MDedge Dermatology

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source

Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.

Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).

Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.

Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.

Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source

Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.

Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).

Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.

Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.

Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source

Key clinical point: Skin care by washing with water alone is not inferior to washing with a cleanser for the maintenance of remission in children with atopic dermatitis (AD) during the summer.

Major finding: The mean modified Eczema Area and Severity Index scores at 8 ± 4 weeks were similar in children who washed their upper and lower limbs with water and those who used a cleanser (0.00 and 0.15, respectively; P = .74). No difference was observed in the occurrence of skin infection, Patient-Oriented Eczema Measure, and other secondary outcomes with water vs cleanser use (all P > .05).

Study details: This noninferiority study included 43 children (age < 15 years) with AD having controlled eczema following regular steroid ointment application, who washed the randomly assigned left or right limb with a cleanser and the other limb with water alone.

Disclosures: This study was funded by the Maruho Scholarship Donations Support Program, Japan. Osamu Natsume declared receiving grants from several sources. The other authors declared no conflicts of interest.

Source: Katoh Y, Natsume O, Yasuoka R, et al. Skin care by washing with water is not inferior to washing with a cleanser in children with atopic dermatitis in remission in summer: WASH study. Allergol Int. 2024 (Feb 2). doi: 10.1016/j.alit.2024.01.007 Source

Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).

Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.

Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.

Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.

Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058  Source

Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).

Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.

Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.

Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.

Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058  Source

Key clinical point: A significant positive, dose-dependent association was observed between air quality index (AQI) and the incidence of atopic dermatitis (AD).

Major finding: The participants were classified into four AQI value quantiles (Q), with the mean AQI values from the lowest Q1 to the highest Q4 being 69.0, 78.9, 89.8, and 104.0, respectively. Compared with Q1, the risk for AD increased significantly in Q2 (adjusted hazard ratio [aHR] 1.29; 95% CI 1.04-1.65), Q3 (aHR 4.71; 95% CI 3.78-6.04), and Q4 (aHR 13.20; 95% CI 10.86-16.60). An increase of one unit in the AQI value increased the risk for AD by 7%.

Study details: This cohort study included 21,278,938 individuals without AD, with the long-term average AQI value before AD diagnosis being calculated and linked for each of the individuals.

Disclosures: This study was sponsored by grants from the Ministry of Science and Technology, Taiwan, Republic of China. The authors declared no conflicts of interest.

Source: Wu CY, Wu CY, Li MC, Ho HJ, Ao CK. Association of air quality index (AQI) with incidence of atopic dermatitis in Taiwan: A nationwide population-based cohort study. J Am Acad Dermatol. 2024 (Feb 1). doi: 10.1016/j.jaad.2024.01.058  Source

Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).

Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.

Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.

Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066  Source

Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).

Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.

Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.

Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066  Source

Key clinical point: Dupilumab monotherapy is safe and leads to rapid and significant improvements in disease signs and symptoms in patients with hand and foot (HF) atopic dermatitis (AD).

Major finding: At week 16, a significantly higher number of patients receiving dupilumab vs placebo achieved an HF Investigator’s Global Assessment score of 0 or 1 (P = .003) and ≥4-point reduction in HF Peak Pruritus Numeric Rating Scale score (P < .0001), with the difference between groups evident from weeks 4 and 1, respectively. Safety was consistent with the known dupilumab profile.

Study details: Findings are from the phase 3 LIBERTY-AD-HAFT study, which included 106 adults and 27 adolescents (≥ 12 to < 18 years) with moderate to severe HF AD who were randomized (1:1) to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Ten authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors, except Ewa Sygula, declared serving as investigators, consultants, etc., for or receiving personal fees, grants, honoraria, etc., from Sanofi, Regeneron, or others.

Source: Simpson E, Silverberg JI, Worm M, et al. Dupilumab treatment improves signs, symptoms, quality of life and work productivity in patients with atopic hand and foot dermatitis: Results from a phase 3, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024 (Jan 29). doi: 10.1016/j.jaad.2023.12.066  Source

Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.

Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.

Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.

Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.

Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005  Source

Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.

Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.

Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.

Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.

Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005  Source

Key clinical point: A significant causal relationship was observed between atopic dermatitis (AD) and autoimmune diseases in children, and this was supported by the presence of shared genetic factors.

Major finding: At a follow-up of 12 years, children with vs without AD had a significantly increased risk for autoimmune diseases (adjusted hazard ratio [aHR] 1.27; 95% CI 1.23-1.32), particularly psoriasis vulgaris (aHR 2.55; 95% CI 2.25-2.80). Boys were significantly more susceptible to autoimmune diseases than girls (P for interaction = .04). Sixteen shared genes were identified between AD and autoimmune diseases and were associated with comorbidities, such as asthma and bronchiolitis.

Study details: This large-scale cohort study included 39,832 children with AD born between 2002 and 2018, who were matched with 159,328 children without AD.

Disclosures: This study was supported by the Korea Health Technology R&D. The authors declared no conflicts of interest.

Source: Ahn J, Shin S, Lee GC, et al. Unraveling the link between atopic dermatitis and autoimmune diseases in children: Insights from a large-scale cohort study with 15-year follow-up and shared gene ontology analysis. Allergol Int. 2024 (Jan 17). doi: 10.1016/j.alit.2023.12.005  Source

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

“You’ll never walk alone.” — Nettie Fowler, Carousel

A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.

I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. As anyone who has lost a loved one to suicide knows, it is an unknowable, fatal disease. Very few of my patients know my story. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.

Kaiser Permanente

At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.

Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.

Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.

Courtesy Jeffrey Benabio, MD

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

“You’ll never walk alone.” — Nettie Fowler, Carousel

A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.

I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. As anyone who has lost a loved one to suicide knows, it is an unknowable, fatal disease. Very few of my patients know my story. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.

Kaiser Permanente

At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.

Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.

Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.

Courtesy Jeffrey Benabio, MD

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

“You’ll never walk alone.” — Nettie Fowler, Carousel

A few winters ago, a young man and his fiancée were driving on the 91 freeway in southern California during a torrential downpour when their Honda Civic hydroplaned, slamming into the jersey barrier. They were both unhurt. Unsure what to do next, they made the catastrophic decision to exit the vehicle. As the man walked around the back of the car he was nearly hit by a black sedan sliding out of control trying to avoid them. When he came around the car, his fiancé was nowhere to be found. She had been struck at highway speed and lay crushed under the sedan hundreds of feet away.

I know this poor man because he was referred to me. Not as a dermatologist, but as a fellow human healing from trauma. On January 1, 2019, at about 9:30 PM, while we were home together, my beloved wife of 24 years took her own life. Even 5 years on it is difficult to believe that she isn’t proofing this paragraph like she had done for every one of my Derm News columns for years. We had been together since teenagers and had lived a joy-filled life. As anyone who has lost a loved one to suicide knows, it is an unknowable, fatal disease. Very few of my patients know my story. There isn’t any medical reason to share. But that day I joined the community of those who have carried unbearable heaviness of grief and survived. Sometimes others seek me out for help.

Kaiser Permanente

At first, my instinct was to guide them, to give advice, to tell them what to do and where to go. But I’ve learned that people in this dark valley don’t need a guide. They need someone to accompany them. To walk with them for a few minutes on their lonely journey. I recently read David Brooks’s new book, How to Know a Person. I’ve been a fan of his since he joined the New York Times in 2003 and have read almost everything he’s written. I sometimes even imagine how he might approach a column whenever I’m stuck (thank you, David). His The Road to Character book is in my canon of literature for self-growth. This latest book is an interesting digression from that central theme. He argues that our society is in acute need of forming better connections and that an important way we can be moral is to learn, and to practice, how to know each other. He shares an emotional experience of losing a close friend to suicide and writes a poignant explanation of what it means to accompany someone in need. It particularly resonated with me. We are doctors and are wired to find the source of a problem, like quickly rotating through the 4X, 10X, 40X on a microscope. Once identified, we spend most of our time creating and explaining treatments. I see how this makes me a great dermatologist but just an average human.

Brooks tells the story of a woman with a brain tumor who often finds herself on the ground surrounded by well-meaning people trying to help. She explains later that what she really needs in those moments is just for someone to get on the ground and lie with her. To accompany her.

Having crossed the midpoint of life, I see with the benefit of perspective how suffering has afforded me wisdom: I am more sensitive and attuned to others. It also gave me credibility: I know how it feels to walk life’s loneliest journey. I’ve also learned to make myself vulnerable for someone to share their story with me. I won’t be afraid to hear the details. I won’t judge them for weeping too little or for sobbing too much. I don’t answer whys. I won’t say what they should do next. But for a few minutes I can walk beside them as a person who cares.

Courtesy Jeffrey Benabio, MD

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.