Psoriatic arthritis (PsA) is consistent with the patient's joint pain, dactylitis, enthesitis, skin plaques, and radiographic findings, making it the most likely diagnosis. 

Rheumatoid arthritis (RA) is possible because of the patient's joint symptoms; however, it is not the correct answer because of negative RF and ACPA tests and skin plaques. 

Osteoarthritis might cause joint pain but does not typically present with prolonged morning stiffness, skin plaques, or the "pencil-in-cup" radiographic finding. 

Gout, an inflammatory arthritis, primarily affects the big toe and does not align with the patient's skin and radiographic manifestations. 

PsA is a chronic inflammatory arthritis that often develops in people with psoriasis. It affects roughly 0.05%- 0.25% of the general population and up to 41% of people with psoriasis. PsA is most seen in White patients between 35 and 55 years and affects both men and women equally. PsA is linked to a higher risk for obesity, hypertension, hyperlipidemia, type 2 diabetes, metabolic syndrome, and other conditions, including uveitis and inflammatory bowel disease.

Clinically, PsA presents with a diverse range of manifestations, encompassing peripheral joint inflammation, often with an asymmetric distribution; axial skeletal involvement reminiscent of spondylitis; dactylitis characterized by sausage-like swelling of fingers or toes; and enthesitis. Common symptoms or findings include early morning stiffness for > 30 minutes; joint pain, tenderness, and swelling; back pain aggravated by rest and relieved by exercise; limited joint motion; and deformity. Although most patients have a preceding condition in skin psoriasis, diagnosis of PsA is often delayed. Furthermore, nearly 80% of patients may exhibit nail changes, such as pitting or onycholysis, compared with about 40% of patients with psoriasis without arthritis. The heterogeneity of its clinical features often necessitates a comprehensive differential diagnosis to distinguish PsA from other spondyloarthropathies and rheumatic diseases. The most accepted classification criteria for PsA are the Classification of Psoriatic Arthritis (CASPAR) criteria, which have been used since 2006.

No laboratory tests are specific for PsA; however, a normal ESR and CRP level should not be used to rule out a diagnosis of PsA because these values are increased in only about 40% of patients. RF and ACPA are classically considered absent in PsA, and a negative RF is regarded as a criterion for diagnosing PsA per the CASPAR classification criteria. Radiographic changes show some characteristic patterns in PsA, including erosive damage, gross joint destruction, joint space narrowing, and "pencil-in-cup" deformity.

PsA treatment options have evolved over the years. Whereas in the past, nonsteroidal anti-inflammatory drugs, glucocorticoids, methotrexate, sulfasalazine, and cyclosporine were commonly prescribed, the development of immunologically targeted biological disease-modifying antirheumatic drugs (DMARDs) and targeted synthetic DMARDs since 2000 has revolutionized the treatment of PsA. Tumor necrosis factor inhibitors (ie, etanercept, infliximab, and adalimumab) have been shown to improve all domains (psoriatic and articular disease) of PsA and are considered a milestone in managing the condition. Other emerging therapeutic strategies in recent years have demonstrated efficacy in treating PsA, including monoclonal antibodies targeting interleukin (IL)-12, IL-23, and IL-17, as well as small-molecule phosphodiesterase 4 and Janus kinase inhibitors.

Although most of these options have the potential to be effective in all clinical domains of the disease, their cross-domain efficacy can vary from patient to patient. In some cases, treatment may not be practical or can lose effectiveness over time, and true disease remission is rare. As a result, clinicians must regularly assess each domain and aim to achieve remission or low disease activity across the different active domains while also being aware of potential adverse events.

Alan Irvine, MD, DSc, Consultant Dermatologist, ADI Dermatology LTD, Dublin, Ireland

Alan Irvine, MD, DSc, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.
Serve(d) as a speaker or member of a speakers bureau for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Received income in an amount equal to or greater than $250 from: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
 

Psoriatic arthritis (PsA) is consistent with the patient's joint pain, dactylitis, enthesitis, skin plaques, and radiographic findings, making it the most likely diagnosis. 

Rheumatoid arthritis (RA) is possible because of the patient's joint symptoms; however, it is not the correct answer because of negative RF and ACPA tests and skin plaques. 

Osteoarthritis might cause joint pain but does not typically present with prolonged morning stiffness, skin plaques, or the "pencil-in-cup" radiographic finding. 

Gout, an inflammatory arthritis, primarily affects the big toe and does not align with the patient's skin and radiographic manifestations. 

PsA is a chronic inflammatory arthritis that often develops in people with psoriasis. It affects roughly 0.05%- 0.25% of the general population and up to 41% of people with psoriasis. PsA is most seen in White patients between 35 and 55 years and affects both men and women equally. PsA is linked to a higher risk for obesity, hypertension, hyperlipidemia, type 2 diabetes, metabolic syndrome, and other conditions, including uveitis and inflammatory bowel disease.

Clinically, PsA presents with a diverse range of manifestations, encompassing peripheral joint inflammation, often with an asymmetric distribution; axial skeletal involvement reminiscent of spondylitis; dactylitis characterized by sausage-like swelling of fingers or toes; and enthesitis. Common symptoms or findings include early morning stiffness for > 30 minutes; joint pain, tenderness, and swelling; back pain aggravated by rest and relieved by exercise; limited joint motion; and deformity. Although most patients have a preceding condition in skin psoriasis, diagnosis of PsA is often delayed. Furthermore, nearly 80% of patients may exhibit nail changes, such as pitting or onycholysis, compared with about 40% of patients with psoriasis without arthritis. The heterogeneity of its clinical features often necessitates a comprehensive differential diagnosis to distinguish PsA from other spondyloarthropathies and rheumatic diseases. The most accepted classification criteria for PsA are the Classification of Psoriatic Arthritis (CASPAR) criteria, which have been used since 2006.

No laboratory tests are specific for PsA; however, a normal ESR and CRP level should not be used to rule out a diagnosis of PsA because these values are increased in only about 40% of patients. RF and ACPA are classically considered absent in PsA, and a negative RF is regarded as a criterion for diagnosing PsA per the CASPAR classification criteria. Radiographic changes show some characteristic patterns in PsA, including erosive damage, gross joint destruction, joint space narrowing, and "pencil-in-cup" deformity.

PsA treatment options have evolved over the years. Whereas in the past, nonsteroidal anti-inflammatory drugs, glucocorticoids, methotrexate, sulfasalazine, and cyclosporine were commonly prescribed, the development of immunologically targeted biological disease-modifying antirheumatic drugs (DMARDs) and targeted synthetic DMARDs since 2000 has revolutionized the treatment of PsA. Tumor necrosis factor inhibitors (ie, etanercept, infliximab, and adalimumab) have been shown to improve all domains (psoriatic and articular disease) of PsA and are considered a milestone in managing the condition. Other emerging therapeutic strategies in recent years have demonstrated efficacy in treating PsA, including monoclonal antibodies targeting interleukin (IL)-12, IL-23, and IL-17, as well as small-molecule phosphodiesterase 4 and Janus kinase inhibitors.

Although most of these options have the potential to be effective in all clinical domains of the disease, their cross-domain efficacy can vary from patient to patient. In some cases, treatment may not be practical or can lose effectiveness over time, and true disease remission is rare. As a result, clinicians must regularly assess each domain and aim to achieve remission or low disease activity across the different active domains while also being aware of potential adverse events.

Alan Irvine, MD, DSc, Consultant Dermatologist, ADI Dermatology LTD, Dublin, Ireland

Alan Irvine, MD, DSc, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.
Serve(d) as a speaker or member of a speakers bureau for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Received income in an amount equal to or greater than $250 from: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
 

Psoriatic arthritis (PsA) is consistent with the patient's joint pain, dactylitis, enthesitis, skin plaques, and radiographic findings, making it the most likely diagnosis. 

Rheumatoid arthritis (RA) is possible because of the patient's joint symptoms; however, it is not the correct answer because of negative RF and ACPA tests and skin plaques. 

Osteoarthritis might cause joint pain but does not typically present with prolonged morning stiffness, skin plaques, or the "pencil-in-cup" radiographic finding. 

Gout, an inflammatory arthritis, primarily affects the big toe and does not align with the patient's skin and radiographic manifestations. 

PsA is a chronic inflammatory arthritis that often develops in people with psoriasis. It affects roughly 0.05%- 0.25% of the general population and up to 41% of people with psoriasis. PsA is most seen in White patients between 35 and 55 years and affects both men and women equally. PsA is linked to a higher risk for obesity, hypertension, hyperlipidemia, type 2 diabetes, metabolic syndrome, and other conditions, including uveitis and inflammatory bowel disease.

Clinically, PsA presents with a diverse range of manifestations, encompassing peripheral joint inflammation, often with an asymmetric distribution; axial skeletal involvement reminiscent of spondylitis; dactylitis characterized by sausage-like swelling of fingers or toes; and enthesitis. Common symptoms or findings include early morning stiffness for > 30 minutes; joint pain, tenderness, and swelling; back pain aggravated by rest and relieved by exercise; limited joint motion; and deformity. Although most patients have a preceding condition in skin psoriasis, diagnosis of PsA is often delayed. Furthermore, nearly 80% of patients may exhibit nail changes, such as pitting or onycholysis, compared with about 40% of patients with psoriasis without arthritis. The heterogeneity of its clinical features often necessitates a comprehensive differential diagnosis to distinguish PsA from other spondyloarthropathies and rheumatic diseases. The most accepted classification criteria for PsA are the Classification of Psoriatic Arthritis (CASPAR) criteria, which have been used since 2006.

No laboratory tests are specific for PsA; however, a normal ESR and CRP level should not be used to rule out a diagnosis of PsA because these values are increased in only about 40% of patients. RF and ACPA are classically considered absent in PsA, and a negative RF is regarded as a criterion for diagnosing PsA per the CASPAR classification criteria. Radiographic changes show some characteristic patterns in PsA, including erosive damage, gross joint destruction, joint space narrowing, and "pencil-in-cup" deformity.

PsA treatment options have evolved over the years. Whereas in the past, nonsteroidal anti-inflammatory drugs, glucocorticoids, methotrexate, sulfasalazine, and cyclosporine were commonly prescribed, the development of immunologically targeted biological disease-modifying antirheumatic drugs (DMARDs) and targeted synthetic DMARDs since 2000 has revolutionized the treatment of PsA. Tumor necrosis factor inhibitors (ie, etanercept, infliximab, and adalimumab) have been shown to improve all domains (psoriatic and articular disease) of PsA and are considered a milestone in managing the condition. Other emerging therapeutic strategies in recent years have demonstrated efficacy in treating PsA, including monoclonal antibodies targeting interleukin (IL)-12, IL-23, and IL-17, as well as small-molecule phosphodiesterase 4 and Janus kinase inhibitors.

Although most of these options have the potential to be effective in all clinical domains of the disease, their cross-domain efficacy can vary from patient to patient. In some cases, treatment may not be practical or can lose effectiveness over time, and true disease remission is rare. As a result, clinicians must regularly assess each domain and aim to achieve remission or low disease activity across the different active domains while also being aware of potential adverse events.

Alan Irvine, MD, DSc, Consultant Dermatologist, ADI Dermatology LTD, Dublin, Ireland

Alan Irvine, MD, DSc, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.
Serve(d) as a speaker or member of a speakers bureau for: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Received income in an amount equal to or greater than $250 from: Sanofi; Abbvie; Regeneron; Leo; Pfizer; Janssen.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
 

SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.

While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.

Indiana University

For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.

Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.

Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.

A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.

This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.

In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.

Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.

The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.

Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.

While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.

UChicago Medicine

“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.

Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.

She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.

“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”

Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.

“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.

While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.

“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”

Dr. Huynh and Dr. Edens had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.

While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.

Indiana University

For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.

Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.

Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.

A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.

This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.

In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.

Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.

The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.

Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.

While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.

UChicago Medicine

“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.

Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.

She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.

“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”

Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.

“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.

While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.

“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”

Dr. Huynh and Dr. Edens had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Only half of teens and young adults on teratogenic medication report being asked about sexual activity by their rheumatologist, and 38% did not know that their medication would be harmful to a fetus, according to a new survey.

While pediatric rheumatology providers may think that health screenings and contraceptive counseling are happening elsewhere, “this study suggests that a lot of patients are being missed, including those on teratogens,” noted Brittany M. Huynh, MD, MPH, a pediatric rheumatology fellow at the Indiana University School of Medicine in Indianapolis. She led the study and presented the findings at the American College of Rheumatology annual meeting.

Indiana University

For the study, Dr. Huynh and colleagues recruited patients aged 14-23 years who were assigned female at birth and were followed at pediatric rheumatology clinics affiliated with Indiana University. Participants completed a one-time survey between October 2020 and July 2022 and were asked about their sexual reproductive health experience and knowledge. Notably, all but four surveys were completed prior to the US Supreme Court Dobbs decision overturning Roe v. Wade.

Of responses from 108 participants, the most common diagnoses were juvenile idiopathic arthritis (52%) and systemic lupus erythematosus (16%). About one third (36%) of patients were on teratogenic medication, with the most common being methotrexate. About three fourths (76%) were White, and the average age of respondents was 16.7.

Most participants (82%) said they had been asked about sexual activity by a health care provider, but only 38% said their pediatric rheumatologist discussed this topic with them. Of the 39 patients on teratogenic medication, 54% said they had been asked about sexual activity by their pediatric rheumatologist, and only 51% said they had received teratogenicity counseling.

A larger percentage (85%) of this group reported receiving sexual activity screenings by any provider, but there was little difference in counseling about teratogenic medication.

This suggests that this type of risk counseling “is almost exclusively done by (pediatric rheumatologists), if at all,” Dr. Huynh noted during her presentation.

In total, 56% of all patients said a provider had talked to them about how to prevent pregnancy, and 20% said they had been counseled about how to get and use emergency contraception. Only 6% of patients said their pediatric rheumatologist had discussed emergency contraception during appointments.

Although sexual activity screenings were associated with current teratogen use, pregnancy prevention counseling and emergency contraceptive counseling were not associated with teratogen use or reported sexual activity.

The survey also revealed that there were gaps in knowledge about the health effects of rheumatic medication. Of the patients on teratogens, 38% did not know that their medication could harm a fetus if they became pregnant. Only 9% of patients not on teratogens correctly answered that their medication would not harm a fetus.

Previous studies have also shown that rheumatology patients do not know that their medications can be teratogenic, noted Cuoghi Edens, MD, a rheumatologist at the University of Chicago, who sees both adult and pediatric patients. She was not involved with the study. The larger challenge is how to best educate patients, she said.

While hopefully a patient’s primary care provider is discussing these issues with them, these patients often see their rheumatologist more frequently and more consistently than other providers, Dr. Edens said.

UChicago Medicine

“We are sometimes the continuity of care for the patient versus their primary care, even though it should be a group effort of trying to some of these questions,” she said.

Conducting reproductive health screenings in pediatric rheumatology clinics can be difficult though, Dr. Edens noted, not only because of time constraints but also because parents often attend appointments with their child and likely have been for years. These screenings are most accurate when done one-on-one, so pivoting and removing the parents from the room can be awkward for providers, Dr. Edens said.

She advised that starting these conversations early on can be one way to ease into talking about reproductive health. In her own practice, Dr. Huynh sets aside time during appointments to speak with adolescent patients privately.

“We always discuss teratogenic medication. I always talk to them about the fact that I’m going to be doing pregnancy testing with their other screening labs because of the risks associated,” she said. “I also specifically set time aside for patients on teratogens to talk about emergency contraception and offer a prescription, if they’re interested.”

Dr. Huynh emphasized that providing easy access to emergency contraception is key. The ACR reproductive health guidelines — although geared toward adults — recommend discussing emergency contraception with patients, and Dr. Huynh advocates writing prescriptions for interested patients.

“They can fill it and have it easily accessible, so that there are no additional barriers, particularly for people who have these higher risks,” she said.

While emergency contraceptives are also available over the counter, it can be awkward for young people to ask for them, she said, and they can be expensive if not covered under insurance. Providing a prescription is one way to avoid those issues, Dr. Huynh said.

“Certainly, you have to have some parent buy-in, because if there is going to be a script, it’s probably going to be under insurance,” she said. “But in my experience, parents are happy to have it around as long as you’re talking it through with them as well as the young person.”

Dr. Huynh and Dr. Edens had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Long-term follow-up from the only randomized controlled trial to compare salvage autologous stem cell transplant with a standard two-drug regimen in patients with relapsed or refractory multiple myeloma found no benefit to salvage transplant. 

Patients receiving a second, salvage-autologous stem cell transplant alongside lenalidomide-dexamethasone maintenance therapy did not demonstrate improved progression-free survival (PFS) or overall survival compared with patients who continued the two-drug regimen without salvage transplant, according to research presented at the American Society of Hematology annual meeting.

The primary phase 3 analysis, published in 2021, showed no survival benefit following salvage transplant at the time of relapse, though it only followed patients for a median of 37 months. 

However, because a significant fraction of patients in the transplant arm — about 29% — did not undergo the planned salvage transplant before dropping out of the study, the researchers performed further analyses that “suggested a survival benefit in patients who actually received the transplant,” first author Marc-Andrea Baertsch, MD, of the German Cancer Research Center and University Hospital Heidelberg, reported at ASH.

Now, the latest analysis, which followed patients for a median of 99 months (8.25 years), confirmed the initial 2021 findings, Dr. Baertsch explained. 

“The writing on the wall is clear: Don’t repeat a transplant at the time of relapse for those who have already gotten a transplant,” said Manni Mohyuddin, MD, of the University of Utah in Salt Lake City, who was not involved in the research. Dr. Mohyuddin added, however, that this finding doesn’t apply to those who haven’t yet gotten a transplant. “Data from other trials suggests a role of transplant in this situation, depending on the unique circumstances.” 

The current trial included 282 adult patients, aged 75 years or younger, with relapsed or refractory multiple myeloma. Between 2010 and 2016, patients in the intention-to-treat analysis (n = 277) were randomized to lenalidomide-dexamethasone reinduction and maintenance, along with salvage high-dose chemotherapy with melphalan and autologous stem cell transplantation (n = 139) or just continuous lenalidomide-dexamethasone until progression (n = 138). 

Patients in both arms received three cycles of lenalidomide-dexamethasone up front: 25 mg of lenalidomide on days 1 through 21, and 40 mg of dexamethasone on days 1, 8, 15, and 22 in 4-week cycles. Those in the salvage transplant arm then received high-dose chemotherapy with 200 mg/m² of melphalan followed by transplant and 10 mg of lenalidomide maintenance therapy daily, while those in the control arm continued with receiving lenalidomide-dexamethasone.

All patients had received one to three prior lines of therapy, had good performance status, and had a time-to-disease-progression of at least 12 months after frontline autologous stem cell transplant.

In the primary 2021 study, patients in the salvage transplant group did not demonstrate a survival benefit (hazard ratio [HR] for PFS, 0.87; HR for overall survival, 0.81). 

In the latest analysis, no survival benefit emerged after following patients for a median of about 8 years. Patients in the salvage transplant arm had a median PFS of 20.5 months vs 19.3 months in the continuous therapy arms (HR, 0.98; 95% CI, 0.76-1.27; P = .9). Median overall survival was 67.1 months in the salvage transplant arm and 62.7 months in the continuous treatment arm (HR, 0.89; 95% CI, 0.66 - 1.20; P = .44).

Time to first progression after frontline transplant was associated with a PFS benefit but did not predict an overall survival benefit, Dr. Baertsch noted. 

When evaluating outcomes from the time of salvage transplant to account for the high number of dropouts, the PFS and overall survival findings held. Patients who received salvage transplant did not experience significantly improved PFS (HR, 0.91) or overall survival (76.3 months in the salvage group vs 65.9 months in the continuous treatment arm; HR, 0.80). 

The lack of PFS and overall survival benefit occurred across all myeloma subgroups, Dr. Baertsch said. 

Overall, the results indicate that “ a repeat transplant at the time of relapse for patients who had already gotten a transplant previously was no better than continuing a two-drug regimen,” Dr. Mohyuddin said.

However, he noted, “a lot has changed for myeloma care” since this trial was initially conducted. “We now have better regimens available that do not involve a transplant. If a repeat transplant couldn’t beat a two-drug regimen, it surely cannot beat a three drug or four drug regimen.” 

Dr. Baertsch reported no disclosures.

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

SAN DIEGO — Long-term follow-up from the only randomized controlled trial to compare salvage autologous stem cell transplant with a standard two-drug regimen in patients with relapsed or refractory multiple myeloma found no benefit to salvage transplant. 

Patients receiving a second, salvage-autologous stem cell transplant alongside lenalidomide-dexamethasone maintenance therapy did not demonstrate improved progression-free survival (PFS) or overall survival compared with patients who continued the two-drug regimen without salvage transplant, according to research presented at the American Society of Hematology annual meeting.

The primary phase 3 analysis, published in 2021, showed no survival benefit following salvage transplant at the time of relapse, though it only followed patients for a median of 37 months. 

However, because a significant fraction of patients in the transplant arm — about 29% — did not undergo the planned salvage transplant before dropping out of the study, the researchers performed further analyses that “suggested a survival benefit in patients who actually received the transplant,” first author Marc-Andrea Baertsch, MD, of the German Cancer Research Center and University Hospital Heidelberg, reported at ASH.

Now, the latest analysis, which followed patients for a median of 99 months (8.25 years), confirmed the initial 2021 findings, Dr. Baertsch explained. 

“The writing on the wall is clear: Don’t repeat a transplant at the time of relapse for those who have already gotten a transplant,” said Manni Mohyuddin, MD, of the University of Utah in Salt Lake City, who was not involved in the research. Dr. Mohyuddin added, however, that this finding doesn’t apply to those who haven’t yet gotten a transplant. “Data from other trials suggests a role of transplant in this situation, depending on the unique circumstances.” 

The current trial included 282 adult patients, aged 75 years or younger, with relapsed or refractory multiple myeloma. Between 2010 and 2016, patients in the intention-to-treat analysis (n = 277) were randomized to lenalidomide-dexamethasone reinduction and maintenance, along with salvage high-dose chemotherapy with melphalan and autologous stem cell transplantation (n = 139) or just continuous lenalidomide-dexamethasone until progression (n = 138). 

Patients in both arms received three cycles of lenalidomide-dexamethasone up front: 25 mg of lenalidomide on days 1 through 21, and 40 mg of dexamethasone on days 1, 8, 15, and 22 in 4-week cycles. Those in the salvage transplant arm then received high-dose chemotherapy with 200 mg/m² of melphalan followed by transplant and 10 mg of lenalidomide maintenance therapy daily, while those in the control arm continued with receiving lenalidomide-dexamethasone.

All patients had received one to three prior lines of therapy, had good performance status, and had a time-to-disease-progression of at least 12 months after frontline autologous stem cell transplant.

In the primary 2021 study, patients in the salvage transplant group did not demonstrate a survival benefit (hazard ratio [HR] for PFS, 0.87; HR for overall survival, 0.81). 

In the latest analysis, no survival benefit emerged after following patients for a median of about 8 years. Patients in the salvage transplant arm had a median PFS of 20.5 months vs 19.3 months in the continuous therapy arms (HR, 0.98; 95% CI, 0.76-1.27; P = .9). Median overall survival was 67.1 months in the salvage transplant arm and 62.7 months in the continuous treatment arm (HR, 0.89; 95% CI, 0.66 - 1.20; P = .44).

Time to first progression after frontline transplant was associated with a PFS benefit but did not predict an overall survival benefit, Dr. Baertsch noted. 

When evaluating outcomes from the time of salvage transplant to account for the high number of dropouts, the PFS and overall survival findings held. Patients who received salvage transplant did not experience significantly improved PFS (HR, 0.91) or overall survival (76.3 months in the salvage group vs 65.9 months in the continuous treatment arm; HR, 0.80). 

The lack of PFS and overall survival benefit occurred across all myeloma subgroups, Dr. Baertsch said. 

Overall, the results indicate that “ a repeat transplant at the time of relapse for patients who had already gotten a transplant previously was no better than continuing a two-drug regimen,” Dr. Mohyuddin said.

However, he noted, “a lot has changed for myeloma care” since this trial was initially conducted. “We now have better regimens available that do not involve a transplant. If a repeat transplant couldn’t beat a two-drug regimen, it surely cannot beat a three drug or four drug regimen.” 

Dr. Baertsch reported no disclosures.

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

SAN DIEGO — Long-term follow-up from the only randomized controlled trial to compare salvage autologous stem cell transplant with a standard two-drug regimen in patients with relapsed or refractory multiple myeloma found no benefit to salvage transplant. 

Patients receiving a second, salvage-autologous stem cell transplant alongside lenalidomide-dexamethasone maintenance therapy did not demonstrate improved progression-free survival (PFS) or overall survival compared with patients who continued the two-drug regimen without salvage transplant, according to research presented at the American Society of Hematology annual meeting.

The primary phase 3 analysis, published in 2021, showed no survival benefit following salvage transplant at the time of relapse, though it only followed patients for a median of 37 months. 

However, because a significant fraction of patients in the transplant arm — about 29% — did not undergo the planned salvage transplant before dropping out of the study, the researchers performed further analyses that “suggested a survival benefit in patients who actually received the transplant,” first author Marc-Andrea Baertsch, MD, of the German Cancer Research Center and University Hospital Heidelberg, reported at ASH.

Now, the latest analysis, which followed patients for a median of 99 months (8.25 years), confirmed the initial 2021 findings, Dr. Baertsch explained. 

“The writing on the wall is clear: Don’t repeat a transplant at the time of relapse for those who have already gotten a transplant,” said Manni Mohyuddin, MD, of the University of Utah in Salt Lake City, who was not involved in the research. Dr. Mohyuddin added, however, that this finding doesn’t apply to those who haven’t yet gotten a transplant. “Data from other trials suggests a role of transplant in this situation, depending on the unique circumstances.” 

The current trial included 282 adult patients, aged 75 years or younger, with relapsed or refractory multiple myeloma. Between 2010 and 2016, patients in the intention-to-treat analysis (n = 277) were randomized to lenalidomide-dexamethasone reinduction and maintenance, along with salvage high-dose chemotherapy with melphalan and autologous stem cell transplantation (n = 139) or just continuous lenalidomide-dexamethasone until progression (n = 138). 

Patients in both arms received three cycles of lenalidomide-dexamethasone up front: 25 mg of lenalidomide on days 1 through 21, and 40 mg of dexamethasone on days 1, 8, 15, and 22 in 4-week cycles. Those in the salvage transplant arm then received high-dose chemotherapy with 200 mg/m² of melphalan followed by transplant and 10 mg of lenalidomide maintenance therapy daily, while those in the control arm continued with receiving lenalidomide-dexamethasone.

All patients had received one to three prior lines of therapy, had good performance status, and had a time-to-disease-progression of at least 12 months after frontline autologous stem cell transplant.

In the primary 2021 study, patients in the salvage transplant group did not demonstrate a survival benefit (hazard ratio [HR] for PFS, 0.87; HR for overall survival, 0.81). 

In the latest analysis, no survival benefit emerged after following patients for a median of about 8 years. Patients in the salvage transplant arm had a median PFS of 20.5 months vs 19.3 months in the continuous therapy arms (HR, 0.98; 95% CI, 0.76-1.27; P = .9). Median overall survival was 67.1 months in the salvage transplant arm and 62.7 months in the continuous treatment arm (HR, 0.89; 95% CI, 0.66 - 1.20; P = .44).

Time to first progression after frontline transplant was associated with a PFS benefit but did not predict an overall survival benefit, Dr. Baertsch noted. 

When evaluating outcomes from the time of salvage transplant to account for the high number of dropouts, the PFS and overall survival findings held. Patients who received salvage transplant did not experience significantly improved PFS (HR, 0.91) or overall survival (76.3 months in the salvage group vs 65.9 months in the continuous treatment arm; HR, 0.80). 

The lack of PFS and overall survival benefit occurred across all myeloma subgroups, Dr. Baertsch said. 

Overall, the results indicate that “ a repeat transplant at the time of relapse for patients who had already gotten a transplant previously was no better than continuing a two-drug regimen,” Dr. Mohyuddin said.

However, he noted, “a lot has changed for myeloma care” since this trial was initially conducted. “We now have better regimens available that do not involve a transplant. If a repeat transplant couldn’t beat a two-drug regimen, it surely cannot beat a three drug or four drug regimen.” 

Dr. Baertsch reported no disclosures.

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

To the Editor:

Capillary malformations (CMs), the most common vascular malformations that can affect the skin,¹ present clinically as macules and patches of various colors, shapes, and sizes. Congenital structural abnormalities are associated with conditions such as Klippel-Trenaunay syndrome (KTS), cutis marmorata telangiectatica congenita (CMTC), and megalencephaly–capillary malformation syndrome.² Diffuse CM with overgrowth (DCMO) of the soft tissue and bones is an established association of CMs; however, diffuse capillary malformation with undergrowth (DCMU) is a more recent term that describes the lesser-recognized counterpart to DCMO.³ Herein, we describe a case of CM with left-sided undergrowth.

An 11-year-old boy presented to our clinic with asymptomatic vascular patterning on the left side of the body that had been present since birth. He previously was diagnosed with congenital right hemihypertrophy. He reported that the areas gradually lightened over time, and he denied any history of ulceration or venous or lymphatic malformations. Additionally, he explained how the left arm and leg have been noticeably smaller than the right extremities throughout his life. Physical examination revealed superficial, violaceous, reticulated patches along the left upper back tracking down the arm, abdomen (Figure 1A), and anterior thigh (Figure 1B) without crossing the midline. A few dilated veins were noted in the same region as the patches. There was no evidence of scarring or depression found in the skin. The right arms and legs were visibly larger compared to the left side (Figure 2A), and there also was macrodactyly of the third digit of the left hand (Figure 2B). Radiography confirmed the limb length discrepancy and showed the right and left legs to measure 73.2 cm and 71.3 cm, respectively. Given the patient’s multifocal reticulated CMs and ipsilateral undergrowth, a diagnosis of DCMU was rendered. The superficial vascular pattern is likely to fade over time, which will partially be hidden by his darker complexion. He also was advised to continue to see an orthopedist to monitor the limb length incongruity. Surgical intervention was not recommended.

It ordinarily is thought that vascular anomalies of a limb may result in hypertrophy due to increased blood flow such as in KTS, but there are occasions where the affected limb(s) are inexplicably smaller.^2,4 Cubiró et al³ observed that in 6 patients with unilateral CMs, all had ipsilateral limb undergrowth. They proposed the term diffuse capillary malformation with undergrowth as a distinct counterpart to DCMO. Diffuse capillary malformation with undergrowth is most similar to CMTC, as both can present with patchy or reticulated capillary staining with ipsilateral limb hypotrophy, but girth more often is affected than length; CMTC also may be associated with dermal atrophy and ulceration.² The lesions of CMTC typically diminish within the first few years of life whereas those in DCMU tend to persist. Patients with KTS also can exhibit soft-tissue and bony undergrowth, which is termed inverse Klippel-Trenaunay syndrome³; however, the lack of the triad of capillary-lymphatic-venous malformation in our patient made this condition less likely. Additionally, it appears that our patient had left-sided undergrowth rather than the previously diagnosed right hemihypertrophy. The ipsilateral macrodactyly of the third digit of the left hand was an interesting observation and contrasted the undergrowth apparent in the rest of the left limb, which could be caused by increased blood flow specifically to the third digit resembling DCMO.⁴

Of note, genetic mutations have been implicated as a cause of vascular malformations and growth abnormalities. Specifically, mutations in the phosphoinositide-3-kinase–AKT pathway have been reported in these cases likely due its role in cell growth, proliferation, and angiogenesis.^3,4 Future studies should investigate genetic associations in patients with DCMU to determine if there is a robust genotypic-phenotypic link.

Although CMs are a common occurrence in pediatric dermatology, CMs with concurrent limb undergrowth are rare. Our patient’s unique features included involvement of both an arm and leg as well as the presence of macrodactyly. We agree with the terminology for DCMU to describe multifocal reticulated vascular patterning with ipsilateral undergrowth.³

To the Editor:

Capillary malformations (CMs), the most common vascular malformations that can affect the skin,¹ present clinically as macules and patches of various colors, shapes, and sizes. Congenital structural abnormalities are associated with conditions such as Klippel-Trenaunay syndrome (KTS), cutis marmorata telangiectatica congenita (CMTC), and megalencephaly–capillary malformation syndrome.² Diffuse CM with overgrowth (DCMO) of the soft tissue and bones is an established association of CMs; however, diffuse capillary malformation with undergrowth (DCMU) is a more recent term that describes the lesser-recognized counterpart to DCMO.³ Herein, we describe a case of CM with left-sided undergrowth.

An 11-year-old boy presented to our clinic with asymptomatic vascular patterning on the left side of the body that had been present since birth. He previously was diagnosed with congenital right hemihypertrophy. He reported that the areas gradually lightened over time, and he denied any history of ulceration or venous or lymphatic malformations. Additionally, he explained how the left arm and leg have been noticeably smaller than the right extremities throughout his life. Physical examination revealed superficial, violaceous, reticulated patches along the left upper back tracking down the arm, abdomen (Figure 1A), and anterior thigh (Figure 1B) without crossing the midline. A few dilated veins were noted in the same region as the patches. There was no evidence of scarring or depression found in the skin. The right arms and legs were visibly larger compared to the left side (Figure 2A), and there also was macrodactyly of the third digit of the left hand (Figure 2B). Radiography confirmed the limb length discrepancy and showed the right and left legs to measure 73.2 cm and 71.3 cm, respectively. Given the patient’s multifocal reticulated CMs and ipsilateral undergrowth, a diagnosis of DCMU was rendered. The superficial vascular pattern is likely to fade over time, which will partially be hidden by his darker complexion. He also was advised to continue to see an orthopedist to monitor the limb length incongruity. Surgical intervention was not recommended.

It ordinarily is thought that vascular anomalies of a limb may result in hypertrophy due to increased blood flow such as in KTS, but there are occasions where the affected limb(s) are inexplicably smaller.^2,4 Cubiró et al³ observed that in 6 patients with unilateral CMs, all had ipsilateral limb undergrowth. They proposed the term diffuse capillary malformation with undergrowth as a distinct counterpart to DCMO. Diffuse capillary malformation with undergrowth is most similar to CMTC, as both can present with patchy or reticulated capillary staining with ipsilateral limb hypotrophy, but girth more often is affected than length; CMTC also may be associated with dermal atrophy and ulceration.² The lesions of CMTC typically diminish within the first few years of life whereas those in DCMU tend to persist. Patients with KTS also can exhibit soft-tissue and bony undergrowth, which is termed inverse Klippel-Trenaunay syndrome³; however, the lack of the triad of capillary-lymphatic-venous malformation in our patient made this condition less likely. Additionally, it appears that our patient had left-sided undergrowth rather than the previously diagnosed right hemihypertrophy. The ipsilateral macrodactyly of the third digit of the left hand was an interesting observation and contrasted the undergrowth apparent in the rest of the left limb, which could be caused by increased blood flow specifically to the third digit resembling DCMO.⁴

Of note, genetic mutations have been implicated as a cause of vascular malformations and growth abnormalities. Specifically, mutations in the phosphoinositide-3-kinase–AKT pathway have been reported in these cases likely due its role in cell growth, proliferation, and angiogenesis.^3,4 Future studies should investigate genetic associations in patients with DCMU to determine if there is a robust genotypic-phenotypic link.

Although CMs are a common occurrence in pediatric dermatology, CMs with concurrent limb undergrowth are rare. Our patient’s unique features included involvement of both an arm and leg as well as the presence of macrodactyly. We agree with the terminology for DCMU to describe multifocal reticulated vascular patterning with ipsilateral undergrowth.³

To the Editor:

Capillary malformations (CMs), the most common vascular malformations that can affect the skin,¹ present clinically as macules and patches of various colors, shapes, and sizes. Congenital structural abnormalities are associated with conditions such as Klippel-Trenaunay syndrome (KTS), cutis marmorata telangiectatica congenita (CMTC), and megalencephaly–capillary malformation syndrome.² Diffuse CM with overgrowth (DCMO) of the soft tissue and bones is an established association of CMs; however, diffuse capillary malformation with undergrowth (DCMU) is a more recent term that describes the lesser-recognized counterpart to DCMO.³ Herein, we describe a case of CM with left-sided undergrowth.

An 11-year-old boy presented to our clinic with asymptomatic vascular patterning on the left side of the body that had been present since birth. He previously was diagnosed with congenital right hemihypertrophy. He reported that the areas gradually lightened over time, and he denied any history of ulceration or venous or lymphatic malformations. Additionally, he explained how the left arm and leg have been noticeably smaller than the right extremities throughout his life. Physical examination revealed superficial, violaceous, reticulated patches along the left upper back tracking down the arm, abdomen (Figure 1A), and anterior thigh (Figure 1B) without crossing the midline. A few dilated veins were noted in the same region as the patches. There was no evidence of scarring or depression found in the skin. The right arms and legs were visibly larger compared to the left side (Figure 2A), and there also was macrodactyly of the third digit of the left hand (Figure 2B). Radiography confirmed the limb length discrepancy and showed the right and left legs to measure 73.2 cm and 71.3 cm, respectively. Given the patient’s multifocal reticulated CMs and ipsilateral undergrowth, a diagnosis of DCMU was rendered. The superficial vascular pattern is likely to fade over time, which will partially be hidden by his darker complexion. He also was advised to continue to see an orthopedist to monitor the limb length incongruity. Surgical intervention was not recommended.

It ordinarily is thought that vascular anomalies of a limb may result in hypertrophy due to increased blood flow such as in KTS, but there are occasions where the affected limb(s) are inexplicably smaller.^2,4 Cubiró et al³ observed that in 6 patients with unilateral CMs, all had ipsilateral limb undergrowth. They proposed the term diffuse capillary malformation with undergrowth as a distinct counterpart to DCMO. Diffuse capillary malformation with undergrowth is most similar to CMTC, as both can present with patchy or reticulated capillary staining with ipsilateral limb hypotrophy, but girth more often is affected than length; CMTC also may be associated with dermal atrophy and ulceration.² The lesions of CMTC typically diminish within the first few years of life whereas those in DCMU tend to persist. Patients with KTS also can exhibit soft-tissue and bony undergrowth, which is termed inverse Klippel-Trenaunay syndrome³; however, the lack of the triad of capillary-lymphatic-venous malformation in our patient made this condition less likely. Additionally, it appears that our patient had left-sided undergrowth rather than the previously diagnosed right hemihypertrophy. The ipsilateral macrodactyly of the third digit of the left hand was an interesting observation and contrasted the undergrowth apparent in the rest of the left limb, which could be caused by increased blood flow specifically to the third digit resembling DCMO.⁴

Of note, genetic mutations have been implicated as a cause of vascular malformations and growth abnormalities. Specifically, mutations in the phosphoinositide-3-kinase–AKT pathway have been reported in these cases likely due its role in cell growth, proliferation, and angiogenesis.^3,4 Future studies should investigate genetic associations in patients with DCMU to determine if there is a robust genotypic-phenotypic link.

Although CMs are a common occurrence in pediatric dermatology, CMs with concurrent limb undergrowth are rare. Our patient’s unique features included involvement of both an arm and leg as well as the presence of macrodactyly. We agree with the terminology for DCMU to describe multifocal reticulated vascular patterning with ipsilateral undergrowth.³

A multicomponent exercise program that includes strength, aerobic, agility, and balance training exercises is cost-effective and results in improved cognition among stroke survivors, compared with a balance and tone control group, according to a new analysis.

On the other hand, a program consisting of cognitive and social enrichment activities that includes memory, brain training, and group social games entailed higher costs, compared with the balance and tone group, which included stretches, deep breathing and relaxation techniques, posture education, and core control exercises.

“Cognitive impairment is experienced in approximately one-third of stroke survivors,” study author Jennifer Davis, PhD, a Canada research chair in applied health economics and assistant professor of management at the University of British Columbia in Kelowna, said in an interview.

“The economic evaluation of the exercise intervention demonstrated that the multicomponent exercise program provided good value for the money when comparing costs and cognitive outcomes,” she said. However, “impacts on health-related quality of life were not observed.”

The study was published online November 30 in JAMA Network Open. 
 

Comparing Three Approaches

Despite improved care, patients with stroke often face challenges with physical function, cognitive abilities, and quality of life, the authors wrote. Among older adults, in particular, cognitive deficits remain prevalent and are associated with increased risks for dementia, mortality, and increased burdens for patients, caregivers, and health systems.

Numerous interventions have shown promise for post-stroke cognitive rehabilitation, including exercise and cognitive training, the authors wrote. Research hasn’t indicated which programs offer the most efficient or cost-effective options, however.

Dr. Davis and colleagues conducted an economic evaluation alongside the Vitality study, a three-group randomized clinical trial that examined the efficacy of improving cognitive function among patients with chronic stroke through a multicomponent exercise program, cognitive and social enrichment activities, or a control group with balance and tone activities. 

The economic evaluation team included a cost-effectiveness analysis (based on incremental cost per cognitive function change) and a cost-utility analysis (incremental cost per quality-adjusted life-year [QALY] gained). The researchers used a cost-effectiveness threshold of CAD $50,000 (Canadian dollars) per QALY for the cost-utility analysis, which was based on precedent treatment in Canada.

The clinical trial included 120 community-dwelling adults aged 55 years and older who had a stroke at least 12 months before the study. Based in the Vancouver metropolitan area, participants were randomly assigned to twice-weekly, 60-minute classes led by trained instructors for 26 weeks. The mean age was 71 years, and 62% of participants were men.

Exercise Effective

Overall, the balance and tone control group had the lowest delivery cost at CAD $777 per person, followed by CAD $1090 per person for the exercise group and CAD $1492 per person for the cognitive and social enrichment group.

After the 6-month intervention, the mean cognitive scores were –0.192 for the exercise group, –0.184 for the cognitive and social enrichment group, and –0.171 for the balance and tone group, indicating better cognitive function across all three groups.

In the cost-effectiveness analysis, the exercise intervention was costlier but more effective than the control group, with an incremental cost-effectiveness ratio (ICER) of CAD –$8823.

In the cost-utility analysis, the exercise intervention was cost saving (less costly and more effective), compared with the control group, with an ICER of CAD –$3381 per QALY gained at the end of the intervention and an ICER of CAD –$154,198 per QALY gained at the end of the 12-month follow-up period. The cognitive and social enrichment program was more costly and more effective than the control group, with an ICER of CAD $101,687 per QALY gained at the end of the intervention and an ICER of CAD $331,306 per QALY gained at the end of the follow-up period.

In additional analyses, the exercise group had the lowest healthcare resource utilization due to lower healthcare costs for physician visits and lab tests.

“This study provides initial data that suggests multicomponent exercise may be a cost-effective solution for combating cognitive decline among stroke survivors,” said Dr. Davis.

Overall, exercise was cost-effective for improving cognitive function but not quality of life among participants. The clinical trial was powered to detect changes in cognitive function rather than quality of life, so it lacked statistical power to detect differences in quality of life, said Dr. Davis.

Exercise programs and cognitive and social enrichment programs show promise for improving cognitive function after stroke, the authors wrote, though future research should focus on optimizing cost-effectiveness and enhancing health-related quality of life.

Considering Additional Benefits

Commenting on the study, Alan Tam, MD, a physiatrist at the Toronto Rehabilitation Institute’s Brain Rehabilitation Program, said, “The authors show that within the timeframe of their analysis, there is a trend to cost-effectiveness for the cognitive intervention being offered.” Dr. Tam did not participate in the research.

“However, the finding is not robust, as less than 50% of their simulations would meet their acceptability level they have defined,” he said. “Given that most of the cost of the intervention is up front, but the benefits are likely lifelong, potentially taking the 12-month analysis to a lifetime analysis would show more significant findings.”

Dr. Tam researches factors associated with brain injury rehabilitation and has explored the cost-effectiveness of a high-intensity outpatient stroke rehabilitation program.

“Presenting this type of work is important,” he said. “While there are interventions that do not meet our definition of statistical significance, especially in the rehabilitation world, there can still be a benefit for patients and health systems.”

The primary study was funded by the Canadian Institutes of Health Research (CIHR) and the Jack Brown and Family Alzheimer Research Foundation Society. Dr. Davis reported receiving grants from the CIHR and Michael Smith Health Research BC during the conduct of the study. Dr. Tam reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A multicomponent exercise program that includes strength, aerobic, agility, and balance training exercises is cost-effective and results in improved cognition among stroke survivors, compared with a balance and tone control group, according to a new analysis.

On the other hand, a program consisting of cognitive and social enrichment activities that includes memory, brain training, and group social games entailed higher costs, compared with the balance and tone group, which included stretches, deep breathing and relaxation techniques, posture education, and core control exercises.

“Cognitive impairment is experienced in approximately one-third of stroke survivors,” study author Jennifer Davis, PhD, a Canada research chair in applied health economics and assistant professor of management at the University of British Columbia in Kelowna, said in an interview.

“The economic evaluation of the exercise intervention demonstrated that the multicomponent exercise program provided good value for the money when comparing costs and cognitive outcomes,” she said. However, “impacts on health-related quality of life were not observed.”

The study was published online November 30 in JAMA Network Open. 
 

Comparing Three Approaches

Despite improved care, patients with stroke often face challenges with physical function, cognitive abilities, and quality of life, the authors wrote. Among older adults, in particular, cognitive deficits remain prevalent and are associated with increased risks for dementia, mortality, and increased burdens for patients, caregivers, and health systems.

Numerous interventions have shown promise for post-stroke cognitive rehabilitation, including exercise and cognitive training, the authors wrote. Research hasn’t indicated which programs offer the most efficient or cost-effective options, however.

Dr. Davis and colleagues conducted an economic evaluation alongside the Vitality study, a three-group randomized clinical trial that examined the efficacy of improving cognitive function among patients with chronic stroke through a multicomponent exercise program, cognitive and social enrichment activities, or a control group with balance and tone activities. 

The economic evaluation team included a cost-effectiveness analysis (based on incremental cost per cognitive function change) and a cost-utility analysis (incremental cost per quality-adjusted life-year [QALY] gained). The researchers used a cost-effectiveness threshold of CAD $50,000 (Canadian dollars) per QALY for the cost-utility analysis, which was based on precedent treatment in Canada.

The clinical trial included 120 community-dwelling adults aged 55 years and older who had a stroke at least 12 months before the study. Based in the Vancouver metropolitan area, participants were randomly assigned to twice-weekly, 60-minute classes led by trained instructors for 26 weeks. The mean age was 71 years, and 62% of participants were men.

Exercise Effective

Overall, the balance and tone control group had the lowest delivery cost at CAD $777 per person, followed by CAD $1090 per person for the exercise group and CAD $1492 per person for the cognitive and social enrichment group.

After the 6-month intervention, the mean cognitive scores were –0.192 for the exercise group, –0.184 for the cognitive and social enrichment group, and –0.171 for the balance and tone group, indicating better cognitive function across all three groups.

In the cost-effectiveness analysis, the exercise intervention was costlier but more effective than the control group, with an incremental cost-effectiveness ratio (ICER) of CAD –$8823.

In the cost-utility analysis, the exercise intervention was cost saving (less costly and more effective), compared with the control group, with an ICER of CAD –$3381 per QALY gained at the end of the intervention and an ICER of CAD –$154,198 per QALY gained at the end of the 12-month follow-up period. The cognitive and social enrichment program was more costly and more effective than the control group, with an ICER of CAD $101,687 per QALY gained at the end of the intervention and an ICER of CAD $331,306 per QALY gained at the end of the follow-up period.

In additional analyses, the exercise group had the lowest healthcare resource utilization due to lower healthcare costs for physician visits and lab tests.

“This study provides initial data that suggests multicomponent exercise may be a cost-effective solution for combating cognitive decline among stroke survivors,” said Dr. Davis.

Overall, exercise was cost-effective for improving cognitive function but not quality of life among participants. The clinical trial was powered to detect changes in cognitive function rather than quality of life, so it lacked statistical power to detect differences in quality of life, said Dr. Davis.

Exercise programs and cognitive and social enrichment programs show promise for improving cognitive function after stroke, the authors wrote, though future research should focus on optimizing cost-effectiveness and enhancing health-related quality of life.

Considering Additional Benefits

Commenting on the study, Alan Tam, MD, a physiatrist at the Toronto Rehabilitation Institute’s Brain Rehabilitation Program, said, “The authors show that within the timeframe of their analysis, there is a trend to cost-effectiveness for the cognitive intervention being offered.” Dr. Tam did not participate in the research.

“However, the finding is not robust, as less than 50% of their simulations would meet their acceptability level they have defined,” he said. “Given that most of the cost of the intervention is up front, but the benefits are likely lifelong, potentially taking the 12-month analysis to a lifetime analysis would show more significant findings.”

Dr. Tam researches factors associated with brain injury rehabilitation and has explored the cost-effectiveness of a high-intensity outpatient stroke rehabilitation program.

“Presenting this type of work is important,” he said. “While there are interventions that do not meet our definition of statistical significance, especially in the rehabilitation world, there can still be a benefit for patients and health systems.”

The primary study was funded by the Canadian Institutes of Health Research (CIHR) and the Jack Brown and Family Alzheimer Research Foundation Society. Dr. Davis reported receiving grants from the CIHR and Michael Smith Health Research BC during the conduct of the study. Dr. Tam reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A multicomponent exercise program that includes strength, aerobic, agility, and balance training exercises is cost-effective and results in improved cognition among stroke survivors, compared with a balance and tone control group, according to a new analysis.

On the other hand, a program consisting of cognitive and social enrichment activities that includes memory, brain training, and group social games entailed higher costs, compared with the balance and tone group, which included stretches, deep breathing and relaxation techniques, posture education, and core control exercises.

“Cognitive impairment is experienced in approximately one-third of stroke survivors,” study author Jennifer Davis, PhD, a Canada research chair in applied health economics and assistant professor of management at the University of British Columbia in Kelowna, said in an interview.

“The economic evaluation of the exercise intervention demonstrated that the multicomponent exercise program provided good value for the money when comparing costs and cognitive outcomes,” she said. However, “impacts on health-related quality of life were not observed.”

The study was published online November 30 in JAMA Network Open. 
 

Comparing Three Approaches

Despite improved care, patients with stroke often face challenges with physical function, cognitive abilities, and quality of life, the authors wrote. Among older adults, in particular, cognitive deficits remain prevalent and are associated with increased risks for dementia, mortality, and increased burdens for patients, caregivers, and health systems.

Numerous interventions have shown promise for post-stroke cognitive rehabilitation, including exercise and cognitive training, the authors wrote. Research hasn’t indicated which programs offer the most efficient or cost-effective options, however.

Dr. Davis and colleagues conducted an economic evaluation alongside the Vitality study, a three-group randomized clinical trial that examined the efficacy of improving cognitive function among patients with chronic stroke through a multicomponent exercise program, cognitive and social enrichment activities, or a control group with balance and tone activities. 

The economic evaluation team included a cost-effectiveness analysis (based on incremental cost per cognitive function change) and a cost-utility analysis (incremental cost per quality-adjusted life-year [QALY] gained). The researchers used a cost-effectiveness threshold of CAD $50,000 (Canadian dollars) per QALY for the cost-utility analysis, which was based on precedent treatment in Canada.

The clinical trial included 120 community-dwelling adults aged 55 years and older who had a stroke at least 12 months before the study. Based in the Vancouver metropolitan area, participants were randomly assigned to twice-weekly, 60-minute classes led by trained instructors for 26 weeks. The mean age was 71 years, and 62% of participants were men.

Exercise Effective

Overall, the balance and tone control group had the lowest delivery cost at CAD $777 per person, followed by CAD $1090 per person for the exercise group and CAD $1492 per person for the cognitive and social enrichment group.

After the 6-month intervention, the mean cognitive scores were –0.192 for the exercise group, –0.184 for the cognitive and social enrichment group, and –0.171 for the balance and tone group, indicating better cognitive function across all three groups.

In the cost-effectiveness analysis, the exercise intervention was costlier but more effective than the control group, with an incremental cost-effectiveness ratio (ICER) of CAD –$8823.

In the cost-utility analysis, the exercise intervention was cost saving (less costly and more effective), compared with the control group, with an ICER of CAD –$3381 per QALY gained at the end of the intervention and an ICER of CAD –$154,198 per QALY gained at the end of the 12-month follow-up period. The cognitive and social enrichment program was more costly and more effective than the control group, with an ICER of CAD $101,687 per QALY gained at the end of the intervention and an ICER of CAD $331,306 per QALY gained at the end of the follow-up period.

In additional analyses, the exercise group had the lowest healthcare resource utilization due to lower healthcare costs for physician visits and lab tests.

“This study provides initial data that suggests multicomponent exercise may be a cost-effective solution for combating cognitive decline among stroke survivors,” said Dr. Davis.

Overall, exercise was cost-effective for improving cognitive function but not quality of life among participants. The clinical trial was powered to detect changes in cognitive function rather than quality of life, so it lacked statistical power to detect differences in quality of life, said Dr. Davis.

Exercise programs and cognitive and social enrichment programs show promise for improving cognitive function after stroke, the authors wrote, though future research should focus on optimizing cost-effectiveness and enhancing health-related quality of life.

Considering Additional Benefits

Commenting on the study, Alan Tam, MD, a physiatrist at the Toronto Rehabilitation Institute’s Brain Rehabilitation Program, said, “The authors show that within the timeframe of their analysis, there is a trend to cost-effectiveness for the cognitive intervention being offered.” Dr. Tam did not participate in the research.

“However, the finding is not robust, as less than 50% of their simulations would meet their acceptability level they have defined,” he said. “Given that most of the cost of the intervention is up front, but the benefits are likely lifelong, potentially taking the 12-month analysis to a lifetime analysis would show more significant findings.”

Dr. Tam researches factors associated with brain injury rehabilitation and has explored the cost-effectiveness of a high-intensity outpatient stroke rehabilitation program.

“Presenting this type of work is important,” he said. “While there are interventions that do not meet our definition of statistical significance, especially in the rehabilitation world, there can still be a benefit for patients and health systems.”

The primary study was funded by the Canadian Institutes of Health Research (CIHR) and the Jack Brown and Family Alzheimer Research Foundation Society. Dr. Davis reported receiving grants from the CIHR and Michael Smith Health Research BC during the conduct of the study. Dr. Tam reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Fertility preservation and/or assisted reproductive technologies do not increase the risk for short-term cancer recurrence in young women with early hormone receptor (HR)-positive breast cancer who pause endocrine therapy to conceive, according to new data from the POSITIVE trial.

“We believe these data are of vital importance for the oncofertility counseling of young breast cancer patients,” Hatem A. Azim Jr., MD, PhD, adjunct professor, School of Medicine and Breast Cancer Center, Monterrey Institute of Technology, Mexico, said in a presentation at the San Antonio Breast Cancer Symposium.

As reported previously by this news organization, the primary results of the POSITIVE trial showed that interrupting endocrine therapy to allow pregnancy does not increase the risk of recurrence at 41 months follow-up. 

Yet, there is concern that use of fertility preservation or assisted reproductive technology methods — especially those that entail the use of hormones — could have harmful effects on patients with HR-positive breast cancers, Dr. Azim explained. 

To investigate, Dr. Azim and colleagues did a secondary analysis of outcomes from the POSITIVE trial, focusing on resumption of menstruation and use of fertility preservation and assisted reproductive technologies. 

Among 516 women evaluated for the menstruation analysis, two thirds were aged 35 and older and a little more than half (53%) reported amenorrhea at enrollment, “which is not surprising,” Dr. Azim said. 

“What is encouraging,” he said, is that 85% of women recovered menses within 6 months and 94% within 12 months of pausing endocrine therapy.

Among 497 evaluable participants who paused endocrine therapy to attempt pregnancy, 368 (74%) became pregnant.

Looking at time to pregnancy, there was a clear association between younger age at enrollment and shorter time to pregnancy. The cumulative incidence of pregnancy at 12 months was 64% in women younger than age 35 years, 54% in those aged 35-39, and 38% in those age 40-42. In a multivariable model, age < 35 was the only factor independently associated with a shorter time to pregnancy. 
 

No Harmful Impact on Breast Cancer Outcomes

Turning to fertility preservation and use of assisted reproductive technologies, roughly half of the women (51%) underwent some form of fertility preservation at breast cancer diagnosis and before trial enrollment, most commonly ovarian stimulation for embryo or oocyte cryopreservation.

After enrollment, 43% of women underwent some form of assisted reproductive technology to attempt pregnancy, most commonly ovarian stimulation for in vitro fertilization (IVF) and cryopreserved embryo transfer.

In the multivariable model, cryopreserved embryo transfer was the only assisted reproductive technology significantly associated with a greater chance of becoming pregnant, more than doubling patients’ odds (odds ratio, 2.4).

“This means that at breast cancer diagnosis, we should consider cryopreservation of embryos for future use if desired,” Dr. Azim said. 

Again, age mattered. Women younger than 35 undergoing assisted reproductive technologies had a 50% higher chance of becoming pregnant compared with peers aged 35-39, and an 84% higher chance than women aged 40-42. 

Importantly, there was no apparent short-term detrimental impact of fertility preservation and/or assisted reproductive technologies on breast cancer outcomes, Dr. Azim reported. At 3 years, the breast cancer-free interval was almost identical between women who underwent ovarian stimulation for cryopreservation and those who did not (9.7% vs 8.7%).

“POSITIVE showed positive results that emphasize the importance of active oncofertility counseling with the patient starting at diagnosis,” said Hee Jeong Kim, MD, PhD, professor, Division of Breast Surgery, Asan Medical Center, Seoul, Republic of Korea, and discussant for the study. 

“These data are reassuring for our young patients with a diagnosis of breast cancer and shows that assisted reproductive technology is an option and is probably safe to do with the caveat that it needs longer follow-up,” added SABCS codirector Carlos Arteaga, MD, director, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas.

Dr. Azim has no relevant disclosures. Dr. Arteaga is a scientific adviser to Novartis, Lilly, Merck, AstraZeneca, Daiichi Sankyo, OrigiMed, Immunomedics, PUMA Biotechnology, TAIHO Oncology, Sanofi, and the Susan G. Komen Foundation. He has received grant support from Pfizer, Lilly, and Takeda. Dr. Kim reports no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Women with early breast cancer who have less extensive axillary surgery see no effect on their 10-year rates of locoregional recurrence and mortality than do those who have more extensive surgery, according to findings from a large meta-analysis.

Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.

These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.

Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population. 

To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.

In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain. 

Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).

The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).

Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).

Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.

“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.

To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained. 

These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).

Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.

However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).

This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview. 

“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”

This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added. 

Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”

The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.

No relevant financial relationships have been declared.

A version of this article appeared on Medscape.com.

SAN ANTONIO — Women with early breast cancer who have less extensive axillary surgery see no effect on their 10-year rates of locoregional recurrence and mortality than do those who have more extensive surgery, according to findings from a large meta-analysis.

Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.

These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.

Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population. 

To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.

In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain. 

Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).

The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).

Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).

Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.

“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.

To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained. 

These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).

Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.

However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).

This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview. 

“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”

This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added. 

Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”

The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.

No relevant financial relationships have been declared.

A version of this article appeared on Medscape.com.

SAN ANTONIO — Women with early breast cancer who have less extensive axillary surgery see no effect on their 10-year rates of locoregional recurrence and mortality than do those who have more extensive surgery, according to findings from a large meta-analysis.

Less extensive surgery also reduced patients’ risk for lymphedema, according to research (abstract GS02-05) presented at the San Antonio Breast Cancer Symposium.

These results, which included data from more than 20,000 women, may “reassure” patients and clinicians that more extensive axillary lymph node dissection “does not improve outcomes in many women with early-stage breast cancer,” said Andrea V. Barrio, MD, a breast surgeon at Memorial Sloan Kettering Cancer Center, New York City, who was not involved in the study.

Gurdeep S. Mannu, DPhil, of the University of Oxford, United Kingdom, who presented the findings at SABCS, explained that the optimal surgical management of the axilla remains uncertain in this patient population. 

To better understand the long-term risks and benefits of more vs less aggressive axillary surgery in early breast cancer, Dr. Mannu and colleagues performed a meta-analysis of 29 randomized trials conducted over six decades, which included data on 20,285 women. The trials compared more vs less extensive axillary surgery as well as axillary surgery vs axillary radiotherapy.

In trials comparing more vs less extensive axillary surgery, researchers found that 83% of locoregional recurrences occurred in the breast or in multiple sites/unspecified locations, and the remaining 17% occurred in isolated axilla or other local recurrences, such as in the supraclavicular fossa or internal mammary chain. 

Those with recurrences in the breast or multiple sites/unspecified locations did not benefit from more extensive surgery, demonstrating similar recurrence rates (RR) (RR for breast, 1.13; 95% CI, 0.92-1.40; RR for other, 0.89; 95% CI, 0.67-1.18).

The group with recurrences in isolated axilla or other local recurrences tended to do better with more extensive surgery (RR, 0.43 and 0.41, respectively).

Overall though, after a median follow-up of 10 years, differences in locoregional recurrence rates at any site did not differ among patients who had more vs less extensive axillary surgery (RR, 0.91; P = .22). This finding held even when restricting the analysis to women with node-positive disease/unknown nodal status (RR, 1.00; P = .98) and for node-negative women (RR, 0.88; P = .15).

Dr. Mannu and colleagues observed similar findings for distant recurrence, breast cancer mortality, and death from any cause.

“But where there was quite a striking difference was in morbidity,” said Dr. Mannu.

To examine rates of lymphedema — the surgical complication that has been “one of the main motivations” for the deescalation trials of the past few decades — the researchers focused on more recent trials, which “are most relevant to women treated today,” Dr. Mannu explained. 

These showed that more extensive axillary surgery was associated with almost 2.5-times the rate of lymphedema compared with less extensive treatment (odds ratio [OR], 2.43).

Finally, the team compared axillary dissection with axillary radiotherapy across five trials and found no significant differences in the treatment approaches in terms of locoregional occurrence, distant recurrence, breast cancer mortality, and death from any cause.

However, once again, a notable difference in rates of lymphedema occurred, with axillary dissection associated with higher rates compared with radiotherapy (OR, 1.79).

This is “probably the largest meta-analysis comparing more vs less axillary surgery,” Dr. Barrio said in an interview. 

“When we have one or two positive sentinel nodes, anywhere from 30%-50% of women will have additional positive lymph nodes that we’re not removing” with less extensive surgery, she explained. This study shows that, even then, this “doesn’t seem to impact on survival.”

This is “likely related to better medical treatment and radiation techniques that can treat that disease just as well as big surgery, but with less lymphedema,” she added. 

Nevertheless, Dr. Barrio believes that there are “situations where we still feel that axillary lymph node dissection is important: in women with advanced cancer, like inflammatory breast cancer, and in women who’ve received chemotherapy upfront, then had surgery, and still have positive nodes after the chemo.”

The study was funded by Cancer Research UK, British Heart Foundation, Medical Research Council.

No relevant financial relationships have been declared.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

As revolutionary as glucagon-like peptide 1 (GLP-1) drugs are, they still last for only so long in the body. Patients with diabetes typically must be injected once or twice a day (liraglutide) or once a week (semaglutide). This could hinder proper diabetes management, as adherence tends to go down the more frequent the dose. 

But what if a single GLP-1 injection could last for 4 months?

Stanford engineers have developed an injectable hydrogel depot that releases GLP-1 slowly as the hydrogel gradually “melts away like a sugar cube dissolving in water, molecule by molecule,” said Eric Appel, PhD, the project’s principal investigator and an associate professor of materials science and engineering at Stanford (Calif.) University.

So far, the team has tested the new drug delivery system in rats, and they say human clinical trials could start within 2 years.

Mathematical modeling indicated that one shot of liraglutide could maintain exposure in humans for 120 days, or about 4 months, according to their study in Cell Reports Medicine.

“Patient adherence is of critical importance to diabetes care,” said Alex Abramson, PhD, assistant professor in the chemical and biomolecular engineering department at Georgia Tech, who was not involved in the study. “It’s very exciting to have a potential new system that can last 4 months on a single injection.”

Long-Acting Injectables Have Come a Long Way

The first long-acting injectable — Lupron Depot, a monthly treatment for advanced prostate cancer — was approved in 1989. Since then, long-acting injectable depots have revolutionized the treatment and management of conditions ranging from osteoarthritis knee pain to schizophrenia to opioid use disorder. In 2021, the US Food and Drug Administration approved Apretude — an injectable treatment for HIV pre-exposure prevention that needs to be given every 2 months, compared with daily for the pill equivalent. Other new and innovative developments are underway: Researchers at the University of Connecticut are working on a transdermal microneedle patch — with many tiny vaccine-loaded needles — that could provide multiple doses of a vaccine over time, no boosters needed.

At Stanford, Appel’s lab has spent years developing gels for drug delivery. His team uses a class of hydrogel called polymer-nanoparticle (PNP), which features weakly bound polymers and nanoparticles that can dissipate slowly over time.

The goal is to address a longstanding challenge with long-acting formulations: Achieving steady release. Because the hydrogel is “self-healing” — able to repair damages and restore its shape — it’s less likely to burst and release its drug cargo too early. 

“Our PNP hydrogels possess a number of really unique characteristics,” Dr. Appel said. They have “excellent” biocompatibility, based on animal studies, and could work with a wide range of drugs. In proof-of-concept mouse studies, Dr. Appel and his team have shown that these hydrogels could also be used to make vaccines last longer, ferry cancer immunotherapies directly to tumors, and deliver antibodies for the prevention of infectious diseases like SARS-CoV-2.

Though the recent study on GLP-1s focused on treating type 2 diabetes, the same formulation could also be used to treat obesity, said Dr. Appel.

The researchers tested the tech using two GLP-1 receptor agonists — semaglutide and liraglutide. In rats, one shot maintained therapeutic serum concentrations of semaglutide or liraglutide over 42 days. With semaglutide, a significant portion was released quickly, followed by controlled release. Liraglutide, on the other hand, was released gradually as the hydrogel dissolved. This suggests the liraglutide hydrogel may be better tolerated, as a sudden peak in drug serum concentration is associated with adverse effects.

The researchers used pharmacokinetic modeling to predict how liraglutide would behave in humans with a larger injection volume, finding that a single dose could maintain therapeutic levels for about 4 months.

“Moving forward, it will be important to determine whether a burst release from the formulation causes any side effects,” Dr. Abramson noted. “Furthermore, it will be important to minimize the injection volumes in humans.”

But first, more studies in larger animals are needed. Next, Dr. Appel and his team plan to test the technology in pigs, whose skin and endocrine systems are most like humans’. If those trials go well, Dr. Appel said, human clinical trials could start within 2 years.
 

A version of this article appeared on Medscape.com.

As revolutionary as glucagon-like peptide 1 (GLP-1) drugs are, they still last for only so long in the body. Patients with diabetes typically must be injected once or twice a day (liraglutide) or once a week (semaglutide). This could hinder proper diabetes management, as adherence tends to go down the more frequent the dose. 

But what if a single GLP-1 injection could last for 4 months?

Stanford engineers have developed an injectable hydrogel depot that releases GLP-1 slowly as the hydrogel gradually “melts away like a sugar cube dissolving in water, molecule by molecule,” said Eric Appel, PhD, the project’s principal investigator and an associate professor of materials science and engineering at Stanford (Calif.) University.

So far, the team has tested the new drug delivery system in rats, and they say human clinical trials could start within 2 years.

Mathematical modeling indicated that one shot of liraglutide could maintain exposure in humans for 120 days, or about 4 months, according to their study in Cell Reports Medicine.

“Patient adherence is of critical importance to diabetes care,” said Alex Abramson, PhD, assistant professor in the chemical and biomolecular engineering department at Georgia Tech, who was not involved in the study. “It’s very exciting to have a potential new system that can last 4 months on a single injection.”

Long-Acting Injectables Have Come a Long Way

The first long-acting injectable — Lupron Depot, a monthly treatment for advanced prostate cancer — was approved in 1989. Since then, long-acting injectable depots have revolutionized the treatment and management of conditions ranging from osteoarthritis knee pain to schizophrenia to opioid use disorder. In 2021, the US Food and Drug Administration approved Apretude — an injectable treatment for HIV pre-exposure prevention that needs to be given every 2 months, compared with daily for the pill equivalent. Other new and innovative developments are underway: Researchers at the University of Connecticut are working on a transdermal microneedle patch — with many tiny vaccine-loaded needles — that could provide multiple doses of a vaccine over time, no boosters needed.

At Stanford, Appel’s lab has spent years developing gels for drug delivery. His team uses a class of hydrogel called polymer-nanoparticle (PNP), which features weakly bound polymers and nanoparticles that can dissipate slowly over time.

The goal is to address a longstanding challenge with long-acting formulations: Achieving steady release. Because the hydrogel is “self-healing” — able to repair damages and restore its shape — it’s less likely to burst and release its drug cargo too early. 

“Our PNP hydrogels possess a number of really unique characteristics,” Dr. Appel said. They have “excellent” biocompatibility, based on animal studies, and could work with a wide range of drugs. In proof-of-concept mouse studies, Dr. Appel and his team have shown that these hydrogels could also be used to make vaccines last longer, ferry cancer immunotherapies directly to tumors, and deliver antibodies for the prevention of infectious diseases like SARS-CoV-2.

Though the recent study on GLP-1s focused on treating type 2 diabetes, the same formulation could also be used to treat obesity, said Dr. Appel.

The researchers tested the tech using two GLP-1 receptor agonists — semaglutide and liraglutide. In rats, one shot maintained therapeutic serum concentrations of semaglutide or liraglutide over 42 days. With semaglutide, a significant portion was released quickly, followed by controlled release. Liraglutide, on the other hand, was released gradually as the hydrogel dissolved. This suggests the liraglutide hydrogel may be better tolerated, as a sudden peak in drug serum concentration is associated with adverse effects.

The researchers used pharmacokinetic modeling to predict how liraglutide would behave in humans with a larger injection volume, finding that a single dose could maintain therapeutic levels for about 4 months.

“Moving forward, it will be important to determine whether a burst release from the formulation causes any side effects,” Dr. Abramson noted. “Furthermore, it will be important to minimize the injection volumes in humans.”

But first, more studies in larger animals are needed. Next, Dr. Appel and his team plan to test the technology in pigs, whose skin and endocrine systems are most like humans’. If those trials go well, Dr. Appel said, human clinical trials could start within 2 years.
 

A version of this article appeared on Medscape.com.

As revolutionary as glucagon-like peptide 1 (GLP-1) drugs are, they still last for only so long in the body. Patients with diabetes typically must be injected once or twice a day (liraglutide) or once a week (semaglutide). This could hinder proper diabetes management, as adherence tends to go down the more frequent the dose. 

But what if a single GLP-1 injection could last for 4 months?

Stanford engineers have developed an injectable hydrogel depot that releases GLP-1 slowly as the hydrogel gradually “melts away like a sugar cube dissolving in water, molecule by molecule,” said Eric Appel, PhD, the project’s principal investigator and an associate professor of materials science and engineering at Stanford (Calif.) University.

So far, the team has tested the new drug delivery system in rats, and they say human clinical trials could start within 2 years.

Mathematical modeling indicated that one shot of liraglutide could maintain exposure in humans for 120 days, or about 4 months, according to their study in Cell Reports Medicine.

“Patient adherence is of critical importance to diabetes care,” said Alex Abramson, PhD, assistant professor in the chemical and biomolecular engineering department at Georgia Tech, who was not involved in the study. “It’s very exciting to have a potential new system that can last 4 months on a single injection.”

Long-Acting Injectables Have Come a Long Way

The first long-acting injectable — Lupron Depot, a monthly treatment for advanced prostate cancer — was approved in 1989. Since then, long-acting injectable depots have revolutionized the treatment and management of conditions ranging from osteoarthritis knee pain to schizophrenia to opioid use disorder. In 2021, the US Food and Drug Administration approved Apretude — an injectable treatment for HIV pre-exposure prevention that needs to be given every 2 months, compared with daily for the pill equivalent. Other new and innovative developments are underway: Researchers at the University of Connecticut are working on a transdermal microneedle patch — with many tiny vaccine-loaded needles — that could provide multiple doses of a vaccine over time, no boosters needed.

At Stanford, Appel’s lab has spent years developing gels for drug delivery. His team uses a class of hydrogel called polymer-nanoparticle (PNP), which features weakly bound polymers and nanoparticles that can dissipate slowly over time.

The goal is to address a longstanding challenge with long-acting formulations: Achieving steady release. Because the hydrogel is “self-healing” — able to repair damages and restore its shape — it’s less likely to burst and release its drug cargo too early. 

“Our PNP hydrogels possess a number of really unique characteristics,” Dr. Appel said. They have “excellent” biocompatibility, based on animal studies, and could work with a wide range of drugs. In proof-of-concept mouse studies, Dr. Appel and his team have shown that these hydrogels could also be used to make vaccines last longer, ferry cancer immunotherapies directly to tumors, and deliver antibodies for the prevention of infectious diseases like SARS-CoV-2.

Though the recent study on GLP-1s focused on treating type 2 diabetes, the same formulation could also be used to treat obesity, said Dr. Appel.

The researchers tested the tech using two GLP-1 receptor agonists — semaglutide and liraglutide. In rats, one shot maintained therapeutic serum concentrations of semaglutide or liraglutide over 42 days. With semaglutide, a significant portion was released quickly, followed by controlled release. Liraglutide, on the other hand, was released gradually as the hydrogel dissolved. This suggests the liraglutide hydrogel may be better tolerated, as a sudden peak in drug serum concentration is associated with adverse effects.

The researchers used pharmacokinetic modeling to predict how liraglutide would behave in humans with a larger injection volume, finding that a single dose could maintain therapeutic levels for about 4 months.

“Moving forward, it will be important to determine whether a burst release from the formulation causes any side effects,” Dr. Abramson noted. “Furthermore, it will be important to minimize the injection volumes in humans.”

But first, more studies in larger animals are needed. Next, Dr. Appel and his team plan to test the technology in pigs, whose skin and endocrine systems are most like humans’. If those trials go well, Dr. Appel said, human clinical trials could start within 2 years.
 

A version of this article appeared on Medscape.com.