small retrospective case series suggest.

“Postinflammatory hyperpigmentation is a leading chief of complaint of many skin of color persons seeking a dermatologist,” Elizabeth J. Kream, MD, told this news organization in advance of the annual conference of American Society for Laser Medicine and Surgery. “I describe PIH to patients as the ‘ashes after a fire is extinguished.’ It’s the stubborn brown to gray/black spots that persist after conditions like acne and folliculitis, but it can be caused by any insult to the skin including external injury. In fact, there’s a risk of inciting PIH with lasers and energy-based devices and this risk is greater in skin of color given the greater melanin content. Unfortunately, we see patients present after visiting a med spa who were treated with the wrong devices and/or the wrong settings and they have disfiguring scarring and/or dyspigmentation.”

During an abstract session at the meeting, Dr. Kream, a dermatology resident at the University of Illinois at Chicago, discussed three patients with recalcitrant PIH and Fitzpatrick skin phototype V and VI who were treated in San Diego with a combination of topical and laser therapies. She presented the case series on behalf of coauthors Monica Boen, MD and Douglas C. Wu, MD, dermatologists who practice in San Diego.

The first patient was a 37-year-old Black female who presented for evaluation of longstanding hyperpigmentation on the face and neck determined to be PIH secondary to folliculitis on the chin and neck. She was started on 8% hydroquinone with kojic acid daily and received four treatments spaced 4-8 weeks apart with the 1,927-nm fractional nonablative diode laser. Laser settings were 5 mJ pulse energy and 5% coverage after eight passes. Triamcinolone 0.1% ointment was applied immediately after treatment and for 3 days following treatment, and the “patient experienced near complete resolution of PIH with no unexpected adverse events,” Dr. Kream said.

The second patient was a 20-year-old Black male who presented with a 3-month history of facial hyperpigmentation after suffering a laser-induced injury. He was started on a non-hydroquinone topical lightening agent and received five treatments spaced 2 weeks apart with a 1,927-nm fractional nonablative diode laser. The laser settings were 5 mJ pulse energy and 5% coverage after eight passes. The patient experienced 80%-90% resolution of his PIH with no unexpected adverse reactions.

The third patient in the series was a 39-year-old Black male who presented with a 6-month history of hyperpigmentation on his right shin and calf, secondary to minor occupational-related trauma. Treatment was initiated with a fractional 1,064-nm picosecond laser. The laser settings were 2.1 mJ per microbeam microwave pulse energy and a 450 picosecond pulse duration delivered at 2 Hz through a holographic beam splitter with a 6 x 6–mm spot size containing 101 microbeams, for an estimated coverage of 4% per pulse. Four passes were performed for each area. The endpoint was a mild erythema to several treated areas a few minutes following laser treatment. Postoperative care consisted of applying a non-hydroquinone topical lightening agent twice daily to the affected area for 1 month. Near-complete resolution of the PIH was achieved, with no unexpected adverse reactions.

“In our clinical experience, PIH can be treated with the combination of topical skin lighteners and low density, low fluence laser therapy in almost all skin types,” Dr. Kream said. “The rationale behind this combination is to treat and remove existing pigment with the laser therapy while minimizing and preventing any pigmentary recurrence with diligent topical therapy and photoprotection.”

It is important to identify the cause of PIH “because some cases are trickier than others,” such as a lichenoid process that deposits pigment “a little bit deeper into the dermis,” she said. “When selecting an appropriate laser modality for the treatment of PIH in skin types V and VI, it’s especially important to consider the mechanism of action, depth of penetration, degree of tissue damage, and the extent of disruption to the dermal-epidermal junction.”

Following the presentation, one of the session moderators, Albert Wolkerstorfer, MD, PhD, a dermatologist at Amsterdam University Medical Center, the Netherlands, emphasized the importance of proper patient selection for laser treatment of PIH. “Not every patient with PIH is adapted to treatment with the laser,” Dr. Wolkerstorfer said. “I think it’s also important to choose stable PIH, meaning you often see patients with an underlying disorder who want to get rid of the pigment. They often believe that the laser is the solution, but it often isn’t.”

During a question-and-answer session, a meeting attendee pointed out that the study lacked a control area to compare the treatment results to. “This was a retrospective case series,” Dr. Kream replied. “I’d like to see more elegant studies in the future, with a control [area],” she said.

Dr. Kream reported having no financial disclosures, Dr. Boen has no disclosures, and Dr. Wu has conducted research for many pharmaceutical and device companies. Dr. Wolkerstorfer disclosed that he has received grant or research funding from Lumenis, Novartis, and Avita Medical, and is an advisory board member for Incyte.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

A version of this article first appeared on Medscape.com.

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

A version of this article first appeared on Medscape.com.

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

A version of this article first appeared on Medscape.com.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

A version of this article first appeared on Medscape.com.

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

A version of this article first appeared on Medscape.com.

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

A version of this article first appeared on Medscape.com.