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EPI is common with malabsorption after sorafenib therapy
Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.
Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.
Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.
Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.
Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.
Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.
Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.
Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.
Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.
Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.
Key clinical point: Patients who experience malabsorption with sorafenib treatment may develop exocrine pancreatic insufficiency (EPI); supplementation with pancreatic enzymes may benefit these patients.
Major finding: Two patients had moderate and 6 patients had severe pancreatic insufficiency. Six patients who developed EPI received pancreatic enzymes and recovered from the malabsorption symptoms within 1 month. The fecal elastase values recovered in 5 of 6 patients who received pancreatic enzymes.
Study details: A prospective study of 21 patients with hepatocellular carcinoma treated with sorafenib who developed malabsorption.
Disclosures: No study sponsor was identified. The authors received speaker fees and grants outside the study work.
Citation: Díaz-González A et al. J Clin Gastroenterol. 2021 Mar 1. doi: 10.1097/MCG.0000000000001366.
Exocrine pancreatic insufficiency is a feature of T1D
Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.
Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).
Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).
Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.
Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.
Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.
Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).
Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).
Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.
Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.
Key clinical point: Exocrine pancreatic insufficiency is a feature of type 1 diabetes (T1D). Lower levels of fecal elastase-1 and amylase are reported in patients with T1D vs. healthy individuals.
Major finding: Compared with healthy individuals, fecal elastase-1 levels were significantly lower in participants with new-onset and long-standing T1D (P = .0070 and .0010, respectively). Pancreatic amylase levels were significantly lower in patients with long-standing T1D vs. healthy individuals (P = .0001). The markers of impaired exocrine function tests (fecal elastase-1, serum pancreatic amylase, and lipase) correlated with the reduction of fasting and urinary C-peptide (all P less than .001).
Study details: A single-center, cross-sectional study of pancreatic exocrine function in adult patients with new-onset T1D (n = 12) or long-standing T1D (n = 19) and healthy individuals (n = 25).
Disclosures: This study was supported by a grant received by Battaglia M from the Italian Diabetes Society (SID) Research Foundation SID.
Citation: Dozio N et al. BMJ Open Diab Res Care. 2021 Feb. doi: 10.1136/bmjdrc-2019-001158.
EPI common with somatostatin analog treatment in neuroendocrine neoplasia
Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.
Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.
Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.
Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.
Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.
Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.
Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.
Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.
Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.
Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.
Key clinical point: Exocrine pancreatic insufficiency (EPI) is common in patients with gastroenteropancreatic neuroendocrine neoplasia (NEN) receiving somatostatin analogs. Pancreatic enzyme replacement therapy (PERT) is justified in patients experiencing EPI symptoms.
Major findings: Studies have reported an EPI prevalence of 20% to 38% in patients with NEN receiving somatostatin analogs. Its symptoms overlap with clinical features of tumor and common side effects of somatostatin analogs. EPI can be diagnosed with noninvasive fecal elastase-1 test and is easy to treat using PERT. However, there is a general lack of awareness about EPI and PERT. A multidisciplinary team of gastroenterologists and nutritionists can increase the odds of providing the best care.
Study details: An editorial on EPI in patients with NEN receiving somatostatin analogs.
Disclosures: No specific funding was identified for this editorial. Panzuto F received speaker honoraria from Mylan Italia.
Source: Panzuto F et al. Expert Opin Drug Saf. 2021 Feb 2. doi: 10.1080/14740338.2021.1881478.
COVID vaccines could lose their punch within a year, experts say
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pancrelipase improves EPI symptoms in chronic pancreatitis patients
Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).
Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.
Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.
Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.
Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.
Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).
Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.
Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.
Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.
Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.
Key clinical point: Pancrelipase improves stool consistency and frequency and coefficient of fat absorption (CFA) in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency (EPI).
Major finding: Higher number of patients reported decreased stool frequency at week 1 with pancrelipase vs. placebo (72% vs. 38%; P less than .001). Mean change in CFA from baseline was significantly greater with pancrelipase vs. placebo (24.7% vs. 6.4%; P less than .001). Improvements in stool consistency (P = .03) and frequency (P less than .001) correlated with CFA improvement. Symptom improvements persisted over 52 weeks of treatment.
Study details: A pooled study of 2 randomized double-blind trials including patients with chronic pancreatitis and EPI, who received either pancrelipase (n = 59) or placebo (n = 57). Thirty-four patients received open-label pancrelipase treatment for 51 weeks in another trial.
Disclosures: The editorial support for this study was funded by AbbVie. The authors reported no conflicts of interest.
Source: Barkin JA et al. Pancreas. 2021 Feb 1. doi: 10.1097/MPA.0000000000001733.
Study supports lower starting dose of lenvatinib for endometrial cancer
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
FROM SGO 2021
Oral sarecycline promising for papulopustular rosacea
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
National Psoriasis Foundation recommends some stop methotrexate for 2 weeks after J&J vaccine
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
AI system beats endoscopists for detecting early neoplasia in Barrett’s
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
FROM GUILD 2021