Rheumatology News

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

What you really don’t want to do, if you want to improve diversity, equity, and inclusion (DEI) at your academic institution, is to recruit diverse people to your program and then have them come and feel not included, said Vivian Asare, MD. “That can work against your efforts,” she stated in an oral presentation at the annual meeting of the American College of Chest Physicians (CHEST). Dr. Asare is assistant professor and vice chief of DEI for Yale Pulmonary, Critical Care, and Sleep Medicine, and associate medical director of Yale Centers for Sleep Medicine, New Haven, Conn.

In offering a path to successful DEI, Dr. Asare said: “The first step is to build a team and discuss your mission. Invite everyone to participate and include your leadership because they’re the ones who set the stage, ensure sustainability, and can be a liaison with faculty.” Then a DEI leader should be elected, she added.

The next and very important step is to survey the current institutional climate. “You need to tap into how people feel about DEI in your program.” That entails speaking directly with the stakeholders (faculty, staff, trainees) and identifying their specific concerns and what they think is lacking. Retreats, serious group discussions, and self-reflecting (asking “what initiatives would be good for us?”), and meeting one-on-one with individuals for a truly personalized approach are among potentially productive strategies for identifying the priorities and DEI-related topics specific to a particular academic sleep program.

Dr. Asare offered up a sample DEI survey (Am J Obstet Gynecol. 2020 Nov;223[5]:715.e1-715.e7), that made direct statements inviting the respondent to check off one of the following responses: Yes, No, Somewhat, Do not know, and Not applicable. Among sample statements:

• Our department is actively committed to issues of diversity, equity, and inclusion.
• Faculty searches in the department regularly attract a diverse pool of highly qualified candidates and/or attract a pool that represents the availability of MDs in this field.
• Our outreach and recruitment processes employ targeted practices for attracting diverse populations.

Dr. Asare said that a survey can be a simple approach for garnering information that can be useful for prioritizing DEI topics of concern and igniting interest in them. Engagement requires regular DEI committee meetings with minutes or a newsletter and with updates and topics brought to faculty meetings.
 

Key DEI areas of focus

Dr. Asare listed several key DEI areas: Recruitment/retention, mentorship, scholarship, and inclusion and community engagement. Under scholarship, for example, she cited topics for potential inclusion in a DEI curriculum: Unconscious bias and anti-racism training, racism, discrimination and microaggression education (bystander/deescalation training), cultural competency and awareness, workplace civility, and health disparities. “We all know that implicit bias in providers is a reality, unfortunately,” Dr. Asare said. Being aware of these implicit biases is a start, but instruction on how to actively overcome them has to be provided. Tools may include perspective-taking, exploring common identity, and self-reflection.

To create an inclusive environment for all faculty, trainees, and staff may involve establishing a “welcome committee” for new faculty, perhaps with designating a “peer buddy,” creating social events and other opportunities for all opinions and ideas to be heard and valued. Particularly for underserved and disadvantaged patient populations, patient advocacy and community service need to be fostered through support groups and provision of resources.

Summarizing, Dr. Asare reiterated several key elements for a successful DEI program: Build a team and discuss the mission, survey the current climate allowing open communication and dialogue, plan and engage, organize, and form areas of DEI focus. Find out where you are and where you want to be with respect to DEI, she concluded.

Dr. Asare declared that she had no conflicts of interest.

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

People with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status, researchers suggest.

“We found that the risks of SARS-CoV-2 infection, 30-day hospitalization, and 30-day death among individuals with gout were higher than the general population irrespective of the vaccination status,” lead study author Dongxing Xie, MD, PhD, Xiangya Hospital, Central South University, Changsha, China, and his colleagues write in their large population study. “This finding informs individuals with gout, especially women, that additional measures, even after vaccination, should be considered in order to mitigate the risk of SARS-CoV-2 infection and its severe sequelae.”

People with gout, the most common inflammatory arthritis, often have other conditions that are linked to higher risk for SARS-CoV-2 infection and poor outcomes as well, including obesity, cardiovascular disease, and chronic kidney disease, the authors write. And elevated serum urate may contribute to inflammation and possible COVID-19 complications. But unlike in the case of diseases such as lupus and rheumatoid arthritis, little is known about SARS-CoV-2 infection risk among patients with gout.

As reported in Arthritis & Rheumatology, Dr. Xie and his research team used the Health Improvement Network ([THIN], now called IQVIA Medical Research Database) repository of medical conditions, demographics, and other details of around 17 million people in the United Kingdom to estimate the risk for SARS-CoV-2 infection, hospitalization, and death in people with gout. They compared those outcomes with outcomes of people without gout and compared outcomes of vaccinated vs. nonvaccinated participants.

From December 2020 through October 2021, the researchers investigated the risk for SARS-CoV-2 breakthrough infection in vaccinated people between age 18 and 90 years who had gout and were hospitalized within 30 days after the infection diagnosis or who died within 30 days after the diagnosis. They compared these outcomes with the outcomes of people in the general population without gout after COVID-19 vaccination. They also compared the risk for SARS-CoV-2 infection and its severe outcomes between individuals with gout and the general population among unvaccinated people.

They weighted these comparisons on the basis of age, sex, body mass index, socioeconomic deprivation index score, region, and number of previous COVID-19 tests in one model. A more fully adjusted model also weighted the comparisons for lifestyle factors, comorbidities, medications, and healthcare utilization.

The vaccinated cohort consisted of 54,576 people with gout and 1,336,377 without gout from the general population. The unvaccinated cohort included 61,111 individuals with gout and 1,697,168 individuals without gout from the general population.
 

Women more likely to be hospitalized and die

The risk for breakthrough infection in the vaccinated cohort was significantly higher among people with gout than among those without gout in the general population, particularly for men, who had hazard ratios (HRs) ranging from 1.22 with a fully adjusted exposure score to 1.30 with a partially adjusted score, but this was not seen in women. The overall incidence of breakthrough infection per 1,000 person-months for these groups was 4.68 with gout vs. 3.76 without gout.

The researchers showed a similar pattern of a higher rate of hospitalizations for people with gout vs. without (0.42/1,000 person-months vs. 0.28); in this case, women had higher risks than did men, with HRs for women ranging from 1.55 with a fully adjusted exposure score to 1.91 with a partially adjusted score, compared with 1.22 and 1.43 for men, respectively.

People with gout had significantly higher mortality than did those without (0.06/1,000 person-months vs. 0.04), but the risk for death was only higher for women, with HRs calculated to be 2.23 in fully adjusted exposure scores and 3.01 in partially adjusted scores.

These same comparisons in the unvaccinated cohort all went in the same direction as did those in the vaccinated cohort but showed higher rates for infection (8.69/1,000 person-months vs. 6.89), hospitalization (2.57/1,000 person-months vs. 1.71), and death (0.65/1,000 person-months vs. 0.53). Similar sex-specific links between gout and risks for SARS-CoV-2 infection, hospitalization, and death were seen in the unvaccinated cohort.
 

Patients with gout and COVID-19 need close monitoring

Four experts who were not involved in the study encourage greater attention to the needs of patients with gout.

Earlier studies show links between gout and severe COVID-19 outcomes

Lead author Kanon Jatuworapruk, MD, PhD, of Thammasat University in Pathumthani, Thailand, and his colleagues investigated characteristics and outcomes of people with gout who were hospitalized for COVID-19 between March 2020 and October 2021, using data from the COVID-19 Global Rheumatology Alliance registry.

“This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death,” the authors write in ACR Open Rheumatology . “This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.”

In their study, the average age of the 163 patients was 63 years, and 85% were men. Most lived in the Western Pacific Region and North America, and 46% had two or more comorbidities, most commonly hypertension, cardiovascular disease, diabetes, chronic kidney disease, and obesity. The researchers found that:

• Sixty-eight percent of the cohort required supplemental oxygen or ventilatory support during hospitalization.
• Sixteen percent of deaths were related to COVID-19, with 73% of deaths occurring in people with two or more comorbidities.

Ruth K. Topless, assistant research fellow in the department of biochemistry at the University of Otago in Dunedin, New Zealand, is the lead author on a study she and her colleagues are conducting using the UK Biobank databases of 459,837 participants in the United Kingdom, including 15,871 people with gout, through April 6, 2021, to investigate whether gout is a risk factor for diagnosis of COVID-19 and COVID-19–related death.

“Gout is a risk factor for COVID-19-related death in the UK Biobank cohort, with an increased risk in women with gout, which was driven by risk factors independent of the metabolic comorbidities of gout,” the researchers conclude in The Lancet Rheumatology.

In their study, gout was linked with COVID-19 diagnosis (odds ratio, 1.20; 95% confidence interval, 1.11-1.29) but not with risk for COVID-19–related death in the group of patients with COVID-19 (OR, 1.20; 95% CI, 0.96-1.51). In the entire cohort, gout was linked with COVID-19–related death (OR, 1.29; 95% CI, 1.06-1.56); women with gout were at increased risk for COVID-19–related death (OR, 1.98; 95% CI, 1.34-2.94), but men with gout were not (OR, 1.16; 95% CI, 0.93-1.45). The risk for COVID-19 diagnosis was significant in the nonvaccinated group (OR, 1.21; 95% CI, 1.11-1.30) but not in the vaccinated group (OR, 1.09; 95% CI, 0.65-1.85).
 

Editorial authors join in recommending further related research

In a commentary in The Lancet Rheumatology about the UK Biobank and other related research, Christoffer B. Nissen, MD, of University Hospital of Southern Denmark in Sonderborg, and his co-authors call the Topless and colleagues study “an elegantly conducted analysis of data from the UK Biobank supporting the hypothesis that gout needs attention in patients with COVID-19.”

Further studies are needed to investigate to what degree a diagnosis of gout is a risk factor for COVID-19 and whether treatment modifies the risk of a severe disease course,” they write. “However, in the interim, the results of this study could be considered when risk stratifying patients with gout in view of vaccination recommendations and early treatment interventions.”

Each of the three studies received grant funding. Several of the authors of the studies report financial involvements with pharmaceutical companies. All outside experts commented by email and report no relevant financial involvements.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.

Tumor vs. saxophone: The surgical grudge match

Brain surgery is a notoriously difficult task. There’s a reason we say, “Well, at least it’s not brain surgery” when we’re trying to convince someone that a task isn’t that tough. Make one wrong incision, cut the wrong neuron, and it’s goodbye higher cognitive function. And most people appreciate thinking. Crazy, right?

One would imagine that the act of brain surgery would become even more difficult when the patient brings his saxophone and plays it randomly throughout the operation. It’s a hospital, after all, not a jazz club. Patients don’t get to play musical instruments during other surgeries. Why should brain surgery patients get special treatment?

Paideia International Hospital

As it turns out, the musical performance was actually quite helpful. A man in Italy had a brain tumor in a particularly complex area, and he’s left-handed, which apparently makes the brain’s neural pathways much more complicated. Plus, he insisted that he retain his musical ability after the surgery. So he and his medical team had a crazy thought: Why not play the saxophone throughout the surgery? After all, according to head surgeon Christian Brogna, MD, playing an instrument means you understand music, which tests many higher cognitive functions such as coordination, mathematics, and memory.

And so, at various points throughout the 9-hour surgery, the patient played his saxophone for his doctors. Doing so allowed the surgeons to map the patient’s brain in a more complete and personalized fashion. With that extra knowledge, they were able to successfully remove the tumor while maintaining the patient’s musical ability, and the patient was discharged on Oct. 13, just 3 days after his operation.

While we’re happy the patient recovered, we do have to question his choice of music. During the surgery, he played the theme to the 1970 movie “Love Story” and the Italian national anthem. Perfectly fine pieces, no doubt, but the saxophone solo in “Jungleland” exists. And we could listen to that for 9 hours straight. In fact, we do that every Friday in the LOTME office.
 

Basketball has the Big Dance. Mosquitoes get the Big Sniff

In this week’s installment of our seemingly never-ending series, “Mosquitoes and the scientists who love them,” we visit The Rockefeller University in New York, where the olfactory capabilities of Aedes Aegypti – the primary vector species for Zika, dengue, yellow fever, and chikungunya – became the subject of a round robin–style tournament.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

First things first, though. If you’re going to test mosquito noses, you have to give them something to smell. The researchers enrolled eight humans who were willing to wear nylon stockings on their forearms for 6 hours a day for multiple days. “Over the next few years, the researchers tested the nylons against each other in all possible pairings,” Leslie B. Vosshall, PhD, and associates said in a statement from the university. In other words, mosquito March Madness.

Nylons from different participants were hooked up in pairs to an olfactometer assay consisting of a plexiglass chamber divided into two tubes, each ending in a box that held a stocking. The mosquitoes were placed in the main chamber and observed as they flew down the tubes toward one stocking or the other.

Eventually, the “winner” of the “tournament” was Subject 33. And no, we don’t know why there was a Subject 33 since the study involved only eight participants. We do know that the nylons worn by Subject 33 were “four times more attractive to the mosquitoes than the next most-attractive study participant, and an astonishing 100 times more appealing than the least attractive, Subject 19,” according to the written statement.

Chemical analysis identified 50 molecular compounds that were elevated in the sebum of the high-attracting participants, and eventually the investigators discovered that mosquito magnets produced carboxylic acids at much higher levels than the less-attractive volunteers.

We could go on about the research team genetically engineering mosquitoes without odor receptors, but we have to save something for later. Tune in again next week for another exciting episode of “Mosquitoes and the scientists who love them.”
 

Are women better with words?

Men vs. Women is probably the oldest argument in the book, but there may now be movement. Researchers have been able not only to shift the advantage toward women, but also to use that knowledge to medical advantage.

AndrewLobov/Depositphotos

When it comes to the matter of words and remembering them, women apparently have men beat. The margin is small, said lead author Marco Hirnstein, PhD, of the University of Bergen, Norway, but, after performing a meta-analysis of 168 published studies and PhD theses involving more than 350,000 participants, it’s pretty clear. The research supports women’s advantage over men in recall, verbal fluency (categorical and phonemic), and recognition.

So how is this information useful from a medical standpoint?

Dr. Hirnstein and colleagues suggested that this information can help in interpreting diagnostic assessment results. The example given was dementia diagnosis. Since women are underdiagnosed because their baseline exceeds average while men are overdiagnosed, taking gender and performance into account could clear up or catch cases that might otherwise slip through the cracks.

Now, let’s just put this part of the debate to rest and take this not only as a win for women but for science as well.