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FDA to health care providers: Double-check COVID vaccine dose for children
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
In myasthenia gravis, antibodies pass open-label tests
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
PHOENIX – . The two drugs, rozanolixizumab (Rystiggo, UCB) and efgartigimod PH20 (Vyvgart, Argenx SE), received Food and Drug Administration approval in June 2023 and December 2021, respectively, for the treatment of MG.
The neonatal Fc receptor binds to IgG within cells and recycles it back into the blood, leading to increased serum levels. The antibodies bind to the neonatal Fc receptor and promote its degradation, therefore preventing IgG recycling without interfering with its production. They do not affect the levels of other immunoglobulin isotypes.
At the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM), researchers presented data from an open-label extension study following the phase 3 MycarinG trial of rozanolixizumab and the ADAPT-SC+ study of efgartigimod.
In the MycarinG study, rozanolixizumab “showed both statistically significant and clinically meaningful improvements in multiple endpoints,” said Vera Bril, MD, during a presentation of the results.
Rozanolixizumab is approved for MG patients who are anti–acetylcholine receptor (AchR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positive. Efgartigimod is approved for MG patients who are AChR positive.
After completing MycarinG, patients were eligible to enroll in one of two open-label studies, one of each dose.
The new efficacy analysis focused on 110 patients who underwent two or more consecutive symptom-driven treatment cycles. A safety analysis focused on 188 patients who received at least one cycle of treatment.
“The post hoc analysis showed that the clinically meaningful improvements in the generalized myasthenia gravis symptoms were maintained over time for the cohort across rozanolixizumab cycles, while individual patients move through the consecutive treatment cycles, rozanolixizumab had an acceptable safety profile that was maintained across repeated treatments cycles. This is consistent with previous results of rozanolixizumab,” said Dr. Bril, who is a clinical investigator at University of Toronto
A reduction in steroid use?
During the Q&A session, George Small, MD, asked if the study had shown a reduction in steroid use among patients with MG.
As clinical associate director of neurology at Allegheny Medical Center, Pittsburgh, he has overseen the care of several hundred patients with generalized MG, as well as participated in clinical trials. “Many physicians use steroids for very quick responses in their patients. I love steroids and I hate steroids. I’ve helped save people’s lives with them, but I’ve also probably hastened their demise, unfortunately, because of the long-term side effects of the medications. Many neurologists in the community will over-utilize steroids because they don’t have access to these more expensive therapies. I look forward to both using these medications more as they become FDA approved and being an advocate for them, because it is my belief that they help decrease the use of steroids,” said Dr. Small in an interview.
Even if new medications do reduce steroid use, there remains a hurdle with insurance companies. “I’ve felt I’ve been forced to use treatments that I know may not be efficacious in the short term in order to get authorization for more expensive therapies that I use now. I’ve had patients admitted to the hospital as I’ve tried to jump through hoops that the insurance companies demanded,” said Dr. Small.
Clinical improvements seen
In the MycarinG study, patients received weekly injections of 7 mg/kg, 10 mg/kg rozanolixizumab, or placebo over a 6-week period. Both treatment groups had reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo.
MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were consistent across treatment cycles. The mean MG-ADL score dropped by about 4 points at week 6. At around week 10, the mean improvement declined to 2 points, and then by week 14 it increased to 3 points, where it remained consistent out to 50 weeks. A similar pattern was seen in QMG scores, with an approximate 5-point drop at 6 weeks, then about a 1.5-point improvement at 10 weeks, then a mean decrease of around 4 points that stayed stable out to 50 weeks.
Over all cycles of treatment, 89.9% of patients experienced a treatment-emergent adverse event, including 22.3% who had a serious TEAE; the study dropout rate because of TEAEs was 15.4%.
In the ADAPT-SC study, 110 patients were randomized to 10 mg/kg intravenous efgartigimod or 1,000 mg efgartigimod PH20, which is formulated with recombinant human hyaluronidase to allow for rapid administration of larger volumes. After completion of ADAPT-SC, 105 patients from both groups and an additional 79 patients entered the open-label extension study with 1,000 mg efgartigimod PH20.
The study included 141 patients who were AChR-Ab positive and 38 who were AChR-Ab negative. In the first cycle, 34.6% experienced an injection-site reaction, which steadily dropped to 11.5% by the sixth cycle. After each cycle of treatment, the mean change in MG-ADL from study baseline at week 4 was between 4.1 and 4.7 points. The mean change in Myasthenia Gravis Quality of Life 15-Item Questionnaire revisited from study baseline at week 4 was between 5.1 and 6.5 points. The mean change in EuroQoL 5-dimension, 5-level visual analog scale was between 12.3 and 16.0 points at week 4.
MyCarinG was funded by UCB Pharma. ADAPT-SC was funded by Argenx SE. Dr. Bril has financial relationships with Behring, Argenyx, Alexion, Immunovant, Alnylam, Akcea, Takeda, Sanofi, Ionis, Roche, Novo Nordisk, Octapharma, Momenta, Pfizer, CSL Behring, Grifols, Powell Mansfield, UCB, and Viela Bio. Dr. Small is on the speaker’s bureau for Alexion.
AT AANEM 2023
FDA OKs new treatment for erosive esophagitis
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
DLBCL treatment options: CAR T outperforms ASCT
NEW YORK – according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.
DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).
“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.
The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.
Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.
At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.
Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.
“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.
Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.
NEW YORK – according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.
DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).
“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.
The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.
Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.
At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.
Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.
“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.
Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.
NEW YORK – according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.
DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).
“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.
The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.
Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.
At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.
Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.
“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.
Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.
AT LLM CONGRESS 2023
One-year anniversary
Dear Friends,
It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. , including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.
In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.
Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.
Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.
In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.
If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.
Yours truly,
Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Dear Friends,
It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. , including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.
In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.
Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.
Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.
In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.
If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.
Yours truly,
Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Dear Friends,
It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. , including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.
In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.
Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.
Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.
In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.
If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.
Yours truly,
Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Resources to help new GI fellows thrive
The AGA Gastro Squad is excited you’re here and we’re here to help.
AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.
Start here:
Review and bookmark these guides to make the most out of fellowship.
10 tips for new GI fellows
First year fellows guide
Small talk, big topics
A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.
AGA university
Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.
AGA young delegates program
Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.
Get more advice
Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.
The AGA Gastro Squad is excited you’re here and we’re here to help.
AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.
Start here:
Review and bookmark these guides to make the most out of fellowship.
10 tips for new GI fellows
First year fellows guide
Small talk, big topics
A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.
AGA university
Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.
AGA young delegates program
Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.
Get more advice
Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.
The AGA Gastro Squad is excited you’re here and we’re here to help.
AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.
Start here:
Review and bookmark these guides to make the most out of fellowship.
10 tips for new GI fellows
First year fellows guide
Small talk, big topics
A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.
AGA university
Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.
AGA young delegates program
Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.
Get more advice
Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.
Propel your academic research opportunities with AGA FORWARD
The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:
- Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
- Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
- Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.
Embark on a transformative journey toward a successful and fulfilling career in academic medicine.
Apply today.
The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:
- Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
- Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
- Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.
Embark on a transformative journey toward a successful and fulfilling career in academic medicine.
Apply today.
The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:
- Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
- Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
- Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.
Embark on a transformative journey toward a successful and fulfilling career in academic medicine.
Apply today.
Second pig heart recipient dies
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
Older adults at risk from inappropriate prescribing
Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.
Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”
In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.
The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.
“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”
The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).
“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”
Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada.
The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included.
Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.
“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said, “But generally, it’s not appropriate.”
Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.
The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population.
Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.
Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.
According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications.
Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said.
To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said.
The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.
Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”
In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.
The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.
“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”
The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).
“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”
Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada.
The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included.
Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.
“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said, “But generally, it’s not appropriate.”
Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.
The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population.
Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.
Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.
According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications.
Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said.
To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said.
The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.
Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”
In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.
The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.
“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”
The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).
“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”
Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada.
The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included.
Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.
“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said, “But generally, it’s not appropriate.”
Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.
The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population.
Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.
Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.
According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications.
Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said.
To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said.
The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Omitting surgery may be safe in early BC after neoadjuvant pCR
A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.
Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).
They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.
So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.
Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.
With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.
“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.
However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.
Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
Study details
Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.
Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.
The 38% of women in the study with residual disease after systemic treatment went on to surgery.
Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.
The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.
A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.
Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).
They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.
So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.
Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.
With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.
“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.
However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.
Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
Study details
Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.
Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.
The 38% of women in the study with residual disease after systemic treatment went on to surgery.
Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.
The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.
A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.
Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).
They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.
So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.
Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.
With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.
“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.
However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.
Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
Study details
Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.
Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.
The 38% of women in the study with residual disease after systemic treatment went on to surgery.
Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.
The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.
FROM ESMO 2023