Venous Thromboembolism

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

BOSTON — Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

BOSTON — The sooner that patients with acute pulmonary embolism (PE) get treated with mechanical thrombectomy, the greater the likelihood that they will have favorable short- and long-term outcomes, regardless of their degree of initial risk, a study of registry data showed.

Among nearly 800 patients with acute PE whose data are recorded in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH), a prospective multicenter registry of individuals treated with mechanical thrombectomy using the FlowTriever system (Inari Medical), shorter time from admission to mechanical thrombectomy was associated with significantly greater reductions in intraprocedural mean and systolic pulmonary artery pressures (PAP), greater reductions in the right ventricular/left ventricular (RV/LV) ratio, and longer 6-minute walk times at 6 months, reported Krunal H. Patel, MD, a pulmonary and critical care fellow at the Lewis Katz School of Medicine at Temple University Hospital in Philadelphia.

“Mechanical thrombectomy in the FLASH registry showed a mortality benefit. I think as time progresses and mechanical thrombectomy becomes more popular, we’re just going to need to figure out what is the ideal time for intervention,” he said during an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

“There’s mortality benefit in any case whether the patient is high-risk or intermediate-high. This is a thought-provoking retrospective analysis that says that early intervention is probably better than doing it late, but regardless, the FLASH registry trial showed that early thrombectomy or thrombectomy in general shows positive mortality benefit,” Patel said in an interview.

He likened the challenge for pulmonary and critical care specialists to that of interventional cardiologists, who have determined that the ideal window for starting percutaneous coronary interventions is within 90 minutes of the patient’s arrival at the facility.

“I think we have to get our ‘door-to-balloon’ time for PE care,” he said.
 

Study Details

Patel and colleague Parth M. Rali, MD, FCCP, associate professor of thoracic medicine at Temple, conducted a retrospective review of data on 787 US patients in the FLASH registry for whom time to mechanical thrombectomy data were available. They stratified the patients into short and long time to mechanical thrombectomy groups, with “short” defined as ≤ 12 hours of presentation and “long” as > 12 hours.

They found that the median time to thrombectomy was 19.68 hours. In all, 242 patients (31%) were treated within the short window, and the remaining 545 patients (69%) were treated after at least 12 hours had passed.

Comparing clinical characteristics between the groups, the investigators noted that significantly more patients in the short time group vs long time group were categorized as high-risk (11.2% vs 6.2%; P = .0026). This difference is likely due to the need for greater urgency among high-risk patients, Patel said.

Patients in the short time group also had significantly higher baseline RV/LV ratios and lactate levels, but baseline dyspnea scores and pre-procedure median and systolic PAP were similar between the groups.

The mean time to thrombectomy was 6.08 hours in the short time group vs 34.04 hours in the long time group. Their respective median times were 6.01 and 24.73 hours.

The procedural time was similar between the groups, at 45 and 42 minutes, respectively.

The location of the treated thrombus was central only in 35.1% and 26.5% patients in the short and long time groups, respectively. Lobar-only thrombi were treated in 7.9% and 14.3%, respectively, and both central and lobar thrombi were treated in 57.0% and 59.2%, respectively.

Both 48-hour and 30-day all-cause mortality rates were similar between the groups (0.4%/0.2% and 0.5%/1.0%).

Patients in the short time group had slightly but significantly longer post-procedure hospital and intensive care unit stays, but 30-day readmission rates — whether for PE- or non-PE–related causes — were similar.

Where the differences between the groups really showed, however, were PAP reductions over baseline, with decline in median pressures of −8.7 mm Hg in the short group vs −7.2 mm Hg in the long group (P = .0008), and drops in systolic PAP of −14.4 vs −12.1 mm Hg, respectively (P = .0011).

In addition, reductions in RV/LV ratios from baseline were also significantly greater among patients whose thrombectomies had been expedited at the 48-hour, 30-day, and 6-month follow-up periods.

At 6 months, patients who had received mechanical thrombectomy within 12 hours also had significantly longer 6-minute walk distances (442.2 vs 390.5 m; P = .0032).
 

Low Thrombolysis Rate

Following his presentation, session co-moderator Galina Glazman-Kuczaj, MD, from the Division of Pulmonary and Critical Care Medicine at Albany Med Health System, Albany, New York, asked Patel what percentage of patients, if any, had received thrombolytic therapy before the thrombectomy procedure.

He noted that only 1% or 2% patients in the FLASH registry received thrombolysis.

In an interview, Glazman-Kuczaj said that “it was reassuring for [Patel] to report that it was only a small population of patients who got thrombolysis beforehand in either group because you would expect that maybe people in the group that took longer to have a thrombectomy got some thrombolysis beforehand and that perhaps they were more stable, but it seems like thrombectomy was the first-line treatment in both groups.”

The FLASH Registry is funded by Inari Medical. Patel and Glazman-Kuczaj reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The sooner that patients with acute pulmonary embolism (PE) get treated with mechanical thrombectomy, the greater the likelihood that they will have favorable short- and long-term outcomes, regardless of their degree of initial risk, a study of registry data showed.

Among nearly 800 patients with acute PE whose data are recorded in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH), a prospective multicenter registry of individuals treated with mechanical thrombectomy using the FlowTriever system (Inari Medical), shorter time from admission to mechanical thrombectomy was associated with significantly greater reductions in intraprocedural mean and systolic pulmonary artery pressures (PAP), greater reductions in the right ventricular/left ventricular (RV/LV) ratio, and longer 6-minute walk times at 6 months, reported Krunal H. Patel, MD, a pulmonary and critical care fellow at the Lewis Katz School of Medicine at Temple University Hospital in Philadelphia.

“Mechanical thrombectomy in the FLASH registry showed a mortality benefit. I think as time progresses and mechanical thrombectomy becomes more popular, we’re just going to need to figure out what is the ideal time for intervention,” he said during an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

“There’s mortality benefit in any case whether the patient is high-risk or intermediate-high. This is a thought-provoking retrospective analysis that says that early intervention is probably better than doing it late, but regardless, the FLASH registry trial showed that early thrombectomy or thrombectomy in general shows positive mortality benefit,” Patel said in an interview.

He likened the challenge for pulmonary and critical care specialists to that of interventional cardiologists, who have determined that the ideal window for starting percutaneous coronary interventions is within 90 minutes of the patient’s arrival at the facility.

“I think we have to get our ‘door-to-balloon’ time for PE care,” he said.
 

Study Details

Patel and colleague Parth M. Rali, MD, FCCP, associate professor of thoracic medicine at Temple, conducted a retrospective review of data on 787 US patients in the FLASH registry for whom time to mechanical thrombectomy data were available. They stratified the patients into short and long time to mechanical thrombectomy groups, with “short” defined as ≤ 12 hours of presentation and “long” as > 12 hours.

They found that the median time to thrombectomy was 19.68 hours. In all, 242 patients (31%) were treated within the short window, and the remaining 545 patients (69%) were treated after at least 12 hours had passed.

Comparing clinical characteristics between the groups, the investigators noted that significantly more patients in the short time group vs long time group were categorized as high-risk (11.2% vs 6.2%; P = .0026). This difference is likely due to the need for greater urgency among high-risk patients, Patel said.

Patients in the short time group also had significantly higher baseline RV/LV ratios and lactate levels, but baseline dyspnea scores and pre-procedure median and systolic PAP were similar between the groups.

The mean time to thrombectomy was 6.08 hours in the short time group vs 34.04 hours in the long time group. Their respective median times were 6.01 and 24.73 hours.

The procedural time was similar between the groups, at 45 and 42 minutes, respectively.

The location of the treated thrombus was central only in 35.1% and 26.5% patients in the short and long time groups, respectively. Lobar-only thrombi were treated in 7.9% and 14.3%, respectively, and both central and lobar thrombi were treated in 57.0% and 59.2%, respectively.

Both 48-hour and 30-day all-cause mortality rates were similar between the groups (0.4%/0.2% and 0.5%/1.0%).

Patients in the short time group had slightly but significantly longer post-procedure hospital and intensive care unit stays, but 30-day readmission rates — whether for PE- or non-PE–related causes — were similar.

Where the differences between the groups really showed, however, were PAP reductions over baseline, with decline in median pressures of −8.7 mm Hg in the short group vs −7.2 mm Hg in the long group (P = .0008), and drops in systolic PAP of −14.4 vs −12.1 mm Hg, respectively (P = .0011).

In addition, reductions in RV/LV ratios from baseline were also significantly greater among patients whose thrombectomies had been expedited at the 48-hour, 30-day, and 6-month follow-up periods.

At 6 months, patients who had received mechanical thrombectomy within 12 hours also had significantly longer 6-minute walk distances (442.2 vs 390.5 m; P = .0032).
 

Low Thrombolysis Rate

Following his presentation, session co-moderator Galina Glazman-Kuczaj, MD, from the Division of Pulmonary and Critical Care Medicine at Albany Med Health System, Albany, New York, asked Patel what percentage of patients, if any, had received thrombolytic therapy before the thrombectomy procedure.

He noted that only 1% or 2% patients in the FLASH registry received thrombolysis.

In an interview, Glazman-Kuczaj said that “it was reassuring for [Patel] to report that it was only a small population of patients who got thrombolysis beforehand in either group because you would expect that maybe people in the group that took longer to have a thrombectomy got some thrombolysis beforehand and that perhaps they were more stable, but it seems like thrombectomy was the first-line treatment in both groups.”

The FLASH Registry is funded by Inari Medical. Patel and Glazman-Kuczaj reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The sooner that patients with acute pulmonary embolism (PE) get treated with mechanical thrombectomy, the greater the likelihood that they will have favorable short- and long-term outcomes, regardless of their degree of initial risk, a study of registry data showed.

Among nearly 800 patients with acute PE whose data are recorded in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH), a prospective multicenter registry of individuals treated with mechanical thrombectomy using the FlowTriever system (Inari Medical), shorter time from admission to mechanical thrombectomy was associated with significantly greater reductions in intraprocedural mean and systolic pulmonary artery pressures (PAP), greater reductions in the right ventricular/left ventricular (RV/LV) ratio, and longer 6-minute walk times at 6 months, reported Krunal H. Patel, MD, a pulmonary and critical care fellow at the Lewis Katz School of Medicine at Temple University Hospital in Philadelphia.

“Mechanical thrombectomy in the FLASH registry showed a mortality benefit. I think as time progresses and mechanical thrombectomy becomes more popular, we’re just going to need to figure out what is the ideal time for intervention,” he said during an oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

“There’s mortality benefit in any case whether the patient is high-risk or intermediate-high. This is a thought-provoking retrospective analysis that says that early intervention is probably better than doing it late, but regardless, the FLASH registry trial showed that early thrombectomy or thrombectomy in general shows positive mortality benefit,” Patel said in an interview.

He likened the challenge for pulmonary and critical care specialists to that of interventional cardiologists, who have determined that the ideal window for starting percutaneous coronary interventions is within 90 minutes of the patient’s arrival at the facility.

“I think we have to get our ‘door-to-balloon’ time for PE care,” he said.
 

Study Details

Patel and colleague Parth M. Rali, MD, FCCP, associate professor of thoracic medicine at Temple, conducted a retrospective review of data on 787 US patients in the FLASH registry for whom time to mechanical thrombectomy data were available. They stratified the patients into short and long time to mechanical thrombectomy groups, with “short” defined as ≤ 12 hours of presentation and “long” as > 12 hours.

They found that the median time to thrombectomy was 19.68 hours. In all, 242 patients (31%) were treated within the short window, and the remaining 545 patients (69%) were treated after at least 12 hours had passed.

Comparing clinical characteristics between the groups, the investigators noted that significantly more patients in the short time group vs long time group were categorized as high-risk (11.2% vs 6.2%; P = .0026). This difference is likely due to the need for greater urgency among high-risk patients, Patel said.

Patients in the short time group also had significantly higher baseline RV/LV ratios and lactate levels, but baseline dyspnea scores and pre-procedure median and systolic PAP were similar between the groups.

The mean time to thrombectomy was 6.08 hours in the short time group vs 34.04 hours in the long time group. Their respective median times were 6.01 and 24.73 hours.

The procedural time was similar between the groups, at 45 and 42 minutes, respectively.

The location of the treated thrombus was central only in 35.1% and 26.5% patients in the short and long time groups, respectively. Lobar-only thrombi were treated in 7.9% and 14.3%, respectively, and both central and lobar thrombi were treated in 57.0% and 59.2%, respectively.

Both 48-hour and 30-day all-cause mortality rates were similar between the groups (0.4%/0.2% and 0.5%/1.0%).

Patients in the short time group had slightly but significantly longer post-procedure hospital and intensive care unit stays, but 30-day readmission rates — whether for PE- or non-PE–related causes — were similar.

Where the differences between the groups really showed, however, were PAP reductions over baseline, with decline in median pressures of −8.7 mm Hg in the short group vs −7.2 mm Hg in the long group (P = .0008), and drops in systolic PAP of −14.4 vs −12.1 mm Hg, respectively (P = .0011).

In addition, reductions in RV/LV ratios from baseline were also significantly greater among patients whose thrombectomies had been expedited at the 48-hour, 30-day, and 6-month follow-up periods.

At 6 months, patients who had received mechanical thrombectomy within 12 hours also had significantly longer 6-minute walk distances (442.2 vs 390.5 m; P = .0032).
 

Low Thrombolysis Rate

Following his presentation, session co-moderator Galina Glazman-Kuczaj, MD, from the Division of Pulmonary and Critical Care Medicine at Albany Med Health System, Albany, New York, asked Patel what percentage of patients, if any, had received thrombolytic therapy before the thrombectomy procedure.

He noted that only 1% or 2% patients in the FLASH registry received thrombolysis.

In an interview, Glazman-Kuczaj said that “it was reassuring for [Patel] to report that it was only a small population of patients who got thrombolysis beforehand in either group because you would expect that maybe people in the group that took longer to have a thrombectomy got some thrombolysis beforehand and that perhaps they were more stable, but it seems like thrombectomy was the first-line treatment in both groups.”

The FLASH Registry is funded by Inari Medical. Patel and Glazman-Kuczaj reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.

“There’s a lot of evidence now that demonstrates that ILD, in general, leads to worse mortality, morbidity in hospital complications, and overall [outcomes]. It’s not hard to extrapolate this to pulmonary embolism outcomes, too. Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.

The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.

The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).

Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).

In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.

“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.

He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.

Yuan and Rali disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.

“There’s a lot of evidence now that demonstrates that ILD, in general, leads to worse mortality, morbidity in hospital complications, and overall [outcomes]. It’s not hard to extrapolate this to pulmonary embolism outcomes, too. Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.

The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.

The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).

Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).

In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.

“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.

He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.

Yuan and Rali disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.

“There’s a lot of evidence now that demonstrates that ILD, in general, leads to worse mortality, morbidity in hospital complications, and overall [outcomes]. It’s not hard to extrapolate this to pulmonary embolism outcomes, too. Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.

The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.

The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).

Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).

In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.

“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.

He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.

Yuan and Rali disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.

METHODOLOGY:

• Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
• They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
• Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
• Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
• The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.

TAKEAWAY:

• Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
• The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
• No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.

IN PRACTICE:

“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.

SOURCE:

The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.

LIMITATIONS:

The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.

DISCLOSURES:

This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

There is insufficient evidence that drugs targeting the Janus kinase–signal transducer and activator of transcription (JAK-STAT) pathway increase the risk of cardiovascular or thrombotic complications in people undergoing treatment for a variety of dermatological conditions, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.

Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.

The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.

Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.

These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.

However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
 

Class-Wide Boxed Warning

“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.

ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.

“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
 

Examining Risk in Dermatological Conditions

The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.

Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.

Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.

The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.

No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
 

Reassuring Results?

Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.

This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.

“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.

“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?

“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.

With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”

The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.

There is insufficient evidence that drugs targeting the Janus kinase–signal transducer and activator of transcription (JAK-STAT) pathway increase the risk of cardiovascular or thrombotic complications in people undergoing treatment for a variety of dermatological conditions, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.

Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.

The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.

Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.

These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.

However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
 

Class-Wide Boxed Warning

“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.

ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.

“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
 

Examining Risk in Dermatological Conditions

The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.

Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.

Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.

The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.

No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
 

Reassuring Results?

Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.

This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.

“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.

“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?

“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.

With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”

The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.

There is insufficient evidence that drugs targeting the Janus kinase–signal transducer and activator of transcription (JAK-STAT) pathway increase the risk of cardiovascular or thrombotic complications in people undergoing treatment for a variety of dermatological conditions, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.

Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.

The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.

Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.

These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.

However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
 

Class-Wide Boxed Warning

“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.

ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.

“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
 

Examining Risk in Dermatological Conditions

The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.

Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.

Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.

The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.

No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
 

Reassuring Results?

Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.

This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.

“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.

“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?

“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.

With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”

The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

SAN DIEGO – Pregnant individuals with autoimmune rheumatic diseases (ARDs) are at least four times more likely to experience an acute cardiovascular event (CVE) than are pregnant individuals without these conditions, according to new research presented at the annual meeting of the American College of Rheumatology. Pregnant individuals with primary antiphospholipid syndrome (APS) had a 15-fold increase in CVE risk.

Patients who experienced CVEs were also more likely to experience preterm birth and other adverse pregnancy outcomes (APOs).

zoranm/Getty Images

Rashmi Dhital, MD, a rheumatology fellow at the University of California, San Diego, and colleagues examined the medical records of pregnant individuals in California who had delivered singleton live-born infants from 2005 to 2020. Using data from the Study of Outcomes in Mothers and Infants (SOMI) database, an administrative population-based birth cohort in California, they identified more than 7 million individuals, 19,340 with ARDs and 7,758 with APS.

They then analyzed how many patients experienced an acute CVE during pregnancy and up to 6 weeks after giving birth.

CVEs occurred in 2.0% of patients with ARDs, 6.9% of individuals with APS, and 0.4% of women without these conditions. CVE risk was four times higher in the ARDs group (adjusted relative risk, 4.1; 95% confidence interval, 3.7-4.5) and nearly 15 times higher in the APS group (aRR, 14.7; 95% CI, 13.5-16.0) than in the comparison group. Patients with systemic lupus erythematosus (SLE) had a sixfold higher risk of CVE, which was further exacerbated by concomitant APS (18-fold higher risk) or lupus nephritis (15-fold higher risk).

Dr. Dhital also classified CVEs as either venous thromboembolism and non-VTE events. Pregnant patients with APS had a high risk for VTE-only CVE (40-fold greater) and a 3.7-fold higher risk of non-VTE events, compared with pregnant patients without these conditions. Patients with SLE along with lupus nephritis had a 20-fold increased risk of VTE-only CVE and an 11-fold higher risk of non-VTE CVE.

Although the study grouped rheumatic diseases together, “lupus is generally driving these results,” Sharon Kolasinski, MD, of the University of Pennsylvania, Philadelphia, noted in an interview. She moderated the plenary session where the research was presented. “If you take out lupus, then what is the risk? That would be an interesting question.”

Between 25% and 30% of all CVEs occurred in the postpartum period, highlighting the importance of close monitoring of cardiovascular risks and events in women with ARDs or APS both during pregnancy and postpartum, Dr. Dhital noted.

Recognizing these risks “can sometimes be challenging due to a lower suspicion of CVE in younger patients, and also symptoms overlap with normal pregnancy,” Dr. Dhital said during her plenary presentation. Working with other clinical teams could help physicians detect these risks in patients.

“It’s important for us to remember that there’s increased risk of cardiovascular events in pregnancy in our patients. It’s uncommon, but it’s not zero,” added Dr. Kolasinski, and this study highlighted when physicians should be more focused about that risk.

Dr. Dhital noted there were some limitations to the study that are inherent in using administrative databases for research that relies on ICD codes, including “the availability of information on disease activity, medications, and labs, which may restrict clinical interpretation.”
 

SOMI data reinforced by National Inpatient Sample study

The findings were complemented by a study using the National Inpatient Sample database to explore CVE risk in pregnant individuals with various rheumatic diseases. Lead author Karun Shrestha, MD, a resident physician at St. Barnabas Hospital in New York, and colleagues identified delivery hospitalizations from 2016 to 2019 for individuals with SLE, RA, and systemic vasculitis and looked for CVEs including preeclampsia, peripartum cardiomyopathy (PPCM), heart failure, stroke, cardiac arrhythmias, and VTE.

Lucy Hicks/Medscape Medical News

Out of over 3.4 million delivery hospitalizations, researchers identified 5,900 individuals with SLE, 4,895 with RA, and 325 with vasculitis. After adjusting for confounding factors such as race, age, insurance, and other comorbidities, SLE was identified as an independent risk factor for preeclampsia (odds ratio, 1.5; 95% CI, 1.1-2.1), arrhythmia (OR, 3.17; 95% CI, 1.73-5.79), and venous thrombosis (OR, 8.4; 95% CI, 2.9-22.1). Vasculitis was tied to increased risk for preeclampsia (OR, 4.7; 95% CI, 2-11.3), stroke (OR, 513.3; 95% CI, 114-2,284), heart failure (OR, 24.17; 95% CI, 4.68-124.6), and PPCM (OR, 66.7; 95% CI, 8.7-509.4). RA was tied to an increased risk for preeclampsia (OR, 1.5; 95% CI, 1.05-2.1).

Patients with SLE or vasculitis had longer, more costly hospital stays, compared with those without these conditions, and they experienced higher rates of in-hospital mortality. While previous research has demonstrated that patients with SLE have higher risk of cardiac events, there is less literature on CVE risk in pregnancies for vasculitis, Dr. Shrestha said in an interview.

“It’s something to work on,” he said.
 

Adverse pregnancy outcomes higher with ARDs, APS

In a second abstract also led by Dr. Dhital using SOMI data, researchers found that pregnant individuals with ARDs or APS had a higher risk of experiencing an APO – preterm birth or small-for-gestational age – than individuals without these conditions. CVEs exacerbated that risk, regardless of underlying chronic health conditions.

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

SAN DIEGO – Pregnant individuals with autoimmune rheumatic diseases (ARDs) are at least four times more likely to experience an acute cardiovascular event (CVE) than are pregnant individuals without these conditions, according to new research presented at the annual meeting of the American College of Rheumatology. Pregnant individuals with primary antiphospholipid syndrome (APS) had a 15-fold increase in CVE risk.

Patients who experienced CVEs were also more likely to experience preterm birth and other adverse pregnancy outcomes (APOs).

zoranm/Getty Images

Rashmi Dhital, MD, a rheumatology fellow at the University of California, San Diego, and colleagues examined the medical records of pregnant individuals in California who had delivered singleton live-born infants from 2005 to 2020. Using data from the Study of Outcomes in Mothers and Infants (SOMI) database, an administrative population-based birth cohort in California, they identified more than 7 million individuals, 19,340 with ARDs and 7,758 with APS.

They then analyzed how many patients experienced an acute CVE during pregnancy and up to 6 weeks after giving birth.

CVEs occurred in 2.0% of patients with ARDs, 6.9% of individuals with APS, and 0.4% of women without these conditions. CVE risk was four times higher in the ARDs group (adjusted relative risk, 4.1; 95% confidence interval, 3.7-4.5) and nearly 15 times higher in the APS group (aRR, 14.7; 95% CI, 13.5-16.0) than in the comparison group. Patients with systemic lupus erythematosus (SLE) had a sixfold higher risk of CVE, which was further exacerbated by concomitant APS (18-fold higher risk) or lupus nephritis (15-fold higher risk).

Dr. Dhital also classified CVEs as either venous thromboembolism and non-VTE events. Pregnant patients with APS had a high risk for VTE-only CVE (40-fold greater) and a 3.7-fold higher risk of non-VTE events, compared with pregnant patients without these conditions. Patients with SLE along with lupus nephritis had a 20-fold increased risk of VTE-only CVE and an 11-fold higher risk of non-VTE CVE.

Although the study grouped rheumatic diseases together, “lupus is generally driving these results,” Sharon Kolasinski, MD, of the University of Pennsylvania, Philadelphia, noted in an interview. She moderated the plenary session where the research was presented. “If you take out lupus, then what is the risk? That would be an interesting question.”

Between 25% and 30% of all CVEs occurred in the postpartum period, highlighting the importance of close monitoring of cardiovascular risks and events in women with ARDs or APS both during pregnancy and postpartum, Dr. Dhital noted.

Recognizing these risks “can sometimes be challenging due to a lower suspicion of CVE in younger patients, and also symptoms overlap with normal pregnancy,” Dr. Dhital said during her plenary presentation. Working with other clinical teams could help physicians detect these risks in patients.

“It’s important for us to remember that there’s increased risk of cardiovascular events in pregnancy in our patients. It’s uncommon, but it’s not zero,” added Dr. Kolasinski, and this study highlighted when physicians should be more focused about that risk.

Dr. Dhital noted there were some limitations to the study that are inherent in using administrative databases for research that relies on ICD codes, including “the availability of information on disease activity, medications, and labs, which may restrict clinical interpretation.”
 

SOMI data reinforced by National Inpatient Sample study

The findings were complemented by a study using the National Inpatient Sample database to explore CVE risk in pregnant individuals with various rheumatic diseases. Lead author Karun Shrestha, MD, a resident physician at St. Barnabas Hospital in New York, and colleagues identified delivery hospitalizations from 2016 to 2019 for individuals with SLE, RA, and systemic vasculitis and looked for CVEs including preeclampsia, peripartum cardiomyopathy (PPCM), heart failure, stroke, cardiac arrhythmias, and VTE.

Lucy Hicks/Medscape Medical News

Out of over 3.4 million delivery hospitalizations, researchers identified 5,900 individuals with SLE, 4,895 with RA, and 325 with vasculitis. After adjusting for confounding factors such as race, age, insurance, and other comorbidities, SLE was identified as an independent risk factor for preeclampsia (odds ratio, 1.5; 95% CI, 1.1-2.1), arrhythmia (OR, 3.17; 95% CI, 1.73-5.79), and venous thrombosis (OR, 8.4; 95% CI, 2.9-22.1). Vasculitis was tied to increased risk for preeclampsia (OR, 4.7; 95% CI, 2-11.3), stroke (OR, 513.3; 95% CI, 114-2,284), heart failure (OR, 24.17; 95% CI, 4.68-124.6), and PPCM (OR, 66.7; 95% CI, 8.7-509.4). RA was tied to an increased risk for preeclampsia (OR, 1.5; 95% CI, 1.05-2.1).

Patients with SLE or vasculitis had longer, more costly hospital stays, compared with those without these conditions, and they experienced higher rates of in-hospital mortality. While previous research has demonstrated that patients with SLE have higher risk of cardiac events, there is less literature on CVE risk in pregnancies for vasculitis, Dr. Shrestha said in an interview.

“It’s something to work on,” he said.
 

Adverse pregnancy outcomes higher with ARDs, APS

In a second abstract also led by Dr. Dhital using SOMI data, researchers found that pregnant individuals with ARDs or APS had a higher risk of experiencing an APO – preterm birth or small-for-gestational age – than individuals without these conditions. CVEs exacerbated that risk, regardless of underlying chronic health conditions.

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

SAN DIEGO – Pregnant individuals with autoimmune rheumatic diseases (ARDs) are at least four times more likely to experience an acute cardiovascular event (CVE) than are pregnant individuals without these conditions, according to new research presented at the annual meeting of the American College of Rheumatology. Pregnant individuals with primary antiphospholipid syndrome (APS) had a 15-fold increase in CVE risk.

Patients who experienced CVEs were also more likely to experience preterm birth and other adverse pregnancy outcomes (APOs).

zoranm/Getty Images

Rashmi Dhital, MD, a rheumatology fellow at the University of California, San Diego, and colleagues examined the medical records of pregnant individuals in California who had delivered singleton live-born infants from 2005 to 2020. Using data from the Study of Outcomes in Mothers and Infants (SOMI) database, an administrative population-based birth cohort in California, they identified more than 7 million individuals, 19,340 with ARDs and 7,758 with APS.

They then analyzed how many patients experienced an acute CVE during pregnancy and up to 6 weeks after giving birth.

CVEs occurred in 2.0% of patients with ARDs, 6.9% of individuals with APS, and 0.4% of women without these conditions. CVE risk was four times higher in the ARDs group (adjusted relative risk, 4.1; 95% confidence interval, 3.7-4.5) and nearly 15 times higher in the APS group (aRR, 14.7; 95% CI, 13.5-16.0) than in the comparison group. Patients with systemic lupus erythematosus (SLE) had a sixfold higher risk of CVE, which was further exacerbated by concomitant APS (18-fold higher risk) or lupus nephritis (15-fold higher risk).

Dr. Dhital also classified CVEs as either venous thromboembolism and non-VTE events. Pregnant patients with APS had a high risk for VTE-only CVE (40-fold greater) and a 3.7-fold higher risk of non-VTE events, compared with pregnant patients without these conditions. Patients with SLE along with lupus nephritis had a 20-fold increased risk of VTE-only CVE and an 11-fold higher risk of non-VTE CVE.

Although the study grouped rheumatic diseases together, “lupus is generally driving these results,” Sharon Kolasinski, MD, of the University of Pennsylvania, Philadelphia, noted in an interview. She moderated the plenary session where the research was presented. “If you take out lupus, then what is the risk? That would be an interesting question.”

Between 25% and 30% of all CVEs occurred in the postpartum period, highlighting the importance of close monitoring of cardiovascular risks and events in women with ARDs or APS both during pregnancy and postpartum, Dr. Dhital noted.

Recognizing these risks “can sometimes be challenging due to a lower suspicion of CVE in younger patients, and also symptoms overlap with normal pregnancy,” Dr. Dhital said during her plenary presentation. Working with other clinical teams could help physicians detect these risks in patients.

“It’s important for us to remember that there’s increased risk of cardiovascular events in pregnancy in our patients. It’s uncommon, but it’s not zero,” added Dr. Kolasinski, and this study highlighted when physicians should be more focused about that risk.

Dr. Dhital noted there were some limitations to the study that are inherent in using administrative databases for research that relies on ICD codes, including “the availability of information on disease activity, medications, and labs, which may restrict clinical interpretation.”
 

SOMI data reinforced by National Inpatient Sample study

The findings were complemented by a study using the National Inpatient Sample database to explore CVE risk in pregnant individuals with various rheumatic diseases. Lead author Karun Shrestha, MD, a resident physician at St. Barnabas Hospital in New York, and colleagues identified delivery hospitalizations from 2016 to 2019 for individuals with SLE, RA, and systemic vasculitis and looked for CVEs including preeclampsia, peripartum cardiomyopathy (PPCM), heart failure, stroke, cardiac arrhythmias, and VTE.

Lucy Hicks/Medscape Medical News

Out of over 3.4 million delivery hospitalizations, researchers identified 5,900 individuals with SLE, 4,895 with RA, and 325 with vasculitis. After adjusting for confounding factors such as race, age, insurance, and other comorbidities, SLE was identified as an independent risk factor for preeclampsia (odds ratio, 1.5; 95% CI, 1.1-2.1), arrhythmia (OR, 3.17; 95% CI, 1.73-5.79), and venous thrombosis (OR, 8.4; 95% CI, 2.9-22.1). Vasculitis was tied to increased risk for preeclampsia (OR, 4.7; 95% CI, 2-11.3), stroke (OR, 513.3; 95% CI, 114-2,284), heart failure (OR, 24.17; 95% CI, 4.68-124.6), and PPCM (OR, 66.7; 95% CI, 8.7-509.4). RA was tied to an increased risk for preeclampsia (OR, 1.5; 95% CI, 1.05-2.1).

Patients with SLE or vasculitis had longer, more costly hospital stays, compared with those without these conditions, and they experienced higher rates of in-hospital mortality. While previous research has demonstrated that patients with SLE have higher risk of cardiac events, there is less literature on CVE risk in pregnancies for vasculitis, Dr. Shrestha said in an interview.

“It’s something to work on,” he said.
 

Adverse pregnancy outcomes higher with ARDs, APS

In a second abstract also led by Dr. Dhital using SOMI data, researchers found that pregnant individuals with ARDs or APS had a higher risk of experiencing an APO – preterm birth or small-for-gestational age – than individuals without these conditions. CVEs exacerbated that risk, regardless of underlying chronic health conditions.

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

Short-term use of JAK inhibitors for a dermatologic indication appears to not be associated with an increased risk of all-cause mortality, major adverse cardiovascular events (MACE) and venous thromboembolic events (VTE), results from a systematic literature review, and meta-analysis showed.

“There remains a knowledge gap regarding the risk of JAK inhibitor use and VTE and/or MACE in the dermatologic population,” researchers led by Michael S. Garshick, MD, a cardiologist at New York University Langone Health, wrote in their study, which was published online in JAMA Dermatology . “Pooled safety studies suggest that the risk of MACE and VTE may be lower in patients treated with JAK inhibitors for a dermatologic indication than the risk observed in the ORAL Surveillance study, which may be related to the younger age and better health status of those enrolled in trials for dermatologic indications.” The results of that study, which included patients with rheumatoid arthritis only, resulted in the addition of a boxed warning in the labels for topical and oral JAK inhibitors regarding the increased risk of MACE, VTE, serious infections, malignancies, and death .

For the review – thought to be the first to specifically evaluate these risks for dermatologic indications – the researchers searched PubMed and ClinicalTrials.gov from inception through April 1, 2023, for phase 3 dermatology randomized clinical trials (RCTs) to evaluate the risk of MACE, VTE, and all-cause mortality with JAK inhibitors, compared with placebo or an active comparator in the treatment of immune-mediated inflammatory skin diseases. They followed Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and used a random-effects model and the DerSimonian-Laird method to calculate adverse events with odds ratios.

The database search yielded 35 RCTs with a total of 20,651 patients. Their mean age was 38.5 years, 54% were male, and the mean follow-up time was 4.9 months. Of the 35 trials, most (21) involved patients with atopic dermatitis, followed by psoriasis/psoriatic arthritis (9 trials), alopecia areata (3 trials) and vitiligo (2 trials).

The researchers found no significant difference between JAK inhibitors and placebo/active comparator in composite MACE and all-cause mortality (odds ratio, 0.83; 95% confidence interval, 0.44-1.57) or in VTE (OR, 0.52; 95% CI, 0.26-1.04).

In a secondary analysis, which included additional psoriatic arthritis RCTs, no significant differences between the treatment and placebo/active comparator groups were observed. Similarly, subgroup analyses of oral versus topical JAK inhibitors and a sensitivity analysis that excluded pediatric trials showed no significant differences between patients exposed to JAK inhibitors and those not exposed.

The researchers acknowledged certain limitations of the review, including the lack of access to patient-level data, the fact that most trials only included short-term follow-up, and that the findings have limited generalizability to an older patient population. “It remains unclear if the cardiovascular risks of JAK inhibitors are primarily due to patient level cardiovascular risk factors or are drug mediated,” they concluded. “Dermatologists should carefully select patients and assess baseline cardiovascular risk factors when considering JAK therapy. Cardiovascular risk assessment should continue for the duration of treatment.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, who was asked to comment on the study results, characterized the findings as reassuring to dermatologists who may be reluctant to initiate therapy with JAK inhibitors based on concerns about safety signals for MACE, VTE, and all-cause mortality.

“These data systematically show that across medications and across conditions, there doesn’t appear to be an increased signal for these events during the short-term, placebo-controlled period which generally spans a few months in most studies,” he told this news organization. The findings, he added, “align well with our clinical experience to date for JAK inhibitor use in inflammatory skin disease. Short-term safety, particularly in relation to boxed warning events such MACE, VTE, and all-cause mortality, have generally been favorable with real-world use. It’s good to have a rigorous statistical analysis to refer to when setting patient expectations.”

However, he noted that these data only examined short-term safety during the placebo or active comparator-controlled periods. “Considering that events like MACE or VTE may take many months or years to manifest, continued long-term data generation is needed to fully answer the question of risk,” he said.

Dr. Garshick disclosed that he received grants from Pfizer and personal fees from Bristol Myers Squibb during the conduct of the study and personal fees from Kiniksa Pharmaceuticals outside the submitted work. Several other coauthors reported having advisory board roles and/or having received funding or support from several pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including those that develop JAK inhibitors.

Short-term use of JAK inhibitors for a dermatologic indication appears to not be associated with an increased risk of all-cause mortality, major adverse cardiovascular events (MACE) and venous thromboembolic events (VTE), results from a systematic literature review, and meta-analysis showed.

“There remains a knowledge gap regarding the risk of JAK inhibitor use and VTE and/or MACE in the dermatologic population,” researchers led by Michael S. Garshick, MD, a cardiologist at New York University Langone Health, wrote in their study, which was published online in JAMA Dermatology . “Pooled safety studies suggest that the risk of MACE and VTE may be lower in patients treated with JAK inhibitors for a dermatologic indication than the risk observed in the ORAL Surveillance study, which may be related to the younger age and better health status of those enrolled in trials for dermatologic indications.” The results of that study, which included patients with rheumatoid arthritis only, resulted in the addition of a boxed warning in the labels for topical and oral JAK inhibitors regarding the increased risk of MACE, VTE, serious infections, malignancies, and death .

For the review – thought to be the first to specifically evaluate these risks for dermatologic indications – the researchers searched PubMed and ClinicalTrials.gov from inception through April 1, 2023, for phase 3 dermatology randomized clinical trials (RCTs) to evaluate the risk of MACE, VTE, and all-cause mortality with JAK inhibitors, compared with placebo or an active comparator in the treatment of immune-mediated inflammatory skin diseases. They followed Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and used a random-effects model and the DerSimonian-Laird method to calculate adverse events with odds ratios.

The database search yielded 35 RCTs with a total of 20,651 patients. Their mean age was 38.5 years, 54% were male, and the mean follow-up time was 4.9 months. Of the 35 trials, most (21) involved patients with atopic dermatitis, followed by psoriasis/psoriatic arthritis (9 trials), alopecia areata (3 trials) and vitiligo (2 trials).

The researchers found no significant difference between JAK inhibitors and placebo/active comparator in composite MACE and all-cause mortality (odds ratio, 0.83; 95% confidence interval, 0.44-1.57) or in VTE (OR, 0.52; 95% CI, 0.26-1.04).

In a secondary analysis, which included additional psoriatic arthritis RCTs, no significant differences between the treatment and placebo/active comparator groups were observed. Similarly, subgroup analyses of oral versus topical JAK inhibitors and a sensitivity analysis that excluded pediatric trials showed no significant differences between patients exposed to JAK inhibitors and those not exposed.

The researchers acknowledged certain limitations of the review, including the lack of access to patient-level data, the fact that most trials only included short-term follow-up, and that the findings have limited generalizability to an older patient population. “It remains unclear if the cardiovascular risks of JAK inhibitors are primarily due to patient level cardiovascular risk factors or are drug mediated,” they concluded. “Dermatologists should carefully select patients and assess baseline cardiovascular risk factors when considering JAK therapy. Cardiovascular risk assessment should continue for the duration of treatment.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, who was asked to comment on the study results, characterized the findings as reassuring to dermatologists who may be reluctant to initiate therapy with JAK inhibitors based on concerns about safety signals for MACE, VTE, and all-cause mortality.

“These data systematically show that across medications and across conditions, there doesn’t appear to be an increased signal for these events during the short-term, placebo-controlled period which generally spans a few months in most studies,” he told this news organization. The findings, he added, “align well with our clinical experience to date for JAK inhibitor use in inflammatory skin disease. Short-term safety, particularly in relation to boxed warning events such MACE, VTE, and all-cause mortality, have generally been favorable with real-world use. It’s good to have a rigorous statistical analysis to refer to when setting patient expectations.”

However, he noted that these data only examined short-term safety during the placebo or active comparator-controlled periods. “Considering that events like MACE or VTE may take many months or years to manifest, continued long-term data generation is needed to fully answer the question of risk,” he said.

Dr. Garshick disclosed that he received grants from Pfizer and personal fees from Bristol Myers Squibb during the conduct of the study and personal fees from Kiniksa Pharmaceuticals outside the submitted work. Several other coauthors reported having advisory board roles and/or having received funding or support from several pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including those that develop JAK inhibitors.

Short-term use of JAK inhibitors for a dermatologic indication appears to not be associated with an increased risk of all-cause mortality, major adverse cardiovascular events (MACE) and venous thromboembolic events (VTE), results from a systematic literature review, and meta-analysis showed.

“There remains a knowledge gap regarding the risk of JAK inhibitor use and VTE and/or MACE in the dermatologic population,” researchers led by Michael S. Garshick, MD, a cardiologist at New York University Langone Health, wrote in their study, which was published online in JAMA Dermatology . “Pooled safety studies suggest that the risk of MACE and VTE may be lower in patients treated with JAK inhibitors for a dermatologic indication than the risk observed in the ORAL Surveillance study, which may be related to the younger age and better health status of those enrolled in trials for dermatologic indications.” The results of that study, which included patients with rheumatoid arthritis only, resulted in the addition of a boxed warning in the labels for topical and oral JAK inhibitors regarding the increased risk of MACE, VTE, serious infections, malignancies, and death .

For the review – thought to be the first to specifically evaluate these risks for dermatologic indications – the researchers searched PubMed and ClinicalTrials.gov from inception through April 1, 2023, for phase 3 dermatology randomized clinical trials (RCTs) to evaluate the risk of MACE, VTE, and all-cause mortality with JAK inhibitors, compared with placebo or an active comparator in the treatment of immune-mediated inflammatory skin diseases. They followed Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and used a random-effects model and the DerSimonian-Laird method to calculate adverse events with odds ratios.

The database search yielded 35 RCTs with a total of 20,651 patients. Their mean age was 38.5 years, 54% were male, and the mean follow-up time was 4.9 months. Of the 35 trials, most (21) involved patients with atopic dermatitis, followed by psoriasis/psoriatic arthritis (9 trials), alopecia areata (3 trials) and vitiligo (2 trials).

The researchers found no significant difference between JAK inhibitors and placebo/active comparator in composite MACE and all-cause mortality (odds ratio, 0.83; 95% confidence interval, 0.44-1.57) or in VTE (OR, 0.52; 95% CI, 0.26-1.04).

In a secondary analysis, which included additional psoriatic arthritis RCTs, no significant differences between the treatment and placebo/active comparator groups were observed. Similarly, subgroup analyses of oral versus topical JAK inhibitors and a sensitivity analysis that excluded pediatric trials showed no significant differences between patients exposed to JAK inhibitors and those not exposed.

The researchers acknowledged certain limitations of the review, including the lack of access to patient-level data, the fact that most trials only included short-term follow-up, and that the findings have limited generalizability to an older patient population. “It remains unclear if the cardiovascular risks of JAK inhibitors are primarily due to patient level cardiovascular risk factors or are drug mediated,” they concluded. “Dermatologists should carefully select patients and assess baseline cardiovascular risk factors when considering JAK therapy. Cardiovascular risk assessment should continue for the duration of treatment.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, who was asked to comment on the study results, characterized the findings as reassuring to dermatologists who may be reluctant to initiate therapy with JAK inhibitors based on concerns about safety signals for MACE, VTE, and all-cause mortality.

“These data systematically show that across medications and across conditions, there doesn’t appear to be an increased signal for these events during the short-term, placebo-controlled period which generally spans a few months in most studies,” he told this news organization. The findings, he added, “align well with our clinical experience to date for JAK inhibitor use in inflammatory skin disease. Short-term safety, particularly in relation to boxed warning events such MACE, VTE, and all-cause mortality, have generally been favorable with real-world use. It’s good to have a rigorous statistical analysis to refer to when setting patient expectations.”

However, he noted that these data only examined short-term safety during the placebo or active comparator-controlled periods. “Considering that events like MACE or VTE may take many months or years to manifest, continued long-term data generation is needed to fully answer the question of risk,” he said.

Dr. Garshick disclosed that he received grants from Pfizer and personal fees from Bristol Myers Squibb during the conduct of the study and personal fees from Kiniksa Pharmaceuticals outside the submitted work. Several other coauthors reported having advisory board roles and/or having received funding or support from several pharmaceutical companies. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including those that develop JAK inhibitors.