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bDMARDs Preserve Renal Function in Most Patients With AA Amyloidosis
TOPLINE:
Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.
METHODOLOGY:
- AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
- This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
- The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
- Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
- Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
- Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
- Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
- All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.
TAKEAWAY:
- After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
- bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
- Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
- None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.
IN PRACTICE:
“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.
SOURCE:
This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.
LIMITATIONS:
Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.
DISCLOSURES:
This study did not report any source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.
METHODOLOGY:
- AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
- This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
- The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
- Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
- Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
- Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
- Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
- All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.
TAKEAWAY:
- After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
- bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
- Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
- None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.
IN PRACTICE:
“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.
SOURCE:
This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.
LIMITATIONS:
Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.
DISCLOSURES:
This study did not report any source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.
METHODOLOGY:
- AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
- This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
- The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
- Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
- Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
- Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
- Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
- All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.
TAKEAWAY:
- After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
- bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
- Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
- None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.
IN PRACTICE:
“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.
SOURCE:
This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.
LIMITATIONS:
Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.
DISCLOSURES:
This study did not report any source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Energy-Restricted Diet Twice Weekly Tops Exercise in T2D
TOPLINE:
Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).
METHODOLOGY:
- Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
- Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
- The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
- The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
- The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.
TAKEAWAY:
- Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
- The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
- Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
- However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.
IN PRACTICE:
“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.”
SOURCE:
Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.
LIMITATIONS:
Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.
DISCLOSURES:
This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).
METHODOLOGY:
- Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
- Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
- The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
- The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
- The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.
TAKEAWAY:
- Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
- The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
- Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
- However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.
IN PRACTICE:
“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.”
SOURCE:
Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.
LIMITATIONS:
Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.
DISCLOSURES:
This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).
METHODOLOGY:
- Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
- Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
- The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
- The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
- The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.
TAKEAWAY:
- Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
- The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
- Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
- However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.
IN PRACTICE:
“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.”
SOURCE:
Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.
LIMITATIONS:
Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.
DISCLOSURES:
This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Children With Chronic Skin Disorders Face Substantial Stigma
TOPLINE:
METHODOLOGY:
- Stigmatization has been addressed for several chronic medical conditions, such as HIV/AIDS, obesity, and mental illness; however, it has received limited attention in children living with chronic skin disorders.
- This cross-sectional, single-visit study examined the prevalence of stigma, its dependence on disease visibility and severity, and its association with mental health and QoL in children with chronic skin disorders.
- A total of 1671 children aged 8-17 years (57.9% girls; mean age, 13.7 years) were recruited from 32 pediatric dermatology centers in the United States and Canada from November 2018 to November 2021. The most common conditions were acne, atopic dermatitis/eczematous disorders, alopecia, and psoriasis, but rare genetic disorders were also represented.
- The primary outcome was the extent of stigmatization in relation to disease visibility, assessed using the Patient-Reported Outcomes Measurement Instrumentation System Pediatric Stigma-Skin.
- Secondary outcomes were the extent of stigmatization in relation to disease severity, along with QoL, depression, anxiety, and poor peer relationships.
TAKEAWAY:
- Approximately half (56.4%) of the children self-reported their skin condition as highly visible; 50.5% reported their disease severity as moderate, while 21.3% reported it as severe.
- Stigma was experienced by 73% of children and adolescents with chronic skin disease, with 43.8% reporting moderate stigma.
- Stigma scores correlated strongly with impaired QOL (Spearman’s rank correlation coefficient = 0.73) and child-reported scores for depression (Spearman’s rank correlation coefficient = 0.61) and moderately with anxiety (Spearman’s rank correlation coefficient = 0.54) and peer relationships (Spearman’s rank correlation coefficient = −0.49; all P < .001).
- Although stigma is increased for children with higher disease visibility and severity, the relatively weak correlation between child-assessed disease visibility and stigma (Spearman’s rank correlation coefficient = 0.22) showed that stigma is common in children even when diseases are not highly visible.
IN PRACTICE:
“Better treatment approaches for chronic skin diseases in children remain an unmet need. Increased awareness and instituting medical and psychological interventions to identify and reduce stigma and disease severity are important directions for improving QOL,” the authors concluded.
SOURCE:
Amy S. Paller, MD, professor of pediatrics and dermatology, Northwestern University, Chicago, led the study, which was published online in JAMA Dermatology.
LIMITATIONS:
Stigmatization needs to be assessed in children from low- and middle-income countries. Investigators enrolled children who had physician-assessed moderate to severe disease severity and/or at least some visibility of skin disease while wearing clothing, which resulted in exclusion of children with mild chronic disease, and the pandemic limited enrollment.
DISCLOSURES:
This study was funded through a grant from the Pediatric Dermatology Research Alliance (PeDRA). The authors declared receiving grants, personal fees, and honorarium and having other ties with various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Stigmatization has been addressed for several chronic medical conditions, such as HIV/AIDS, obesity, and mental illness; however, it has received limited attention in children living with chronic skin disorders.
- This cross-sectional, single-visit study examined the prevalence of stigma, its dependence on disease visibility and severity, and its association with mental health and QoL in children with chronic skin disorders.
- A total of 1671 children aged 8-17 years (57.9% girls; mean age, 13.7 years) were recruited from 32 pediatric dermatology centers in the United States and Canada from November 2018 to November 2021. The most common conditions were acne, atopic dermatitis/eczematous disorders, alopecia, and psoriasis, but rare genetic disorders were also represented.
- The primary outcome was the extent of stigmatization in relation to disease visibility, assessed using the Patient-Reported Outcomes Measurement Instrumentation System Pediatric Stigma-Skin.
- Secondary outcomes were the extent of stigmatization in relation to disease severity, along with QoL, depression, anxiety, and poor peer relationships.
TAKEAWAY:
- Approximately half (56.4%) of the children self-reported their skin condition as highly visible; 50.5% reported their disease severity as moderate, while 21.3% reported it as severe.
- Stigma was experienced by 73% of children and adolescents with chronic skin disease, with 43.8% reporting moderate stigma.
- Stigma scores correlated strongly with impaired QOL (Spearman’s rank correlation coefficient = 0.73) and child-reported scores for depression (Spearman’s rank correlation coefficient = 0.61) and moderately with anxiety (Spearman’s rank correlation coefficient = 0.54) and peer relationships (Spearman’s rank correlation coefficient = −0.49; all P < .001).
- Although stigma is increased for children with higher disease visibility and severity, the relatively weak correlation between child-assessed disease visibility and stigma (Spearman’s rank correlation coefficient = 0.22) showed that stigma is common in children even when diseases are not highly visible.
IN PRACTICE:
“Better treatment approaches for chronic skin diseases in children remain an unmet need. Increased awareness and instituting medical and psychological interventions to identify and reduce stigma and disease severity are important directions for improving QOL,” the authors concluded.
SOURCE:
Amy S. Paller, MD, professor of pediatrics and dermatology, Northwestern University, Chicago, led the study, which was published online in JAMA Dermatology.
LIMITATIONS:
Stigmatization needs to be assessed in children from low- and middle-income countries. Investigators enrolled children who had physician-assessed moderate to severe disease severity and/or at least some visibility of skin disease while wearing clothing, which resulted in exclusion of children with mild chronic disease, and the pandemic limited enrollment.
DISCLOSURES:
This study was funded through a grant from the Pediatric Dermatology Research Alliance (PeDRA). The authors declared receiving grants, personal fees, and honorarium and having other ties with various sources.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Stigmatization has been addressed for several chronic medical conditions, such as HIV/AIDS, obesity, and mental illness; however, it has received limited attention in children living with chronic skin disorders.
- This cross-sectional, single-visit study examined the prevalence of stigma, its dependence on disease visibility and severity, and its association with mental health and QoL in children with chronic skin disorders.
- A total of 1671 children aged 8-17 years (57.9% girls; mean age, 13.7 years) were recruited from 32 pediatric dermatology centers in the United States and Canada from November 2018 to November 2021. The most common conditions were acne, atopic dermatitis/eczematous disorders, alopecia, and psoriasis, but rare genetic disorders were also represented.
- The primary outcome was the extent of stigmatization in relation to disease visibility, assessed using the Patient-Reported Outcomes Measurement Instrumentation System Pediatric Stigma-Skin.
- Secondary outcomes were the extent of stigmatization in relation to disease severity, along with QoL, depression, anxiety, and poor peer relationships.
TAKEAWAY:
- Approximately half (56.4%) of the children self-reported their skin condition as highly visible; 50.5% reported their disease severity as moderate, while 21.3% reported it as severe.
- Stigma was experienced by 73% of children and adolescents with chronic skin disease, with 43.8% reporting moderate stigma.
- Stigma scores correlated strongly with impaired QOL (Spearman’s rank correlation coefficient = 0.73) and child-reported scores for depression (Spearman’s rank correlation coefficient = 0.61) and moderately with anxiety (Spearman’s rank correlation coefficient = 0.54) and peer relationships (Spearman’s rank correlation coefficient = −0.49; all P < .001).
- Although stigma is increased for children with higher disease visibility and severity, the relatively weak correlation between child-assessed disease visibility and stigma (Spearman’s rank correlation coefficient = 0.22) showed that stigma is common in children even when diseases are not highly visible.
IN PRACTICE:
“Better treatment approaches for chronic skin diseases in children remain an unmet need. Increased awareness and instituting medical and psychological interventions to identify and reduce stigma and disease severity are important directions for improving QOL,” the authors concluded.
SOURCE:
Amy S. Paller, MD, professor of pediatrics and dermatology, Northwestern University, Chicago, led the study, which was published online in JAMA Dermatology.
LIMITATIONS:
Stigmatization needs to be assessed in children from low- and middle-income countries. Investigators enrolled children who had physician-assessed moderate to severe disease severity and/or at least some visibility of skin disease while wearing clothing, which resulted in exclusion of children with mild chronic disease, and the pandemic limited enrollment.
DISCLOSURES:
This study was funded through a grant from the Pediatric Dermatology Research Alliance (PeDRA). The authors declared receiving grants, personal fees, and honorarium and having other ties with various sources.
A version of this article appeared on Medscape.com.
Botulinum Toxin, Dermal Fillers Safe in Skin of Color Patients, Review Finds
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
Too Little Sleep Raises Health Risks for Teens With T1D
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
Sugar Substitutes Satisfy Appetite, Blunt Insulin Response
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
Endoscopic Sleeve Gastroplasty More Cost-Effective Long Term Than Semaglutide for Treating Obesity
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
Parotid and Labial Gland Biopsies Provide Similar Help in Diagnosing Sjögren Syndrome
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
Bone Infections Increase After S. aureus Bacteremia in Patients With Rheumatoid Arthritis
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
Study Highlights Some Semaglutide-Associated Skin Effects
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.