Dermatology News

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

Given the clinical presentation and the absence of other systemic or dermatological findings, the diagnosis of chevron nails was made.

Discussion

Chevron nails, also known as V-shaped nails or herringbone nails, are an uncommon but benign nail condition typically observed in infancy and early childhood. The condition is characterized by transverse ridges on the nails that converge towards the center, forming a V or chevron shape. This condition was first described by Perry et al. and later by Shuster et al., who explained that the condition might result from axial growth of the nail with synchronous growth occurring from a chevron-shaped growing edge of the nail root. Alternatively, Shuster suggested that sequential growth, with localized variation in the nail production rate, could propagate a wave from the center of the nail to the edge.

The etiology of chevron nails is not well understood, but it is believed to result from temporary disruptions in the nail matrix, possibly related to minor illness or physiological stress during infancy.

In the case of our 7-month-old patient, the history of mild upper respiratory infections might have contributed to the development of chevron nails. However, the lack of other significant illness, skin involvement, or systemic findings supports the benign and self-limiting nature of this condition. Parents were reassured that chevron nails typically resolve on their own as the child grows and that no specific treatment is necessary.
 

Differential Diagnosis

The differential diagnosis of transverse nail changes in children includes other conditions such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita.

Trachyonychia, also known as “sandpaper nails,” trachyonychia is characterized by the roughening of the nail surface, giving it a dull and ridged appearance. The condition may affect all 20 nails and is often associated with underlying dermatological conditions such as lichen planus or alopecia areata. Unlike chevron nails, trachyonychia presents with more diffuse nail changes and does not typically feature the distinct V-shaped ridging seen in this patient.

Lichen planus is an inflammatory condition that can affect the skin, mucous membranes, and nails. Nail involvement in lichen planus can lead to longitudinal ridging, thinning, and sometimes even complete nail loss. The absence of other characteristic features of lichen planus, such as violaceous papules on the skin or white lacy patterns on mucous membranes (Wickham striae), makes this diagnosis less likely in our patient.

Darier disease, also known as keratosis follicularis, is a genetic disorder characterized by greasy, warty papules primarily on seborrheic areas of the skin, nail abnormalities, and sometimes mucosal involvement. Nail changes in Darier disease include longitudinal red and white streaks, V-shaped notching at the free edge of the nails, and subungual hyperkeratosis. These nail changes are more severe and distinct than the simple transverse ridging seen in chevron nails. The absence of other clinical signs of Darier disease, such as skin papules or characteristic nail notching, makes this diagnosis unlikely in our patient.

Pachyonychia congenita is a rare genetic disorder characterized by thickened nails (pachyonychia), painful plantar keratoderma, and sometimes oral leukokeratosis. The condition typically presents with significant nail thickening and other systemic findings, which were absent in our patient. The distinct pattern of V-shaped ridging observed in chevron nails does not align with the typical presentation of pachyonychia congenita.
 

Next Steps

No specific treatment is required for chevron nails. The condition is typically self-resolving, and the nails usually return to a normal appearance as the child continues to grow. Parents were advised to monitor the nails for any changes or new symptoms and were reassured about the benign nature of the findings. Follow-up was scheduled to ensure the resolution of the condition as the child develops.

Conclusion

Chevron nails are an important consideration in the differential diagnosis of transverse nail ridging in infants and young children. While the condition is benign and self-limiting, it is crucial to differentiate it from other nail dystrophies, such as trachyonychia, lichen planus, Darier disease, and pachyonychia congenita, which may require further investigation or intervention. Awareness of chevron nails can help prevent unnecessary worry and provide reassurance to parents and caregivers.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Delano S, Belazarian L. Chevron nails: A normal variant in the pediatric population. Pediatr Dermatol. 2014 Jan-Feb;31(1):e24-5. doi: 10.1111/pde.12193.

John JM et al. Chevron nail — An under-recognised normal variant of nail development. Arch Dis Child. 2024 Jul 18;109(8):648. doi: 10.1136/archdischild-2024-326975.

Shuster S. The significance of chevron nails. Br J Dermatol. 1996;135:151–152. doi: 10.1046/j.1365-2133.1996.d01-961.x.

Starace M et al. Nail disorders in children. Skin Appendage Disord. 2018 Oct;4(4):217-229. doi: 10.1159/000486020.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

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

TOPLINE:

The first year after the diagnosis of systemic lupus erythematosus (SLE) is crucial, with the highest percentage of patients experiencing organ damage. Cardiovascular issues are the second most prevalent after musculoskeletal damage in both early and later stages of SLE.

METHODOLOGY:

• Researchers assessed organ damage persisting at least 6 months over different stages of lupus in 4219 patients with SLE (mean age, 35.9 years; 89.6% women) from the Spanish Society of Rheumatology Lupus Registry.
• Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
• Longitudinal analysis was conducted globally and by each SDI domain on 1274 patients with recorded damage event dates.
• Follow-up data were available out to 10 years in 1113 patients and to 20 years in 601.

TAKEAWAY:

• New damage was recorded in 20% of the patients with SLE within the first year after diagnosis, with the annual percentage of patients with new damage decreasing to 5% after the first 5 years of follow-up.
• In the first year, musculoskeletal damage was reported by the highest proportion of patients (21%), followed by cardiovascular damage inclusive of cerebrovascular accidents and claudication for 6 months (19%).
• The cardiovascular system remained the second most affected system even during the later stages of the diseases at years 10 and 20 of follow-up (20%-25%).
• Apart from musculoskeletal and cardiovascular damage, patients with lupus also showed renal and ocular damage in the early and later stages of the disease, respectively.

IN PRACTICE:

“Our study highlights the importance of cardiovascular damage and the need for its prevention during the earliest stages of the disease,” the authors wrote.

SOURCE:

The study was led by Irene Altabás-González, MD, PhD, Rheumatology Department, Vigo University Hospital Group, Vigo, Spain. It was published online in Lupus Science & Medicine.

LIMITATIONS:

The retrospective collection of data in the study may have led to missing items; for example, the dates of damage events for the whole cohort were not available. 

DISCLOSURES:

The registry was supported by the Spanish Society of Rheumatology. No specific funding was received for the study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

The first year after the diagnosis of systemic lupus erythematosus (SLE) is crucial, with the highest percentage of patients experiencing organ damage. Cardiovascular issues are the second most prevalent after musculoskeletal damage in both early and later stages of SLE.

METHODOLOGY:

• Researchers assessed organ damage persisting at least 6 months over different stages of lupus in 4219 patients with SLE (mean age, 35.9 years; 89.6% women) from the Spanish Society of Rheumatology Lupus Registry.
• Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
• Longitudinal analysis was conducted globally and by each SDI domain on 1274 patients with recorded damage event dates.
• Follow-up data were available out to 10 years in 1113 patients and to 20 years in 601.

TAKEAWAY:

• New damage was recorded in 20% of the patients with SLE within the first year after diagnosis, with the annual percentage of patients with new damage decreasing to 5% after the first 5 years of follow-up.
• In the first year, musculoskeletal damage was reported by the highest proportion of patients (21%), followed by cardiovascular damage inclusive of cerebrovascular accidents and claudication for 6 months (19%).
• The cardiovascular system remained the second most affected system even during the later stages of the diseases at years 10 and 20 of follow-up (20%-25%).
• Apart from musculoskeletal and cardiovascular damage, patients with lupus also showed renal and ocular damage in the early and later stages of the disease, respectively.

IN PRACTICE:

“Our study highlights the importance of cardiovascular damage and the need for its prevention during the earliest stages of the disease,” the authors wrote.

SOURCE:

The study was led by Irene Altabás-González, MD, PhD, Rheumatology Department, Vigo University Hospital Group, Vigo, Spain. It was published online in Lupus Science & Medicine.

LIMITATIONS:

The retrospective collection of data in the study may have led to missing items; for example, the dates of damage events for the whole cohort were not available. 

DISCLOSURES:

The registry was supported by the Spanish Society of Rheumatology. No specific funding was received for the study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

The first year after the diagnosis of systemic lupus erythematosus (SLE) is crucial, with the highest percentage of patients experiencing organ damage. Cardiovascular issues are the second most prevalent after musculoskeletal damage in both early and later stages of SLE.

METHODOLOGY:

• Researchers assessed organ damage persisting at least 6 months over different stages of lupus in 4219 patients with SLE (mean age, 35.9 years; 89.6% women) from the Spanish Society of Rheumatology Lupus Registry.
• Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
• Longitudinal analysis was conducted globally and by each SDI domain on 1274 patients with recorded damage event dates.
• Follow-up data were available out to 10 years in 1113 patients and to 20 years in 601.

TAKEAWAY:

• New damage was recorded in 20% of the patients with SLE within the first year after diagnosis, with the annual percentage of patients with new damage decreasing to 5% after the first 5 years of follow-up.
• In the first year, musculoskeletal damage was reported by the highest proportion of patients (21%), followed by cardiovascular damage inclusive of cerebrovascular accidents and claudication for 6 months (19%).
• The cardiovascular system remained the second most affected system even during the later stages of the diseases at years 10 and 20 of follow-up (20%-25%).
• Apart from musculoskeletal and cardiovascular damage, patients with lupus also showed renal and ocular damage in the early and later stages of the disease, respectively.

IN PRACTICE:

“Our study highlights the importance of cardiovascular damage and the need for its prevention during the earliest stages of the disease,” the authors wrote.

SOURCE:

The study was led by Irene Altabás-González, MD, PhD, Rheumatology Department, Vigo University Hospital Group, Vigo, Spain. It was published online in Lupus Science & Medicine.

LIMITATIONS:

The retrospective collection of data in the study may have led to missing items; for example, the dates of damage events for the whole cohort were not available. 

DISCLOSURES:

The registry was supported by the Spanish Society of Rheumatology. No specific funding was received for the study. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Uptake of infliximab biosimilars rose slowly across private insurance, Medicaid, and Medicare when two were available in the United States during 2016-2020 but increased significantly through 2022 after the third biosimilar became available in July 2020. However, prescriptions in Medicare still lagged behind those in private insurance and Medicaid.

METHODOLOGY:

• Researchers analyzed electronic health records from over 1100 US rheumatologists who participated in a national registry, the Rheumatology Informatics System for Effectiveness (RISE), for all infliximab administrations (bio-originator or biosimilar) to patients older than 18 years from April 2016 to September 2022.
• They conducted an interrupted time series to account for autocorrelation and model the effect of each infliximab biosimilar release (infliximab-dyyb in November 2016, infliximab-abda in July 2017, and infliximab-axxq in July 2020) on uptake across Medicare, Medicaid, and private insurers.

TAKEAWAY:

• The researchers identified 659,988 infliximab administrations for 37,560 unique patients, with 52% on Medicare, 4.8% on Medicaid, and 43% on private insurance.
• Biosimilar uptake rose slowly with average annual increases < 5% from 2016 to June 2020 (Medicare, 3.2%; Medicaid, 5.2%; private insurance, 1.8%).
• After the third biosimilar release in July 2020, the average annual increase reached 13% for Medicaid and 16.4% for private insurance but remained low for Medicare (5.6%).
• By September 2022, biosimilar uptake was higher for Medicaid (43.8%) and private insurance (38.5%) than for Medicare (24%).

IN PRACTICE:

“Our results suggest policymakers may need to do more to allow biosimilars to get a foothold in the market by incentivizing the development and entry of multiple biosimilars, address anticompetitive pricing strategies, and may need to amend Medicare policy to [incentivize] uptake in order to ensure a competitive and sustainable biosimilar market that gradually reduces total drug expenditures and out-of-pocket costs over time,” wrote the authors of the study.

SOURCE:

The study was led by Eric T. Roberts, PhD, University of California, San Francisco. It was published online on July 30, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

First, while the biosimilar introductions are likely catalysts for many changes in the market, some changes in slopes may also be attributable to the natural growth of the market over time. Second, this study may neither be generalizable to academic medical centers, which are underrepresented in RISE, nor be generalizable to infliximab prescriptions from other specialties. Third, uptake among privately insured patients changed shortly after November-December 2020, raising the possibility that the delay reflected negotiations between insurance companies and relevant entities regarding formulary coverage.

DISCLOSURES:

This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author disclosed receiving consulting fees from Pfizer, AstraZeneca, and Bristol-Myers Squibb and grant funding from AstraZeneca, the Bristol-Myers Squibb Foundation, and Aurinia.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Uptake of infliximab biosimilars rose slowly across private insurance, Medicaid, and Medicare when two were available in the United States during 2016-2020 but increased significantly through 2022 after the third biosimilar became available in July 2020. However, prescriptions in Medicare still lagged behind those in private insurance and Medicaid.

METHODOLOGY:

• Researchers analyzed electronic health records from over 1100 US rheumatologists who participated in a national registry, the Rheumatology Informatics System for Effectiveness (RISE), for all infliximab administrations (bio-originator or biosimilar) to patients older than 18 years from April 2016 to September 2022.
• They conducted an interrupted time series to account for autocorrelation and model the effect of each infliximab biosimilar release (infliximab-dyyb in November 2016, infliximab-abda in July 2017, and infliximab-axxq in July 2020) on uptake across Medicare, Medicaid, and private insurers.

TAKEAWAY:

• The researchers identified 659,988 infliximab administrations for 37,560 unique patients, with 52% on Medicare, 4.8% on Medicaid, and 43% on private insurance.
• Biosimilar uptake rose slowly with average annual increases < 5% from 2016 to June 2020 (Medicare, 3.2%; Medicaid, 5.2%; private insurance, 1.8%).
• After the third biosimilar release in July 2020, the average annual increase reached 13% for Medicaid and 16.4% for private insurance but remained low for Medicare (5.6%).
• By September 2022, biosimilar uptake was higher for Medicaid (43.8%) and private insurance (38.5%) than for Medicare (24%).

IN PRACTICE:

“Our results suggest policymakers may need to do more to allow biosimilars to get a foothold in the market by incentivizing the development and entry of multiple biosimilars, address anticompetitive pricing strategies, and may need to amend Medicare policy to [incentivize] uptake in order to ensure a competitive and sustainable biosimilar market that gradually reduces total drug expenditures and out-of-pocket costs over time,” wrote the authors of the study.

SOURCE:

The study was led by Eric T. Roberts, PhD, University of California, San Francisco. It was published online on July 30, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

First, while the biosimilar introductions are likely catalysts for many changes in the market, some changes in slopes may also be attributable to the natural growth of the market over time. Second, this study may neither be generalizable to academic medical centers, which are underrepresented in RISE, nor be generalizable to infliximab prescriptions from other specialties. Third, uptake among privately insured patients changed shortly after November-December 2020, raising the possibility that the delay reflected negotiations between insurance companies and relevant entities regarding formulary coverage.

DISCLOSURES:

This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author disclosed receiving consulting fees from Pfizer, AstraZeneca, and Bristol-Myers Squibb and grant funding from AstraZeneca, the Bristol-Myers Squibb Foundation, and Aurinia.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Uptake of infliximab biosimilars rose slowly across private insurance, Medicaid, and Medicare when two were available in the United States during 2016-2020 but increased significantly through 2022 after the third biosimilar became available in July 2020. However, prescriptions in Medicare still lagged behind those in private insurance and Medicaid.

METHODOLOGY:

• Researchers analyzed electronic health records from over 1100 US rheumatologists who participated in a national registry, the Rheumatology Informatics System for Effectiveness (RISE), for all infliximab administrations (bio-originator or biosimilar) to patients older than 18 years from April 2016 to September 2022.
• They conducted an interrupted time series to account for autocorrelation and model the effect of each infliximab biosimilar release (infliximab-dyyb in November 2016, infliximab-abda in July 2017, and infliximab-axxq in July 2020) on uptake across Medicare, Medicaid, and private insurers.

TAKEAWAY:

• The researchers identified 659,988 infliximab administrations for 37,560 unique patients, with 52% on Medicare, 4.8% on Medicaid, and 43% on private insurance.
• Biosimilar uptake rose slowly with average annual increases < 5% from 2016 to June 2020 (Medicare, 3.2%; Medicaid, 5.2%; private insurance, 1.8%).
• After the third biosimilar release in July 2020, the average annual increase reached 13% for Medicaid and 16.4% for private insurance but remained low for Medicare (5.6%).
• By September 2022, biosimilar uptake was higher for Medicaid (43.8%) and private insurance (38.5%) than for Medicare (24%).

IN PRACTICE:

“Our results suggest policymakers may need to do more to allow biosimilars to get a foothold in the market by incentivizing the development and entry of multiple biosimilars, address anticompetitive pricing strategies, and may need to amend Medicare policy to [incentivize] uptake in order to ensure a competitive and sustainable biosimilar market that gradually reduces total drug expenditures and out-of-pocket costs over time,” wrote the authors of the study.

SOURCE:

The study was led by Eric T. Roberts, PhD, University of California, San Francisco. It was published online on July 30, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

First, while the biosimilar introductions are likely catalysts for many changes in the market, some changes in slopes may also be attributable to the natural growth of the market over time. Second, this study may neither be generalizable to academic medical centers, which are underrepresented in RISE, nor be generalizable to infliximab prescriptions from other specialties. Third, uptake among privately insured patients changed shortly after November-December 2020, raising the possibility that the delay reflected negotiations between insurance companies and relevant entities regarding formulary coverage.

DISCLOSURES:

This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One author disclosed receiving consulting fees from Pfizer, AstraZeneca, and Bristol-Myers Squibb and grant funding from AstraZeneca, the Bristol-Myers Squibb Foundation, and Aurinia.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Published data on laser treatment of nonmelanoma skin cancer (NMSC) is encouraging, although the therapy is not yet approved by the Food and Drug Administration (FDA) for this use.

METHODOLOGY:

• Using MEDLINE, the Cochrane Library, and www.clinicaltrials.gov, researchers systematically reviewed 50 unique published articles that evaluated the role of laser therapy for NMSC.
• Of the 50 studies, 37 focused on lasers for the treatment of basal cell carcinoma (BCC), 10 on lasers for the treatment of squamous cell carcinoma (SCC), and three on the treatment of both tumor types.
• The analysis was limited to studies published in English from the first data available through May 1, 2023.

TAKEAWAY:

• Data was strongest for the use of lasers for treating BCC, especially pulsed-dye lasers (PDL). Of 11 unique studies on PDL as monotherapy for managing BCCs, clearance rates ranged from 14.3% to 90.0%.
• For SCCs, 13 studies were identified that evaluated the use of lasers alone or in combination with PDL for treating SCC in situ. Among case reports that used PDL and thulium lasers separately, clearance rates of 100% were reported, while several case series that used the CO₂ laser reported response rates that ranged from 61.5% to 100%.
• The best evidence for clearing both BCC and SCC tumors was observed when ablative lasers such as the CO₂ or erbium yttrium aluminum garnet are combined with methyl aminolevulinate–photodynamic therapy (PDT) or 5-aminolevulinic acid–PDT, “likely due to increased delivery of the photosensitizing compound to neoplastic cells,” the authors wrote.

IN PRACTICE:

“Additional investigations with longer follow-up periods are needed to determine optimal laser parameters, number of treatment sessions required, and recurrence rates (using complete histologic analysis through step sectioning) before lasers can fully be adopted into clinical practice,” the authors wrote. “Surgical excision, specifically Mohs micrographic surgery,” they added, “persists as the gold standard for high-risk and cosmetically sensitive tumors, offering the highest cure rates in a single office visit.”

SOURCE:

Amanda Rosenthal, MD, of the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center in California, and colleagues conducted the review. The study was published in the August 2024 issue of Dermatologic Surgery.

LIMITATIONS:

Laser therapy is not FDA approved for the treatment of NMSC and remains an alternative treatment option. Also, most published studies focus on BCCs, while studies on cutaneous SCCs are more limited.

DISCLOSURES:

The researchers reported having no financial disclosures.

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

TOPLINE:

Published data on laser treatment of nonmelanoma skin cancer (NMSC) is encouraging, although the therapy is not yet approved by the Food and Drug Administration (FDA) for this use.

METHODOLOGY:

• Using MEDLINE, the Cochrane Library, and www.clinicaltrials.gov, researchers systematically reviewed 50 unique published articles that evaluated the role of laser therapy for NMSC.
• Of the 50 studies, 37 focused on lasers for the treatment of basal cell carcinoma (BCC), 10 on lasers for the treatment of squamous cell carcinoma (SCC), and three on the treatment of both tumor types.
• The analysis was limited to studies published in English from the first data available through May 1, 2023.

TAKEAWAY:

• Data was strongest for the use of lasers for treating BCC, especially pulsed-dye lasers (PDL). Of 11 unique studies on PDL as monotherapy for managing BCCs, clearance rates ranged from 14.3% to 90.0%.
• For SCCs, 13 studies were identified that evaluated the use of lasers alone or in combination with PDL for treating SCC in situ. Among case reports that used PDL and thulium lasers separately, clearance rates of 100% were reported, while several case series that used the CO₂ laser reported response rates that ranged from 61.5% to 100%.
• The best evidence for clearing both BCC and SCC tumors was observed when ablative lasers such as the CO₂ or erbium yttrium aluminum garnet are combined with methyl aminolevulinate–photodynamic therapy (PDT) or 5-aminolevulinic acid–PDT, “likely due to increased delivery of the photosensitizing compound to neoplastic cells,” the authors wrote.

IN PRACTICE:

“Additional investigations with longer follow-up periods are needed to determine optimal laser parameters, number of treatment sessions required, and recurrence rates (using complete histologic analysis through step sectioning) before lasers can fully be adopted into clinical practice,” the authors wrote. “Surgical excision, specifically Mohs micrographic surgery,” they added, “persists as the gold standard for high-risk and cosmetically sensitive tumors, offering the highest cure rates in a single office visit.”

SOURCE:

Amanda Rosenthal, MD, of the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center in California, and colleagues conducted the review. The study was published in the August 2024 issue of Dermatologic Surgery.

LIMITATIONS:

Laser therapy is not FDA approved for the treatment of NMSC and remains an alternative treatment option. Also, most published studies focus on BCCs, while studies on cutaneous SCCs are more limited.

DISCLOSURES:

The researchers reported having no financial disclosures.

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

TOPLINE:

Published data on laser treatment of nonmelanoma skin cancer (NMSC) is encouraging, although the therapy is not yet approved by the Food and Drug Administration (FDA) for this use.

METHODOLOGY:

• Using MEDLINE, the Cochrane Library, and www.clinicaltrials.gov, researchers systematically reviewed 50 unique published articles that evaluated the role of laser therapy for NMSC.
• Of the 50 studies, 37 focused on lasers for the treatment of basal cell carcinoma (BCC), 10 on lasers for the treatment of squamous cell carcinoma (SCC), and three on the treatment of both tumor types.
• The analysis was limited to studies published in English from the first data available through May 1, 2023.

TAKEAWAY:

• Data was strongest for the use of lasers for treating BCC, especially pulsed-dye lasers (PDL). Of 11 unique studies on PDL as monotherapy for managing BCCs, clearance rates ranged from 14.3% to 90.0%.
• For SCCs, 13 studies were identified that evaluated the use of lasers alone or in combination with PDL for treating SCC in situ. Among case reports that used PDL and thulium lasers separately, clearance rates of 100% were reported, while several case series that used the CO₂ laser reported response rates that ranged from 61.5% to 100%.
• The best evidence for clearing both BCC and SCC tumors was observed when ablative lasers such as the CO₂ or erbium yttrium aluminum garnet are combined with methyl aminolevulinate–photodynamic therapy (PDT) or 5-aminolevulinic acid–PDT, “likely due to increased delivery of the photosensitizing compound to neoplastic cells,” the authors wrote.

IN PRACTICE:

“Additional investigations with longer follow-up periods are needed to determine optimal laser parameters, number of treatment sessions required, and recurrence rates (using complete histologic analysis through step sectioning) before lasers can fully be adopted into clinical practice,” the authors wrote. “Surgical excision, specifically Mohs micrographic surgery,” they added, “persists as the gold standard for high-risk and cosmetically sensitive tumors, offering the highest cure rates in a single office visit.”

SOURCE:

Amanda Rosenthal, MD, of the Department of Dermatology, Kaiser Permanente Los Angeles Medical Center in California, and colleagues conducted the review. The study was published in the August 2024 issue of Dermatologic Surgery.

LIMITATIONS:

Laser therapy is not FDA approved for the treatment of NMSC and remains an alternative treatment option. Also, most published studies focus on BCCs, while studies on cutaneous SCCs are more limited.

DISCLOSURES:

The researchers reported having no financial disclosures.

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

TOPLINE:

Nemolizumab, an interleukin 31 receptor antagonist, was well tolerated and significantly improved inflammation and pruritus in patients with moderate to severe atopic dermatitis (AD).

METHODOLOGY:

• The researchers conducted two 48-week randomized, double-blind, placebo-controlled phase 3 trials, ARCADIA 1 (n = 941; 47% women) and ARCADIA 2 (n = 787; 52% women), involving patients aged 12 and older with moderate to severe AD.
• Participants were randomly assigned in a 2:1 ratio to receive either 30 mg nemolizumab (with a 60-mg loading dose) or placebo, along with background topical corticosteroids with or without topical calcineurin inhibitors. The mean age range was 33.3-35.2 years.
• The coprimary endpoints were Investigator’s Global Assessment (IGA) success (score of 0 or 1 with at least a two-point improvement from baseline) and at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 16.

TAKEAWAY:

• At week 16, significantly more patients receiving nemolizumab vs placebo achieved IGA success in both the ARCADIA 1 (36% vs 25%; P = .0003) and ARCADIA 2 (38% vs 26%; P = .0006) trials.
• EASI-75 response rates were also significantly higher in the nemolizumab group than in the placebo group in both trials: ARCADIA 1 (44% vs 29%; P < .0001) and 2 (42% vs 30%; P = .0006).
• Significant improvements in pruritus were observed as early as week 1, with a greater proportion of participants in the nemolizumab vs placebo group achieving at least a four-point reduction in the Peak Pruritus Numerical Rating Scale score in both trials.
• Rates of adverse events were similar between the nemolizumab and placebo groups, with severe treatment-emergent adverse events occurring in 2%-4% of patients.

IN PRACTICE:

“Nemolizumab showed statistically and clinically significant improvements in inflammation and pruritus in adults and adolescents with moderate to severe atopic dermatitis and a rapid effect in reducing pruritus, as one of the primary complaints of patients. As such, nemolizumab might offer a valuable extension of the therapeutic armament if approved,” the authors concluded.

SOURCE:

The study was led by Jonathan Silverberg, MD, PhD, from the Department of Dermatology, George Washington University, Washington, DC. It was published online in The Lancet.

LIMITATIONS:

The study’s limitations included the absence of longer-term safety data. Additionally, the predominantly White population of the trials may limit the generalizability of the findings to other racial and ethnic groups. The use of concomitant topical therapy might have influenced the placebo response.

DISCLOSURES:

This study was funded by Galderma. Dr. Silverberg received honoraria from pharmaceutical companies, including Galderma, and his institution also received grants from Galderma, Incyte, and Pfizer. Four authors were employees of Galderma. Other authors also declared having ties with pharmaceutical companies, including Galderma, outside this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Nemolizumab, an interleukin 31 receptor antagonist, was well tolerated and significantly improved inflammation and pruritus in patients with moderate to severe atopic dermatitis (AD).

METHODOLOGY:

• The researchers conducted two 48-week randomized, double-blind, placebo-controlled phase 3 trials, ARCADIA 1 (n = 941; 47% women) and ARCADIA 2 (n = 787; 52% women), involving patients aged 12 and older with moderate to severe AD.
• Participants were randomly assigned in a 2:1 ratio to receive either 30 mg nemolizumab (with a 60-mg loading dose) or placebo, along with background topical corticosteroids with or without topical calcineurin inhibitors. The mean age range was 33.3-35.2 years.
• The coprimary endpoints were Investigator’s Global Assessment (IGA) success (score of 0 or 1 with at least a two-point improvement from baseline) and at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 16.

TAKEAWAY:

• At week 16, significantly more patients receiving nemolizumab vs placebo achieved IGA success in both the ARCADIA 1 (36% vs 25%; P = .0003) and ARCADIA 2 (38% vs 26%; P = .0006) trials.
• EASI-75 response rates were also significantly higher in the nemolizumab group than in the placebo group in both trials: ARCADIA 1 (44% vs 29%; P < .0001) and 2 (42% vs 30%; P = .0006).
• Significant improvements in pruritus were observed as early as week 1, with a greater proportion of participants in the nemolizumab vs placebo group achieving at least a four-point reduction in the Peak Pruritus Numerical Rating Scale score in both trials.
• Rates of adverse events were similar between the nemolizumab and placebo groups, with severe treatment-emergent adverse events occurring in 2%-4% of patients.

IN PRACTICE:

“Nemolizumab showed statistically and clinically significant improvements in inflammation and pruritus in adults and adolescents with moderate to severe atopic dermatitis and a rapid effect in reducing pruritus, as one of the primary complaints of patients. As such, nemolizumab might offer a valuable extension of the therapeutic armament if approved,” the authors concluded.

SOURCE:

The study was led by Jonathan Silverberg, MD, PhD, from the Department of Dermatology, George Washington University, Washington, DC. It was published online in The Lancet.

LIMITATIONS:

The study’s limitations included the absence of longer-term safety data. Additionally, the predominantly White population of the trials may limit the generalizability of the findings to other racial and ethnic groups. The use of concomitant topical therapy might have influenced the placebo response.

DISCLOSURES:

This study was funded by Galderma. Dr. Silverberg received honoraria from pharmaceutical companies, including Galderma, and his institution also received grants from Galderma, Incyte, and Pfizer. Four authors were employees of Galderma. Other authors also declared having ties with pharmaceutical companies, including Galderma, outside this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Nemolizumab, an interleukin 31 receptor antagonist, was well tolerated and significantly improved inflammation and pruritus in patients with moderate to severe atopic dermatitis (AD).

METHODOLOGY:

• The researchers conducted two 48-week randomized, double-blind, placebo-controlled phase 3 trials, ARCADIA 1 (n = 941; 47% women) and ARCADIA 2 (n = 787; 52% women), involving patients aged 12 and older with moderate to severe AD.
• Participants were randomly assigned in a 2:1 ratio to receive either 30 mg nemolizumab (with a 60-mg loading dose) or placebo, along with background topical corticosteroids with or without topical calcineurin inhibitors. The mean age range was 33.3-35.2 years.
• The coprimary endpoints were Investigator’s Global Assessment (IGA) success (score of 0 or 1 with at least a two-point improvement from baseline) and at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 16.

TAKEAWAY:

• At week 16, significantly more patients receiving nemolizumab vs placebo achieved IGA success in both the ARCADIA 1 (36% vs 25%; P = .0003) and ARCADIA 2 (38% vs 26%; P = .0006) trials.
• EASI-75 response rates were also significantly higher in the nemolizumab group than in the placebo group in both trials: ARCADIA 1 (44% vs 29%; P < .0001) and 2 (42% vs 30%; P = .0006).
• Significant improvements in pruritus were observed as early as week 1, with a greater proportion of participants in the nemolizumab vs placebo group achieving at least a four-point reduction in the Peak Pruritus Numerical Rating Scale score in both trials.
• Rates of adverse events were similar between the nemolizumab and placebo groups, with severe treatment-emergent adverse events occurring in 2%-4% of patients.

IN PRACTICE:

“Nemolizumab showed statistically and clinically significant improvements in inflammation and pruritus in adults and adolescents with moderate to severe atopic dermatitis and a rapid effect in reducing pruritus, as one of the primary complaints of patients. As such, nemolizumab might offer a valuable extension of the therapeutic armament if approved,” the authors concluded.

SOURCE:

The study was led by Jonathan Silverberg, MD, PhD, from the Department of Dermatology, George Washington University, Washington, DC. It was published online in The Lancet.

LIMITATIONS:

The study’s limitations included the absence of longer-term safety data. Additionally, the predominantly White population of the trials may limit the generalizability of the findings to other racial and ethnic groups. The use of concomitant topical therapy might have influenced the placebo response.

DISCLOSURES:

This study was funded by Galderma. Dr. Silverberg received honoraria from pharmaceutical companies, including Galderma, and his institution also received grants from Galderma, Incyte, and Pfizer. Four authors were employees of Galderma. Other authors also declared having ties with pharmaceutical companies, including Galderma, outside this work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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

TORONTO — When it comes to using artificial intelligence (AI) in your practice, pediatric dermatologist Albert Yan, MD, professor of pediatrics and dermatology at the University of Pennsylvania, Philadelphia, suggests that dermatologists “just jump in” and become familiar with the various AI models.

He reminds doctors that many of their colleagues and patients and their families are already using these systems, “and you don’t want to be left behind.”

In an interview following his presentation on AI at the annual meeting of the Society for Pediatric Dermatology (SPD), Dr. Yan discussed his tips for using AI.
 

Changing Fast 

From the outset, most generative AI systems have been very good at processing language — for example, generating letters of medical necessity and summarizing disease processes into lay terms. But now they’re becoming “truly multimodal,” said Dr. Yan. “You can enter images; you could have it process audio; you can even start to have it refine video.”

To get started, he recommends signing up for a free account with ChatGPT, Gemini, Perplexity, Claude, and/or Microsoft Copilot. “To make the best choice, you have to try them out yourself because they each have their own kind of flavor and strengths and weaknesses,” said Dr. Yan.

Personally, he finds that ChatGPT is the most versatile, Gemini perhaps a little better in terms of image generation, and Perplexity probably the best at references because it was designed as an online library.

Once you figure out which platforms you prefer, consider signing up for a premium subscription, which is typically month to month and can be canceled at any time, Dr. Yan said. “This will allow you to get the most out of the AI model.”

As these AI systems are based on large language models, they are excellent at text, Dr. Yan noted. He suggests asking one to generate a letter or patient instruction sheet. “If you have a premium model, give it a PDF to summarize an article or take a photo of something that you want its opinion on.”

Privacy Critical

Always pay attention to privacy issues and avoid entering any private health information that would violate the Health Insurance Portability and Accountability Act (HIPAA), he said.

“We have to be very careful about how we interact with AI,” said Dr. Yan. “We can’t be posting private patient health information into these systems, no matter how useful these systems are.” Many academic institutions are creating “walled gardens” — private areas of AI access that don’t allow patient information to “leak out,” he said. “These AI models may have HIPAA protections in place and come with specific guidelines of use.”

The AI “scribe,” which helps with electronic health record documentation, is one of the most useful tools for clinicians, he said. He referred to a recent study showing that an AI scribe saved users an average of 1 hour at the keyboard every day, and a small patient survey showing 71% reported that it led to spending more time with their physician.

When entering requests into a prompt line with an AI system, Dr. Yan stressed that these prompts need to be clear and concise. For a complicated calculation or multistep problem, try adding the words “let’s do this step by step,” he said. “This is a technique invoking a ‘chain of thought’ that allows the system to enhance its accuracy when solving problems.”

If the response is not satisfactory, try being more detailed in the request, he advised, and consider giving the system examples of what you’re looking for and telling it what you don’t want in the output.

“For instance, if you’re asking for a differential diagnosis of rashes that affect the hands and feet, you can stipulate that you only want rashes that are vesicular or that arise in neonates, so you can get a more focused answer,” said Dr. Yan.

If there are “long-winded verbose” responses, add the phrase “be concise,” and it will shorten the response by about 50%, he added.
 

AI Hallucinations

Dr. Yan broached an issue that occasionally comes up, AI hallucinations, which refer to inaccurate or misleading responses on the basis of incomplete training or intrinsic biases within the model. He pointed to the case of a doctor discussing issues related to a patient’s hands, feet, and mouth, which the AI-generated model summarized as “the patient being diagnosed with hand, foot, and mouth disease.”

Another example he provided was a request to generate a letter of medical necessity for using ustekinumab (Stelara) for treating hidradenitis suppurative in a child that included references for its effectiveness and safety in children. The AI system generated “false references that sounded like they should be real because the authors are often people who have written in that field or on that subject,” said Dr. Yan.

When pressed, the system did acknowledge the references were hypothetical but were meant to illustrate the types of studies that would typically support the use of this drug in pediatric patients with HS. “ It’s well meaning, in the sense that it’s trying to help you achieve your goals using this training system,” said Dr. Yan.

“If you’re skeptical about a response, double-check the answer with a Google search or run the response through another AI [tool] asking it to check if the response is accurate,” he added.

While AI systems won’t replace the clinician, they are continuing to improve and becoming more sophisticated. Dr. Yan advises keeping up with emerging developments and engaging and adapting the most appropriate AI tool for an individual clinician’s work.

Asked to comment on the presentation at the SPD meeting, Sheilagh Maguiness, MD, director of the Division of Pediatric Dermatology at the University of Minnesota, Minneapolis, who, like other doctors, is increasingly testing AI, said she foresees a time when AI scribes fully replace humans for completing tasks during patient interactions.

“The hope is that if the AI scribes get good enough, we can just open our phone, have them translate the interaction, and create the notes for us.”

While she likes the idea of using ChatGPT to help with tasks like letters of recommendation for medications, Dr. Yan’s comments reiterated the importance of “checking and double-checking ChatGPT because it’s not correct all the time.” She particularly welcomed the advice “that we can just go back and ask it again to clarify, and that may improve its answers.”

Dr. Yan’s disclosures included an investment portfolio that includes companies working in the AI space, including Google, Apple, Nvidia, Amazon, Microsoft, and Arm. Dr. Maguiness had no relevant disclosures.

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