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Risk factors for mortality in patients with RA-associated interstitial lung disease
Key clinical point: Patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) were at an increased risk for mortality, with age, chronic obstructive pulmonary disease (COPD), diabetes mellitus with end-organ damage (DM-EOD), and corticosteroid dose being the major risk factors.
Major finding: Risk for mortality was higher in patients with RA-ILD vs RA without ILD (adjusted hazard ratio [aHR] 4.38; 95% CI 2.03-9.43). Age at ILD diagnosis (aHR 1.05; P < .001), comorbidities, such as COPD (aHR 2.12; P = .005) and DM-EOD (aHR 33.85; P = .002), and average daily prednisolone dose (aHR 1.09; P < .001) were associated with an increased risk for mortality in patients with RA-ILD.
Study details: Findings are from a population-based cohort study including patients with RA-ILD (n = 214) and RA without ILD (n = 30,882) who were propensity-matched (1:1) for selected comorbidities.
Disclosures: This study did not receive any funding. No conflicts of interest were declared.
Source: Ng K-H et al. Analysis of risk factors of mortality in rheumatoid arthritis patients with interstitial lung disease: A nationwide, population-based cohort study in Taiwan. RMD Open. 2022;8(2):e002343 (Aug 22). Doi: 10.1136/rmdopen-2022-002343
Key clinical point: Patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) were at an increased risk for mortality, with age, chronic obstructive pulmonary disease (COPD), diabetes mellitus with end-organ damage (DM-EOD), and corticosteroid dose being the major risk factors.
Major finding: Risk for mortality was higher in patients with RA-ILD vs RA without ILD (adjusted hazard ratio [aHR] 4.38; 95% CI 2.03-9.43). Age at ILD diagnosis (aHR 1.05; P < .001), comorbidities, such as COPD (aHR 2.12; P = .005) and DM-EOD (aHR 33.85; P = .002), and average daily prednisolone dose (aHR 1.09; P < .001) were associated with an increased risk for mortality in patients with RA-ILD.
Study details: Findings are from a population-based cohort study including patients with RA-ILD (n = 214) and RA without ILD (n = 30,882) who were propensity-matched (1:1) for selected comorbidities.
Disclosures: This study did not receive any funding. No conflicts of interest were declared.
Source: Ng K-H et al. Analysis of risk factors of mortality in rheumatoid arthritis patients with interstitial lung disease: A nationwide, population-based cohort study in Taiwan. RMD Open. 2022;8(2):e002343 (Aug 22). Doi: 10.1136/rmdopen-2022-002343
Key clinical point: Patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) were at an increased risk for mortality, with age, chronic obstructive pulmonary disease (COPD), diabetes mellitus with end-organ damage (DM-EOD), and corticosteroid dose being the major risk factors.
Major finding: Risk for mortality was higher in patients with RA-ILD vs RA without ILD (adjusted hazard ratio [aHR] 4.38; 95% CI 2.03-9.43). Age at ILD diagnosis (aHR 1.05; P < .001), comorbidities, such as COPD (aHR 2.12; P = .005) and DM-EOD (aHR 33.85; P = .002), and average daily prednisolone dose (aHR 1.09; P < .001) were associated with an increased risk for mortality in patients with RA-ILD.
Study details: Findings are from a population-based cohort study including patients with RA-ILD (n = 214) and RA without ILD (n = 30,882) who were propensity-matched (1:1) for selected comorbidities.
Disclosures: This study did not receive any funding. No conflicts of interest were declared.
Source: Ng K-H et al. Analysis of risk factors of mortality in rheumatoid arthritis patients with interstitial lung disease: A nationwide, population-based cohort study in Taiwan. RMD Open. 2022;8(2):e002343 (Aug 22). Doi: 10.1136/rmdopen-2022-002343
Effect of rituximab dose on seroconversion after a third COVID-19 vaccine
Key clinical point: Ultra-low dosing and repeated COVID-19 vaccination as late as possible after the latest rituximab infusion seems to be the best vaccination strategy in rituximab-treated patients with rheumatoid arthritis (RA).
Major finding: Humoral response after the third COVID-19 vaccination was numerically higher with 200 vs 1000 mg as the latest rituximab dose for the first vaccination (38% vs 15%; P = .06), with a trend toward improved response observed with a longer time between rituximab infusion and vaccination (odds ratio 1.16 per month increased time; P = .10). Overall, the humoral response persisted in 96% of patients, with response being persistent in 89% of patients despite intercurrent rituximab infusion.
Study details: Findings are from a follow-up study of the RTX-COVAC cohort including 121 rituximab-treated patients with RA who received a third COVID-19 vaccination.
Disclosures: This study did not receive any funding. AA den Broeder reported receiving grants outside the submitted work from various sources. The other authors declared no conflicts of interest.
Source: van der Togt CJT et al. Seroconversion after a third COVID-19 vaccine is affected by rituximab dose but persistence is not in patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Aug 24). Doi: 10.1093/rheumatology/keac486
Key clinical point: Ultra-low dosing and repeated COVID-19 vaccination as late as possible after the latest rituximab infusion seems to be the best vaccination strategy in rituximab-treated patients with rheumatoid arthritis (RA).
Major finding: Humoral response after the third COVID-19 vaccination was numerically higher with 200 vs 1000 mg as the latest rituximab dose for the first vaccination (38% vs 15%; P = .06), with a trend toward improved response observed with a longer time between rituximab infusion and vaccination (odds ratio 1.16 per month increased time; P = .10). Overall, the humoral response persisted in 96% of patients, with response being persistent in 89% of patients despite intercurrent rituximab infusion.
Study details: Findings are from a follow-up study of the RTX-COVAC cohort including 121 rituximab-treated patients with RA who received a third COVID-19 vaccination.
Disclosures: This study did not receive any funding. AA den Broeder reported receiving grants outside the submitted work from various sources. The other authors declared no conflicts of interest.
Source: van der Togt CJT et al. Seroconversion after a third COVID-19 vaccine is affected by rituximab dose but persistence is not in patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Aug 24). Doi: 10.1093/rheumatology/keac486
Key clinical point: Ultra-low dosing and repeated COVID-19 vaccination as late as possible after the latest rituximab infusion seems to be the best vaccination strategy in rituximab-treated patients with rheumatoid arthritis (RA).
Major finding: Humoral response after the third COVID-19 vaccination was numerically higher with 200 vs 1000 mg as the latest rituximab dose for the first vaccination (38% vs 15%; P = .06), with a trend toward improved response observed with a longer time between rituximab infusion and vaccination (odds ratio 1.16 per month increased time; P = .10). Overall, the humoral response persisted in 96% of patients, with response being persistent in 89% of patients despite intercurrent rituximab infusion.
Study details: Findings are from a follow-up study of the RTX-COVAC cohort including 121 rituximab-treated patients with RA who received a third COVID-19 vaccination.
Disclosures: This study did not receive any funding. AA den Broeder reported receiving grants outside the submitted work from various sources. The other authors declared no conflicts of interest.
Source: van der Togt CJT et al. Seroconversion after a third COVID-19 vaccine is affected by rituximab dose but persistence is not in patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Aug 24). Doi: 10.1093/rheumatology/keac486
Detachment predicts worse posttraumatic outcomes
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
The results highlight the importance of screening for dissociation in patients who have experienced trauma, study investigator Lauren A.M. Lebois, PhD, director of the dissociative disorders and trauma research program at McLean Hospital in Belmont, Mass., told this news organization.
“Clinicians could identify individuals potentially at risk of a chronic, more severe psychiatric course before these people go down that road, and they have the opportunity to connect folks with a phased trauma treatment approach to speed their recovery,” said Dr. Lebois, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.
The study was published in the American Journal of Psychiatry.
Underdiagnosed
Feelings of detachment or derealization are a type of dissociation. Patients with the syndrome report feeling foggy or as if they are in a dream. Dissociative diagnoses are not rare and, in fact, are more prevalent than schizophrenia.
Research supports a powerful relationship between dissociation and traumatic experiences. However, dissociation is among the most stigmatized of psychiatric conditions. Even among clinicians and researchers, beliefs about dissociation are often not based on the scientific literature, said Dr. Lebois.
“For instance, skepticism, misunderstanding, and lack of professional education about dissociation all contribute to striking rates of underdiagnosis and misdiagnoses,” she said.
Dr. Lebois and colleagues used data from the larger Advancing Understanding of Recovery After Trauma (AURORA) study and included 1,464 adults, mean age 35 years, appearing at 22 U.S. emergency departments. Patients experienced a traumatic event such as a motor vehicle crash or physical or sexual assault.
About 2 weeks after the trauma, participants reported symptoms of derealization as measured by a two-item version of the Brief Dissociative Experiences Scale.
Brain imaging data
A subset of 145 patients underwent functional MRI (fMRI), during which they completed an emotion reactivity task (viewing fearful-looking human faces) and a resting-state scan.
In addition to measuring history of childhood maltreatment, researchers assessed posttraumatic stress symptom severity at 2 weeks and again at 3 months using the posttraumatic stress disorder checklist. Also at 3 months, they measured depression and anxiety symptoms, pain, and functional impairment.
About 55% of self-report participants and 50% of MRI participants endorsed some level of persistent derealization at 2 weeks.
After controlling for potential confounders, including sex, age, childhood maltreatment, and current posttraumatic stress symptoms, researchers found persistent derealization was associated with increased ventromedial prefrontal cortex (vmPFC) activity while viewing fearful faces.
The vmPFC helps to regulate emotional and physical reactions. “This region puts the ‘brakes’ on your emotional and physical reactivity – helping you to calm down” after a threatening or stressful experience has passed, said Dr. Lebois.
Researchers also found an association between higher self-reported derealization and decreased resting-state connectivity between the vmPFC and the orbitofrontal cortex and right lobule VIIIa – a region of the cerebellum involved in sensorimotor function.
“This may contribute to perceptual and affective distortions experienced during derealization – for example, feelings that surroundings are fading away, unreal, or strange,” said Dr. Lebois.
More pain, depression, anxiety
Higher levels of self-reported derealization at 2 weeks post trauma predicted higher levels of PTSD, anxiety, and depression as well as more bodily pain and impairment in work, family, and social life at 3 months.
“When we accounted for baseline levels of posttraumatic stress symptoms and trauma history, higher levels of self-reported derealization still predicted higher posttraumatic stress disorder and depression symptoms at 3 months,” said Dr. Lebois.
Additional adjusted analyses showed increased vmPFC activity during the fearful face task predicted 3-month self-reported PTSD symptoms.
Dr. Lebois “highly recommends” clinicians screen for dissociative symptoms, including derealization, in patients with trauma. Self-report screening tools are freely available online.
She noted patients with significant dissociative symptoms often do better with a “phase-oriented” approach to trauma treatment.
“In phase one, they learn emotional regulation skills to help them take more control over when they dissociate. Then they can successfully move on to trauma processing in phase two, which can involve exposure to trauma details.”
Although the field is not yet ready to use brain scans to diagnose dissociative symptoms, the new results “take us one step closer to being able to use objective neuroimaging biomarkers of derealization to augment subjective self-report measures,” said Dr. Lebois.
A limitation of the study was it could not determine a causal relationship, as some derealization may have been present before the traumatic event. The findings may not generalize to other types of dissociation, and the derealization assessment was measured only through a self-report 2 weeks after the trauma.
Another limitation was exclusion of patients with self-inflicted injuries or who were involved in domestic violence. The researchers noted the prevalence of derealization might have been even higher if such individuals were included.
An important investigation
In an accompanying editorial, Lisa M. Shin, PhD, department of psychology, Tufts University, and department of psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, notes having both clinical and neuroimaging variables as well as a large sample size makes the study “an important investigation” into predictors of psychiatric symptoms post-trauma.
Investigating a specific subtype of dissociation – persistent derealization – adds to the “novelty” of the study, she said.
The new findings “are certainly exciting for their potential clinical relevance and contributions to neurocircuitry models of PTSD,” she writes.
Some may argue administering a short, self-report measure of derealization “is far more efficient, cost-effective, and inclusive than conducting a specialized and expensive fMRI scan that is unlikely to be available to everyone,” notes Dr. Shin.
However, she added, a potential benefit of such a scan is identification of specific brain regions as potential targets for intervention. “For example, the results of this and other studies suggest that the vmPFC is a reasonable target for transcranial magnetic stimulation or its variants.”
The new results need to be replicated in a large, independent sample, said Dr. Shin. She added it would be helpful to know if other types of dissociation, and activation in other subregions of the vmPFC, also predict psychiatric outcomes after a trauma.
The study was supported by National Institute of Mental Health grants, the U.S. Army Medical Research and Material Command, One Mind, and the Mayday Fund. Dr. Lebois has received grant support from NIMH, and her spouse receives payments from Vanderbilt University for technology licensed to Acadia Pharmaceuticals. Dr. Shin receives textbook-related royalties from Pearson.
A version of this article first appeared on Medscape.com.
FROM AMERICAN JOURNAL OF PSYCHIATRY
Early RA: Sex difference in remission rates may be specific to interleukin-6 blockade
Key clinical point: Despite no significant treatment difference between the sexes, the time-averaged difference in remission rates between men and women with early rheumatoid arthritis (RA) was significantly greater with tocilizumab than with active conventional treatment.
Major finding: The remission rates were only numerically higher in men vs women. However, when averaged over time, tocilizumab vs active conventional therapy was associated with a higher probability of Clinical Disease Activity Index (CDAI) remission in men (risk difference [RD] 0.12; P = .04) but with a lower probability of CDAI remission in women (RD −0.05; P = .17).
Study details: This was a post hoc analysis of the phase 4 trial, NORD-STAR, including 812 treatment-naive patients with early RA who were randomly assigned to receive active conventional treatment or certolizumab-pegol or abatacept or tocilizumab in combination with methotrexate.
Disclosures: This study did not receive any funding. Several authors reported receiving institutional grants, honoraria, consulting or personal fees, travel support, or personal data safety monitoring or advisory board fees from various sources.
Source: Lend K et al. Sex differences in remission rates over 24 weeks among three different biological treatments compared to conventional therapy in patients with early rheumatoid arthritis (NORD-STAR): A post-hoc analysis of a randomised controlled trial. Lancet Rheumatol. 2022 (Aug 23). Doi: 10.1016/S2665-9913(22)00186-2
Key clinical point: Despite no significant treatment difference between the sexes, the time-averaged difference in remission rates between men and women with early rheumatoid arthritis (RA) was significantly greater with tocilizumab than with active conventional treatment.
Major finding: The remission rates were only numerically higher in men vs women. However, when averaged over time, tocilizumab vs active conventional therapy was associated with a higher probability of Clinical Disease Activity Index (CDAI) remission in men (risk difference [RD] 0.12; P = .04) but with a lower probability of CDAI remission in women (RD −0.05; P = .17).
Study details: This was a post hoc analysis of the phase 4 trial, NORD-STAR, including 812 treatment-naive patients with early RA who were randomly assigned to receive active conventional treatment or certolizumab-pegol or abatacept or tocilizumab in combination with methotrexate.
Disclosures: This study did not receive any funding. Several authors reported receiving institutional grants, honoraria, consulting or personal fees, travel support, or personal data safety monitoring or advisory board fees from various sources.
Source: Lend K et al. Sex differences in remission rates over 24 weeks among three different biological treatments compared to conventional therapy in patients with early rheumatoid arthritis (NORD-STAR): A post-hoc analysis of a randomised controlled trial. Lancet Rheumatol. 2022 (Aug 23). Doi: 10.1016/S2665-9913(22)00186-2
Key clinical point: Despite no significant treatment difference between the sexes, the time-averaged difference in remission rates between men and women with early rheumatoid arthritis (RA) was significantly greater with tocilizumab than with active conventional treatment.
Major finding: The remission rates were only numerically higher in men vs women. However, when averaged over time, tocilizumab vs active conventional therapy was associated with a higher probability of Clinical Disease Activity Index (CDAI) remission in men (risk difference [RD] 0.12; P = .04) but with a lower probability of CDAI remission in women (RD −0.05; P = .17).
Study details: This was a post hoc analysis of the phase 4 trial, NORD-STAR, including 812 treatment-naive patients with early RA who were randomly assigned to receive active conventional treatment or certolizumab-pegol or abatacept or tocilizumab in combination with methotrexate.
Disclosures: This study did not receive any funding. Several authors reported receiving institutional grants, honoraria, consulting or personal fees, travel support, or personal data safety monitoring or advisory board fees from various sources.
Source: Lend K et al. Sex differences in remission rates over 24 weeks among three different biological treatments compared to conventional therapy in patients with early rheumatoid arthritis (NORD-STAR): A post-hoc analysis of a randomised controlled trial. Lancet Rheumatol. 2022 (Aug 23). Doi: 10.1016/S2665-9913(22)00186-2
Olokizumab noninferior to adalimumab in phase 3 trial
Key clinical point: In patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (methotrexate-IR), olokizumab fared better than placebo and was noninferior to adalimumab in improving the American College of Rheumatology (ACR20) response by ≥ 20%.
Major finding: Olokizumab once every 2 (q2w) or 4 weeks (q4w) was superior to placebo (P < .001 for superiority) for ACR20. However, a similar proportion of patients receiving olokizumab q2w (difference 3.4 percentage points; 97.5% CI −3.5 to 10.2) and q4w (difference 4.5 percentage points; 97.5% CI −2.2 to 11.2) vs adalimumab achieved ACR20 at week 12, with the incidence of serious adverse events being similar.
Study details: Findings are from the CREDO2 phase 3 trial, including 1648 patients with RA who were taking methotrexate-IR who were randomly assigned to receive 64 mg olokizumab (q2w/q4w), 40 mg adalimumab (q2w), or placebo (q2w) while continuing methotrexate.
Disclosures: This study was supported by R-Pharm. Three authors declared being employees of R-Pharm. Several authors served as consultants or received grants or contracts from various sources, including R-Pharm.
Source: Smolen JS et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2022;387(8):715-726 (Aug 25). Doi: 10.1056/NEJMoa2201302
Key clinical point: In patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (methotrexate-IR), olokizumab fared better than placebo and was noninferior to adalimumab in improving the American College of Rheumatology (ACR20) response by ≥ 20%.
Major finding: Olokizumab once every 2 (q2w) or 4 weeks (q4w) was superior to placebo (P < .001 for superiority) for ACR20. However, a similar proportion of patients receiving olokizumab q2w (difference 3.4 percentage points; 97.5% CI −3.5 to 10.2) and q4w (difference 4.5 percentage points; 97.5% CI −2.2 to 11.2) vs adalimumab achieved ACR20 at week 12, with the incidence of serious adverse events being similar.
Study details: Findings are from the CREDO2 phase 3 trial, including 1648 patients with RA who were taking methotrexate-IR who were randomly assigned to receive 64 mg olokizumab (q2w/q4w), 40 mg adalimumab (q2w), or placebo (q2w) while continuing methotrexate.
Disclosures: This study was supported by R-Pharm. Three authors declared being employees of R-Pharm. Several authors served as consultants or received grants or contracts from various sources, including R-Pharm.
Source: Smolen JS et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2022;387(8):715-726 (Aug 25). Doi: 10.1056/NEJMoa2201302
Key clinical point: In patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (methotrexate-IR), olokizumab fared better than placebo and was noninferior to adalimumab in improving the American College of Rheumatology (ACR20) response by ≥ 20%.
Major finding: Olokizumab once every 2 (q2w) or 4 weeks (q4w) was superior to placebo (P < .001 for superiority) for ACR20. However, a similar proportion of patients receiving olokizumab q2w (difference 3.4 percentage points; 97.5% CI −3.5 to 10.2) and q4w (difference 4.5 percentage points; 97.5% CI −2.2 to 11.2) vs adalimumab achieved ACR20 at week 12, with the incidence of serious adverse events being similar.
Study details: Findings are from the CREDO2 phase 3 trial, including 1648 patients with RA who were taking methotrexate-IR who were randomly assigned to receive 64 mg olokizumab (q2w/q4w), 40 mg adalimumab (q2w), or placebo (q2w) while continuing methotrexate.
Disclosures: This study was supported by R-Pharm. Three authors declared being employees of R-Pharm. Several authors served as consultants or received grants or contracts from various sources, including R-Pharm.
Source: Smolen JS et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2022;387(8):715-726 (Aug 25). Doi: 10.1056/NEJMoa2201302
Medical coding creates barriers to care for transgender patients
In 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.
Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.
Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.
Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.
“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.
She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.
The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.
A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.
However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.
Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.
Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”
However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.
Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”
Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.
Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.
“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.
For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.
In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.
Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.
When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.
“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”
Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.
One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.
Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.
Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.
“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.
Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.
Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.
Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.
“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.
She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.
The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.
A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.
However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.
Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.
Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”
However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.
Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”
Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.
Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.
“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.
For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.
In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.
Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.
When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.
“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”
Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.
One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.
Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.
Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.
“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.
Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.
Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.
Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.
“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.
She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.
The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.
A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.
However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.
Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.
Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”
However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.
Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”
Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.
Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.
“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.
For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.
In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.
Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.
When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.
“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”
Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.
One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.
Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.
Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.
“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
PsA: Sustained improvement in dactylitis with tofacitinib
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
PsA: Sustained improvement in dactylitis with tofacitinib
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Key clinical point: Tofacitinib improved dactylitis irrespective of the location and prevented its emergence in the majority of patients with psoriatic arthritis (PsA).
Major finding: In patients with Dactylitis Severity Scores (DSS) > 0, 10 mg tofacitinib twice daily vs placebo led to greater improvements in DSS for feet and other locations at month 1. By month 6, ≤15% of patients with DSS > 0 and <2% of patients with DSS = 0 reported the presence of dactylitis in all digits in the tofacitinib group.
Study details: Findings are from a post hoc analysis of two phase 3 trials including 710 patients with active PsA and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (OPAL Broaden) or tumor necrosis factor inhibitors (OPAL Beyond) and who received 5/10 mg tofacitinib twice daily or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Orbai AM et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: Post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68 (Sep 1). Doi: 10.1186/s41927-022-00298-4
Precision medicine based on peripheral T-lymphocyte phenotyping is effective in the real world
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
Key clinical point: Patients with psoriatic arthritis (PsA) who received strategic treatment with biological disease-modifying anti-rheumatic drugs (bDMARD) based on peripheral T-lymphocyte phenotyping achieved greater reduction in disease activity than patients who did not undergo phenotyping or bDMARD selection strategy.
Major finding: A significantly higher proportion of patients in the strategic vs standard bDMARD treatment group achieved disease activity of PsA-remission (90.2% vs 67.8%; P = .0132) and minimal disease activity (80.5% vs 60.7%; P = .0464) by month 6.
Study details: Findings are from a real-world, retrospective study that included 97 patients with PsA who received bDMARD for ≥1 year and compared 1-year treatment response between the strategic (n = 41) and standard (n = 56) bDMARD treatment groups.
Disclosures: This work was supported by Research on Rare and Intractable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labor, and Welfare of Japan, and other sources. The authors declared receiving grants, honoraria, speaking fees, or consulting fees from several sources.
Source: Miyagawa I et al. Precision medicine based on the phenotypic differences in peripheral T helper cells in patients with psoriatic arthritis: One year follow-up outcomes. Front Med (Lausanne). 2022;9:934937 (Jul 27). Doi: 10.3389/fmed.2022.934937
PEST and BMI predict development of PsA in psoriasis patients
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060
Key clinical point: Tools like Psoriasis Epidemiology Screening Tool (PEST) and body mass index (BMI) can predict the 2-year risk of developing psoriatic arthritis (PsA) in patients with psoriasis (PsO).
Major finding: Approximately 10% of patients with PsO developed PsA after 2 years. PEST, BMI, modified Rheumatic Disease Comorbidity Index, work status, alcohol use, and fatigue (area under the curve [AUC] 68.9%; sensitivity 82.9%; specificity 48.8%) were most efficient in predicting PsA development; however, another model including only PEST and BMI produced similar results (AUC 68.8%; sensitivity 92.7%; specificity 36.5%).
Study details: The findings are from a prospective cohort study including 1489 patients with PsO and no prior diagnosis of PsA from the CorEvitas Psoriasis Registry who were followed-up for 24 months.
Disclosures: This study was sponsored by CorEvitas, LLC. Three authors declared being employees of CorEvitas, LLC, and the other authors reported ties with several sources, including CorEvitas.
Source: Ogdie A et al. Prospective cohort study of psoriatic arthritis risk in patients with psoriasis in a real-world psoriasis registry. J Am Acad Dermatol. 2022 (Aug 17). Doi: 10.1016/j.jaad.2022.07.060