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Pruritus: Diagnosing and Treating Older Adults
Chronic pruritus is a common problem among older individuals. During a session at the Dermatology Days of Paris 2024 conference dedicated to general practitioners, Juliette Delaunay, MD, a dermatologist and venereologist at Angers University Hospital Center in Angers, France, and Gabrielle Lisembard, MD, a general practitioner in the French town Grand-Fort-Philippe, discussed diagnostic approaches and key principles for the therapeutic management of pruritus.
Identifying Causes
“Pruritus in older people is most often linked to physiological changes in the skin caused by aging, leading to significant xerosis. However, before attributing it to aging, we need to rule out several causes,” Delaunay noted.
Beyond simple aging, one must consider autoimmune bullous dermatoses (bullous pemphigoid), drug-related causes, metabolic disorders (can occur at any age), cutaneous T-cell lymphomas, scabies, lice, and HIV infection.
Senile Pruritus
Aging-related xerosis can cause senile pruritus, often presenting as itching with scratch marks and dry skin. “This is a diagnosis of exclusion,” Delaunay insisted.
In older individuals with pruritus, initial examinations should include complete blood cell count (CBC), liver function tests, and thyroid-stimulating hormone levels. Syphilis serology, HIV testing, and beta-2 microglobulin levels are secondary evaluations. Renal function analysis may also be performed, and imaging may be required to investigate neoplasia.
“Annual etiological reassessment is essential if the initial evaluation is negative, as patients may later develop or report a neoplasia or hematological disorder,” Delaunay emphasized.
Paraneoplastic pruritus can occur, particularly those linked to hematological disorders (lymphomas, polycythemia, or myeloma).
Bullous Pemphigoid
Bullous pemphigoid often begins with pruritus, which can be severe and lead to insomnia. General practitioners should consider bullous pemphigoids when there is a bullous rash (tense blisters with citrine content) or an urticarial or chronic eczematous rash that does not heal spontaneously within a few days. The first-line biologic test to confirm the diagnosis is the CBC, which may reveal significant hypereosinophilia.
The diagnosis is confirmed by a skin biopsy showing a subepidermal blister with a preserved roof, unlike intraepidermal dermatoses, where the roof ruptures.
Direct immunofluorescence revealed deposits of immunoglobulin G antibodies along the dermoepidermal junction.
Approximately 40% of cases of bullous pemphigoid are associated with neurodegenerative diseases, such as stroke, parkinsonism, or dementia syndromes — occurring at a rate two to three times higher than in the general population.
It’s important to identify drugs that induce bullous pemphigoid, such as gliptins, anti-programmed cell death protein 1-programmed death-ligand 1 agents, loop diuretics (furosemide and bumetanide), anti-aldosterones (spironolactone), antiarrhythmics (amiodarone), and neuroleptics (phenothiazines).
“Stopping the medication is not mandatory if the bullous pemphigoid is well controlled by local or systemic treatments and the medication is essential. The decision to stop should be made on a case-by-case basis in consultation with the treating specialist,” Delaunay emphasized.
Treatment consists of very strong local corticosteroid therapy as the first-line treatment. If ineffective, systemic treatments based on methotrexate, oral corticosteroids, or immunomodulatory agents may be considered. Hospitalization is sometimes required.
Drug-Induced Pruritus
Drug-induced pruritus is common because older individuals often take multiple medications (antihypertensives, statins, oral hypoglycemics, psychotropic drugs, antiarrhythmics, etc.). “Sometimes, drug-induced pruritus can occur even if the medication was started several months or years ago,” Delaunay emphasized.
The lesions are generally nonspecific and scratching.
“This is a diagnosis of exclusion for other causes of pruritus. In the absence of specific lesions pointing to a dermatosis, eviction/reintroduction tests with treatments should be conducted one by one, which can be quite lengthy,” she explained.
Awareness for Scabies
Delaunay reminded attendees to consider scabies in older individuals when classic signs of pruritus flare up at night, with a rash affecting the face, scabs, or vesicles in the interdigital spaces of the hands, wrists, scrotal area, or the peri-mammary region.
“The incidence is increasing, particularly in nursing homes, where outbreaks pose a significant risk of rapid spread. Treatment involves three courses of topical and oral treatments administered on days 0, 7, and 14. All contact cases must also be treated. Sometimes, these thick lesions are stripped with 10% salicylated petroleum jelly. Environmental treatment with acaricides is essential, along with strict isolation measures,” Delaunay emphasized.
Adherent nits on the scalp or other hairy areas should raise suspicion of pediculosis.
Neurogenic and Psychogenic Origins
Neurogenic pruritus can occur during a stroke, presenting as contralateral pruritus, or in the presence of a brain tumor or following neurosurgery. Opioid-containing medications may also induce neurogenic pruritus.
The presence of unilateral painful or itchy sensations should prompt the investigation of shingles in older individuals.
Psychogenic pruritus is also common and can arise in the context of psychosis with parasitophobia or as part of anxiety-depression syndromes.
Supportive Measures
For managing pruritus, it is essential to:
- Keep nails trimmed short
- Wash with cold or lukewarm water
- Use lipid-rice soaps and syndets
- Avoid irritants, including antiseptics, cologne, no-rinse cleansers, and steroidal or nonsteroidal anti-inflammatory drugs
- Limit bathing frequency
- Avoid wearing nylon, wool, or tight clothing
- Minimize exposure to heat and excessive heating
“Alternatives to scratching, such as applying a moisturizing emollient, can be beneficial and may have a placebo effect,” explained the dermatologist. She further emphasized that local corticosteroids are effective only in the presence of inflammatory dermatosis and should not be applied to healthy skin. Similarly, antihistamines should only be prescribed if the pruritus is histamine-mediated.
Capsaicin may be useful in the treatment of localized neuropathic pruritus.
In cases of neurogenic pruritus, gabapentin and pregabalin may be prescribed, but tolerance can be problematic at this age. Other measures include acupuncture, cryotherapy, relaxation, hypnosis, psychotherapy, and music therapy. In cases of repeated therapeutic failure, patients may be treated with biotherapy (dupilumab) by a dermatologist.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Chronic pruritus is a common problem among older individuals. During a session at the Dermatology Days of Paris 2024 conference dedicated to general practitioners, Juliette Delaunay, MD, a dermatologist and venereologist at Angers University Hospital Center in Angers, France, and Gabrielle Lisembard, MD, a general practitioner in the French town Grand-Fort-Philippe, discussed diagnostic approaches and key principles for the therapeutic management of pruritus.
Identifying Causes
“Pruritus in older people is most often linked to physiological changes in the skin caused by aging, leading to significant xerosis. However, before attributing it to aging, we need to rule out several causes,” Delaunay noted.
Beyond simple aging, one must consider autoimmune bullous dermatoses (bullous pemphigoid), drug-related causes, metabolic disorders (can occur at any age), cutaneous T-cell lymphomas, scabies, lice, and HIV infection.
Senile Pruritus
Aging-related xerosis can cause senile pruritus, often presenting as itching with scratch marks and dry skin. “This is a diagnosis of exclusion,” Delaunay insisted.
In older individuals with pruritus, initial examinations should include complete blood cell count (CBC), liver function tests, and thyroid-stimulating hormone levels. Syphilis serology, HIV testing, and beta-2 microglobulin levels are secondary evaluations. Renal function analysis may also be performed, and imaging may be required to investigate neoplasia.
“Annual etiological reassessment is essential if the initial evaluation is negative, as patients may later develop or report a neoplasia or hematological disorder,” Delaunay emphasized.
Paraneoplastic pruritus can occur, particularly those linked to hematological disorders (lymphomas, polycythemia, or myeloma).
Bullous Pemphigoid
Bullous pemphigoid often begins with pruritus, which can be severe and lead to insomnia. General practitioners should consider bullous pemphigoids when there is a bullous rash (tense blisters with citrine content) or an urticarial or chronic eczematous rash that does not heal spontaneously within a few days. The first-line biologic test to confirm the diagnosis is the CBC, which may reveal significant hypereosinophilia.
The diagnosis is confirmed by a skin biopsy showing a subepidermal blister with a preserved roof, unlike intraepidermal dermatoses, where the roof ruptures.
Direct immunofluorescence revealed deposits of immunoglobulin G antibodies along the dermoepidermal junction.
Approximately 40% of cases of bullous pemphigoid are associated with neurodegenerative diseases, such as stroke, parkinsonism, or dementia syndromes — occurring at a rate two to three times higher than in the general population.
It’s important to identify drugs that induce bullous pemphigoid, such as gliptins, anti-programmed cell death protein 1-programmed death-ligand 1 agents, loop diuretics (furosemide and bumetanide), anti-aldosterones (spironolactone), antiarrhythmics (amiodarone), and neuroleptics (phenothiazines).
“Stopping the medication is not mandatory if the bullous pemphigoid is well controlled by local or systemic treatments and the medication is essential. The decision to stop should be made on a case-by-case basis in consultation with the treating specialist,” Delaunay emphasized.
Treatment consists of very strong local corticosteroid therapy as the first-line treatment. If ineffective, systemic treatments based on methotrexate, oral corticosteroids, or immunomodulatory agents may be considered. Hospitalization is sometimes required.
Drug-Induced Pruritus
Drug-induced pruritus is common because older individuals often take multiple medications (antihypertensives, statins, oral hypoglycemics, psychotropic drugs, antiarrhythmics, etc.). “Sometimes, drug-induced pruritus can occur even if the medication was started several months or years ago,” Delaunay emphasized.
The lesions are generally nonspecific and scratching.
“This is a diagnosis of exclusion for other causes of pruritus. In the absence of specific lesions pointing to a dermatosis, eviction/reintroduction tests with treatments should be conducted one by one, which can be quite lengthy,” she explained.
Awareness for Scabies
Delaunay reminded attendees to consider scabies in older individuals when classic signs of pruritus flare up at night, with a rash affecting the face, scabs, or vesicles in the interdigital spaces of the hands, wrists, scrotal area, or the peri-mammary region.
“The incidence is increasing, particularly in nursing homes, where outbreaks pose a significant risk of rapid spread. Treatment involves three courses of topical and oral treatments administered on days 0, 7, and 14. All contact cases must also be treated. Sometimes, these thick lesions are stripped with 10% salicylated petroleum jelly. Environmental treatment with acaricides is essential, along with strict isolation measures,” Delaunay emphasized.
Adherent nits on the scalp or other hairy areas should raise suspicion of pediculosis.
Neurogenic and Psychogenic Origins
Neurogenic pruritus can occur during a stroke, presenting as contralateral pruritus, or in the presence of a brain tumor or following neurosurgery. Opioid-containing medications may also induce neurogenic pruritus.
The presence of unilateral painful or itchy sensations should prompt the investigation of shingles in older individuals.
Psychogenic pruritus is also common and can arise in the context of psychosis with parasitophobia or as part of anxiety-depression syndromes.
Supportive Measures
For managing pruritus, it is essential to:
- Keep nails trimmed short
- Wash with cold or lukewarm water
- Use lipid-rice soaps and syndets
- Avoid irritants, including antiseptics, cologne, no-rinse cleansers, and steroidal or nonsteroidal anti-inflammatory drugs
- Limit bathing frequency
- Avoid wearing nylon, wool, or tight clothing
- Minimize exposure to heat and excessive heating
“Alternatives to scratching, such as applying a moisturizing emollient, can be beneficial and may have a placebo effect,” explained the dermatologist. She further emphasized that local corticosteroids are effective only in the presence of inflammatory dermatosis and should not be applied to healthy skin. Similarly, antihistamines should only be prescribed if the pruritus is histamine-mediated.
Capsaicin may be useful in the treatment of localized neuropathic pruritus.
In cases of neurogenic pruritus, gabapentin and pregabalin may be prescribed, but tolerance can be problematic at this age. Other measures include acupuncture, cryotherapy, relaxation, hypnosis, psychotherapy, and music therapy. In cases of repeated therapeutic failure, patients may be treated with biotherapy (dupilumab) by a dermatologist.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Chronic pruritus is a common problem among older individuals. During a session at the Dermatology Days of Paris 2024 conference dedicated to general practitioners, Juliette Delaunay, MD, a dermatologist and venereologist at Angers University Hospital Center in Angers, France, and Gabrielle Lisembard, MD, a general practitioner in the French town Grand-Fort-Philippe, discussed diagnostic approaches and key principles for the therapeutic management of pruritus.
Identifying Causes
“Pruritus in older people is most often linked to physiological changes in the skin caused by aging, leading to significant xerosis. However, before attributing it to aging, we need to rule out several causes,” Delaunay noted.
Beyond simple aging, one must consider autoimmune bullous dermatoses (bullous pemphigoid), drug-related causes, metabolic disorders (can occur at any age), cutaneous T-cell lymphomas, scabies, lice, and HIV infection.
Senile Pruritus
Aging-related xerosis can cause senile pruritus, often presenting as itching with scratch marks and dry skin. “This is a diagnosis of exclusion,” Delaunay insisted.
In older individuals with pruritus, initial examinations should include complete blood cell count (CBC), liver function tests, and thyroid-stimulating hormone levels. Syphilis serology, HIV testing, and beta-2 microglobulin levels are secondary evaluations. Renal function analysis may also be performed, and imaging may be required to investigate neoplasia.
“Annual etiological reassessment is essential if the initial evaluation is negative, as patients may later develop or report a neoplasia or hematological disorder,” Delaunay emphasized.
Paraneoplastic pruritus can occur, particularly those linked to hematological disorders (lymphomas, polycythemia, or myeloma).
Bullous Pemphigoid
Bullous pemphigoid often begins with pruritus, which can be severe and lead to insomnia. General practitioners should consider bullous pemphigoids when there is a bullous rash (tense blisters with citrine content) or an urticarial or chronic eczematous rash that does not heal spontaneously within a few days. The first-line biologic test to confirm the diagnosis is the CBC, which may reveal significant hypereosinophilia.
The diagnosis is confirmed by a skin biopsy showing a subepidermal blister with a preserved roof, unlike intraepidermal dermatoses, where the roof ruptures.
Direct immunofluorescence revealed deposits of immunoglobulin G antibodies along the dermoepidermal junction.
Approximately 40% of cases of bullous pemphigoid are associated with neurodegenerative diseases, such as stroke, parkinsonism, or dementia syndromes — occurring at a rate two to three times higher than in the general population.
It’s important to identify drugs that induce bullous pemphigoid, such as gliptins, anti-programmed cell death protein 1-programmed death-ligand 1 agents, loop diuretics (furosemide and bumetanide), anti-aldosterones (spironolactone), antiarrhythmics (amiodarone), and neuroleptics (phenothiazines).
“Stopping the medication is not mandatory if the bullous pemphigoid is well controlled by local or systemic treatments and the medication is essential. The decision to stop should be made on a case-by-case basis in consultation with the treating specialist,” Delaunay emphasized.
Treatment consists of very strong local corticosteroid therapy as the first-line treatment. If ineffective, systemic treatments based on methotrexate, oral corticosteroids, or immunomodulatory agents may be considered. Hospitalization is sometimes required.
Drug-Induced Pruritus
Drug-induced pruritus is common because older individuals often take multiple medications (antihypertensives, statins, oral hypoglycemics, psychotropic drugs, antiarrhythmics, etc.). “Sometimes, drug-induced pruritus can occur even if the medication was started several months or years ago,” Delaunay emphasized.
The lesions are generally nonspecific and scratching.
“This is a diagnosis of exclusion for other causes of pruritus. In the absence of specific lesions pointing to a dermatosis, eviction/reintroduction tests with treatments should be conducted one by one, which can be quite lengthy,” she explained.
Awareness for Scabies
Delaunay reminded attendees to consider scabies in older individuals when classic signs of pruritus flare up at night, with a rash affecting the face, scabs, or vesicles in the interdigital spaces of the hands, wrists, scrotal area, or the peri-mammary region.
“The incidence is increasing, particularly in nursing homes, where outbreaks pose a significant risk of rapid spread. Treatment involves three courses of topical and oral treatments administered on days 0, 7, and 14. All contact cases must also be treated. Sometimes, these thick lesions are stripped with 10% salicylated petroleum jelly. Environmental treatment with acaricides is essential, along with strict isolation measures,” Delaunay emphasized.
Adherent nits on the scalp or other hairy areas should raise suspicion of pediculosis.
Neurogenic and Psychogenic Origins
Neurogenic pruritus can occur during a stroke, presenting as contralateral pruritus, or in the presence of a brain tumor or following neurosurgery. Opioid-containing medications may also induce neurogenic pruritus.
The presence of unilateral painful or itchy sensations should prompt the investigation of shingles in older individuals.
Psychogenic pruritus is also common and can arise in the context of psychosis with parasitophobia or as part of anxiety-depression syndromes.
Supportive Measures
For managing pruritus, it is essential to:
- Keep nails trimmed short
- Wash with cold or lukewarm water
- Use lipid-rice soaps and syndets
- Avoid irritants, including antiseptics, cologne, no-rinse cleansers, and steroidal or nonsteroidal anti-inflammatory drugs
- Limit bathing frequency
- Avoid wearing nylon, wool, or tight clothing
- Minimize exposure to heat and excessive heating
“Alternatives to scratching, such as applying a moisturizing emollient, can be beneficial and may have a placebo effect,” explained the dermatologist. She further emphasized that local corticosteroids are effective only in the presence of inflammatory dermatosis and should not be applied to healthy skin. Similarly, antihistamines should only be prescribed if the pruritus is histamine-mediated.
Capsaicin may be useful in the treatment of localized neuropathic pruritus.
In cases of neurogenic pruritus, gabapentin and pregabalin may be prescribed, but tolerance can be problematic at this age. Other measures include acupuncture, cryotherapy, relaxation, hypnosis, psychotherapy, and music therapy. In cases of repeated therapeutic failure, patients may be treated with biotherapy (dupilumab) by a dermatologist.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Break the Itch-Scratch Cycle to Treat Prurigo Nodularis
Break the Itch-Scratch Cycle to Treat Prurigo Nodularis
Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6
PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

Epidemiology
PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5
Key Clinical Features
Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4
Worth Noting
Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.
Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4
Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15
The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.
Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.
Health Disparity Highlight
Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20
- Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
- Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
- Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
- Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
- Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
- Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
- Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
- Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
- Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
- Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
- Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
- Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
- Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
- Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
- Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
- Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
- Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
- Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
- Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
- Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6
PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

Epidemiology
PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5
Key Clinical Features
Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4
Worth Noting
Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.
Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4
Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15
The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.
Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.
Health Disparity Highlight
Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20
Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by firm hyperkeratotic nodules that develops when patients persistently scratch or rub intensely itchy areas of the skin. This potent itch-scratch cycle can be traced back to a dysfunctional interplay between cutaneous nerve fibers and the local immune environment.1-3 Pruritis lasting at least 6 weeks is a hallmark symptom of PN and can be accompanied by pain and/or a burning sensation.4 The lesions are symmetrically distributed in areas that are easy to scratch (eg, arms, legs, trunk), typically sparing the face, palms, and soles; however, facial lesions have been reported in pediatric patients with PN, who also are more likely to have back, hand, and foot involvement.5,6
PN can greatly affect patients’ quality of life, leading to increased rates of depression and anxiety.7-9 Patients with severe symptoms also report increased sleep disturbance, distraction from work, selfconsciousness leading to social isolation, and missed days of work/school.9 In one study, patients with PN reported missing at least 1 day of work, school, training, or learning; giving up a leisure activity or sport; or refusing an invitation to dinner or a party in the past 3 months due to the disease.10

Epidemiology
PN has a prevalence of 72 per 100,000 individuals in the United States, most commonly affecting adults aged 51 to 65 years and disproportionately affecting African American and female patients.11-13 Most patients with PN experience a 2-year delay in diagnosis after initial onset of symptoms. 10 Adults with PN have an increased likelihood of having other dermatologic conditions, including atopic dermatitis (AD) and psoriasis.11 Nearly two-thirds of pediatric patients with PN present with AD, and those with AD showed more resistance to first-line treatment options.5
Key Clinical Features
Compared to White patients, who typically present with lesions that appear erythematous or pink, patients with darker skin tones may present with hyperpigmented nodules that are larger and darker.12 The pruritic nodules often show signs of scratching or picking (eg, excoriations, lichenification, and angulated erosions).4
Worth Noting
Diagnosis of PN is made clinically, but skin biopsy may be helpful to rule out alternative diseases. Histologically, the hairy palm sign may be present in addition to other histologic features commonly associated with excessive scratching or rubbing of the skin.
Patients with PN have a high risk for HIV, which is not surprising considering HIV is a known systemic cause of generalized chronic pruritus. Other associations include type 2 diabetes mellitus and thyroid, kidney, and liver disease. 11,13 Workup for patients with PN should include a complete blood count with differential; liver and renal function testing; and testing for C-reactive protein, thyroid-stimulating hormone, and lactate dehydrogenase.4,14 Hemoglobin A1c and HIV testing as well as a hepatitis panel should be considered when appropriate. Because generalized pruritus may be a sign of malignancy, chest radiography and lymph node and abdominal ultrasonography should be performed in patients who have experienced itch for less than 1 year along with B symptoms (fever, night sweats, ≥ 10% weight loss over 6 months, fatigue).14 Frequent scratching can disrupt the skin barrier, contributing to the increased risk for skin infections.13 All patients with a suspected PN diagnosis also should undergo screening for depression and anxiety, as patients with PN are at an increased risk for these conditions.4
Treatment of PN starts with breaking the itch-scratch cycle by addressing the underlying cause of the pruritus. Therapies are focused on addressing the immunologic and neural components of the disease. Topical treatments include moderate to strong corticosteroids, calcineurin inhibitors (tacrolimus or pimecrolimus), capsaicin, and antipruritic emollients. Systemic agents include phototherapy (narrow-band UVB or excimer laser), gabapentin, pregabalin, paroxetine, and amitriptyline to address the neural component of itch. Methotrexate or cyclosporine can be used to address the immunologic component of PN and diminish the itch. That said, methotrexate and cyclosporine often are inadequate to control pruritus. 10 Of note, sedating antihistamines are not effective in treating itch in PN but can be used as an adjuvant therapy for sleep disturbances in these patients.15
The only drugs currently approved by the US Food and Drug Administration to treat PN are the biologics dupilumab (targeting the IL-4 receptor) approved in 2022 and nemolizumab (targeting the IL-31 receptor) approved in 2024.16-18 The evidence that these injectable biologics work is heartening in a condition that has historically been very challenging to treat.16,18 It should be noted that the high cost of these 2 medications can restrict access to care for patients who are uninsured or underinsured.
Resolution of a prurigo nodule may result in a hyperpigmented macule taking months to years to fade.
Health Disparity Highlight
Patients with PN have a considerable comorbidity burden, negative impact on quality of life, and increased health care utilization rates.12 PN is 3.4 times more common in Black patients than White patients.13 Black patients with PN have increased mortality, higher health care utilization rates, and increased systemic inflammation compared to White patients.12,19,20
- Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
- Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
- Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
- Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
- Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
- Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
- Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
- Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
- Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
- Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
- Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
- Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
- Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
- Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
- Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
- Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
- Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
- Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
- Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
- Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
- Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron– expressed IL-31 receptor mediates T helper cell–dependent itch: involvement of TRPV1 and TRPA1. J Allergy Clin Immunol. 2014;133:448-460.
- Lou H, Lu J, Choi EB, et al. Expression of IL-22 in the skin causes Th2-biased immunity, epidermal barrier dysfunction, and pruritus via stimulating epithelial Th2 cytokines and the GRP pathway. J Immunol. 2017;198:2543-2555.
- Sutaria N, Adawi W, Goldberg R, et al. Itch: pathogenesis and treatment. J Am Acad Dermatol. 2022;86:17-34.
- Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84:747-760.
- Kyvayko R, Fachler-Sharp T, Greenberger S, et al. Characterization of paediatric prurigo nodularis: a multicentre retrospective, observational study. Acta Derm Venereol. 2024;104:adv15771.
- Aggarwal P, Choi J, Sutaria N, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46:1277-1284.
- Whang KA, Le TK, Khanna R, et al. Health-related quality of life and economic burden of prurigo nodularis. J Am Acad Dermatol. 2022;86:573-580.
- Jørgensen KM, Egeberg A, Gislason GH, et al. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol. 2017;31:E106-E107.
- Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159:1205-1212.
- Misery L, Patras de Campaigno C, Taieb C, et al. Impact of chronic prurigo nodularis on daily life and stigmatization. J Eur Acad Dermatol Venereol. 2023;37:E908-E909.
- Huang AH, Canner JK, Khanna R, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140:480-483.e4.
- Sutaria N, Adawi W, Brown I, et al. Racial disparities in mortality among patients with prurigo nodularis: a multicenter cohort study. J Am Acad Dermatol. 2022;82:487- 490.
- Boozalis E, Tang O, Patel S, et al. Ethnic differences and comorbidities of 909 prurigo nodularis patients. J Am Acad Dermatol. 2018;79:714-719.e3.
- Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. Am J Clin Dermatol. 2024;25:15-33.
- Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14:67-77.
- Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-1589.
- Beck KM, Yang EJ, Sekhon S, et al. Dupilumab treatment for generalized prurigo nodularis. JAMA Dermatol. 2019;155:118-120.
- Yosipovitch G, Mollanazar N, Ständer S, et al. Dupilumab in patients with prurigo nodularis: two randomized, double- blind, placebo- controlled phase 3 trials. Nat Med. 2023;29:1180-1190.
- Wongvibulsin S, Sutaria N, Williams KA, et al. A nationwide study of prurigo nodularis: disease burden and healthcare utilization in the United States. J Invest Dermatol. 2021;141:2530-2533.e1.
- Sutaria N, Alphonse MP, Marani M, et al. Cluster analysis of circulating plasma biomarkers in prurigo nodularis reveals a distinct systemic inflammatory signature in African Americans. J Invest Dermatol. 2022;142:1300-1308.e3.
Break the Itch-Scratch Cycle to Treat Prurigo Nodularis
Break the Itch-Scratch Cycle to Treat Prurigo Nodularis
Cardiac Risks of Newer Psoriasis Biologics vs. TNF Inhibitors Compared
TOPLINE:
The newer biologics — .
METHODOLOGY:
- In a retrospective cohort study, researchers conducted an emulated target trial analysis using data of 32,098 biologic-naive patients with psoriasis or PsA who were treated with one of the newer biologics (infliximab, adalimumab, etanercept, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, risankizumab, guselkumab, and tildrakizumab) from the TriNetX Research Network between 2014 and 2022.
- Patients received TNF inhibitors (n = 20,314), IL-17 inhibitors (n = 5073), IL-12/23 inhibitors (n = 3573), or IL-23 inhibitors (n = 3138).
- A propensity-matched analysis compared each class of newer biologics with TNF inhibitors, adjusting for demographics, comorbidities, and medication use.
- The primary outcomes were major adverse cardiovascular events (MACE; myocardial infarction and stroke) or venous thromboembolic events (VTE).
TAKEAWAY:
- Compared with patients who received TNF inhibitors, the risk for MACE was not significantly different between patients who received IL-17 inhibitors (incidence rate ratio [IRR], 1.14; 95% CI, 0.86-1.52), IL-12/23 inhibitors (IRR, 1.24; 95% CI, 0.84-1.78), or IL-23 inhibitors (IRR, 0.93; 95% CI, 0.61-1.38)
- The VTE risk was also not significantly different between patients who received IL-17 inhibitors (IRR, 1.12; 95% CI, 0.63-2.08), IL-12/23 inhibitors (IRR, 1.51; 95% CI, 0.73-3.19), or IL-23 inhibitors (IRR, 1.42; 95% CI, 0.64-3.25) compared with those who received TNF inhibitors.
- Subgroup analyses for psoriasis or psoriatic arthritis alone confirmed consistent findings.
- Patients with preexisting hyperlipidemia and diabetes mellitus showed lower risks for MACE and VTE with newer biologics compared with TNF inhibitors.
IN PRACTICE:
“No significant MACE and VTE risk differences were detected in patients with psoriasis or PsA between those receiving IL-17, IL-12/23, and IL-23 inhibitors and those with TNF inhibitors,” the authors concluded. These findings, they added “can be considered by physicians and patients when making treatment decisions” and also provide “evidence for future pharmacovigilance studies.”
SOURCE:
The study was led by Tai-Li Chen, MD, of the Department of Dermatology, Taipei Veterans General Hospital in Taipei, Taiwan. It was published online on December 27, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Study limitations included potential residual confounding factors, lack of information on disease severity, and inclusion of predominantly White individuals.
DISCLOSURES:
The study received support from Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The newer biologics — .
METHODOLOGY:
- In a retrospective cohort study, researchers conducted an emulated target trial analysis using data of 32,098 biologic-naive patients with psoriasis or PsA who were treated with one of the newer biologics (infliximab, adalimumab, etanercept, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, risankizumab, guselkumab, and tildrakizumab) from the TriNetX Research Network between 2014 and 2022.
- Patients received TNF inhibitors (n = 20,314), IL-17 inhibitors (n = 5073), IL-12/23 inhibitors (n = 3573), or IL-23 inhibitors (n = 3138).
- A propensity-matched analysis compared each class of newer biologics with TNF inhibitors, adjusting for demographics, comorbidities, and medication use.
- The primary outcomes were major adverse cardiovascular events (MACE; myocardial infarction and stroke) or venous thromboembolic events (VTE).
TAKEAWAY:
- Compared with patients who received TNF inhibitors, the risk for MACE was not significantly different between patients who received IL-17 inhibitors (incidence rate ratio [IRR], 1.14; 95% CI, 0.86-1.52), IL-12/23 inhibitors (IRR, 1.24; 95% CI, 0.84-1.78), or IL-23 inhibitors (IRR, 0.93; 95% CI, 0.61-1.38)
- The VTE risk was also not significantly different between patients who received IL-17 inhibitors (IRR, 1.12; 95% CI, 0.63-2.08), IL-12/23 inhibitors (IRR, 1.51; 95% CI, 0.73-3.19), or IL-23 inhibitors (IRR, 1.42; 95% CI, 0.64-3.25) compared with those who received TNF inhibitors.
- Subgroup analyses for psoriasis or psoriatic arthritis alone confirmed consistent findings.
- Patients with preexisting hyperlipidemia and diabetes mellitus showed lower risks for MACE and VTE with newer biologics compared with TNF inhibitors.
IN PRACTICE:
“No significant MACE and VTE risk differences were detected in patients with psoriasis or PsA between those receiving IL-17, IL-12/23, and IL-23 inhibitors and those with TNF inhibitors,” the authors concluded. These findings, they added “can be considered by physicians and patients when making treatment decisions” and also provide “evidence for future pharmacovigilance studies.”
SOURCE:
The study was led by Tai-Li Chen, MD, of the Department of Dermatology, Taipei Veterans General Hospital in Taipei, Taiwan. It was published online on December 27, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Study limitations included potential residual confounding factors, lack of information on disease severity, and inclusion of predominantly White individuals.
DISCLOSURES:
The study received support from Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The newer biologics — .
METHODOLOGY:
- In a retrospective cohort study, researchers conducted an emulated target trial analysis using data of 32,098 biologic-naive patients with psoriasis or PsA who were treated with one of the newer biologics (infliximab, adalimumab, etanercept, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, risankizumab, guselkumab, and tildrakizumab) from the TriNetX Research Network between 2014 and 2022.
- Patients received TNF inhibitors (n = 20,314), IL-17 inhibitors (n = 5073), IL-12/23 inhibitors (n = 3573), or IL-23 inhibitors (n = 3138).
- A propensity-matched analysis compared each class of newer biologics with TNF inhibitors, adjusting for demographics, comorbidities, and medication use.
- The primary outcomes were major adverse cardiovascular events (MACE; myocardial infarction and stroke) or venous thromboembolic events (VTE).
TAKEAWAY:
- Compared with patients who received TNF inhibitors, the risk for MACE was not significantly different between patients who received IL-17 inhibitors (incidence rate ratio [IRR], 1.14; 95% CI, 0.86-1.52), IL-12/23 inhibitors (IRR, 1.24; 95% CI, 0.84-1.78), or IL-23 inhibitors (IRR, 0.93; 95% CI, 0.61-1.38)
- The VTE risk was also not significantly different between patients who received IL-17 inhibitors (IRR, 1.12; 95% CI, 0.63-2.08), IL-12/23 inhibitors (IRR, 1.51; 95% CI, 0.73-3.19), or IL-23 inhibitors (IRR, 1.42; 95% CI, 0.64-3.25) compared with those who received TNF inhibitors.
- Subgroup analyses for psoriasis or psoriatic arthritis alone confirmed consistent findings.
- Patients with preexisting hyperlipidemia and diabetes mellitus showed lower risks for MACE and VTE with newer biologics compared with TNF inhibitors.
IN PRACTICE:
“No significant MACE and VTE risk differences were detected in patients with psoriasis or PsA between those receiving IL-17, IL-12/23, and IL-23 inhibitors and those with TNF inhibitors,” the authors concluded. These findings, they added “can be considered by physicians and patients when making treatment decisions” and also provide “evidence for future pharmacovigilance studies.”
SOURCE:
The study was led by Tai-Li Chen, MD, of the Department of Dermatology, Taipei Veterans General Hospital in Taipei, Taiwan. It was published online on December 27, 2024, in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Study limitations included potential residual confounding factors, lack of information on disease severity, and inclusion of predominantly White individuals.
DISCLOSURES:
The study received support from Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Online CBT for Patients with AD: Self-Guided vs. Clinician-Guided Intervention Compared
TOPLINE:
A brief on the Patient-Oriented Eczema Measure (POEM).
METHODOLOGY:
- Researchers conducted a single-blind randomized clinical noninferiority trial at Karolinska Institutet in Stockholm, Sweden, enrolling 168 adults with AD (mean age, 39 years; 84.5% women) from November 2022 to April 2023.
- Participants were randomly assigned to either a 12-week self-guided online CBT intervention (n = 86) without clinician support or a comprehensive 12-week clinician-guided online CBT program (n = 82).
- The primary outcome was the change in POEM score from baseline; reduction of 4 or more points was considered a response, and the predefined noninferiority margin was 3 points.
TAKEAWAY:
- The clinician-guided group improved by 4.20 points on POEM, while the self-guided group improved by 4.60 points, with an estimated mean difference in change of 0.36 points, which was below noninferiority margin.
- Clinicians spent a mean of 36 minutes on treatment guidance and an additional 14 minutes on assessments in the clinician-guided group, whereas they spent only 15.8 minutes on assessments in the self-guided group.
- Both groups demonstrated significant improvements in quality of life, sleep, depressive mood, pruritus, and stress, with no serious adverse events being reported.
- Completion rates were higher in the self-guided group with 81% of participants completing five or more modules, compared with 67% in the clinician-guided group.
IN PRACTICE:
“Overall, the findings support a self-guided intervention as a noninferior and cost-effective alternative to a previously evaluated clinician-guided treatment,” the authors wrote. “Because psychological interventions are rare in dermatological care, this study is an important step toward implementation of CBT for people with AD. The effectiveness of CBT interventions in primary and dermatological specialist care should be investigated.”
SOURCE:
The study was led by Dorian Kern, PhD, Division of Psychology, Karolinska Institutet, and was published online in JAMA Dermatology.
LIMITATIONS:
High data loss for secondary measurements could affect interpretation of these results. The study relied solely on self-reported measures. The predominance of women participants and the Swedish-language requirement may have limited participation from migrant populations, which could hinder the broader implementation of the study’s findings.
DISCLOSURES:
The study was supported by the Swedish Ministry of Health and Social Affairs. Kern reported receiving grants from the Swedish Ministry of Health and Social Affairs during the conduct of the study. Other authors also reported authorships and royalties, personal fees, grants, or held stocks in DahliaQomit.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A brief on the Patient-Oriented Eczema Measure (POEM).
METHODOLOGY:
- Researchers conducted a single-blind randomized clinical noninferiority trial at Karolinska Institutet in Stockholm, Sweden, enrolling 168 adults with AD (mean age, 39 years; 84.5% women) from November 2022 to April 2023.
- Participants were randomly assigned to either a 12-week self-guided online CBT intervention (n = 86) without clinician support or a comprehensive 12-week clinician-guided online CBT program (n = 82).
- The primary outcome was the change in POEM score from baseline; reduction of 4 or more points was considered a response, and the predefined noninferiority margin was 3 points.
TAKEAWAY:
- The clinician-guided group improved by 4.20 points on POEM, while the self-guided group improved by 4.60 points, with an estimated mean difference in change of 0.36 points, which was below noninferiority margin.
- Clinicians spent a mean of 36 minutes on treatment guidance and an additional 14 minutes on assessments in the clinician-guided group, whereas they spent only 15.8 minutes on assessments in the self-guided group.
- Both groups demonstrated significant improvements in quality of life, sleep, depressive mood, pruritus, and stress, with no serious adverse events being reported.
- Completion rates were higher in the self-guided group with 81% of participants completing five or more modules, compared with 67% in the clinician-guided group.
IN PRACTICE:
“Overall, the findings support a self-guided intervention as a noninferior and cost-effective alternative to a previously evaluated clinician-guided treatment,” the authors wrote. “Because psychological interventions are rare in dermatological care, this study is an important step toward implementation of CBT for people with AD. The effectiveness of CBT interventions in primary and dermatological specialist care should be investigated.”
SOURCE:
The study was led by Dorian Kern, PhD, Division of Psychology, Karolinska Institutet, and was published online in JAMA Dermatology.
LIMITATIONS:
High data loss for secondary measurements could affect interpretation of these results. The study relied solely on self-reported measures. The predominance of women participants and the Swedish-language requirement may have limited participation from migrant populations, which could hinder the broader implementation of the study’s findings.
DISCLOSURES:
The study was supported by the Swedish Ministry of Health and Social Affairs. Kern reported receiving grants from the Swedish Ministry of Health and Social Affairs during the conduct of the study. Other authors also reported authorships and royalties, personal fees, grants, or held stocks in DahliaQomit.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A brief on the Patient-Oriented Eczema Measure (POEM).
METHODOLOGY:
- Researchers conducted a single-blind randomized clinical noninferiority trial at Karolinska Institutet in Stockholm, Sweden, enrolling 168 adults with AD (mean age, 39 years; 84.5% women) from November 2022 to April 2023.
- Participants were randomly assigned to either a 12-week self-guided online CBT intervention (n = 86) without clinician support or a comprehensive 12-week clinician-guided online CBT program (n = 82).
- The primary outcome was the change in POEM score from baseline; reduction of 4 or more points was considered a response, and the predefined noninferiority margin was 3 points.
TAKEAWAY:
- The clinician-guided group improved by 4.20 points on POEM, while the self-guided group improved by 4.60 points, with an estimated mean difference in change of 0.36 points, which was below noninferiority margin.
- Clinicians spent a mean of 36 minutes on treatment guidance and an additional 14 minutes on assessments in the clinician-guided group, whereas they spent only 15.8 minutes on assessments in the self-guided group.
- Both groups demonstrated significant improvements in quality of life, sleep, depressive mood, pruritus, and stress, with no serious adverse events being reported.
- Completion rates were higher in the self-guided group with 81% of participants completing five or more modules, compared with 67% in the clinician-guided group.
IN PRACTICE:
“Overall, the findings support a self-guided intervention as a noninferior and cost-effective alternative to a previously evaluated clinician-guided treatment,” the authors wrote. “Because psychological interventions are rare in dermatological care, this study is an important step toward implementation of CBT for people with AD. The effectiveness of CBT interventions in primary and dermatological specialist care should be investigated.”
SOURCE:
The study was led by Dorian Kern, PhD, Division of Psychology, Karolinska Institutet, and was published online in JAMA Dermatology.
LIMITATIONS:
High data loss for secondary measurements could affect interpretation of these results. The study relied solely on self-reported measures. The predominance of women participants and the Swedish-language requirement may have limited participation from migrant populations, which could hinder the broader implementation of the study’s findings.
DISCLOSURES:
The study was supported by the Swedish Ministry of Health and Social Affairs. Kern reported receiving grants from the Swedish Ministry of Health and Social Affairs during the conduct of the study. Other authors also reported authorships and royalties, personal fees, grants, or held stocks in DahliaQomit.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Central Line Skin Reactions in Children: Survey Addresses Treatment Protocols in Use
TOPLINE:
A and reported varying management approaches.
METHODOLOGY:
- Researchers developed and administered a 14-item Qualtrics survey to 107 dermatologists providing pediatric inpatient care through the Society for Pediatric Dermatology’s Inpatient Dermatology Section and Section Chief email lists.
- A total of 35 dermatologists (33%) from multiple institutions responded to the survey; most respondents (94%) specialized in pediatric dermatology.
- Researchers assessed management of CLD-associated adverse skin reactions.
TAKEAWAY:
- All respondents reported receiving CLD-related consults, but 66% indicated there was no personal or institutional standardized approach for managing CLD-associated skin reactions.
- Respondents said most reactions were in children aged 1-12 years (19 or 76% of 25 respondents) compared with those aged < 1 year (3 or 12% of 25 respondents).
- Management strategies included switching to alternative products, applying topical corticosteroids, and performing patch testing for allergies.
IN PRACTICE:
“Insights derived from this study, including variation in clinician familiarity with reaction patterns, underscore the necessity of a standardized protocol for classifying and managing cutaneous CLD reactions in pediatric patients,” the authors wrote. “Further investigation is needed to better characterize CLD-associated allergic CD [contact dermatitis], irritant CD, and skin infections, as well as at-risk populations, to better inform clinical approaches,” they added.
SOURCE:
The study was led by Carly Mulinda, Columbia University College of Physicians and Surgeons, New York, and was published online on December 16 in Pediatric Dermatology.
LIMITATIONS:
The authors noted variable respondent awareness of institutional CLD and potential recency bias as key limitations of the study.
DISCLOSURES:
Study funding source was not declared. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A and reported varying management approaches.
METHODOLOGY:
- Researchers developed and administered a 14-item Qualtrics survey to 107 dermatologists providing pediatric inpatient care through the Society for Pediatric Dermatology’s Inpatient Dermatology Section and Section Chief email lists.
- A total of 35 dermatologists (33%) from multiple institutions responded to the survey; most respondents (94%) specialized in pediatric dermatology.
- Researchers assessed management of CLD-associated adverse skin reactions.
TAKEAWAY:
- All respondents reported receiving CLD-related consults, but 66% indicated there was no personal or institutional standardized approach for managing CLD-associated skin reactions.
- Respondents said most reactions were in children aged 1-12 years (19 or 76% of 25 respondents) compared with those aged < 1 year (3 or 12% of 25 respondents).
- Management strategies included switching to alternative products, applying topical corticosteroids, and performing patch testing for allergies.
IN PRACTICE:
“Insights derived from this study, including variation in clinician familiarity with reaction patterns, underscore the necessity of a standardized protocol for classifying and managing cutaneous CLD reactions in pediatric patients,” the authors wrote. “Further investigation is needed to better characterize CLD-associated allergic CD [contact dermatitis], irritant CD, and skin infections, as well as at-risk populations, to better inform clinical approaches,” they added.
SOURCE:
The study was led by Carly Mulinda, Columbia University College of Physicians and Surgeons, New York, and was published online on December 16 in Pediatric Dermatology.
LIMITATIONS:
The authors noted variable respondent awareness of institutional CLD and potential recency bias as key limitations of the study.
DISCLOSURES:
Study funding source was not declared. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A and reported varying management approaches.
METHODOLOGY:
- Researchers developed and administered a 14-item Qualtrics survey to 107 dermatologists providing pediatric inpatient care through the Society for Pediatric Dermatology’s Inpatient Dermatology Section and Section Chief email lists.
- A total of 35 dermatologists (33%) from multiple institutions responded to the survey; most respondents (94%) specialized in pediatric dermatology.
- Researchers assessed management of CLD-associated adverse skin reactions.
TAKEAWAY:
- All respondents reported receiving CLD-related consults, but 66% indicated there was no personal or institutional standardized approach for managing CLD-associated skin reactions.
- Respondents said most reactions were in children aged 1-12 years (19 or 76% of 25 respondents) compared with those aged < 1 year (3 or 12% of 25 respondents).
- Management strategies included switching to alternative products, applying topical corticosteroids, and performing patch testing for allergies.
IN PRACTICE:
“Insights derived from this study, including variation in clinician familiarity with reaction patterns, underscore the necessity of a standardized protocol for classifying and managing cutaneous CLD reactions in pediatric patients,” the authors wrote. “Further investigation is needed to better characterize CLD-associated allergic CD [contact dermatitis], irritant CD, and skin infections, as well as at-risk populations, to better inform clinical approaches,” they added.
SOURCE:
The study was led by Carly Mulinda, Columbia University College of Physicians and Surgeons, New York, and was published online on December 16 in Pediatric Dermatology.
LIMITATIONS:
The authors noted variable respondent awareness of institutional CLD and potential recency bias as key limitations of the study.
DISCLOSURES:
Study funding source was not declared. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Axolotl Salamander Holds Potential for Cosmeceuticals, Wound Healing
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
Allergic Contact Dermatitis: New Culprits
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Skin Cancer Risk Elevated Among Blood, Marrow Transplant Survivors
TOPLINE:
with a cumulative incidence of 27.4% over 30 years, according to the results of a cohort study.
METHODOLOGY:
- The retrospective cohort study included 3880 BMT survivors (median age, 44 years; 55.8% men; 4.9% Black, 12.1 Hispanic, and 74.7% non-Hispanic White individuals) who underwent transplant between 1974 to 2014.
- Participants completed the BMT Survivor Study survey and were followed up for a median of 9.5 years.
- The primary outcomes were the development of subsequent cutaneous malignant neoplasms (BCC, SCC, or melanoma).
TAKEAWAY:
- The 30-year cumulative incidence of any cutaneous malignant neoplasm was 27.4% — 18% for BCC, 9.8% for SCC, and 3.7% for melanoma.
- A higher risk for skin cancer was reported for patients aged 50 years or more (subdistribution hazard ratio [SHR], 2.23; 95% CI, 1.83-2.71), and men (SHR, 1.40; 95% CI, 1.18-1.65).
- Allogeneic BMT with chronic graft-vs-host disease (cGVHD) increased the risk for skin cancer (SHR, 1.84; 95% CI, 1.37-2.47), compared with autologous BMT, while post-BMT immunosuppression increased risk for all types (overall SHR, 1.53; 95% CI, 1.26-1.86).
- The risk for any skin cancer was significantly lower in Black individuals (SHR, 0.14; 95% CI, 0.05-0.37), Hispanic individuals (SHR, 0.29; 95%CI, 0.20-0.62), and patients of other races or who were multiracial (SHR, 0.22; 95% CI, 0.13-0.37) than in non-Hispanic White patients.
IN PRACTICE:
In the study, “risk factors for post-BMT cutaneous malignant neoplasms included pretransplant treatment with a monoclonal antibody, cGVHD, and posttransplant immunosuppression,” the authors wrote, adding that the findings “could inform targeted surveillance of BMT survivors.” Most BMT survivors, “do not undergo routine dermatologic surveillance, highlighting the need to understand risk factors and incorporate risk-informed dermatologic surveillance into survivorship care plans.”
SOURCE:
The study was led by Kristy K. Broman, MD, MPH, University of Alabama at Birmingham, and was published online on December 18 in JAMA Dermatology.
LIMITATIONS:
Limitations included self-reported data and possible underreporting of melanoma cases in the SEER database. Additionally, the study did not capture other risk factors for cutaneous malignant neoplasms such as skin phototype, ultraviolet light exposure, or family history. The duration of posttransplant immunosuppression was not collected, and surveys were administered at variable intervals, though all were completed more than 2 years post BMT.
DISCLOSURES:
The study was supported by the National Cancer Institute (NCI) and the Leukemia and Lymphoma Society. Broman received grants from NCI, the National Center for Advancing Translational Sciences, the American Society of Clinical Oncology, and the American College of Surgeons. Another author reported receiving grants outside this work.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
with a cumulative incidence of 27.4% over 30 years, according to the results of a cohort study.
METHODOLOGY:
- The retrospective cohort study included 3880 BMT survivors (median age, 44 years; 55.8% men; 4.9% Black, 12.1 Hispanic, and 74.7% non-Hispanic White individuals) who underwent transplant between 1974 to 2014.
- Participants completed the BMT Survivor Study survey and were followed up for a median of 9.5 years.
- The primary outcomes were the development of subsequent cutaneous malignant neoplasms (BCC, SCC, or melanoma).
TAKEAWAY:
- The 30-year cumulative incidence of any cutaneous malignant neoplasm was 27.4% — 18% for BCC, 9.8% for SCC, and 3.7% for melanoma.
- A higher risk for skin cancer was reported for patients aged 50 years or more (subdistribution hazard ratio [SHR], 2.23; 95% CI, 1.83-2.71), and men (SHR, 1.40; 95% CI, 1.18-1.65).
- Allogeneic BMT with chronic graft-vs-host disease (cGVHD) increased the risk for skin cancer (SHR, 1.84; 95% CI, 1.37-2.47), compared with autologous BMT, while post-BMT immunosuppression increased risk for all types (overall SHR, 1.53; 95% CI, 1.26-1.86).
- The risk for any skin cancer was significantly lower in Black individuals (SHR, 0.14; 95% CI, 0.05-0.37), Hispanic individuals (SHR, 0.29; 95%CI, 0.20-0.62), and patients of other races or who were multiracial (SHR, 0.22; 95% CI, 0.13-0.37) than in non-Hispanic White patients.
IN PRACTICE:
In the study, “risk factors for post-BMT cutaneous malignant neoplasms included pretransplant treatment with a monoclonal antibody, cGVHD, and posttransplant immunosuppression,” the authors wrote, adding that the findings “could inform targeted surveillance of BMT survivors.” Most BMT survivors, “do not undergo routine dermatologic surveillance, highlighting the need to understand risk factors and incorporate risk-informed dermatologic surveillance into survivorship care plans.”
SOURCE:
The study was led by Kristy K. Broman, MD, MPH, University of Alabama at Birmingham, and was published online on December 18 in JAMA Dermatology.
LIMITATIONS:
Limitations included self-reported data and possible underreporting of melanoma cases in the SEER database. Additionally, the study did not capture other risk factors for cutaneous malignant neoplasms such as skin phototype, ultraviolet light exposure, or family history. The duration of posttransplant immunosuppression was not collected, and surveys were administered at variable intervals, though all were completed more than 2 years post BMT.
DISCLOSURES:
The study was supported by the National Cancer Institute (NCI) and the Leukemia and Lymphoma Society. Broman received grants from NCI, the National Center for Advancing Translational Sciences, the American Society of Clinical Oncology, and the American College of Surgeons. Another author reported receiving grants outside this work.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
with a cumulative incidence of 27.4% over 30 years, according to the results of a cohort study.
METHODOLOGY:
- The retrospective cohort study included 3880 BMT survivors (median age, 44 years; 55.8% men; 4.9% Black, 12.1 Hispanic, and 74.7% non-Hispanic White individuals) who underwent transplant between 1974 to 2014.
- Participants completed the BMT Survivor Study survey and were followed up for a median of 9.5 years.
- The primary outcomes were the development of subsequent cutaneous malignant neoplasms (BCC, SCC, or melanoma).
TAKEAWAY:
- The 30-year cumulative incidence of any cutaneous malignant neoplasm was 27.4% — 18% for BCC, 9.8% for SCC, and 3.7% for melanoma.
- A higher risk for skin cancer was reported for patients aged 50 years or more (subdistribution hazard ratio [SHR], 2.23; 95% CI, 1.83-2.71), and men (SHR, 1.40; 95% CI, 1.18-1.65).
- Allogeneic BMT with chronic graft-vs-host disease (cGVHD) increased the risk for skin cancer (SHR, 1.84; 95% CI, 1.37-2.47), compared with autologous BMT, while post-BMT immunosuppression increased risk for all types (overall SHR, 1.53; 95% CI, 1.26-1.86).
- The risk for any skin cancer was significantly lower in Black individuals (SHR, 0.14; 95% CI, 0.05-0.37), Hispanic individuals (SHR, 0.29; 95%CI, 0.20-0.62), and patients of other races or who were multiracial (SHR, 0.22; 95% CI, 0.13-0.37) than in non-Hispanic White patients.
IN PRACTICE:
In the study, “risk factors for post-BMT cutaneous malignant neoplasms included pretransplant treatment with a monoclonal antibody, cGVHD, and posttransplant immunosuppression,” the authors wrote, adding that the findings “could inform targeted surveillance of BMT survivors.” Most BMT survivors, “do not undergo routine dermatologic surveillance, highlighting the need to understand risk factors and incorporate risk-informed dermatologic surveillance into survivorship care plans.”
SOURCE:
The study was led by Kristy K. Broman, MD, MPH, University of Alabama at Birmingham, and was published online on December 18 in JAMA Dermatology.
LIMITATIONS:
Limitations included self-reported data and possible underreporting of melanoma cases in the SEER database. Additionally, the study did not capture other risk factors for cutaneous malignant neoplasms such as skin phototype, ultraviolet light exposure, or family history. The duration of posttransplant immunosuppression was not collected, and surveys were administered at variable intervals, though all were completed more than 2 years post BMT.
DISCLOSURES:
The study was supported by the National Cancer Institute (NCI) and the Leukemia and Lymphoma Society. Broman received grants from NCI, the National Center for Advancing Translational Sciences, the American Society of Clinical Oncology, and the American College of Surgeons. Another author reported receiving grants outside this work.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FDA Approves Ustekinumab Biosimilar Steqeyma, the Seventh of Its Kind
The Food and Drug Administration (FDA) has approved ustekinumab-stba (Steqeyma) as a biosimilar to the interleukin-12 and -23 inhibitor ustekinumab (Stelara) for the treatment of adults with active Crohn’s disease or ulcerative colitis and for both children aged ≥ 6 years and adults with moderate to severe plaque psoriasis or active psoriatic arthritis.
This is the seventh ustekinumab biosimilar approved by the FDA. The biosimilar, developed by Celltrion, has a license entry date in February 2025 as part of the settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson.
Ustekinumab-stba will be available in two formulations: A subcutaneous injection in two strengths — a 45 mg/0.5 mL or 90 mg/1 mL solution in a single-dose, prefilled syringe — and an intravenous infusion of a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.
“The approval of Steqeyma reflects Celltrion’s continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn’s disease, psoriasis, and psoriatic arthritis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, Jersey City, New Jersey, in a press release.
The FDA has previously approved the company’s adalimumab biosimilar Yuflyma and its infliximab biosimilar Zymfentra.
The full prescribing information for ustekinumab-stba is available here.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved ustekinumab-stba (Steqeyma) as a biosimilar to the interleukin-12 and -23 inhibitor ustekinumab (Stelara) for the treatment of adults with active Crohn’s disease or ulcerative colitis and for both children aged ≥ 6 years and adults with moderate to severe plaque psoriasis or active psoriatic arthritis.
This is the seventh ustekinumab biosimilar approved by the FDA. The biosimilar, developed by Celltrion, has a license entry date in February 2025 as part of the settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson.
Ustekinumab-stba will be available in two formulations: A subcutaneous injection in two strengths — a 45 mg/0.5 mL or 90 mg/1 mL solution in a single-dose, prefilled syringe — and an intravenous infusion of a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.
“The approval of Steqeyma reflects Celltrion’s continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn’s disease, psoriasis, and psoriatic arthritis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, Jersey City, New Jersey, in a press release.
The FDA has previously approved the company’s adalimumab biosimilar Yuflyma and its infliximab biosimilar Zymfentra.
The full prescribing information for ustekinumab-stba is available here.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved ustekinumab-stba (Steqeyma) as a biosimilar to the interleukin-12 and -23 inhibitor ustekinumab (Stelara) for the treatment of adults with active Crohn’s disease or ulcerative colitis and for both children aged ≥ 6 years and adults with moderate to severe plaque psoriasis or active psoriatic arthritis.
This is the seventh ustekinumab biosimilar approved by the FDA. The biosimilar, developed by Celltrion, has a license entry date in February 2025 as part of the settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson.
Ustekinumab-stba will be available in two formulations: A subcutaneous injection in two strengths — a 45 mg/0.5 mL or 90 mg/1 mL solution in a single-dose, prefilled syringe — and an intravenous infusion of a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.
“The approval of Steqeyma reflects Celltrion’s continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn’s disease, psoriasis, and psoriatic arthritis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, Jersey City, New Jersey, in a press release.
The FDA has previously approved the company’s adalimumab biosimilar Yuflyma and its infliximab biosimilar Zymfentra.
The full prescribing information for ustekinumab-stba is available here.
A version of this article first appeared on Medscape.com.
Infants Exposed to Minoxidil May Develop Hypertrichosis
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM THE SPANISH PHARMACOVIGILANCE CONGRESS 2024