Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

Childhood autism rates are at the highest level since the Centers for Disease Control and Prevention began tracking the disorder in 2000, new data released Dec. 2 show.

The increase likely reflects improvements in diagnosis and identification of autism spectrum disorder (ASD), not an increase in incidence, study authors with the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network told this news organization.

Using a new surveillance methodology, researchers found that 2.3% of 8-year-olds in communities in 11 states across the United States had an autism diagnosis in 2018, up from 1.9% in 2016.

A separate report on early identification in 4-year-olds shows that children born in 2014 were 50% more likely to receive an autism diagnosis or ASD special education classification by 48 months of age than those born in 2010, signaling improved early diagnosis.

Taken together, the data suggest efforts to raise awareness about autism are working, though researchers were quick to say much work remains.

“It was not surprising to me and in fact it was reassuring that the number of children diagnosed with autism is higher and is actually approaching prevalence of autism that has been noted in some national surveys of parents,” Stuart Shapira, MD, PhD, associate director for science in CDC’s National Center on Birth Defects and Developmental Disability, told this news organization.

“It means we’re doing a better job of identifying children, which helps to get them into services earlier so they can achieve their best developmental outcome.”

The studies, published online in Morbidity and Mortality Weekly Report, are the first to use a new ASD surveillance protocol that relies on ASD diagnosis or special education classification and billing codes and eliminates comprehensive records analysis by trained clinician reviewers.

Racial disparities

The updated methodology was less labor intensive and reduced the time it took to produce the report, but it is not without its critics, who claim the new protocol will undercount the number of children with ASD.

Created in 2000 and funded by the CDC, the ADDM Network is the only surveillance program in the United States that tracks the number and characteristics of children with ASD in multiple communities in the U.S.

When ADDM released its first report in 2007 from six states and based on data from the year 2000, ASD prevalence was 6.7 per 1,000 children, or 1 in 150 children.

In the latest report, which includes data from 2018, the autism prevalence rate across 11 states was 23.0 per 1,000 children, or 1 in 44 children.

That rate is closer to reported autism prevalence from the National Survey of Children’s Health and the National Health Interview Survey, both of which rely on parent-reported ASD diagnoses.

For the report, researchers analyzed medical and special education records of 220,281 children who were born in 2010 in Arizona, Arkansas, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, Tennessee, Utah, and Wisconsin.

Children were counted as having autism if their records included an ASD diagnosis, a special education classification of ASD, or an ASD International Classification of Diseases (ICD) code. A total of 5,058 children met those criteria.

Rates of ASD ranged from a low of 1.7% in Missouri to 3.9% in California and were 4.2 times higher in boys than in girls. Just under half of the children with ASD were evaluated by age 36 months.

Although the overall ASD prevalence was similar among White, Black, Hispanic, and Asian/Pacific Islander children, the report highlighted a number of other racial disparities overall and in individual states.

For example, among those with ASD and data on cognitive ability, 35.2% had an intelligence quotient score of 70 or lower. Black children with ASD were far more likely to have an IQ of 70 or less (49.8%) than Hispanic (33.1%) or White (29.7%) children.

“The persistent disparities in co-occurring intellectual disabilities in children with autism is something that we continue to see and suggests that we need to better understand exactly what’s happening,” Matthew Maenner, PhD, an epidemiologist and autism surveillance team lead with the CDC’s National Center on Birth Defects and Developmental Disabilities, told this news organization.

Another long-standing trend observed again in the new report on prevalence among 8-year-olds is low ASD prevalence among Hispanic children. While the overall estimate showed similar autism rates, a closer review of state-level data reveals a different picture.

“In almost half of the sites, Hispanic children were less likely to be identified as having ASD,” he said. “This gets lost if you look only at the overall estimate.”

New methodology

When ADDM released its first report in 2007, autism diagnosis was widely inadequate in the United States. Relying on only confirmed ASD diagnoses would significantly underestimate the number of children with the disorder, so the CDC added “active case finding” to the protocol.

Trained clinician reviewers analyzed individual notes from medical and educational records for every 8-year-old in ADDM Network sites, looking for evidence of characteristics and behaviors associated with autism. The process was labor- and time-intensive and took up to 4 years to complete.

In 2018, the CDC began investigating ways to speed the process and came up with the strategy used in the latest report. The new protocol was faster, easier, and less expensive. Although he says cost was never the deciding factor, Dr. Maenner acknowledges that had they stuck with the original protocol, they would have been forced to reduce the number of ADDM Network sites.

Dr. Maenner argues that a comparison of the two protocols shows the new method doesn’t compromise accuracy and may actually capture children who lacked the medical or educational records the previous protocol required for a count. But not everyone agrees.

“I thought the point was to be as accurate and complete as possible in doing the surveillance,” Walter Zahorodny, PhD, associate professor of pediatrics at Rutgers University, New Brunswick, N.J., and principal investigator of the New Jersey ADDM Network site, told this news organization. “In states where there’s a high detail of information in records, like New Jersey, it’s going to underestimate the count.”

Dr. Zahorodny says the latest data prove his point. In 2016, under the old methodology, ASD prevalence was 3.1% in the state. In 2018, under the new protocol, prevalence was 2.84%, a decrease of about 20% that Dr. Zahorodny pins squarely on the elimination of ADDM clinical reviewers.

But New Jersey is the only state that participated in both the 2016 and 2018 surveillance periods to report a decrease in ASD prevalence. The other eight states all found autism rates in their states went up.

Sydney Pettygrove, PhD, associate professor of public health and pediatrics at the University of Arizona, Tucson, and a principal investigator for the ADDM site in Arizona, told this news organization that when she first learned the CDC was rolling out a new methodology, she and other investigators were concerned.

“People were really upset. I was really upset,” she said. “I had formed an opinion based on the earlier data that this would not be a good idea.”

In 2000, when ASD surveillance began in Arizona, nearly 30% of children identified by ADDM clinical reviewers as having autism had no mention of the disorder in their records. Today, that percentage is closer to 5%.

“In 2000 it would have been catastrophic to try to estimate the prevalence of autism with the new protocol,” said Dr. Pettygrove. As it turns out, under the new protocol, prevalence rates in Arizona increased from 16.0 per 1,000 children in 2016 to 24.9 in 2018.

Built-in bias eliminated?

In addition to speeding up the process, the new methodology might have other benefits as well. Under the old ADDM surveillance protocol, children who lacked certain medical or educational records did not meet the ASD case definition and weren’t counted.

A 2019 study showed that this disproportionately affected Black and Hispanic children, who had significantly less access to health care professionals than White children.

As a result, “the old methodology had a bias built into it,” Maureen Durkin, PhD, DrPH, coauthor of that study and chair of population health sciences at the University of Wisconsin–Madison and principal investigator for the ADDM site in Wisconsin, told this news organization.

“Clinician reviewers ended up putting these children in the ‘suspected ASD’ category because they couldn’t call it a case under the case definition,” Dr. Durkin said. “There was a fairly large percentage of suspected cases and a disproportionate number of those kids were children of color.”

Although she can’t say for sure, Dr. Durkin said it’s possible the new protocol could eliminate some of that bias.

CDC researchers also attribute the new method to an expanded study of early diagnosis among 4-year-olds. In previous years, only a handful of the ADDM Network sites participating in the 8-year-old surveillance project also studied early diagnosis in 4-year-olds.

This year, all 11 sites took part in the early diagnosis analysis, tripling the number of children included in the analysis. That made it possible to include, for the first time, Asian/Pacific Islander children in this analysis.

In the past, ASD prevalence has trended higher in White children, compared with other racial groups. The new data found that ASD prevalence among 4-year-olds was significantly lower in White children (12.9 per 1,000 children) than in Black, Hispanic, or Asian/Pacific Islander children (16.6, 21.1, and 22.7 per 1,000, respectively). Prevalence in American Indian/Alaska Native children was the lowest among all racial groups (11.5 per 1,000).

It’s the first time researchers have seen this pattern in any ADDM report, Kelly Shaw, PhD, lead author of that study and an epidemiologist with the National Center on Birth Defects and Developmental Disability at the CDC, told this news organization.

These data don’t provide clues about the potential cause of that disparity, Dr. Shaw said. It’s likely an indication of better identification of ASD in those communities, she said, and not a sign of increased incidence of autism among Black, Hispanic, or Asian/Pacific Islander children.

“We don’t have any evidence to suggest or expect that autism would be increasing differentially among groups,” Dr. Shaw said.

The data suggest “we are making some progress but there certainly is still room for improvement,” Dr. Shaw said.

Study authors report no conflicts of interest.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Development of bacteremia in immunocompetent adult patients managed in the ICU for severe pneumococcal community-acquired pneumonia (CAP) had no effect on mortality.

Main finding: In-hospital mortality (21.5% vs. 16.9%; P = .11) or baseline variables associated with in-hospital death, such as the age ≥65 years (P interaction = .45) and bilateral pulmonary infection (P interaction = .77), were not significantly different between patients with and without bacteremia.

Study details: This was a post hoc analysis of the prospective STREPTOGENE study including 614 immunocompetent adult white patients admitted to an ICU for severe pneumococcal CAP. Of these, 270 patients had a positive blood culture for Streptococcus pneumoniae at admission.

Disclosures: The study was sponsored by 2 public health care and research agencies: the Assistance Publique Hôpitaux de Paris and Délégation à la Recherche Clinique et au Développement. None of the authors declared any conflict of interests.

Source: Bellut H et al. Ann Intensive Care. 2021;11:148 (Oct 24). Doi: 10.1186/s13613-021-00936-z.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Pneumococcal urinary antigen testing (PUAT) effectuated early de-escalation of broad-spectrum antibiotics among positive patients with community-acquired pneumonia (CAP) and thus should be widely performed to substantiate antimicrobial stewardship interventions.

Main finding: PUAT-positive patients showed a significantly shorter median (interquartile range) time to de-escalation vs. PUAT-negative patients (1 [0-2] days vs. 1 [1-2] days; P = .01) and a higher atypical (azithromycin or doxycycline) coverage discontinuation rate within 24 hours of PUAT (61.3% vs. 47.2%; P = .026), with no significant difference in methicillin-resistant Staphylococcus aureus agent discontinuation (P = .610) or antipseudomonal de-escalation (P = .895).

Study details: The data come from a retrospective chart review study including 910 adult patients who were hospitalized for CAP and, as part of the diagnostic procedure, underwent PUAT, which returned a positive result in 121 patients.

Disclosures: The authors reported no financial support or conflict of interests.

Source: Greenfield A et al. Open Forum Infect Dis. 2021;ofab522 (Oct 22). Doi: 10.1093/ofid/ofab522.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Heparin-binding protein (HBP) may outperform the conventional biomarkers in predicting disease progression in children with severe community-acquired pneumonia (CAP).

Main finding: After adjusting for age, high HBP levels showed an independent correlation with respiratory failure (RF; odds ratio [OR] 1.008; 95% CI 1.003-1.013) in children with severe CAP. Among other biomarkers, HBP exhibited the highest predictive power for identifying children developing RF or sepsis, yielding areas under the receiver operating characteristic curves of 0.68 and 0.85, respectively, along with the best specificity at 96.3%.

Study details: Findings are from a retrospective observational study on 157 children who were admitted to an ICU ward for severe CAP, of which 106 presented with RF and 48 developed sepsis.

Disclosures: The study was sponsored by the Changsha Science and Technology Bureau Science Foundation, China. The authors declared no conflict of interests.

Source: Huang C et al. Front Pediatr. 2021 (Oct 28). Doi: 10.3389/fped.2021.759535.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: Administration of ceftaroline alone or in combination resulted in lower in-hospital mortality rates in patients with community-acquired pneumonia (CAP) vs. standard therapy.

Main finding: After adjustment for confounding factors, patients receiving ceftaroline had a lower in-hospital mortality rate (13% vs. 21%; adjusted hazard ratio 0.41; P = .031) and longer median hospital stay (13 days vs. 10 days; P = .007) than those receiving standard therapy.

Study details: This retrospective observational study matched 78 patients with CAP who received ceftaroline (as monotherapy or in combination with azithromycin, levofloxacin, etc.) with 78 control patients who received standard therapy.

Disclosures: The study received financial support from Pfizer, CIBER de Enfermedades Respiratorias, and 2009 Support to Research Groups of Catalonia 911, IDIBAPS. Pfizer, in addition to a couple of other sources, provided research grants/fellowships to Dr. Cilloniz and other authors.

Source: Cilloniz C et al. Eur J Clin Microbiol Infect Dis. 2021 (Nov 12). Doi: 10.1007/s10096-021-04378-0.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: On comparing regimes recommended by the 2019 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, those containing doxycycline were associated with decreased mortality in elderly patients with community-acquired pneumonia (CAP).

Main finding: After propensity-matching, patients receiving beta-lactam + doxycycline showed significantly reduced 30-day (odds ratio [OR] 0.72; 95% CI 0.63-0.84) and 90-day (OR 0.83; 95% CI 0.74-0.92) mortality vs. those on nondoxycycline-containing regimes.

Study details: This retrospective observational cohort study included 70,533 patients aged ≥65 years who were admitted to a non-ICU hospital ward for CAP and received at least 1 dose of the 2019 ATS/IDSA guideline-recommended antimicrobial therapy within 48 hours after admission. Of these, 5,282 patients received doxycycline-containing combinations.

Disclosures: The study was supported by the US National Institute of Nursing Research. CA Alvarez declared serving as an advisory board member for a pharmaceutical organization.

Source: Uddin M et al. Clin Infect Dis. 2021;ciab863 (Nov 9). Doi: 10.1093/cid/ciab863.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.

Key clinical point: Occurrence of community-acquired pneumonia (CAP) in infants aged below 2 years increases their risk for subsequent respiratory disease when between 2 and 5 years of age.

Main finding: The rate of chronic respiratory disorder from 2-5 years of age, reactive airway disease, and CAP hospitalization after 2 years of age was 2.4-fold (95% CI 2.1-2.6), 3.2-fold (95% CI 2.6-3.8), and 6.3-fold (95% CI 3.6-10.9) higher in patients with CAP vs. comparison patients.

Study details: The data come from a retrospective study including 1,343 infants less than 2 years of age who were hospitalized once or more for CAP and matched with 6,715 comparator infants with no evidence of pneumonia.

Disclosures: The study was sponsored by Pfizer Inc. Some of the authors declared being directly employed by Pfizer or another organization that received financial support from Pfizer.

Source: Lapidot R et al. Repir Med. 2021:106671 (Oct 27). Doi: 10.1016/j.rmed.2021.106671.