Over half of surgeons who reported treating melanoma with Mohs micrographic surgery (MMS) are using the technique to treat invasive melanoma, according to a national cross-sectional survey of members of the American College of Mohs Surgery.

Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.

The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.

It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.

With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.

That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.

The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).

There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.

The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.

The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)

Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.

“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.

Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”

Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.

“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.

Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.

The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.

Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.

Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.

SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
 

Over half of surgeons who reported treating melanoma with Mohs micrographic surgery (MMS) are using the technique to treat invasive melanoma, according to a national cross-sectional survey of members of the American College of Mohs Surgery.

Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.

The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.

It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.

With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.

That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.

The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).

There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.

The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.

The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)

Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.

“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.

Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”

Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.

“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.

Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.

The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.

Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.

Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.

SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
 

Over half of surgeons who reported treating melanoma with Mohs micrographic surgery (MMS) are using the technique to treat invasive melanoma, according to a national cross-sectional survey of members of the American College of Mohs Surgery.

Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.

The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.

It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.

With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.

That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.

The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).

There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.

The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.

The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)

Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.

“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.

Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”

Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.

“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.

Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.

The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.

Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.

Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.

SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
 

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.

While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.

Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.

To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm² high-power field), food impaction requiring endoscopic intervention, and dilation.

After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.

Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.

The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.

SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.

Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.

While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.

Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.

To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm² high-power field), food impaction requiring endoscopic intervention, and dilation.

After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.

Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.

The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.

SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.

Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.

While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.

Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.

To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm² high-power field), food impaction requiring endoscopic intervention, and dilation.

After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.

Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.

The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.

SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Express Scripts Covers Rhofade on the National Preferred Formulary

EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.

MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream

MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.

Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis

Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Express Scripts Covers Rhofade on the National Preferred Formulary

EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.

MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream

MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.

Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis

Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Express Scripts Covers Rhofade on the National Preferred Formulary

EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.

MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream

MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.

Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis

Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”¹ I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.

Inappropriate comments providers make

A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:

“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”

“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”

“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”

Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
 

Help parents make good memories

Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:

“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”

“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”

“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”

“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”

“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”

“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”

“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”

Don’t use the ‘silver lining’ theme

A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:

“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”

“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”

“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”

“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”

“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”

“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
 

Handling patient care after the loss

A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.

“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”

“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”

“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”

“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
 

When the patient returns to the office

The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.

“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”

“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”

“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”

“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”

“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”

“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”

“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
 

Continuing care in the office

The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.

“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”

“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”

“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”

“Saying nothing is worse than saying you don’t know what to say and you are sorry.”

“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”

Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
 

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].

Reference

1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.

As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”¹ I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.

Inappropriate comments providers make

A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:

“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”

“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”

“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”

Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
 

Help parents make good memories

Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:

“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”

“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”

“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”

“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”

“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”

“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”

“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”

Don’t use the ‘silver lining’ theme

A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:

“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”

“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”

“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”

“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”

“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”

“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
 

Handling patient care after the loss

A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.

“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”

“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”

“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”

“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
 

When the patient returns to the office

The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.

“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”

“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”

“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”

“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”

“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”

“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”

“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
 

Continuing care in the office

The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.

“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”

“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”

“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”

“Saying nothing is worse than saying you don’t know what to say and you are sorry.”

“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”

Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
 

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].

Reference

1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.

As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”¹ I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.

Inappropriate comments providers make

A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:

“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”

“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”

“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”

Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
 

Help parents make good memories

Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:

“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”

“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”

“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”

“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”

“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”

“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”

“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”

Don’t use the ‘silver lining’ theme

A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:

“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”

“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”

“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”

“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”

“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”

“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
 

Handling patient care after the loss

A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.

“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”

“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”

“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”

“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
 

When the patient returns to the office

The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.

“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”

“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”

“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”

“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”

“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”

“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”

“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
 

Continuing care in the office

The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.

“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”

“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”

“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”

“Saying nothing is worse than saying you don’t know what to say and you are sorry.”

“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”

Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
 

Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].

Reference

1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Long-acting cabotegravir and rilpivirine (CAB/RPV) administered intramuscularly monthly or every 2 months yielded high rates of efficacy and a favorable safety profile in women with HIV, according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.

Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.

Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.

Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.

At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.

Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.

There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.

Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.

Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
 

This article first appeared on Medscape.com.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.