MDedge Dermatology

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Among patients with at least mild psoriasis, calcipotriol/betamethasone (Cal/BD) aerosol foam appeared to be beneficial with substantial itch relief and improvement in itch-related sleep loss, itch severity, and quality of life (QoL).

Major finding: The proportion of patients with itch and itch-related sleep loss reduced from 89.3% at baseline to 43.5% at week 4, and 93.4% of patients reported a 30% or more reduction in itch severity. The mean change in Dermatology Life Quality Index score at week 4 was −5.9±4.7, with 76.3% of patients achieving a score of 5 or lesser indicating no/small effect on QoL.

Study details: Findings are from CELSUS, a noninterventional prospective study including 400 patients with plaque psoriasis treated with Cal/BD aerosol foam.

Disclosures: This study was supported by LEO Pharma. Dr. Rigopoulos, Dr. Lazaridou, Dr. Georgiou, Dr. Chasapi, and Dr. Ioannides reported receiving personal fees from various sources including LEO Pharma, outside the submitted work.

Source: Rigopoulos D et al. J Eur Acad Dermatol Venereol. 2021 Aug 9. doi: 10.1111/jdv.17593.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Prevalence of subclinical atherosclerosis is higher among patients with psoriasis and nonalcoholic fatty liver disease (NAFLD). Additionally, those with elevated hepatic inflammation had a higher burden of coronary atherosclerosis.

Major finding: Among patients with psoriasis, the prevalence of subclinical atherosclerosis was higher among those with vs without NAFLD (61% vs 23%; P = .006). Uptake of 2-[fluorine-18]fluoro-2-deoxy-D-glucose was significantly associated with noncalcified (β, 0.28; P < .001), fibrofatty (β, 0.49; P less than 001), and lipid-rich necrotic core (β, 0.28; P = .003) coronary burden.

Study details: Findings are from a 2-cohort cross-sectional study including 314 patients with psoriasis. The European cohort consisted of 76 patients with psoriasis and 76 control patients and the United States cohort consisted of 162 patients with psoriasis.

Disclosures: This study was funded by National Heart, Lung, and Blood Institute Intramural Research Program. Dr. Mehta, Dr. Gelfand, Dr. González-Cantero, and Dr. Prussick declared serving as a consultant and/or speaker and receiving research grants and personal fees from various sources.

Source: Gonzalez-Cantero A et al. J Invest Dermatol. 2021 Jul 19. doi: 10.1016/j.jid.2021.05.034.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Compared with the general population, patients with moderate-to-severe plaque psoriasis were at an increased risk for lympho-hematological malignancies (LHM) and lymphoma, particularly cutaneous T-cell lymphoma (CTCL).

Major finding: Patients with moderate-to-severe plaque psoriasis vs general population had significantly higher risk for LHM (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.24-2.94) and lymphoma (HR, 1.27; 95% CI, 1.08-1.50). The risk for CTCL was markedly augmented in patients with psoriasis (HR, 6.22; 95% CI, 3.39-11.42).

Study details: Findings are from a meta-analysis of 25 observational studies including 2,501,652 study subjects. Most of the studies included patients with moderate-to-severe psoriasis.

Disclosures: The study did not receive any funding. P Gisondi and G Girolomoni declared serving as a consultant and/or speaker for various sources.

Source: Bellinato F et al. J Am Acad Dermatol. 2021 Aug 3. doi: 10.1016/j.jaad.2021.07.050.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]

Most over-the-counter (OTC) products for molluscum contagiosum (MC) do not include sufficient information about their plant-based ingredients or appropriate dosing, according to an analysis of eight such products available to U.S. consumers

“It’s important for clinicians who see children with molluscum to be aware of the many products marketed to patients and to be able to provide objective information about them,” senior author Elaine Siegfried, MD, said in an interview following the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session.

In the text of their abstract, Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and coauthors Isaac Hoft, of Open Mind Holistics in Ft. Collins, Colo., and Samantha K. Ong, BA, a student at SLU, noted that MC primarily infects children, with an annual incidence of 8%. “Although the disease is self-limited, associated symptoms, contagion and an average 1-year duration prompt concern and frequent medical visits,” they wrote.

The optimal treatment for MC has not been defined and there is currently no approved medication approved for the condition, although three products are in development: VP-102 (cantharidin) by Verrica Pharmaceuticals; SB206, a topical antiviral by Novan; and 10%-15% KOH formulation by the Gurina Foundation.

But many OTC products have been marketed to treat the condition. To identify the OTC products and to assess accompanying information related to safety, efficacy, and cost, the researchers performed an internet search using the terms “molluscum” plus “treatment,” “treatment at home,” “relief,” and “medication.” Eight products were identified for analysis: Conzerol (Elroselabs), Molleave (Innovative Med), Mollenol (Jeva Laboratories), MolluscumBLAST (Revitalize Life Organics), Molluscum Away Patches (Molluscum Away), Naturasil (Nature’s Innovation), Terrasil (Advanced Skincare % Topical Solutions), and Zymaderm (Naturopathix). Package sizes ranged from 0.78 to 1.5 ounces, and prices ranged from about $19 to almost $55.

Dr. Siegfried and colleagues found that all products provided instructions on application and use but most package labels did not include sufficient information about their plant-based ingredients or appropriate dosing. Six of the eight products contained Thuja occidentalis (Arbor vitae), a coniferous cedar whose essential oil has been used in homeopathic products for its anti-inflammatory and antiviral properties. Lemon extract, tea tree oil, and other botanicals were present in no more than three products each. Only two of the products provided information about the number of lesions that could be treated per package.

“The lack of national oversight as well as robust methods for high-level data analysis make safety and efficacy unclear for a Thuja extract marketed to treat MC,” the researchers wrote. “Numerous adverse drug events and positive intradermal skin tests related to Thuja have been reported.”

Dr. Siegfried added that many OTC products offer a money-back guarantee, “so when seeing a patient who failed to respond to one of these products, encourage them, at least, to request a refund, but to also submit a comment about lack of efficacy, in order to provide more balanced Internet information.”

Dr. Siegfried disclosed that she has served as an investigator and consultant for Verrica Pharmaceuticals, and as a consultant and Data Safety Monitoring board member for Novan, two of the companies currently developing drugs to treat molluscum. Her coauthors had no conflicts of interest to disclose.

[email protected]

Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.

Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.

The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.

Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.

In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.

“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.

Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.

Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
 

Recommendations have global relevance

She said although the recommendations are coming from the EAACI group, they apply worldwide.

“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.

She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.

Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.

“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.

“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”

The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.

The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.

Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.

Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.

Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.

“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.

Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.

“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.

The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.

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

Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.

Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.

The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.

Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.

In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.

“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.

Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.

Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
 

Recommendations have global relevance

She said although the recommendations are coming from the EAACI group, they apply worldwide.

“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.

She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.

Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.

“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.

“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”

The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.

The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.

Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.

Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.

Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.

“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.

Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.

“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.

The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.

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

Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.

Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.

The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.

Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.

In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.

“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.

Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.

Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
 

Recommendations have global relevance

She said although the recommendations are coming from the EAACI group, they apply worldwide.

“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.

She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.

Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.

“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.

“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”

The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.

The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.

Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.

Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.

Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.

“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.

Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.

“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.

The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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

As politicians battle over masks and mandates, heated rhetoric has been used to describe the fourth heartbreaking surge in COVID as a “pandemic of the unvaccinated.”

While it may serve to further divide red and blue states, I disagree with the assertion that the current surge in cases is driven simply by the unvaccinated. Why? First, the premise would assume complete efficacy with our vaccinated population, which is statistically incorrect (at least 15 million of the U.S. population never completed a second round of injections), which means they were not considered “fully vaccinated.”

Alternately, we need to examine what has occurred in nations with significantly higher vaccination rates than ours (the United Kingdom and Israel) to realize that variants have overrun the dramatic success achieved in those countries as well. Israel, once considered to be the most vaccinated country in the world, is facing a brutal fourth wave of COVID that has sent the country spiraling into another heartbreaking lockdown.

The unvaccinated could hardly be blamed for what is happening in either of these highly vaccinated countries.
 

The concept of blame

So why use blame? It defeats the purpose of encouraging those who are hesitant or possibly misinformed or disenfranchised to move forward. It lacks compassion. It does not encompass the art and science of nursing (for example, the University of Southern Indiana), such as those that hospitals have used to frame optimal nursing care. I abhor the idea of labeling because it denies the prospect of future comprehension.

Labeling reminds me of one of the saddest cases in my career.
 

An unfortunate case

I was the nurse caring for a man from a motor vehicular accident where an entire family was brutally killed. My patient was alleged to be the cause, with a blood alcohol level of 0.40%+ post hydration, intubated and ventilated, with a flailed chest and multiple orthopedic injuries as well as blunt head trauma. He was secured to the bed with handcuffs, although that was unnecessary. Multiple times I was asked how I could possibly care for such an individual, by the police and even a few colleagues. But it was not my place to judge the man.

He was in pain, and he was dying. I comforted him for the 2 weeks it took his battered body to pass into the next realm. No one visited him except the police, eagerly waiting for the man to wake up to explain the tragic events that occurred. It was my job to ease what pain I could and protect him from labels. Did he deserve the labels? Who knew? I did not care. I cared about his writhing and his physical anguish.
 

The comparison

Blame did not help the situation then, nor does it help us move forward now. As nurses, we seek to work within a framework of understanding. As we tire of caring for thousands of COVID patients, we do not stop to ask if they “deserve” care or if they have taken precautions and lived reasonably prior to seeking assistance for disease. We would not be nurses if we did this.

Think about Gov. Greg Abbott, who has asked that Texans not be allowed to mandate masks for children returning to school. He has recently been diagnosed with COVID, despite assuring the public he is fully vaccinated. Politically, his diagnosis could be visualized as a fiasco for a purple state where he has been adamant in denying the efficacy of masks for children.

Yet, his diagnosis should not be fodder for the press. The first concern should be his health and well-being, similar for any man of his age and potential comorbidity.
 

Conclusion

We should be people first, human beings that remain interconnected by our need for care and survival, not conservatives, independents, or liberals, not “vaccinated or unvaccinated,” not seen as “breakthrough” infections, or the immunosuppressed possibly unable to mount a robust response to COVID.

Labels do not define the ability to effectively defeat coronavirus or variants, as highly vaccinated countries have demonstrated in recent months. We are in the midst of a global pandemic, and the battle is raging onward.

In fact, the longer this pandemic continues, the more likely it is we will need to live with this as an endemic disease, so we should stop blaming those who become ill and need support.

It could be any of us.

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