Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

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

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

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

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

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

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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

Historical food-borne outbreaks of botulism and identification of Clostridium botulinum as the bacterium responsible have had an enormous impact in medicine related to its therapeutic and cosmetic uses. The timeline of botulinum toxin discovery began with deadly outbreaks related to contaminated food across Europe in the late 1700s, the largest of which occurred in 1793 in Wildebrad, in southern Germany. In 1811, “prussic acid” was named as the culprit in what was referred to as sausage poisoning. Between 1817 and 1822, German physician Justinus Kerner noted that the active substance interrupted signals from motor nerves to muscles, but spared sensory and cognitive abilities, accurately describing botulism. He hypothesized that this substance could possibly be used as treatment for medical conditions when ingested orally. It wasn’t until 1895 that microbiologist Emile Pierre Van Ermengem, a professor of bacteriology in Belgium, identified the bacterium responsible as Bacillus botulinus, later renamed C. botulinum.

In 1905, it was discovered that C. botulinum produced a substance that affected neurotransmitter function, and between 1895 and 1915, seven toxin serotypes were recognized. In 1928, Herman Sommer, PhD, at the Hooper Foundation, at the University of California, San Francisco, isolated the most potent serotype: botulinum toxin type A (BoNT-A).

In 1946, Carl Lamanna and James Duff developed concentration and crystallization techniques that were subsequently used by Edward Schantz, PhD, at Fort Detrick, Md., for a possible biologic weapon. In 1972, Dr. Schantz took his research to the University of Wisconsin, where he produced a large batch of BoNT-A that remained in clinical use until December 1997.

In the late 1960s and early 1970s, an ophthalmologist in San Francisco, Alan Scott, MD, began animal studies with BoNT-A supplied by Dr. Schantz, as a possible treatment for strabismus, publishing his first report of BoNT-A in primates in 1973. In 1978, the Food and Drug Administration granted approval to begin testing small amounts of the toxin in human volunteers. In 1980, a landmark paper was published demonstrating that BoNT-A corrects gaze misalignment in humans. By 1989, it was approved as Oculinum by the FDA for the treatment of strabismus and blepharospasm.

Keen clinical observation and a serendipitous discovery led to botulinum toxin’s first uses for cosmetic purposes. In the mid-1980s, Jean Carruthers, MD, an ophthalmologist in Vancouver, noted an unexpected concomitant improvement of glabellar rhytids in a patient treated with BoNT for blepharospasm. The result of the treatment was a more serene, untroubled expression. Dr. Carruthers discussed the observation with her dermatologist spouse, Alastair Carruthers, MD, who was attempting to use soft tissue–augmenting agents available at the time to soften forehead wrinkles. Intrigued by the possibilities, the Carruthers subsequently injected a small amount of BoNT-A between the eyebrows of their assistant, Cathy Bickerton Swann, also now known as “patient zero” and awaited the results.

Seventeen additional patients followed, aged 34-51, who collectively, would become part of the first report on the efficacy of BoNT-A for cosmetic use – for the treatment of glabellar frown lines – published in 1992.

Between 1992 and 1997, the popularity of off-label use of BoNT-A grew so rapidly that Allergan’s supply temporarily ran out. By 2002, safety and efficacy profiles of use in medical conditions such as strabismus, blepharospasm, hemifacial spasm, cervical dystonia, cerebral palsy, poststroke spasticity, hyperhidrosis, headache, and back pain had been well-established, facilitating the comfort and use for cosmetic purposes.

By 2002, open-label studies of more than 800 patients confirmed the efficacy and safety of BoNT for the treatment of dynamic facial rhytids. And in April 2002, the FDA granted approval of BoNT for the nonsurgical reduction of glabellar rhytids. The rest, some would say, is history. On this 20th-year anniversary of the approval of botulinum toxin for cosmetic use, special recognition is given here for the physicians and scientists who were astute enough to make this discovery, as botulinum toxin use remains one of the most popular and effective nonsurgical cosmetic procedures today.

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley disclosed that she has been a clinical investigator and consultant for Botox manufacturer Allergan in the past, and manufacturers of other brands of botulinum toxins available for cosmetic use; Dysport (Galderma), Xeomin (Merz), and Jeuveau (Evolus). Dr. Talakoub had no disclosures.

Reference

“Botulinum Toxin: Procedures in Cosmetic Dermatology Series 3rd Edition” (Philadelphia: Saunders Elsevier, 2013)

Historical food-borne outbreaks of botulism and identification of Clostridium botulinum as the bacterium responsible have had an enormous impact in medicine related to its therapeutic and cosmetic uses. The timeline of botulinum toxin discovery began with deadly outbreaks related to contaminated food across Europe in the late 1700s, the largest of which occurred in 1793 in Wildebrad, in southern Germany. In 1811, “prussic acid” was named as the culprit in what was referred to as sausage poisoning. Between 1817 and 1822, German physician Justinus Kerner noted that the active substance interrupted signals from motor nerves to muscles, but spared sensory and cognitive abilities, accurately describing botulism. He hypothesized that this substance could possibly be used as treatment for medical conditions when ingested orally. It wasn’t until 1895 that microbiologist Emile Pierre Van Ermengem, a professor of bacteriology in Belgium, identified the bacterium responsible as Bacillus botulinus, later renamed C. botulinum.

In 1905, it was discovered that C. botulinum produced a substance that affected neurotransmitter function, and between 1895 and 1915, seven toxin serotypes were recognized. In 1928, Herman Sommer, PhD, at the Hooper Foundation, at the University of California, San Francisco, isolated the most potent serotype: botulinum toxin type A (BoNT-A).

In 1946, Carl Lamanna and James Duff developed concentration and crystallization techniques that were subsequently used by Edward Schantz, PhD, at Fort Detrick, Md., for a possible biologic weapon. In 1972, Dr. Schantz took his research to the University of Wisconsin, where he produced a large batch of BoNT-A that remained in clinical use until December 1997.

In the late 1960s and early 1970s, an ophthalmologist in San Francisco, Alan Scott, MD, began animal studies with BoNT-A supplied by Dr. Schantz, as a possible treatment for strabismus, publishing his first report of BoNT-A in primates in 1973. In 1978, the Food and Drug Administration granted approval to begin testing small amounts of the toxin in human volunteers. In 1980, a landmark paper was published demonstrating that BoNT-A corrects gaze misalignment in humans. By 1989, it was approved as Oculinum by the FDA for the treatment of strabismus and blepharospasm.

Keen clinical observation and a serendipitous discovery led to botulinum toxin’s first uses for cosmetic purposes. In the mid-1980s, Jean Carruthers, MD, an ophthalmologist in Vancouver, noted an unexpected concomitant improvement of glabellar rhytids in a patient treated with BoNT for blepharospasm. The result of the treatment was a more serene, untroubled expression. Dr. Carruthers discussed the observation with her dermatologist spouse, Alastair Carruthers, MD, who was attempting to use soft tissue–augmenting agents available at the time to soften forehead wrinkles. Intrigued by the possibilities, the Carruthers subsequently injected a small amount of BoNT-A between the eyebrows of their assistant, Cathy Bickerton Swann, also now known as “patient zero” and awaited the results.

Seventeen additional patients followed, aged 34-51, who collectively, would become part of the first report on the efficacy of BoNT-A for cosmetic use – for the treatment of glabellar frown lines – published in 1992.

Between 1992 and 1997, the popularity of off-label use of BoNT-A grew so rapidly that Allergan’s supply temporarily ran out. By 2002, safety and efficacy profiles of use in medical conditions such as strabismus, blepharospasm, hemifacial spasm, cervical dystonia, cerebral palsy, poststroke spasticity, hyperhidrosis, headache, and back pain had been well-established, facilitating the comfort and use for cosmetic purposes.

By 2002, open-label studies of more than 800 patients confirmed the efficacy and safety of BoNT for the treatment of dynamic facial rhytids. And in April 2002, the FDA granted approval of BoNT for the nonsurgical reduction of glabellar rhytids. The rest, some would say, is history. On this 20th-year anniversary of the approval of botulinum toxin for cosmetic use, special recognition is given here for the physicians and scientists who were astute enough to make this discovery, as botulinum toxin use remains one of the most popular and effective nonsurgical cosmetic procedures today.

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley disclosed that she has been a clinical investigator and consultant for Botox manufacturer Allergan in the past, and manufacturers of other brands of botulinum toxins available for cosmetic use; Dysport (Galderma), Xeomin (Merz), and Jeuveau (Evolus). Dr. Talakoub had no disclosures.

Reference

“Botulinum Toxin: Procedures in Cosmetic Dermatology Series 3rd Edition” (Philadelphia: Saunders Elsevier, 2013)

Historical food-borne outbreaks of botulism and identification of Clostridium botulinum as the bacterium responsible have had an enormous impact in medicine related to its therapeutic and cosmetic uses. The timeline of botulinum toxin discovery began with deadly outbreaks related to contaminated food across Europe in the late 1700s, the largest of which occurred in 1793 in Wildebrad, in southern Germany. In 1811, “prussic acid” was named as the culprit in what was referred to as sausage poisoning. Between 1817 and 1822, German physician Justinus Kerner noted that the active substance interrupted signals from motor nerves to muscles, but spared sensory and cognitive abilities, accurately describing botulism. He hypothesized that this substance could possibly be used as treatment for medical conditions when ingested orally. It wasn’t until 1895 that microbiologist Emile Pierre Van Ermengem, a professor of bacteriology in Belgium, identified the bacterium responsible as Bacillus botulinus, later renamed C. botulinum.

In 1905, it was discovered that C. botulinum produced a substance that affected neurotransmitter function, and between 1895 and 1915, seven toxin serotypes were recognized. In 1928, Herman Sommer, PhD, at the Hooper Foundation, at the University of California, San Francisco, isolated the most potent serotype: botulinum toxin type A (BoNT-A).

In 1946, Carl Lamanna and James Duff developed concentration and crystallization techniques that were subsequently used by Edward Schantz, PhD, at Fort Detrick, Md., for a possible biologic weapon. In 1972, Dr. Schantz took his research to the University of Wisconsin, where he produced a large batch of BoNT-A that remained in clinical use until December 1997.

In the late 1960s and early 1970s, an ophthalmologist in San Francisco, Alan Scott, MD, began animal studies with BoNT-A supplied by Dr. Schantz, as a possible treatment for strabismus, publishing his first report of BoNT-A in primates in 1973. In 1978, the Food and Drug Administration granted approval to begin testing small amounts of the toxin in human volunteers. In 1980, a landmark paper was published demonstrating that BoNT-A corrects gaze misalignment in humans. By 1989, it was approved as Oculinum by the FDA for the treatment of strabismus and blepharospasm.

Keen clinical observation and a serendipitous discovery led to botulinum toxin’s first uses for cosmetic purposes. In the mid-1980s, Jean Carruthers, MD, an ophthalmologist in Vancouver, noted an unexpected concomitant improvement of glabellar rhytids in a patient treated with BoNT for blepharospasm. The result of the treatment was a more serene, untroubled expression. Dr. Carruthers discussed the observation with her dermatologist spouse, Alastair Carruthers, MD, who was attempting to use soft tissue–augmenting agents available at the time to soften forehead wrinkles. Intrigued by the possibilities, the Carruthers subsequently injected a small amount of BoNT-A between the eyebrows of their assistant, Cathy Bickerton Swann, also now known as “patient zero” and awaited the results.

Seventeen additional patients followed, aged 34-51, who collectively, would become part of the first report on the efficacy of BoNT-A for cosmetic use – for the treatment of glabellar frown lines – published in 1992.

Between 1992 and 1997, the popularity of off-label use of BoNT-A grew so rapidly that Allergan’s supply temporarily ran out. By 2002, safety and efficacy profiles of use in medical conditions such as strabismus, blepharospasm, hemifacial spasm, cervical dystonia, cerebral palsy, poststroke spasticity, hyperhidrosis, headache, and back pain had been well-established, facilitating the comfort and use for cosmetic purposes.

By 2002, open-label studies of more than 800 patients confirmed the efficacy and safety of BoNT for the treatment of dynamic facial rhytids. And in April 2002, the FDA granted approval of BoNT for the nonsurgical reduction of glabellar rhytids. The rest, some would say, is history. On this 20th-year anniversary of the approval of botulinum toxin for cosmetic use, special recognition is given here for the physicians and scientists who were astute enough to make this discovery, as botulinum toxin use remains one of the most popular and effective nonsurgical cosmetic procedures today.

Dr. Wesley and Dr. Lily Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley disclosed that she has been a clinical investigator and consultant for Botox manufacturer Allergan in the past, and manufacturers of other brands of botulinum toxins available for cosmetic use; Dysport (Galderma), Xeomin (Merz), and Jeuveau (Evolus). Dr. Talakoub had no disclosures.

Reference

“Botulinum Toxin: Procedures in Cosmetic Dermatology Series 3rd Edition” (Philadelphia: Saunders Elsevier, 2013)

A balance between fear and relaxation is normal. However, mental dispositions and the continuous influence of environmental stimuli can disrupt this balance. A failure in therapy can often conceal unvoiced fears.

This article is based on the lecture “State of the Art: Treating Anxiety Disorders” by Christian Albus, MD, director of the Clinic and Polyclinic for Psychosomatics and Psychotherapy, University Hospital Cologne (Germany), at the 128th conference of the German Society of Internal Medicine.
 

Hidden fears

Poor compliance often has a simple cause: The patients are scared. They are afraid of bad news, for example through further investigations. Taking medication regularly reminds them, over and over, of their threatening problem. Those affected rarely speak about these delicate issues of their own volition, said Dr. Albus. But latent fears are no trivial issue.

Cardiac prognosis

A third of those affected by acute coronary syndrome (ACS) subsequently suffer from long-term anxiety disorders. The fear that they will relive their experiences overshadows their zest for life. As a result, signs of clinical depression can be detected in 50% of patients with ACS. Posttraumatic stress disorders have even been observed in up to 30% of patients. Fear also exacerbates the prognosis. Patients suffering from heart attack and subsequent cardiac failure demonstrate a significant correlation between stress and increased mortality.

Self-diagnosis

The fact that we are living in an age of fear is influenced by technological advances. “Dr. Google” is the first source to be consulted for almost half of adults who need their symptoms explained. Well-informed patients improve patient-doctor communication. But unfortunately, many people are becoming addicted to searching for diagnoses and symptoms online. Primarily harmless symptoms are associated with catastrophic diagnoses. Regrettably, Google’s search algorithm also increases this tendency. If someone starts to look for serious diseases, Google will show you these sorts of potential catastrophes on an ever more frequent basis. Google ultimately orients itself around the interests of its users. The result is a spiral of fear that can cause illness.

Cyberchondria

Compulsive searching on the internet for more and more new dangers to health has now developed into its own medical condition, termed cyberchondria. The therapy is strict internet abstinence. The gross exaggeration of health problems by the media also contributes to this. This is because it’s not just sex that sells, but also fear. The current example is long COVID. In the much-cited Gutenberg study, over half of coronavirus patients subsequently exhibited the typical symptoms: fatigue, concentration disorders, and breathing issues. Most media ignore the crucial detail that the same problems were also registered in 40% of the coronavirus-free control group. Dr. Albus pointed out that it’s no wonder that so much fear is being spread by long COVID.

The first step

Responsible medicine must counteract these developments. The first step is actively to address the fear problem. Patients who seem tense benefit enormously from the simple question: “How are you otherwise?” This question may open doors. Suddenly, patients begin to talk about their anxieties and fears. Of course, this approach to patients is time consuming. Still, this time must be taken, said Dr. Albus. In a survey of oncology patients, the majority reported that none of their physicians are ever interested in their emotional state. This is a sign of inadequate care, since psychosomatic primary care should be a standard nowadays in every specialty.

This article was translated from Coliquio.

A balance between fear and relaxation is normal. However, mental dispositions and the continuous influence of environmental stimuli can disrupt this balance. A failure in therapy can often conceal unvoiced fears.

This article is based on the lecture “State of the Art: Treating Anxiety Disorders” by Christian Albus, MD, director of the Clinic and Polyclinic for Psychosomatics and Psychotherapy, University Hospital Cologne (Germany), at the 128th conference of the German Society of Internal Medicine.
 

Hidden fears

Poor compliance often has a simple cause: The patients are scared. They are afraid of bad news, for example through further investigations. Taking medication regularly reminds them, over and over, of their threatening problem. Those affected rarely speak about these delicate issues of their own volition, said Dr. Albus. But latent fears are no trivial issue.

Cardiac prognosis

A third of those affected by acute coronary syndrome (ACS) subsequently suffer from long-term anxiety disorders. The fear that they will relive their experiences overshadows their zest for life. As a result, signs of clinical depression can be detected in 50% of patients with ACS. Posttraumatic stress disorders have even been observed in up to 30% of patients. Fear also exacerbates the prognosis. Patients suffering from heart attack and subsequent cardiac failure demonstrate a significant correlation between stress and increased mortality.

Self-diagnosis

The fact that we are living in an age of fear is influenced by technological advances. “Dr. Google” is the first source to be consulted for almost half of adults who need their symptoms explained. Well-informed patients improve patient-doctor communication. But unfortunately, many people are becoming addicted to searching for diagnoses and symptoms online. Primarily harmless symptoms are associated with catastrophic diagnoses. Regrettably, Google’s search algorithm also increases this tendency. If someone starts to look for serious diseases, Google will show you these sorts of potential catastrophes on an ever more frequent basis. Google ultimately orients itself around the interests of its users. The result is a spiral of fear that can cause illness.

Cyberchondria

Compulsive searching on the internet for more and more new dangers to health has now developed into its own medical condition, termed cyberchondria. The therapy is strict internet abstinence. The gross exaggeration of health problems by the media also contributes to this. This is because it’s not just sex that sells, but also fear. The current example is long COVID. In the much-cited Gutenberg study, over half of coronavirus patients subsequently exhibited the typical symptoms: fatigue, concentration disorders, and breathing issues. Most media ignore the crucial detail that the same problems were also registered in 40% of the coronavirus-free control group. Dr. Albus pointed out that it’s no wonder that so much fear is being spread by long COVID.

The first step

Responsible medicine must counteract these developments. The first step is actively to address the fear problem. Patients who seem tense benefit enormously from the simple question: “How are you otherwise?” This question may open doors. Suddenly, patients begin to talk about their anxieties and fears. Of course, this approach to patients is time consuming. Still, this time must be taken, said Dr. Albus. In a survey of oncology patients, the majority reported that none of their physicians are ever interested in their emotional state. This is a sign of inadequate care, since psychosomatic primary care should be a standard nowadays in every specialty.

This article was translated from Coliquio.

A balance between fear and relaxation is normal. However, mental dispositions and the continuous influence of environmental stimuli can disrupt this balance. A failure in therapy can often conceal unvoiced fears.

This article is based on the lecture “State of the Art: Treating Anxiety Disorders” by Christian Albus, MD, director of the Clinic and Polyclinic for Psychosomatics and Psychotherapy, University Hospital Cologne (Germany), at the 128th conference of the German Society of Internal Medicine.
 

Hidden fears

Poor compliance often has a simple cause: The patients are scared. They are afraid of bad news, for example through further investigations. Taking medication regularly reminds them, over and over, of their threatening problem. Those affected rarely speak about these delicate issues of their own volition, said Dr. Albus. But latent fears are no trivial issue.

Cardiac prognosis

A third of those affected by acute coronary syndrome (ACS) subsequently suffer from long-term anxiety disorders. The fear that they will relive their experiences overshadows their zest for life. As a result, signs of clinical depression can be detected in 50% of patients with ACS. Posttraumatic stress disorders have even been observed in up to 30% of patients. Fear also exacerbates the prognosis. Patients suffering from heart attack and subsequent cardiac failure demonstrate a significant correlation between stress and increased mortality.

Self-diagnosis

The fact that we are living in an age of fear is influenced by technological advances. “Dr. Google” is the first source to be consulted for almost half of adults who need their symptoms explained. Well-informed patients improve patient-doctor communication. But unfortunately, many people are becoming addicted to searching for diagnoses and symptoms online. Primarily harmless symptoms are associated with catastrophic diagnoses. Regrettably, Google’s search algorithm also increases this tendency. If someone starts to look for serious diseases, Google will show you these sorts of potential catastrophes on an ever more frequent basis. Google ultimately orients itself around the interests of its users. The result is a spiral of fear that can cause illness.

Cyberchondria

Compulsive searching on the internet for more and more new dangers to health has now developed into its own medical condition, termed cyberchondria. The therapy is strict internet abstinence. The gross exaggeration of health problems by the media also contributes to this. This is because it’s not just sex that sells, but also fear. The current example is long COVID. In the much-cited Gutenberg study, over half of coronavirus patients subsequently exhibited the typical symptoms: fatigue, concentration disorders, and breathing issues. Most media ignore the crucial detail that the same problems were also registered in 40% of the coronavirus-free control group. Dr. Albus pointed out that it’s no wonder that so much fear is being spread by long COVID.

The first step

Responsible medicine must counteract these developments. The first step is actively to address the fear problem. Patients who seem tense benefit enormously from the simple question: “How are you otherwise?” This question may open doors. Suddenly, patients begin to talk about their anxieties and fears. Of course, this approach to patients is time consuming. Still, this time must be taken, said Dr. Albus. In a survey of oncology patients, the majority reported that none of their physicians are ever interested in their emotional state. This is a sign of inadequate care, since psychosomatic primary care should be a standard nowadays in every specialty.

This article was translated from Coliquio.

Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine

Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine

Qualitative interviews with a group of female physicians identified several concerns about fertility and family planning and how those concerns affected their career choices.

Among the findings in a new study were that all 16 women interviewed said medical school education surrounding fertility was inadequate. Many said students should get comprehensive information about fertility’s decline with age and fertility preservation options and that information should be presented early in medical training so students can make choices. Yet, such issues are rarely discussed as part of medical training.

“[I]t would also be helpful for medical students and trainees to know what their options are, what insurance covers ... It wasn’t even touched at my orientation,” said one participant.

The findings from the hour-long interviews were used to build a survey. In a pilot test of the survey on 24 female physicians, researchers found that 71% had delayed childbearing and 67% had altered their careers to build families.

Kathryn S. Smith of Northwestern University, Chicago, led the research. Results were published online in JAMA Network Open.

In addition, 29% of survey respondents turned down career advancement opportunities; 21% chose a different specialty; and 17% changed from an academic to private practice setting to accommodate having children.

Women in the survey cited as factors in their decisions lack of support from physician peers and leadership, particularly around time off for pregnancy, maternity leave, infertility treatments, or parental responsibilities.
 

Results ‘alarming’

“These results are alarming, particularly in light of known gender disparities that exist within academic medicine in time to promotion, achievement of academic rank, and appointment to leadership positions,” the authors wrote.

As of 2020, women made up 43% of medical school faculty but only 21% of department chairs and 19% of medical school deans, according to Association of American Medical Colleges data.

Navigating motherhood as a physician also can take a physical and mental toll. Recent data presented at the American College of Obstetricians and Gynecologists (ACOG) 2022 annual meeting found that one in four physicians who are new mothers report struggling with postpartum depression, a rate twice that of the general population.

And one in four women in a recent survey of 600 female physicians who had attempted conception were diagnosed with infertility.
 

Lack of support ‘pronounced in medicine’

In an invited commentary, Ariela L. Marshall, MD, of the division of hematology-oncology at University of Pennsylvania, Philadelphia, and Arghavan Salles, MD, PhD, of the department of medicine at Stanford (Calif.) University, noted that career-family struggle is not unique to medicine but “the lack of support for pregnancy is particularly pronounced in medicine.”

The editorialists wrote that they have battled infertility and faced family-building challenges and have intimate familiarity with the struggles.

“Although other workplaces, such as Microsoft, Google, and Facebook, long ago adopted policies to support employees’ family building, including via cryopreservation, those in medicine all too frequently must pay back their parental leave, make up missed call, or even pay back money to their practice,” they wrote. “It is embarrassing that employees of tech companies have better support for reproductive health than do physicians.”

They advocate for change on the entire continuum from fertility awareness and infertility management, bringing children into a family by any method, and child care and career development support for physicians who become parents.

They urge establishing adequate paid parental leave, not just for parents who give birth but for all parents involved in rearing children. They say providing leave to only one parent sets up a discriminatory divide between the partner who continues to work and the person providing care.

Dr. Marshall and Dr. Salles wrote that lack of support is likely part of the reason that 40% of women in medicine switch to part-time positions within their first 6 years in practice.

They also note that too often fertility and family-building discussions focus on cisgendered women who are in heterosexual relationships.

They cite some “nonsensical“ policies around insurance. They give an example of coverage for fertility treatments that often requires trying to conceive before benefits are provided.

“How do two women, two men, or a single person try to conceive?” they ask.

Helen Kang Morgan, MD, clinical professor of obstetrics and gynecology at the University of Michigan, Ann Arbor, said that she, too, has made the trade-off the researchers describe.

She was in her first year as a faculty physician at the University of Michigan when she became a mom and decided to go part time.

Unlike some of the women interviewed in the Smith et al. study, she said she felt lucky to have peer support and the support of leaders in her department who made sure she wasn’t derailed from her career path because she chose part-time work for nearly 5 years.

“For some women, part-time is the right choice and for me, at the time, it was the right choice, but it should not be the only choice. It makes it so much harder for women to advance their careers if part-time is the only option,” she said.

Dr. Morgan said this work highlights that conversations about work and parenting needs in medicine have to go from informal conversations to formal conversations.

Department leaders should be asking what female physicians need and what flexibility is needed, she said.

The COVID-19 pandemic showed how bad things could get, she said.

In Ann Arbor, Dr. Morgan noted, schools were virtual until the spring of 2021, putting demands disproportionately on female physicians who absorbed much of the at-home child care responsibilities.

“That created gender inequities I think it is going to take women many, many years to catch up from,” she said.

COVID-19 also, however, forced medicine to incorporate more virtual options, something that should stay in finding solutions to ease the burden on physicians who are mothers, she said.

Reshma Jagsi, MD, deputy chair in the department of radiation oncology at the University of Michigan, said both policies and cultural norms need to change in medicine.

Courtesy Michigan Medicine

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of baricitinib, a Janus kinase (JAK) inhibitor, for the treatment of adults with severe alopecia areata (AA).

The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.

The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).

According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.

In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.

Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of baricitinib, a Janus kinase (JAK) inhibitor, for the treatment of adults with severe alopecia areata (AA).

The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.

The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).

According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.

In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.

Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of baricitinib, a Janus kinase (JAK) inhibitor, for the treatment of adults with severe alopecia areata (AA).

The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approval of baricitinib (Olumiant) for patients with severe AA, and it is now referred to the European Commission for final action. A decision is expected within the next 2 months.

The committee based its positive opinion on the results of the phase 3 BRAVE-AA1 and BRAVE-AA2 trials, recently published in the New England Journal of Medicine, which evaluated the efficacy and safety of baricitinib in 1,200 patients with severe AA, according to the press release. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score of ≤20 at week 36. In both studies, 1 out of 3 patients treated with baricitinib 4-mg achieved 80% or more scalp hair coverage, compared with 1 out of 20 patients and 1 out of 50 patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (P ≤ .001 for all comparisons to placebo).

According to safety profile information from the phase 3 BRAVE-AA clinical program, few patients discontinued treatment because of adverse events (2.6% or less across both studies), and most treatment-emergent adverse events were mild or moderate in severity.

In February 2022, the Food and Drug Administration granted priority review for baricitinib in adults with severe AA. Lilly expects additional regulatory decisions in the United States and Japan in 2022.

Baricitinib is approved in the United States as a treatment for adults with moderate to severe rheumatoid arthritis. Prescribing information can be viewed here.