Dermatology

Diagnosis: Infection-induced psoriasis (guttate-type, induced by streptococcal intertrigo)

Psoriasis is a chronic inflammatory disorder characterized by well-defined, scaly, erythematous plaques. Guttate psoriasis is a distinct variant of psoriasis that is more common in children and adolescents. Guttate psoriasis usually presents with multiple, scattered, small, drop-like (“guttate”), scaly, erythematous papules and plaques. Guttate psoriasis may be triggered by infections, most commonly recent streptococcal infections.

The pathophysiology of psoriasis involves an interplay between genetic and environmental factors. Guttate psoriasis is a chronic T-cell–mediated inflammatory disease in which there is an altered balance between T-helper-1 (TH1) and TH2 cells, transcription factor genes, and their products. HLA B-13, B-17, and Cw6 are human leukocyte antigen alleles implicated in genetic susceptibility. It is hypothesized that streptococcal infection precipitates guttate psoriasis by streptococcal superantigen–driven activation of cutaneous lymphocyte-associated antigen (CLA)–positive lymphocytes. It has been shown that streptococcal exotoxins and streptococcal M proteins act as superantigens.

Diagnosis is often made clinically based on characteristic physical findings and a possible preceding history of streptococcal infection. In patients with streptococcal infection, culture from an appropriate site and measurement of serum antistreptococcal antibody titers (for example, anti-DNase, antihyaluronidase and antistreptolysin-O) can help. A skin biopsy is usually not necessary but may be considered.

This patient presented with intertrigo of the neck and axillae at the time of presentation with the papulosquamous rash. Culture of the intertrigo yielded 4+ Group A beta streptococcus.
 

Treatment

Although there is currently no cure for guttate psoriasis, various treatment options can relieve symptoms and clear skin lesions, and infection-triggered lesions may remit, usually within several months. However, guttate psoriasis may persist and progress to chronic plaque psoriasis. Many treatment options are based mainly on clinical trials targeted for plaque psoriasis treatment.

For mild psoriasis, topical corticosteroids are first-line treatment. Other topical steroids include vitamin D analogs (calcipotriene), topical retinoids (tazarotene), topical calcineurin inhibitors (tacrolimus and pimecrolimus), and newer non-steroidal anti-inflammatory agents (roflumilast or tapinarof), neither approved yet in this young age group. In more severe cases, phototherapy with UVB light, traditional systemic immunosuppressive agents (methotrexate, cyclosporine) or targeted biologic therapies may be considered.
 

Differential Diagnosis

The differential diagnosis may include generalized intertrigo, pityriasis rubra pilaris, tinea corporis, atopic dermatitis, and staphylococcal scalded skin syndrome. Guttate psoriasis can be distinguished by history and physical exam. Further studies such as potassium hydroxide (KOH) scrapings may be helpful in ruling out the other disorders.

Intertrigo is an inflammatory condition of the flexural surfaces irritated by warm temperatures, friction, moisture, and poor ventilation that is commonly associated with Candida infection and/or streptococcal infection. Candidal intertrigo can present with erythematous patches or plaques in an intertriginous area that may develop erosions, macerations, fissures, crust, and weeping. Satellite papules and pustules are pathognomonic for Candida species. Streptococcal intertrigo usually presents with bright red color and may be painful or pruritic. Perianal streptococcal infection is reported as a trigger of guttate psoriasis in pediatric patients.

Pityriasis rubra pilaris is a rare inflammatory papulosquamous disorder with an unknown etiology. Red-orange papules and plaques, hyperkeratotic follicular papules, and palmoplantar hyperkeratosis are primary features. Diagnosis is based on clinical and histopathology. Pityriasis rubra pilaris is self-limited and asymptomatic in many cases. Treatment may not be required, but combination therapy with topical agents includes emollients, keratolytic agents (for example, urea, salicylic acid, alpha-hydroxy acids), topical corticosteroids, tazarotene, and topical calcineurin inhibitors. Systemic agents include oral retinoids and methotrexate.

Atopic dermatitis is a chronic inflammatory skin disease that involves genetic and environmental factors, leading to abnormalities in the epidermis and the immune system presenting with its typical morphology and distribution. The morphology of eczematous lesions is distinct from papulosquamous lesions of psoriasis.

Staphylococcal scalded skin syndrome is a toxin-mediated skin disorder which presents with denuded, peeling skin due to epidermolytic exotoxin producing Staphylococcus species. Fever, erythematous rash, malaise, skin pain, and irritability presents initially. Progressive desquamation with accentuation in folds is typical, with progression usually within 1-2 days. Systemic antibiotics covering Staphylococcus should be administered early. Emollients and nonadherent dressings should be applied to affected areas to promote healing. Supportive care includes dehydration management, temperature regulation, and nutrition. Skin desquamation usually occurs within 5 days with resolution within 2 weeks.

This infant displayed streptococcal intertrigo which triggered an early presentation of guttate psoriasis. The patient was managed with completion of a course of oral cephalexin, midstrength topical corticosteroids to the truncal lesions, and mild topical corticosteroids to the face and diaper area with good clinical response.
 

Danny Lee and Samuel Le serve as research fellows in the Pediatric Dermatology Division of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.

Suggested Reading

Leung AK et al. Childhood guttate psoriasis: An updated review. Drugs Context. 2023 Oct 23:12:2023-8-2. doi: 10.7573/dic.2023-8-2.

Galili E et al. New-onset guttate psoriasis: A long-term follow-up study. Dermatology. 2023;239(2):188-194. doi: 10.1159/000527737.

Duffin KC et al. Advances and controversies in our understanding of guttate and plaque psoriasis. J Rheumatol. 2023 Nov;50(Suppl 2):4-7. doi: 10.3899/jrheum.2023-0500.

Saleh D, Tanner LS. Guttate Psoriasis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2023 Jan-. Available from: www.ncbi.nlm.nih.gov/books/NBK482498/

Dupire G et al. Antistreptococcal interventions for guttate and chronic plaque psoriasis. Cochrane Database Syst Rev. 2019 Mar 5;3(3):CD011571. doi: 10.1002/14651858.CD011571.pub2.

Diagnosis: Infection-induced psoriasis (guttate-type, induced by streptococcal intertrigo)

Psoriasis is a chronic inflammatory disorder characterized by well-defined, scaly, erythematous plaques. Guttate psoriasis is a distinct variant of psoriasis that is more common in children and adolescents. Guttate psoriasis usually presents with multiple, scattered, small, drop-like (“guttate”), scaly, erythematous papules and plaques. Guttate psoriasis may be triggered by infections, most commonly recent streptococcal infections.

The pathophysiology of psoriasis involves an interplay between genetic and environmental factors. Guttate psoriasis is a chronic T-cell–mediated inflammatory disease in which there is an altered balance between T-helper-1 (TH1) and TH2 cells, transcription factor genes, and their products. HLA B-13, B-17, and Cw6 are human leukocyte antigen alleles implicated in genetic susceptibility. It is hypothesized that streptococcal infection precipitates guttate psoriasis by streptococcal superantigen–driven activation of cutaneous lymphocyte-associated antigen (CLA)–positive lymphocytes. It has been shown that streptococcal exotoxins and streptococcal M proteins act as superantigens.

Diagnosis is often made clinically based on characteristic physical findings and a possible preceding history of streptococcal infection. In patients with streptococcal infection, culture from an appropriate site and measurement of serum antistreptococcal antibody titers (for example, anti-DNase, antihyaluronidase and antistreptolysin-O) can help. A skin biopsy is usually not necessary but may be considered.

This patient presented with intertrigo of the neck and axillae at the time of presentation with the papulosquamous rash. Culture of the intertrigo yielded 4+ Group A beta streptococcus.
 

Treatment

Although there is currently no cure for guttate psoriasis, various treatment options can relieve symptoms and clear skin lesions, and infection-triggered lesions may remit, usually within several months. However, guttate psoriasis may persist and progress to chronic plaque psoriasis. Many treatment options are based mainly on clinical trials targeted for plaque psoriasis treatment.

For mild psoriasis, topical corticosteroids are first-line treatment. Other topical steroids include vitamin D analogs (calcipotriene), topical retinoids (tazarotene), topical calcineurin inhibitors (tacrolimus and pimecrolimus), and newer non-steroidal anti-inflammatory agents (roflumilast or tapinarof), neither approved yet in this young age group. In more severe cases, phototherapy with UVB light, traditional systemic immunosuppressive agents (methotrexate, cyclosporine) or targeted biologic therapies may be considered.
 

Differential Diagnosis

The differential diagnosis may include generalized intertrigo, pityriasis rubra pilaris, tinea corporis, atopic dermatitis, and staphylococcal scalded skin syndrome. Guttate psoriasis can be distinguished by history and physical exam. Further studies such as potassium hydroxide (KOH) scrapings may be helpful in ruling out the other disorders.

Intertrigo is an inflammatory condition of the flexural surfaces irritated by warm temperatures, friction, moisture, and poor ventilation that is commonly associated with Candida infection and/or streptococcal infection. Candidal intertrigo can present with erythematous patches or plaques in an intertriginous area that may develop erosions, macerations, fissures, crust, and weeping. Satellite papules and pustules are pathognomonic for Candida species. Streptococcal intertrigo usually presents with bright red color and may be painful or pruritic. Perianal streptococcal infection is reported as a trigger of guttate psoriasis in pediatric patients.

Pityriasis rubra pilaris is a rare inflammatory papulosquamous disorder with an unknown etiology. Red-orange papules and plaques, hyperkeratotic follicular papules, and palmoplantar hyperkeratosis are primary features. Diagnosis is based on clinical and histopathology. Pityriasis rubra pilaris is self-limited and asymptomatic in many cases. Treatment may not be required, but combination therapy with topical agents includes emollients, keratolytic agents (for example, urea, salicylic acid, alpha-hydroxy acids), topical corticosteroids, tazarotene, and topical calcineurin inhibitors. Systemic agents include oral retinoids and methotrexate.

Atopic dermatitis is a chronic inflammatory skin disease that involves genetic and environmental factors, leading to abnormalities in the epidermis and the immune system presenting with its typical morphology and distribution. The morphology of eczematous lesions is distinct from papulosquamous lesions of psoriasis.

Staphylococcal scalded skin syndrome is a toxin-mediated skin disorder which presents with denuded, peeling skin due to epidermolytic exotoxin producing Staphylococcus species. Fever, erythematous rash, malaise, skin pain, and irritability presents initially. Progressive desquamation with accentuation in folds is typical, with progression usually within 1-2 days. Systemic antibiotics covering Staphylococcus should be administered early. Emollients and nonadherent dressings should be applied to affected areas to promote healing. Supportive care includes dehydration management, temperature regulation, and nutrition. Skin desquamation usually occurs within 5 days with resolution within 2 weeks.

This infant displayed streptococcal intertrigo which triggered an early presentation of guttate psoriasis. The patient was managed with completion of a course of oral cephalexin, midstrength topical corticosteroids to the truncal lesions, and mild topical corticosteroids to the face and diaper area with good clinical response.
 

Danny Lee and Samuel Le serve as research fellows in the Pediatric Dermatology Division of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.

Suggested Reading

Leung AK et al. Childhood guttate psoriasis: An updated review. Drugs Context. 2023 Oct 23:12:2023-8-2. doi: 10.7573/dic.2023-8-2.

Galili E et al. New-onset guttate psoriasis: A long-term follow-up study. Dermatology. 2023;239(2):188-194. doi: 10.1159/000527737.

Duffin KC et al. Advances and controversies in our understanding of guttate and plaque psoriasis. J Rheumatol. 2023 Nov;50(Suppl 2):4-7. doi: 10.3899/jrheum.2023-0500.

Saleh D, Tanner LS. Guttate Psoriasis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2023 Jan-. Available from: www.ncbi.nlm.nih.gov/books/NBK482498/

Dupire G et al. Antistreptococcal interventions for guttate and chronic plaque psoriasis. Cochrane Database Syst Rev. 2019 Mar 5;3(3):CD011571. doi: 10.1002/14651858.CD011571.pub2.

Diagnosis: Infection-induced psoriasis (guttate-type, induced by streptococcal intertrigo)

Psoriasis is a chronic inflammatory disorder characterized by well-defined, scaly, erythematous plaques. Guttate psoriasis is a distinct variant of psoriasis that is more common in children and adolescents. Guttate psoriasis usually presents with multiple, scattered, small, drop-like (“guttate”), scaly, erythematous papules and plaques. Guttate psoriasis may be triggered by infections, most commonly recent streptococcal infections.

The pathophysiology of psoriasis involves an interplay between genetic and environmental factors. Guttate psoriasis is a chronic T-cell–mediated inflammatory disease in which there is an altered balance between T-helper-1 (TH1) and TH2 cells, transcription factor genes, and their products. HLA B-13, B-17, and Cw6 are human leukocyte antigen alleles implicated in genetic susceptibility. It is hypothesized that streptococcal infection precipitates guttate psoriasis by streptococcal superantigen–driven activation of cutaneous lymphocyte-associated antigen (CLA)–positive lymphocytes. It has been shown that streptococcal exotoxins and streptococcal M proteins act as superantigens.

Diagnosis is often made clinically based on characteristic physical findings and a possible preceding history of streptococcal infection. In patients with streptococcal infection, culture from an appropriate site and measurement of serum antistreptococcal antibody titers (for example, anti-DNase, antihyaluronidase and antistreptolysin-O) can help. A skin biopsy is usually not necessary but may be considered.

This patient presented with intertrigo of the neck and axillae at the time of presentation with the papulosquamous rash. Culture of the intertrigo yielded 4+ Group A beta streptococcus.
 

Treatment

Although there is currently no cure for guttate psoriasis, various treatment options can relieve symptoms and clear skin lesions, and infection-triggered lesions may remit, usually within several months. However, guttate psoriasis may persist and progress to chronic plaque psoriasis. Many treatment options are based mainly on clinical trials targeted for plaque psoriasis treatment.

For mild psoriasis, topical corticosteroids are first-line treatment. Other topical steroids include vitamin D analogs (calcipotriene), topical retinoids (tazarotene), topical calcineurin inhibitors (tacrolimus and pimecrolimus), and newer non-steroidal anti-inflammatory agents (roflumilast or tapinarof), neither approved yet in this young age group. In more severe cases, phototherapy with UVB light, traditional systemic immunosuppressive agents (methotrexate, cyclosporine) or targeted biologic therapies may be considered.
 

Differential Diagnosis

The differential diagnosis may include generalized intertrigo, pityriasis rubra pilaris, tinea corporis, atopic dermatitis, and staphylococcal scalded skin syndrome. Guttate psoriasis can be distinguished by history and physical exam. Further studies such as potassium hydroxide (KOH) scrapings may be helpful in ruling out the other disorders.

Intertrigo is an inflammatory condition of the flexural surfaces irritated by warm temperatures, friction, moisture, and poor ventilation that is commonly associated with Candida infection and/or streptococcal infection. Candidal intertrigo can present with erythematous patches or plaques in an intertriginous area that may develop erosions, macerations, fissures, crust, and weeping. Satellite papules and pustules are pathognomonic for Candida species. Streptococcal intertrigo usually presents with bright red color and may be painful or pruritic. Perianal streptococcal infection is reported as a trigger of guttate psoriasis in pediatric patients.

Pityriasis rubra pilaris is a rare inflammatory papulosquamous disorder with an unknown etiology. Red-orange papules and plaques, hyperkeratotic follicular papules, and palmoplantar hyperkeratosis are primary features. Diagnosis is based on clinical and histopathology. Pityriasis rubra pilaris is self-limited and asymptomatic in many cases. Treatment may not be required, but combination therapy with topical agents includes emollients, keratolytic agents (for example, urea, salicylic acid, alpha-hydroxy acids), topical corticosteroids, tazarotene, and topical calcineurin inhibitors. Systemic agents include oral retinoids and methotrexate.

Atopic dermatitis is a chronic inflammatory skin disease that involves genetic and environmental factors, leading to abnormalities in the epidermis and the immune system presenting with its typical morphology and distribution. The morphology of eczematous lesions is distinct from papulosquamous lesions of psoriasis.

Staphylococcal scalded skin syndrome is a toxin-mediated skin disorder which presents with denuded, peeling skin due to epidermolytic exotoxin producing Staphylococcus species. Fever, erythematous rash, malaise, skin pain, and irritability presents initially. Progressive desquamation with accentuation in folds is typical, with progression usually within 1-2 days. Systemic antibiotics covering Staphylococcus should be administered early. Emollients and nonadherent dressings should be applied to affected areas to promote healing. Supportive care includes dehydration management, temperature regulation, and nutrition. Skin desquamation usually occurs within 5 days with resolution within 2 weeks.

This infant displayed streptococcal intertrigo which triggered an early presentation of guttate psoriasis. The patient was managed with completion of a course of oral cephalexin, midstrength topical corticosteroids to the truncal lesions, and mild topical corticosteroids to the face and diaper area with good clinical response.
 

Danny Lee and Samuel Le serve as research fellows in the Pediatric Dermatology Division of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California San Diego and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.

Suggested Reading

Leung AK et al. Childhood guttate psoriasis: An updated review. Drugs Context. 2023 Oct 23:12:2023-8-2. doi: 10.7573/dic.2023-8-2.

Galili E et al. New-onset guttate psoriasis: A long-term follow-up study. Dermatology. 2023;239(2):188-194. doi: 10.1159/000527737.

Duffin KC et al. Advances and controversies in our understanding of guttate and plaque psoriasis. J Rheumatol. 2023 Nov;50(Suppl 2):4-7. doi: 10.3899/jrheum.2023-0500.

Saleh D, Tanner LS. Guttate Psoriasis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2023 Jan-. Available from: www.ncbi.nlm.nih.gov/books/NBK482498/

Dupire G et al. Antistreptococcal interventions for guttate and chronic plaque psoriasis. Cochrane Database Syst Rev. 2019 Mar 5;3(3):CD011571. doi: 10.1002/14651858.CD011571.pub2.

TOPLINE:

Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.

METHODOLOGY:

• Few data beyond case reports exist about the course of rosacea during pregnancy.
• Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
• Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.

TAKEAWAY:

• The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
• All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
• Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
• Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.

IN PRACTICE:

“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.

SOURCE:

Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.

LIMITATIONS:

The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.

METHODOLOGY:

• Few data beyond case reports exist about the course of rosacea during pregnancy.
• Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
• Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.

TAKEAWAY:

• The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
• All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
• Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
• Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.

IN PRACTICE:

“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.

SOURCE:

Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.

LIMITATIONS:

The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Among women diagnosed with rosacea, the impact of pregnancy on the disease is unpredictable.

METHODOLOGY:

• Few data beyond case reports exist about the course of rosacea during pregnancy.
• Researchers conducted a telephone survey of 39 women with a diagnosis of rosacea in the electronic medical records prior to the onset of pregnancy who had been admitted to Oregon Health & Science University for labor and delivery from June 27, 2015, to June 27, 2020.
• Patient global assessment of clear (0), mild (1), moderate (2), or severe (3) rosacea was rated across five timepoints: 1-3 months preconception; first, second, and third trimesters; and 6 weeks postpartum.

TAKEAWAY:

• The mean age of the survey participants was 35.5 years, the mean gestational age at delivery was 39.4 weeks, and most had singleton pregnancies.
• All but one study participant (97.4%) reported symptoms of erythematotelangiectatic rosacea, while 26 (67%) reported symptoms of papulopustular rosacea.
• Nearly half of the participants (19, 48.7%) said their rosacea worsened during pregnancy, 13 (33.3%) reported no change in rosacea severity during pregnancy, and 7 (17.9%) reported that their rosacea improved during pregnancy.
• Before conceiving, the mean rosacea severity score among participants was mild (1.10; 95% CI, 0.92-1.29) and did not change significantly over time, a reflection of individual variations. In addition, 83.3% of participants did not use prescription rosacea treatments prior to pregnancy, and 89.6% did not use them during pregnancy.

IN PRACTICE:

“Rosacea, like acne, lacks a predictable group effect, and instead, each individual may have a different response to the physiologic changes of pregnancy,” the authors concluded.

SOURCE:

Genevieve Benedetti, MD, MPP, of the Department of Dermatology at Oregon Health & Science University, Portland, Oregon, led the research, published as a research letter in the International Journal of Women’s Dermatology.

LIMITATIONS:

The small sample size, single-center design, and overall prevalence of mild disease limit the ability to detect change.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Dermatomyositis (DM) is associated with an increased risk for cardiovascular comorbidities, including chronic kidney disease, a new study found.

METHODOLOGY:

• DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
• In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
• They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
• Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.

TAKEAWAY:

• Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
• Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
• In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).

IN PRACTICE:

“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.

SOURCE:

Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.

DISCLOSURES:

The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Dermatomyositis (DM) is associated with an increased risk for cardiovascular comorbidities, including chronic kidney disease, a new study found.

METHODOLOGY:

• DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
• In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
• They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
• Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.

TAKEAWAY:

• Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
• Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
• In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).

IN PRACTICE:

“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.

SOURCE:

Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.

DISCLOSURES:

The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Dermatomyositis (DM) is associated with an increased risk for cardiovascular comorbidities, including chronic kidney disease, a new study found.

METHODOLOGY:

• DM is associated with cardiovascular disease (CVD), but US-based data studies on CVD comorbidities in patients with DM are lacking.
• In a cross-sectional analysis of participants in the All of Us research program aged 18 years and older with at least 1 year of electronic health record (EHR) data, researchers identified DM cases and controls with nearest neighbor propensity score matching by age, sex, race/ethnicity, EHR duration, and healthcare visit quantity.
• They used the Pearson’s chi-squared test, Fisher’s exact test, unpaired t-test, or Mann-Whitney U test to compare clinical characteristics and traditional CV comorbidities.
• Multivariable conditional logistic regression was used with backward elimination of comorbidities with P > .1 or evidence of collinearity.

TAKEAWAY:

• Among 235,161 All of Us participants, researchers identified 206 DM cases and 824 matched controls with largely similar demographic characteristics, including smoking status, obesity, and indicators of socioeconomic status.
• Participants with DM were more likely to have a history of atrial fibrillation (10.1% vs 16.0%, respectively), chronic kidney disease (15.2% vs 29.1%), congestive heart failure (9.6% vs 18.0%), coronary artery disease (CAD) (18.2% vs 34.0%), hypertension (52.5% vs 60.7%), myocardial infarction (7.4% vs 15.0), type 2 diabetes (27.3% vs 47.6%), and valvular heart disease (8.7% vs 16.5%) than matched controls.
• In a multivariable analysis that adjusted for potential confounders, three comorbidities remained associated with DM: CAD (odds ratio [OR], 2.0; P < .001), type 2 diabetes (OR, 2.2; P < .001), and chronic kidney disease (OR, 1.7; P = .015).

IN PRACTICE:

“Our findings are important both for prognosis and clinical care, suggesting DM patients should be screened for CVD risk factors to potentially reduce the increased risk for cardiovascular events and CVD-related mortality in DM,” the authors concluded.

SOURCE:

Corresponding author Alisa N. Femia, MD, of the department of dermatology at NYU Grossman School of Medicine, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

How DM treatments might influence CVD development was not addressed. EHRs may have diagnostic inaccuracies and omissions and lack data on clinical features and severity.

DISCLOSURES:

The project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Femia reported consulting fees from Octagon Therapeutics, Timber Pharmaceuticals, and Guidepoint. Study author Michael S. Garshick, MD, reported consulting fees from AbbVie and Horizon Therapeutics. The remaining authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

On January 5, the Food and Drug Administration (FDA) approved berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC) in adults and children aged 1 year or older.

Approval of berdazimer, a topical nitric oxide–releasing agent, was based largely on a 12-week pivotal phase 3 trial known as B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% of those in the vehicle group (P < .001).

Only 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events in both groups were application-site pain and erythema, and most of these were mild or moderate.

According to a press release announcing the approval from Ligand Pharmaceuticals, which acquired berdazimer topical gel from Novan in September 2023, the development makes berdazimer topical gel 10.3% the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home; outside of a physician›s office; or outside of other medical settings to treat MC. Nitric oxide has been shown to have antiviral effects, although the mechanism of action of berdazimer for treating molluscum “is unknown,” the company said in the release. 

The drug will be marketed under the name Zelsuvmi and is expected to be available in the second half of 2024.

On July 21, 2023, topical cantharidin became the first approved treatment of MC for adults and pediatric patients aged 2 years or older, with the FDA approval of a drug-device combination (Ycanth) that contains a formulation of cantharidin solution 0.7% and is administered by healthcare professionals. 

A version of this article appeared on Medscape.com.

On January 5, the Food and Drug Administration (FDA) approved berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC) in adults and children aged 1 year or older.

Approval of berdazimer, a topical nitric oxide–releasing agent, was based largely on a 12-week pivotal phase 3 trial known as B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% of those in the vehicle group (P < .001).

Only 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events in both groups were application-site pain and erythema, and most of these were mild or moderate.

According to a press release announcing the approval from Ligand Pharmaceuticals, which acquired berdazimer topical gel from Novan in September 2023, the development makes berdazimer topical gel 10.3% the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home; outside of a physician›s office; or outside of other medical settings to treat MC. Nitric oxide has been shown to have antiviral effects, although the mechanism of action of berdazimer for treating molluscum “is unknown,” the company said in the release. 

The drug will be marketed under the name Zelsuvmi and is expected to be available in the second half of 2024.

On July 21, 2023, topical cantharidin became the first approved treatment of MC for adults and pediatric patients aged 2 years or older, with the FDA approval of a drug-device combination (Ycanth) that contains a formulation of cantharidin solution 0.7% and is administered by healthcare professionals. 

A version of this article appeared on Medscape.com.

On January 5, the Food and Drug Administration (FDA) approved berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC) in adults and children aged 1 year or older.

Approval of berdazimer, a topical nitric oxide–releasing agent, was based largely on a 12-week pivotal phase 3 trial known as B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% of those in the vehicle group (P < .001).

Only 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events in both groups were application-site pain and erythema, and most of these were mild or moderate.

According to a press release announcing the approval from Ligand Pharmaceuticals, which acquired berdazimer topical gel from Novan in September 2023, the development makes berdazimer topical gel 10.3% the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home; outside of a physician›s office; or outside of other medical settings to treat MC. Nitric oxide has been shown to have antiviral effects, although the mechanism of action of berdazimer for treating molluscum “is unknown,” the company said in the release. 

The drug will be marketed under the name Zelsuvmi and is expected to be available in the second half of 2024.

On July 21, 2023, topical cantharidin became the first approved treatment of MC for adults and pediatric patients aged 2 years or older, with the FDA approval of a drug-device combination (Ycanth) that contains a formulation of cantharidin solution 0.7% and is administered by healthcare professionals. 

A version of this article appeared on Medscape.com.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

Evidence-based guidelines for managing atopic dermatitis (AD) issued by The American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters (JTFPP) incorporate a decade of new treatments and new methodological standards for making recommendations. The new guidelines update 2012 recommendations.

The JTFPP AD guidelines represent “an evolution” in trustworthy allergy guidelines and provide systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to a rigorous guideline development process, the involvement of the patient and caregiver voice from start to finish, clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation, task force cochair Derek K. Chu, MD, PhD, said in an interview. Dr. Chu, director of the Evidence in Allergy research group at McMaster University, Hamilton, Ontario, Canada, cochaired the task force with Lynda Schneider, MD, section chief of the allergy and asthma program at Boston Children’s Hospital.

The new guidelines were published online on December 17, 2023, in Annals of Allergy, Asthma, & Immunology. They include 25 recommendations and address optimal use of topical treatments, such as topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical crisaborole, and topical antimicrobials; dilute bleach baths; dietary elimination; allergen immunotherapy by subcutaneous (SCIT) and sublingual (SLIT) routes; and systemic treatments with dupilumab and tralokinumab, cyclosporine, azathioprine, methotrexate, mycophenolate, oral JAK inhibitors, systemic corticosteroids; and phototherapy.

“There’s something in here for all clinicians — from primary care to AD experts— and patients may benefit as well, so the key individual recommendations will vary,” Dr. Chu told this news organization.

“Throughout the guideline, we emphasize shared decision-making, key factors to consider for each recommendation, and the specific evidence behind each recommendation,” he said. “There is a major focus on addressing equity, diversity, inclusiveness; and addressing health disparities, and key gaps to address in future research.”

Among the changes to the 2012 JTFPP guidelines, the 2023 update suggests using dilute bleach baths for patients with AD with moderate to severe disease as an additive therapy and suggests using allergen immunotherapy (AIT) for moderate to severe AD.

In other changes, the 2023 update suggests against using elimination diets for AD; recommends against very low dose baricitinib (1 mg); suggests against azathioprine, methotrexate, and mycophenolate mofetil; and suggests against adding topical JAK inhibitors, such as ruxolitinib, for patients with mild to moderate AD refractory to moisturization alone.

The 38-page guidelines include an infographic that summarizes comparative effects of systemic treatments on patient-important outcomes for AD that are important to patients, and includes other key summary tables that can be used at the point of care.

In addition to addressing evidence underlying each recommendation, the guideline’s eAppendix contains 1- to 2-page handouts that address practical issues for each treatment and can be used to facilitate shared decision making.

Dr. Chu said that the updated guidelines “provide important changes to almost all aspects of AD care — my own and my colleagues’ — and I strongly recommend all clinicians treating AD to read the full guidelines and use them in clinical practice. We’re grateful to all our contributors, especially our patient and caregiver partners, for helping make these guidelines. We will continue to periodically update the guidelines as part of maintaining them as living guidelines.”

The guidelines incorporate the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence.

The work was funded by the AAAAI/ACAAI JTFPP. Dr. Chu disclosed that he has received a faculty development award from the AAAAI Foundation and research grants to McMaster from the Canadian Institutes of Health Research, the Ontario Ministry of Health, and the Ontario Medical Association.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

In the opinion of David Rosmarin, MD, the approval of dupilumab in 2017 for the treatment of moderate to severe, resistant atopic dermatitis (AD) marked an inflection point in dermatology.

“Dupilumab has revolutionized AD, and the [interleukin] IL-4 receptor target isn’t going away,” Dr. Rosmarin, who chairs the department of dermatology at Indiana University, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. “It’s truly an exciting time because we have a lot of different treatments in the pipeline that target IL-4 and other receptors.”

In a review of AD biologic therapies in development, he highlighted the following:

CM310 (Stapokibart): This IL-4 receptor alpha monoclonal antibody, which is being developed by Keymed Biosciences, inhibits IL-4 and IL-13 signaling. In a phase 3 randomized study of patients with moderate to severe AD, presented as an abstract at the 2023 European Academy of Dermatology and Venereology (EADV) meeting, it showed results similar to those of dupilumab. Specifically, at week 16, Eczema Area and Severity Index (EASI)-75 scores were achieved in 66.9% of patients in the CM310 group and 25.8% of patients in the placebo group, while the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a reduction of greater than or equal to 2 points from baseline was 44.2% in the CM310 group, compared with 16.1% in the placebo group (P < .0001 for both associations). According to Dr. Rosmarin, other novel anti-IL-4 receptor antibodies for AD include AK120, which is being developed by Akeso Biopharma, and CBP-201 (rademikibart), which is being developed by Connect Biopharma.

Eblasakimab. Under development by ASLAN Pharmaceuticals, this biologic is a potential first-in-class, monoclonal antibody that binds to IL-13Ralpha1 with high affinity and blocks the signaling of IL-4 and IL-13 through the type-2 receptor. In the TREK-AD monotherapy phase 2b trial in patients with moderate to severe AD, presented as an abstract at the 2023 EADV meeting, the primary endpoint of EASI percent change from baseline to week 16, was met for eblasakimab doses 600 mg Q4W, 300mg Q2W, and 400mg Q2W vs. placebo (73.0% [P = .001], 69.8% [P = .005], and 65.8% [P = .029] vs. 51.1%), respectively.

Nemolizumab. Under development by Galderma, nemolizumab is a first-in-class IL-31 receptor alpha antagonist. “Many people refer to IL-31 as the itch cytokine,” Dr. Rosmarin said. “That’s probably a little oversimplified, but it’s certainly a powerful medication in development for prurigo nodularis as well as AD.”

Dr. Rosmarin

Results from the ARCADIA 1 and 2 trials, which included the concurrent use of topical corticosteroids and calcineurin inhibitors and were presented as an abstract at the 2023 EADV meeting, showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared with placebo. Specifically, 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the IGA score, compared with 24.6% and 26.0% in the placebo group (P < .0006, P = .001). In addition, 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the EASI, compared with 29.0% and 30.2% in the placebo group (P < .0001, P = .0011). “There are similar results regardless of the degree of itch patients are starting out with at baseline,” Dr. Rosmarin said. “It’s a very rapid response, by week 4, and that continues to improve through week 16.”

Amlitelimab. Under development by Sanofi, this monoclonal antibody binds to OX40-Ligand, and is designed for patients with moderate to severe AD. According to results of a phase 2b trial that were presented in an abstract at the 2023 EADV meeting, patients treated with amlitelimab 250 mg Q4W with a 500 mg loading dose showed a 61.5% improvement in the average EASI score from baseline at week 16, compared with 29.4% of those who received placebo (P <.0001), with continued improvement seen through 24 weeks. “There are really strong results with EASI scores; clearly this medicine works compared to the placebo,” Dr. Rosmarin said. “It’s also improving other biomarkers as well, including eosinophils, IL-13, TARC [serum thymus and activation-regulated chemokine], and IL-22.”

138559 (Temtokibart). Under development by LEO, 138559 is the first biologic to show the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In a phase 2a study abstract presented at the 2023 EADV meeting, the mean change in EASI from baseline to Week 16 was significantly greater for patients in the 138559-treated group compared with those in the placebo group (–15.3 vs. –3.5; P = .003). In addition, at week 16, significantly greater proportions of patients in the 138559 group relative to those in the placebo group achieved an EASI75 score (41.6% vs. 13.7%; P = .011) and an EASI-90 score (30.8% vs. 3.5%; P = .003). “With this particular receptor you’re not only blocking IL-22, but you’re blocking IL-20 and IL-24 as well,” Dr. Rosmarin said. “It really may be that it’s IL-20 and IL-24 that are more responsible for the pathogenic effect.”

Dr. Rosmarin disclosed that he is speaker for and/or a consultant and advisory board member to many pharmaceutical companies, including Galderma and Sanofi.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

Claiming that both cosmetic and therapeutic uses of Botox and related products can lead to systemic iatrogenic botulism, Public Citizen is asking the Food and Drug Administration (FDA) to strengthen warnings on the labeling of all approved botulinum toxin products.

The nonprofit watchdog group successfully petitioned the FDA in 2008 to require a warning for Botox and related products regarding the risk of distant spread of the toxin. In its latest petition to the agency, it says that the injectables need additional warnings about the possibility of iatrogenic botulism with initial and repeated doses and that individuals who contract the condition may need botulinum antitoxin to avert temporary muscle paralysis, hospitalization, and death.

The current warning does not contain any information about the potential need for antitoxin and downplays the need for giving antitoxin in the settings of excessive dosing, accidental injection, and oral ingestion, said Public Citizen.

“Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no ‘definitive’ cases of botulism have occurred with recommended doses,” Azza AbuDagga, PhD, health services researcher at Public Citizen’s Health Research Group, said in a statement.

Public Citizen said that using data from the FDA’s Adverse Event Reporting System (FAERS), it found 5414 reports of serious outcomes from botulinum toxin products from January 1989 through March 2021. Almost 22% involved cosmetic indications and about 78% involved therapeutic indications.

Of the 5414 reports, 121 (2%) specified botulism as an adverse reaction; 89 involved therapeutic uses of a botulinum toxin products, and 32 involved cosmetic uses. Many of those 121 reports involved doses within the recommended range for the indication, according to Public Citizen.

The group is also asking the FDA to remove what it calls misleading promotional statements in the labeling of Botox and Botox Cosmetic and from the medication guides for those products. The labels state that there have been “no definitive serious adverse event reports of distant spread of toxin effect” with either the cosmetic use or for use in treating chronic migraine, severe underarm sweating, blepharospasm, or strabismus. These statements do not appear in similar labeling in other countries, such as Canada and the United Kingdom, said Public Citizen.

“The FDA needs to implement our two requested actions quickly to warn the public in unambiguous terms about the risk of botulism associated with the use of Botox and related drugs,” Dr. AbuDagga said in the Public Citizen statement. “This will allow health care professionals and patients to make more informed decisions about the benefit-risk profile of these widely used drugs.”

The Public Citizen petition would apply to all seven approved botulinum toxin biological products: abobotulinumtoxinA (Dysport), daxibotulinumtoxinA-lanm (Daxxify), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox, Botox Cosmetic), prabotulinumtoxinA-xvfs (Jeuveau) and rimabotulinumtoxinB (Myobloc).

An FDA spokesperson said the agency is reviewing the citizen petition, and that generally the agency does not comment on pending petitions. “When we respond to the petition, we will respond directly to the petitioner and post the response in the designated agency docket,” the spokesperson told this news organization. At press time, Botox manufacturer AbbVie had not responded to a request for a comment.

Botulinum toxin is the most-used product for nonsurgical cosmetic procedures, according to the International Society of Aesthetic Plastic Surgery (ISAPS). The ISAPS reported that there were more than 7 million botulinum toxin procedures performed by plastic surgeons worldwide in 2021.

The American Society of Plastic Surgery reported that its members performed 4.4 million Botox procedures in 2020, while the American Society of Dermatologic Surgery (ASDS) said its members performed 2.3 million wrinkle-relaxing procedures in 2019, a 60% increase since 2012.

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.