Article

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

The Diagnosis: Neonatal Lupus Erythematosus

A review of the medical records of the patient’s mother from her first pregnancy revealed positive anti-Ro/SSA (Sjögren syndrome A) (>8.0 U [reference range <1.0 U]) and anti-La/SSB (Sjögren syndrome B) antibodies (>8.0 U [reference range <1.0 U]), which were reconfirmed during her pregnancy with our patient (the second child). The patient’s older brother was diagnosed with neonatal lupus erythematosus (NLE) 2 years prior at 1 month of age; therefore, the mother took hydroxychloroquine during the pregnancy with the second child to help prevent heart block if the child was diagnosed with NLE. Given the family history, positive antibodies in the mother, and clinical presentation, our patient was diagnosed with NLE. He was referred to a pediatric cardiologist and pediatrician to continue the workup of systemic manifestations of NLE and to rule out the presence of congenital heart block. The rash resolved 6 months after the initial presentation, and he did not develop any systemic manifestations of NLE.

Neonatal lupus erythematosus is a rare acquired autoimmune disorder caused by the placental transfer of anti-Ro/SSA and anti-La/SSB antibodies and less commonly anti-U1 ribonucleoprotein antinuclear autoantibodies.^1,2 Approximately 1% to 2% of mothers with these positive antibodies will have infants affected with NLE.² The annual prevalence of NLE in the United States is approximately 1 in 20,000 live births. Mothers of children with NLE most commonly have clinical Sjögren syndrome; however, anti-Ro/SSA and anti-LA/SSB antibodies may be present in 0.1% to 1.5% of healthy women, and 25% to 60% of women with autoimmune disease may be asymptomatic.¹ As demonstrated in our case, when there is a family history of NLE in an infant from an earlier pregnancy, the risk for NLE increases to 17% to 20% in subsequent pregnancies^1,3 and up to 25% in subsequent pregnancies if the initial child was diagnosed with a congenital heart block in the setting of NLE.¹

Neonatal lupus erythematosus classically presents as annular erythematous macules and plaques with central scaling, telangictasia, atrophy, and pigmentary changes. It may start on the scalp and face and spread caudally.^1,2 Patients may develop these lesions after UV exposure, and 80% of infants may not have dermatologic findings at birth. Importantly, 40% to 60% of mothers may be asymptomatic at the time of presentation of their child’s NLE.¹ The diagnosis can be confirmed via antibody testing in the mother and/or infant. If performed, a punch biopsy shows interface dermatitis, vacuolar degeneration, and possible periadnexal lymphocytic infiltrates on histopathology.^1,2

Management of cutaneous NLE includes sun protection (eg, application of sunscreen) and topical corticosteroids. Most dermatologic manifestations of NLE are transient, resolving after clearance of maternal IgG antibodies in 6 to 9 months; however, some telangiectasia, dyspigmentation, and atrophic scarring may persist.^1-3

Neonatal lupus erythematosus also may have hepatobiliary, cardiac, hematologic, and less commonly neurologic manifestations. Hepatobiliary manifestations usually present as hepatomegaly or asymptomatic elevated transaminases or γ-glutamyl transferase.^1,3 Approximately 10% to 20% of infants with NLE may present with transient anemia and thrombocytopenia.¹ Cardiac manifestations are permanent and may require pacemaker implantation.^1,3 The incidence of a congenital heart block in infants with NLE is 15% to 30%.³ Cardiac NLE most commonly injures the conductive tissue, leading to a congenital atrioventricular block. The development of a congenital heart block develops in the 18th to 24th week of gestation. Manifestations of a more advanced condition can include dilation of the ascending aorta and dilated cardiomyopathy.¹ As such, patients need to be followed by a pediatric cardiologist for monitoring and treatment of any cardiac manifestations.

The overall prognosis of infants affected with NLE varies. Cardiac involvement is associated with a poor prognosis, while isolated cutaneous involvement requires little treatment and portends a favorable prognosis. It is critical for dermatologists to recognize NLE to refer patients to appropriate specialists to investigate and further monitor possible extracutaneous manifestations. With an understanding of the increased risk for a congenital heart block and NLE in subsequent pregnancies, mothers with positive anti-Ro/La antibodies should receive timely counseling and screening. In expectant mothers with suspected autoimmune disease, testing for antinuclear antibodies and SSA and SSB antibodies can be considered, as administration of hydroxychloroquine or prenatal systemic corticosteroids has proven to be effective in preventing a congenital heart block.¹ Our patient was followed by pediatric cardiology and was not found to have a congenital heart block.

The differential diagnosis includes other causes of annular erythema in infants, as NLE can mimic several conditions. Tinea corporis may present as scaly annular plaques with central clearing; however, it rarely is encountered fulminantly in neonates.⁴ Erythema multiforme is a mucocutaneous hypersensitivy reaction distinguished by targetoid morphology.⁵ It is an exceedingly rare diagnosis in neonates; the average pediatric age of onset is 5.6 years.⁶ Erythema multiforme often is associated with an infection, most commonly herpes simplex virus,⁵ and mucosal involvement is common.⁶ Urticaria multiforme (also known as acute annular urticaria) is a benign disease that appears between 2 months to 3 years of age with blanchable urticarial plaques that likely are triggered by viral or bacterial infections, antibiotics, or vaccines.⁶ Specific lesions usually will resolve within 24 hours. Annular erythema of infancy is a benign and asymptomatic gyrate erythema that presents as annular plaques with palpable borders that spread centrifugally in patients younger than 1 year. Notably, lesions should periodically fade and may reappear cyclically for months to years. Evaluation for underlying disease usually is negative.⁶

The American Diabetes Association recommends that patients on intensive insulin regimens self-monitor blood glucose (SMBG) to assist in therapy optimization.¹ To be useful, SMBG data must be captured by patients, shared with care teams, and used and interpreted by patients and practitioners.^2,3 Communication of SMBG data from the patient to practitioner can be challenging. Although technology can help in this process, limitations exist, such as manual data entry into systems, patient and/or practitioner technological challenges (eg, accessing interface), and compatibility and integration between SMBG devices and electronic health record (EHR) systems.⁴

The Boise Veterans Affairs Medical Center (BVAMC) in Idaho serves more than 100,000 veterans. It includes a main site, community-based outpatient clinics, and a clinical resource hub that provides telehealth services to veterans residing in rural neighboring states. The BVAMC pharmacy department provides both inpatient and outpatient services. At the BVAMC, clinical pharmacist practitioners (CPPs) are independent practitioners who support their care teams in comprehensive medication management and have the ability to initiate, modify, and discontinue drug therapy for referred patients.⁵ A prominent role of CPPs in primary care teams is to manage patients with uncontrolled diabetes and intensive insulin regimens, in which SMBG data are vital to therapy optimization. As collecting SMBG data from patients is seen anecdotally as time intensive, we determined the mean time spent by CPPs collecting patient SMBG data and its potential implications.

Methods

Pharmacists at BVAMC were asked to estimate and record the following: SMBG data collection method, time spent collecting data, extra time spent documenting or formatting SMBG readings, total patient visit time, and visit type. Time was collected in minutes. Extra time spent documenting or formatting SMBG readings included any additional time formatting or entering data in the clinical note after talking to the patient; if this was done while multitasking and talking to the patient, it was not considered extra time. For total patient visit time, pharmacists were asked to estimate only time spent discussing diabetes care and collecting SMBG data. Visit types were categorized as in-person/face-to-face, telephone, and telehealth using clinical video telehealth (CVT)/VA Video Connect (VVC). Data were collected using a standardized spreadsheet. The spreadsheet was pilot tested by a CPP before distribution to all pharmacists.

CPPs were educated about the project in March 2021 and were asked to record data for a 1-week period between April 5, 2021, and April 30, 2021. One CPP also provided delayed data collected from May 17 to 21, 2021, and these data were included in our analysis.

Descriptive statistics were used to determine the mean time spent by CPPs collecting SMBG data. Unpaired t tests were used to compare time spent collecting SMBG data by different collection methods and patient visit types. A P value of ≤ .05 was considered statistically significant. Data were organized in Microsoft Excel, and statistics were completed with JMP Pro v15.

Results

Eight CPPs provided data from 120 patient encounters. For all patient encounter types, the mean time spent collecting SMBG data was 3.3 minutes, and completing additional documentation/formatting was 1.3 minutes (Table 1).

When compared by the SMBG collection method, the longest time spent collecting SMBG data was with patient report (3.7 minutes), and the longest time spent documenting/formatting time was with meter download/home telehealth (2 minutes). There was no statistically significant difference in the time to collect SMBG data between patient report and other methods (3.7 minutes vs 2.8 minutes; P = .07).

When compared by visit type, there was not a statistically significant difference between time spent collecting SMBG data (3.8 minutes vs 3.2 minutes; P = .39) (Table 2).

Discussion

We found that the mean amount of time spent collecting and documenting/formatting SMBG data was only 4.6 minutes; however, this still represented a substantial portion of visit time. For telephone and CVT/VVC appointments, this represented > 25% of total visit time. While CPPs make important contributions to interprofessional team management of patients with diabetes, their cost is not trivial.^6-8 It is worth exploring the most effective and efficient ways to use CPPs. Our results indicate that streamlining SMBG data collection may be beneficial.

Pharmacy technicians, licensed practical nurses/clinical associates, registered nurses/nurse care managers, or other team members could help improve SMBG data collection. Using other team members is also an opportunity for comanagement, for team collaboration, and for more patients to be seen. For example, if a CPP currently has 12 patient encounters that last 20 minutes each, this results in about 240 minutes of direct patient care. If patient encounters were 16 minutes, CPPS could have 15 patient encounters in 240 minutes. Saved time could be used for other clinical tasks involved in disease management or clinical reminder reviews. While there are benefits to CPPs collecting SMBG data, such as further inquiry about patient-reported values, other team members could also be trained to ask appropriate follow-up questions for abnormal blood glucose readings. In addition, leveraging current team members and optimizing their roles could prevent the need to acquire additional full-time equivalent employees.

Another opportunity to increase efficiency in SMBG data collection is with SMBG devices and EHR integration.^4,9 However, integration can be difficult with different types of SMBG devices and EHR platforms. Education for patients and practitioners could help to ensure accurate and reliable data uploads; patient internet availability; data protection, privacy, and sharing; workflow management; and clear patient-practitioner expectations.¹⁰ For example, if patient SMBG data are automatically uploaded to practitioners, patients’ expectations for practitioner review of data and follow-up need to be determined.

We found a subset of patient encounters (n = 23) where data collection and documenting/formatting represented more than half of the total visit time. In this subset, 13 SMBG reports were pulled from a log or meter, 8 were patient reported, and 3 were meter download or home telehealth.

Limitations

A potential reason for the lack of statistically significant differences in SMBG collection method or visit type in this study includes the small sample size. Participation in this work was voluntary, and all participating CPPs had ≥ 3 years of practice in their current setting, which includes a heavy workload of diabetes management. These pharmacists noted self-established procedures/systems for SMBG data collection, including the use of Excel spreadsheets with pregenerated formulas. For less experienced CPPs, SMBG data collection time may be even longer. Pharmacists also noted that they may limit time spent collecting SMBG data depending on the patient encounter and whether they have gathered sufficient data to guide clinical care. Other limitations of this work include data collection from a single institution and that the time documented represented estimates; there was no external monitor.

Conclusions

In this analysis, we found that CPPs spend about 3 minutes collecting SMBG data from patients, and about an additional 1 minute documenting and formatting data. While 4 to 5 minutes may not represent a substantial amount of time for one patient, it can be when multiplied by several patient encounters. The time spent collecting SMBG data did not significantly differ by collection method or visit type. Opportunities to increase efficiency in SMBG data collection, such as the use of nonpharmacist team members are worth exploring.

Acknowledgments

Thank you to the pharmacists at the Boise Veterans Affairs Medical Center for their time and support of this work: Danielle Ahlstrom, Paul Black, Robyn Cruz, Sarah Naidoo, Anthony Nelson, Laura Spoutz, Eileen Twomey, Donovan Victorine, and Michelle Wilkin.

The American Diabetes Association recommends that patients on intensive insulin regimens self-monitor blood glucose (SMBG) to assist in therapy optimization.¹ To be useful, SMBG data must be captured by patients, shared with care teams, and used and interpreted by patients and practitioners.^2,3 Communication of SMBG data from the patient to practitioner can be challenging. Although technology can help in this process, limitations exist, such as manual data entry into systems, patient and/or practitioner technological challenges (eg, accessing interface), and compatibility and integration between SMBG devices and electronic health record (EHR) systems.⁴

The Boise Veterans Affairs Medical Center (BVAMC) in Idaho serves more than 100,000 veterans. It includes a main site, community-based outpatient clinics, and a clinical resource hub that provides telehealth services to veterans residing in rural neighboring states. The BVAMC pharmacy department provides both inpatient and outpatient services. At the BVAMC, clinical pharmacist practitioners (CPPs) are independent practitioners who support their care teams in comprehensive medication management and have the ability to initiate, modify, and discontinue drug therapy for referred patients.⁵ A prominent role of CPPs in primary care teams is to manage patients with uncontrolled diabetes and intensive insulin regimens, in which SMBG data are vital to therapy optimization. As collecting SMBG data from patients is seen anecdotally as time intensive, we determined the mean time spent by CPPs collecting patient SMBG data and its potential implications.

Methods

Pharmacists at BVAMC were asked to estimate and record the following: SMBG data collection method, time spent collecting data, extra time spent documenting or formatting SMBG readings, total patient visit time, and visit type. Time was collected in minutes. Extra time spent documenting or formatting SMBG readings included any additional time formatting or entering data in the clinical note after talking to the patient; if this was done while multitasking and talking to the patient, it was not considered extra time. For total patient visit time, pharmacists were asked to estimate only time spent discussing diabetes care and collecting SMBG data. Visit types were categorized as in-person/face-to-face, telephone, and telehealth using clinical video telehealth (CVT)/VA Video Connect (VVC). Data were collected using a standardized spreadsheet. The spreadsheet was pilot tested by a CPP before distribution to all pharmacists.

CPPs were educated about the project in March 2021 and were asked to record data for a 1-week period between April 5, 2021, and April 30, 2021. One CPP also provided delayed data collected from May 17 to 21, 2021, and these data were included in our analysis.

Descriptive statistics were used to determine the mean time spent by CPPs collecting SMBG data. Unpaired t tests were used to compare time spent collecting SMBG data by different collection methods and patient visit types. A P value of ≤ .05 was considered statistically significant. Data were organized in Microsoft Excel, and statistics were completed with JMP Pro v15.

Results

Eight CPPs provided data from 120 patient encounters. For all patient encounter types, the mean time spent collecting SMBG data was 3.3 minutes, and completing additional documentation/formatting was 1.3 minutes (Table 1).

When compared by the SMBG collection method, the longest time spent collecting SMBG data was with patient report (3.7 minutes), and the longest time spent documenting/formatting time was with meter download/home telehealth (2 minutes). There was no statistically significant difference in the time to collect SMBG data between patient report and other methods (3.7 minutes vs 2.8 minutes; P = .07).

When compared by visit type, there was not a statistically significant difference between time spent collecting SMBG data (3.8 minutes vs 3.2 minutes; P = .39) (Table 2).

Discussion

We found that the mean amount of time spent collecting and documenting/formatting SMBG data was only 4.6 minutes; however, this still represented a substantial portion of visit time. For telephone and CVT/VVC appointments, this represented > 25% of total visit time. While CPPs make important contributions to interprofessional team management of patients with diabetes, their cost is not trivial.^6-8 It is worth exploring the most effective and efficient ways to use CPPs. Our results indicate that streamlining SMBG data collection may be beneficial.

Pharmacy technicians, licensed practical nurses/clinical associates, registered nurses/nurse care managers, or other team members could help improve SMBG data collection. Using other team members is also an opportunity for comanagement, for team collaboration, and for more patients to be seen. For example, if a CPP currently has 12 patient encounters that last 20 minutes each, this results in about 240 minutes of direct patient care. If patient encounters were 16 minutes, CPPS could have 15 patient encounters in 240 minutes. Saved time could be used for other clinical tasks involved in disease management or clinical reminder reviews. While there are benefits to CPPs collecting SMBG data, such as further inquiry about patient-reported values, other team members could also be trained to ask appropriate follow-up questions for abnormal blood glucose readings. In addition, leveraging current team members and optimizing their roles could prevent the need to acquire additional full-time equivalent employees.

Another opportunity to increase efficiency in SMBG data collection is with SMBG devices and EHR integration.^4,9 However, integration can be difficult with different types of SMBG devices and EHR platforms. Education for patients and practitioners could help to ensure accurate and reliable data uploads; patient internet availability; data protection, privacy, and sharing; workflow management; and clear patient-practitioner expectations.¹⁰ For example, if patient SMBG data are automatically uploaded to practitioners, patients’ expectations for practitioner review of data and follow-up need to be determined.

We found a subset of patient encounters (n = 23) where data collection and documenting/formatting represented more than half of the total visit time. In this subset, 13 SMBG reports were pulled from a log or meter, 8 were patient reported, and 3 were meter download or home telehealth.

Limitations

A potential reason for the lack of statistically significant differences in SMBG collection method or visit type in this study includes the small sample size. Participation in this work was voluntary, and all participating CPPs had ≥ 3 years of practice in their current setting, which includes a heavy workload of diabetes management. These pharmacists noted self-established procedures/systems for SMBG data collection, including the use of Excel spreadsheets with pregenerated formulas. For less experienced CPPs, SMBG data collection time may be even longer. Pharmacists also noted that they may limit time spent collecting SMBG data depending on the patient encounter and whether they have gathered sufficient data to guide clinical care. Other limitations of this work include data collection from a single institution and that the time documented represented estimates; there was no external monitor.

Conclusions

In this analysis, we found that CPPs spend about 3 minutes collecting SMBG data from patients, and about an additional 1 minute documenting and formatting data. While 4 to 5 minutes may not represent a substantial amount of time for one patient, it can be when multiplied by several patient encounters. The time spent collecting SMBG data did not significantly differ by collection method or visit type. Opportunities to increase efficiency in SMBG data collection, such as the use of nonpharmacist team members are worth exploring.

Acknowledgments

Thank you to the pharmacists at the Boise Veterans Affairs Medical Center for their time and support of this work: Danielle Ahlstrom, Paul Black, Robyn Cruz, Sarah Naidoo, Anthony Nelson, Laura Spoutz, Eileen Twomey, Donovan Victorine, and Michelle Wilkin.

The American Diabetes Association recommends that patients on intensive insulin regimens self-monitor blood glucose (SMBG) to assist in therapy optimization.¹ To be useful, SMBG data must be captured by patients, shared with care teams, and used and interpreted by patients and practitioners.^2,3 Communication of SMBG data from the patient to practitioner can be challenging. Although technology can help in this process, limitations exist, such as manual data entry into systems, patient and/or practitioner technological challenges (eg, accessing interface), and compatibility and integration between SMBG devices and electronic health record (EHR) systems.⁴

The Boise Veterans Affairs Medical Center (BVAMC) in Idaho serves more than 100,000 veterans. It includes a main site, community-based outpatient clinics, and a clinical resource hub that provides telehealth services to veterans residing in rural neighboring states. The BVAMC pharmacy department provides both inpatient and outpatient services. At the BVAMC, clinical pharmacist practitioners (CPPs) are independent practitioners who support their care teams in comprehensive medication management and have the ability to initiate, modify, and discontinue drug therapy for referred patients.⁵ A prominent role of CPPs in primary care teams is to manage patients with uncontrolled diabetes and intensive insulin regimens, in which SMBG data are vital to therapy optimization. As collecting SMBG data from patients is seen anecdotally as time intensive, we determined the mean time spent by CPPs collecting patient SMBG data and its potential implications.

Methods

Pharmacists at BVAMC were asked to estimate and record the following: SMBG data collection method, time spent collecting data, extra time spent documenting or formatting SMBG readings, total patient visit time, and visit type. Time was collected in minutes. Extra time spent documenting or formatting SMBG readings included any additional time formatting or entering data in the clinical note after talking to the patient; if this was done while multitasking and talking to the patient, it was not considered extra time. For total patient visit time, pharmacists were asked to estimate only time spent discussing diabetes care and collecting SMBG data. Visit types were categorized as in-person/face-to-face, telephone, and telehealth using clinical video telehealth (CVT)/VA Video Connect (VVC). Data were collected using a standardized spreadsheet. The spreadsheet was pilot tested by a CPP before distribution to all pharmacists.

CPPs were educated about the project in March 2021 and were asked to record data for a 1-week period between April 5, 2021, and April 30, 2021. One CPP also provided delayed data collected from May 17 to 21, 2021, and these data were included in our analysis.

Descriptive statistics were used to determine the mean time spent by CPPs collecting SMBG data. Unpaired t tests were used to compare time spent collecting SMBG data by different collection methods and patient visit types. A P value of ≤ .05 was considered statistically significant. Data were organized in Microsoft Excel, and statistics were completed with JMP Pro v15.

Results

Eight CPPs provided data from 120 patient encounters. For all patient encounter types, the mean time spent collecting SMBG data was 3.3 minutes, and completing additional documentation/formatting was 1.3 minutes (Table 1).

When compared by the SMBG collection method, the longest time spent collecting SMBG data was with patient report (3.7 minutes), and the longest time spent documenting/formatting time was with meter download/home telehealth (2 minutes). There was no statistically significant difference in the time to collect SMBG data between patient report and other methods (3.7 minutes vs 2.8 minutes; P = .07).

When compared by visit type, there was not a statistically significant difference between time spent collecting SMBG data (3.8 minutes vs 3.2 minutes; P = .39) (Table 2).

Discussion

We found that the mean amount of time spent collecting and documenting/formatting SMBG data was only 4.6 minutes; however, this still represented a substantial portion of visit time. For telephone and CVT/VVC appointments, this represented > 25% of total visit time. While CPPs make important contributions to interprofessional team management of patients with diabetes, their cost is not trivial.^6-8 It is worth exploring the most effective and efficient ways to use CPPs. Our results indicate that streamlining SMBG data collection may be beneficial.

Pharmacy technicians, licensed practical nurses/clinical associates, registered nurses/nurse care managers, or other team members could help improve SMBG data collection. Using other team members is also an opportunity for comanagement, for team collaboration, and for more patients to be seen. For example, if a CPP currently has 12 patient encounters that last 20 minutes each, this results in about 240 minutes of direct patient care. If patient encounters were 16 minutes, CPPS could have 15 patient encounters in 240 minutes. Saved time could be used for other clinical tasks involved in disease management or clinical reminder reviews. While there are benefits to CPPs collecting SMBG data, such as further inquiry about patient-reported values, other team members could also be trained to ask appropriate follow-up questions for abnormal blood glucose readings. In addition, leveraging current team members and optimizing their roles could prevent the need to acquire additional full-time equivalent employees.

Another opportunity to increase efficiency in SMBG data collection is with SMBG devices and EHR integration.^4,9 However, integration can be difficult with different types of SMBG devices and EHR platforms. Education for patients and practitioners could help to ensure accurate and reliable data uploads; patient internet availability; data protection, privacy, and sharing; workflow management; and clear patient-practitioner expectations.¹⁰ For example, if patient SMBG data are automatically uploaded to practitioners, patients’ expectations for practitioner review of data and follow-up need to be determined.

We found a subset of patient encounters (n = 23) where data collection and documenting/formatting represented more than half of the total visit time. In this subset, 13 SMBG reports were pulled from a log or meter, 8 were patient reported, and 3 were meter download or home telehealth.

Limitations

A potential reason for the lack of statistically significant differences in SMBG collection method or visit type in this study includes the small sample size. Participation in this work was voluntary, and all participating CPPs had ≥ 3 years of practice in their current setting, which includes a heavy workload of diabetes management. These pharmacists noted self-established procedures/systems for SMBG data collection, including the use of Excel spreadsheets with pregenerated formulas. For less experienced CPPs, SMBG data collection time may be even longer. Pharmacists also noted that they may limit time spent collecting SMBG data depending on the patient encounter and whether they have gathered sufficient data to guide clinical care. Other limitations of this work include data collection from a single institution and that the time documented represented estimates; there was no external monitor.

Conclusions

In this analysis, we found that CPPs spend about 3 minutes collecting SMBG data from patients, and about an additional 1 minute documenting and formatting data. While 4 to 5 minutes may not represent a substantial amount of time for one patient, it can be when multiplied by several patient encounters. The time spent collecting SMBG data did not significantly differ by collection method or visit type. Opportunities to increase efficiency in SMBG data collection, such as the use of nonpharmacist team members are worth exploring.

Acknowledgments

Thank you to the pharmacists at the Boise Veterans Affairs Medical Center for their time and support of this work: Danielle Ahlstrom, Paul Black, Robyn Cruz, Sarah Naidoo, Anthony Nelson, Laura Spoutz, Eileen Twomey, Donovan Victorine, and Michelle Wilkin.

Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

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

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

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

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

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

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391