Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The European Alliance of Associations for Rheumatology has started the process of updating their recommendations on how to manage patients with rheumatic and musculoskeletal diseases (RMDs) in the context of the SARS-CoV-2 pandemic.

So far, the first part of the systematic literature review has been performed and the conclusions that have been drawn appear to back up the recommendations that have already been made. It’s “hard to say” if there will need to be changes, said Robert B.M. Landewé, MD, PhD, at the annual European Congress of Rheumatology, as the next phase will be for the task force members to meet and discuss the implications of the literature research.“I think there will only be minor modifications and a few novel recommendations, but that is personal opinion,” speculated Dr. Landewé, who is professor of rheumatology at the Amsterdam Medical Center, University of Amsterdam.

The recommendations, which were developed a little over a year ago and published in Annals of the Rheumatic Diseases, set out provisional guidance covering four themes: infection prevention, managing patients when social distancing measures are in effect, managing patients with RMDs who develop COVID-19, and the prevention of infections other than SARS-CoV-2.
 

Emphasis on quality of evidence

According to EULAR’s standard operating procedures “updates should only be done if the evolving evidence mandates to do so,” and be based on “rational arguments,” Dr. Landewé said. “The last year was a bit unprecedented in that regard as we didn’t have those rational arguments before we designed our first set of recommendations and, as you can expect, that is totally due to the character of the pandemic.”

So much has been published on COVID-19 since then it was time to reappraise the situation. The task force behind the recommendations met in January 2021 to discuss the results of the literature search that was centered around five main research questions.

• Do patients with RMDs face more risk of contracting SARS-CoV-2 than the general population?
• If patients contract the virus, do they have a worse prognosis?
• Are antirheumatic medications associated with a worse outcome in people with RMDs?
• Should patients continue their antirheumatic medications?
• What evidence informs the use of vaccination against SARS-CoV-2 in patients with RMDs?

The latter research question is pending discussion since there were no studies to review at the time as the various vaccines had only just started to be widely available.

“We put a lot of emphasis on the quality of evidence,” Dr. Landewé said. In addition to making sure that patients did indeed have COVID-19 and checking that hospitalization and death records were caused by the disease, the task force team also looked to see if there was a control group being used. An extensive risk of bias assessment was undertaken, the results of which are pending.

Of 6,665 records identified during the literature search, just 113 full-text articles were assessed for eligibility. Of those, 60% were rejected as they did not pass the quality assessment, leaving 49 articles for consideration. The majority of these looked at the incidence of COVID-19, with others focusing on risk factors or both.
 

Literature search findings on main research questions

Dr. Landewé observed that the task force concluded that “current literature provides no evidence that patients with RMDs face more risk of contracting SARS-CoV-2 than individuals without RMDs.” They also concluded that patients with RMDs who do contract COVID-19 do not have a worse prognosis either, even though there have been a few studies suggesting a higher rate of hospitalization.

Both findings are reassuring as they fit with the existing recommendation to follow the same preventive and control measures in patients with RMDs as for the general population, but the task force is yet to determine if that recommendation should be amended.

There did not appear to be any hard evidence of any unique demographic feature or comorbidity that puts people with RMDs at more risk for severe COVID-19 than the general population. Think older age, male gender, high bodyweight, cardiovascular disease, diabetes, and chronic lung disease, Dr. Landewé said.

He noted, however, that there were some single-center reports suggesting that moderate or high levels of disease activity could put people with RMDs at greater risk for COVID-related death, “which is an intriguing finding in the context of discontinuing antirheumatic medication.” That is likely something the task force will be discussing when they decide how to update their recommendations.

The type of RMD may also be important, but again only single-center evidence to show that there might be an increased hospitalization risk in patients with autoinflammatory disease or risk for severe COVID-19 in those with certain connective tissue diseases. “These associations were not consistently found in other studies,” so it’s an open question how the task force decides to incorporate this into the updated guidance.

As for antirheumatic medications, conclusions from the literature review suggest that there doesn’t appear to be an increased or decreased risk for severe COVID-19 among users of NSAIDs or antimalarials.

That’s not the case for glucocorticoids. There appears to be an increased risk for hospitalization and COVID-19–related death, notably among those using higher (>10 mg) daily doses. “This is, so to say, the elephant in the room,” Dr. Landewé said. The current recommendation states that chronic users of glucocorticoids should continue their treatment. “The reports of additional risk could be due to glucocorticoids or to biases such as confounding by indication. So, the conclusion that we draw [is] not completely clear.”

In response to a question, he clarified this a little further: “We think ‘glucocorticoid use’ is a determinant of worse health, as is the case in many RMDs. Be aware that finding a positive association between [glucocorticoid] use and bad outcome does not mean that if you reduce [glucocorticoids], your patient will have a better outcome.”

The jury is also out on rituximab, which has been reported to increase the risk of severe COVID-19 and COVID-related death in two studies. There are also equivocal data on whether not using disease-modifying antirheumatic drugs increases the risk for these worse outcomes.

Asked about the absence of a recommendation on the use of the interleukin-6 inhibitor tocilizumab, Dr. Landewé responded: “We are caught up by evolving evidence. That is a generic problem in a dynamic field of COVID-19, I am afraid. What you recommend today is sometimes ‘old history’ tomorrow.”

Dr. Landewé had no relevant disclosures to make.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

The first multinational, phase 3, placebo-controlled trial conducted with intravenous immunoglobulin therapy (IVIg) for dermatomyositis has confirmed significant efficacy and acceptable safety, according to data presented at the opening plenary abstract session of the annual European Congress of Rheumatology.

At the week 16 evaluation of the trial, called ProDERM, the response rates were 78.7% and 43.8% (P = .0008) for active therapy and placebo, respectively, reported Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh.

ProDERM is a “much-awaited study,” according to session moderator Hendrik Schulze-Koops, MD, PhD, of the division of rheumatology and clinical immunology at Ludwig Maximilian University of Munich (Germany). He was not involved in the study.

“We all have been doing what we have been doing,” Dr. Schulze-Koops said, referring to the use of IVIg for the control of dermatomyositis, “but we had no evidence for support.”

This statement could apply not only to IVIg, which has long been listed among treatment options by the Myositis Association despite the absence of controlled studies, but also to most immunosuppressive therapies and other options used for this challenging disease.

The proprietary IVIg employed in this study, Octagam 10%, has been approved in the United States for the treatment of chronic immune thrombocytopenic purpura. Its manufacturer, Octagam, plans to file a supplemental new drug application with the Food and Drug Administration for the treatment of dermatomyositis. The agent is already approved for dermatomyositis by the European Medicines Agency, according to Dr. Aggarwal.

Multiple response criteria favor IVIg

In the trial, 95 patients with dermatomyositis were randomized to 2 g/kg of IVIg (Octagam 10%) or placebo administered every 4 weeks. In a subsequent open-label extension study in which patients on placebo were switched to active therapy, the same every-4-week treatment schedule was used. The patients’ mean age was 53; 75% were women, and 92% were White.

The primary endpoint was at least minimal improvement on 2016 ACR/EULAR (American College of Rheumatology/European Alliance of Associations for Rheumatology) myositis response criteria, defined as a 20-point or greater gain in the Total Improvement Score (TIS) and no clinical worsening at two consecutive visits. But IVIg also provided a large relative benefit over placebo using more rigorous definitions of improvement. For moderate improvement, defined as at least a 40-point TIS improvement, there was a 45.2% relative advantage for IVIg over placebo (68.1% vs. 22.9%; P < .0001). For major improvement, defined as at least a 60-point TIS improvement, the relative advantage was 23.6% (31.9% vs. 8.3%; P < .0062).

At 16 weeks, the mean TIS score was more than twice as high in those receiving IVIg than in those randomized to placebo (48.4 vs. 21.6). At that point, an open-label extension was initiated. Those in the IVIg group were permitted to remain on therapy for an additional 24 weeks if they had not worsened in the blinded phase.

The mean TIS score in the IVIg group continued to rise during the extension phase. By 12 weeks in this phase, it reached 54.0. Over the same period, mean TIS scores climbed steeply among the placebo-treated patients who had switched to active therapy, reaching 44.4.

At the end of 24 weeks of the extension trial, when patients initiated on IVIg had been on active therapy for 40 weeks, the mean TIS score advantage of starting on IVIg rather than placebo was relatively modest (55.4 vs. 51.1).
 

Benefit is significant for skin and muscle

Changes in the two major components of dermatomyositis were tracked individually. For skin symptoms, patients were evaluated with the Cutaneous Dermatomyositis Disease Areas and Severity Index (CDASI). For muscle involvement, symptoms were evaluated with the 8-item Manual Muscle Testing (MMT-8) tool.

“The effects of IVIg on the muscle and the skin were both highly statistically significant,” Dr. Aggarwal reported. He said the CDASI score was reduced by almost half at the end of 16 weeks among those treated with IVIg relative to those treated with placebo. Improvement in MMT-8 scores were also clinically as well as statistically significant.

The IVIg therapy was well tolerated. The most common adverse effects in this study, like those reported with IVIg when used to treat other diseases, were headache, pyrexia, and nausea, but Dr. Aggarwal reported that these were generally mild.

Serious adverse events, particularly thromboembolism, did occur over the course of the study, but the rate of events was only slightly higher in the group receiving active therapy (5.8% vs. 4.2%).

Patients who entered the study were permitted to remain on most immunosuppressive therapies, such as methotrexate, mycophenolate, tacrolimus, and glucocorticoids. Dr. Aggarwal said that the majority of patients were taking a glucocorticoid and at least one nonglucocorticoid immunosuppressant.

Effect on associated conditions is planned

The data from this trial have not yet been analyzed for the impact of IVIg on conditions that occur frequently in association with dermatomyositis, such as interstitial lung disease (ILD) and dysphagia, but Dr. Aggarwal reported that there are plans to do so. Although severe ILD was a trial exclusion, the presence of mild to moderate ILD and dysphagia were evaluated at baseline, so the impact of treatment can be assessed.

There are also plans to evaluate how the presence or absence of myositis-specific antibodies, which were also evaluated at baseline, affected response to IVIg.

Dr. Aggarwal has financial relationships with more than 15 pharmaceutical companies, including Octapharma, which provided financial support for this trial. Dr. Schulze-Koops reported no relevant potential conflicts of interest.

The intertriginous findings, along with results from a punch biopsy showing resolving lichenoid inflammation with post-inflammatory pigmentary alteration, indicated a diagnosis of lichen planus pigmentosus inversus (LPPI).

Insidious onset of usually asymptomatic, sometimes mildly pruritic, well-defined, hyperpigmented macules and patches with occasional Wickham striae of the intertriginous areas is characteristic of LPPI. It is a variant of lichen planus pigmentosus, which conversely occurs on sun-exposed areas. The etiology is unknown and there is no association with medications or sun exposure. Pathophysiology is thought to be chronic inflammation, mediated by T-lymphocyte cytotoxic activity against basal keratinocytes.¹

At the time of this patient’s clinical presentation, the differential diagnoses for new onset hyperpigmentation included confluent and reticulated papillomatosis, post-inflammatory hyperpigmentation, and erythema dyschromicum perstans. However, further tests were ordered for diagnostic clarification.

The clinical course of LPPI is variable. In some cases, there is complete resolution of lesions without treatment, while in other cases, lesions may last for years despite treatment and the condition may recur. Current management options include topical calcineurin inhibitors (tacrolimus and pimecrolimus) and topical steroids. Response to these topical medications may be variable. The patient in this case was started on topical tacrolimus 0.1% twice daily, with follow-up in 3 months.

‌

Text courtesy of Rachel Rose, BS, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque. Photo courtesy of Daniel Stulberg, MD, FAAFP.

The intertriginous findings, along with results from a punch biopsy showing resolving lichenoid inflammation with post-inflammatory pigmentary alteration, indicated a diagnosis of lichen planus pigmentosus inversus (LPPI).

Insidious onset of usually asymptomatic, sometimes mildly pruritic, well-defined, hyperpigmented macules and patches with occasional Wickham striae of the intertriginous areas is characteristic of LPPI. It is a variant of lichen planus pigmentosus, which conversely occurs on sun-exposed areas. The etiology is unknown and there is no association with medications or sun exposure. Pathophysiology is thought to be chronic inflammation, mediated by T-lymphocyte cytotoxic activity against basal keratinocytes.¹

At the time of this patient’s clinical presentation, the differential diagnoses for new onset hyperpigmentation included confluent and reticulated papillomatosis, post-inflammatory hyperpigmentation, and erythema dyschromicum perstans. However, further tests were ordered for diagnostic clarification.

The clinical course of LPPI is variable. In some cases, there is complete resolution of lesions without treatment, while in other cases, lesions may last for years despite treatment and the condition may recur. Current management options include topical calcineurin inhibitors (tacrolimus and pimecrolimus) and topical steroids. Response to these topical medications may be variable. The patient in this case was started on topical tacrolimus 0.1% twice daily, with follow-up in 3 months.

‌

Text courtesy of Rachel Rose, BS, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque. Photo courtesy of Daniel Stulberg, MD, FAAFP.

The intertriginous findings, along with results from a punch biopsy showing resolving lichenoid inflammation with post-inflammatory pigmentary alteration, indicated a diagnosis of lichen planus pigmentosus inversus (LPPI).

Insidious onset of usually asymptomatic, sometimes mildly pruritic, well-defined, hyperpigmented macules and patches with occasional Wickham striae of the intertriginous areas is characteristic of LPPI. It is a variant of lichen planus pigmentosus, which conversely occurs on sun-exposed areas. The etiology is unknown and there is no association with medications or sun exposure. Pathophysiology is thought to be chronic inflammation, mediated by T-lymphocyte cytotoxic activity against basal keratinocytes.¹

At the time of this patient’s clinical presentation, the differential diagnoses for new onset hyperpigmentation included confluent and reticulated papillomatosis, post-inflammatory hyperpigmentation, and erythema dyschromicum perstans. However, further tests were ordered for diagnostic clarification.

The clinical course of LPPI is variable. In some cases, there is complete resolution of lesions without treatment, while in other cases, lesions may last for years despite treatment and the condition may recur. Current management options include topical calcineurin inhibitors (tacrolimus and pimecrolimus) and topical steroids. Response to these topical medications may be variable. The patient in this case was started on topical tacrolimus 0.1% twice daily, with follow-up in 3 months.

‌

Text courtesy of Rachel Rose, BS, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque. Photo courtesy of Daniel Stulberg, MD, FAAFP.

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

PxHere

In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

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

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

PxHere

In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

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

An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.

PxHere

In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.

“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.

He noted that the text-messaging program also provides information, support, encouragement, and guidance.

“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.

The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
 

Poor adherence

“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”

He added that forgetfulness is a feature of ADHD. In addition, compliance can be difficult and cumbersome when patients require multiple prescriptions, he said.

Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.

“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.

To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.

One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.

As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
 

Timely reminders

Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).

Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).

“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.

Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.

In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).

ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.

Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
 

Clinical guidance

The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.

“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.

The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.

Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.

Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.

The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.

“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
 

Promising results

Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.

He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.

“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.

“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.

Dr. Glick also agreed that text messaging could be very useful for these patients.

“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.

Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.

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

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.