Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

jremaly@mdedge.com

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

jremaly@mdedge.com

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Most children who develop alopecia areata before age 4 years have mild disease with less than 50% hair loss, and present between ages 2 and 4, according to a retrospective chart review of 125 children.

Almost 90% of the children presented between aged 2 and 4 years, compared with 11.9% between ages 1 and 2 years, and 1.6% aged under 1 year, “in keeping with the existing literature,” the study authors reported in Pediatric Dermatology. “A high percentage of patients continued to have mild, patchy alopecia at their follow‐up visits,” they added.

Epidemiologic studies of children with alopecia areata are few and have not focused on the youngest patients, said Sneha Rangu, of the section of dermatology at Children’s Hospital of Philadelphia, and coauthors. They performed a retrospective chart review of 125 patients, who initially presented at the hospital with alopecia areata between Jan. 1, 2016, and June 1, 2018, when they were younger than 4 years. Patients who received systemic therapy or topical JAK inhibitors for alopecia were excluded. Severity was measured with the Severity of Alopecia Tool (SALT) score, to monitor progression of hair loss, analyzing scores at the initial presentation, at 3-6 months, at 1 year, and at 2 or more years.

Almost 70% were female, which the authors said was similar to other studies that have found alopecia areata is more prevalent in females; and 86.6% were between ages 2 and 4 years when they first presented. The initial diagnosis was alopecia areata in 72.0%, alopecia totalis in 8.8%, and alopecia universalis in 19.2%. Of the 41 boys, 39% had alopecia totalis or alopecia universalis, as did 22% of the girls, which suggested that boys presenting under aged 4 years were more likely to have more severe disease, or that “guardians of boys are more likely to present for therapy when disease is more severe,” the authors wrote.

About 40% of the children presented with a history of atopic dermatitis, and 4% had an autoimmune disease (vitiligo, celiac disease, or type 1 diabetes). Twenty-eight percent of patients had a family history of alopecia areata, 27.2% had a family history of other autoimmune diseases, and 32% had a family history of hypothyroidism.

At the first visit, 57.6% had patch‐stage alopecia and SALT scores in the mild range (0%‐24% hair loss), which was present in a high proportion of these patients at follow-up: 49.4% at 3-6 months, 39.5% at 1 year, and 42.9% at two or more years.

At the first visit, 28% had high SALT scores (50%-100% hair loss), increasing to 36% at 3-6 months, 41.8% at 1 year, and 46.4% at 2 or more years. They calculated that for those with more than 50% hair loss at the initial presentation, the likelihood of being in a high category of hair loss, as measured by increasing SALT scores, was significantly higher at 1 year (odds ratio, 1.85, P =.033) and at 2 or more years (OR, 2.29, P = .038).

“While there is a likelihood of increasing disease severity, those with higher severity at initial presentation are likely to stay severe after one or 2 years,” the authors noted.

They concluded that their results add to the understanding of the epidemiology of alopecia areata in children “and perhaps can provide clinicians and families with a better sense of prognosis for progression in the youngest patients presenting with alopecia areata.”

They said the retrospective design and small sample size were among the study’s limitations. They had no conflicts of interest to disclose.

jremaly@mdedge.com

SOURCE: Rangu S et al. Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Adults with moderate to severe regurgitation showed significant improvement after magnetic sphincter augmentation, compared with increased proton pump inhibitor therapy, based on data from 152 patients.

Proton pump inhibitors (PPIs) are often prescribed for patients with refractory gastroesophageal reflux disease (GERD), but these medications do not address the weakness in the lower esophageal sphincter that often contributes to refractory regurgitative GERD, wrote Reginald Bell, MD, of the Institute of Esophageal and Reflux Surgery in Englewood, Colo., and colleagues.

Magnetic sphincter augmentation (MSA) is “an alternative to fundoplication that uses magnetic attraction from inside a series of titanium beads to augment the weak [lower esophageal sphincter] and reestablish the body’s natural barrier to reflux,” the researchers wrote.

In the CALIBER study, published in Clinical Gastroenterology and Hepatology, the researchers randomized 102 patients to twice-daily PPI (20 mg omeprazole) and 50 patients to laparoscopic MSA. Treatment was assessed at 6 months, and patients in the PPI group with persistent regurgitation were invited to cross into the MSA group, with 25 patients doing so. The patients were spread across 20 sites and treated between July 2015 and February 2017. Outcomes including regurgitation, foregut scores, esophageal acid exposure, and adverse events were assessed after 1 year.

MSA controlled regurgitation in 72 of 75 patients (96%) at 1 year, while 8 of 43 PPI patients (19%) reported control of regurgitation. In addition, 81% of the MSA patients reported improvement in GERD health-related quality of life, and 91% discontinued daily use of PPIs. Significant numbers of patients in the MSA group reported decreased dysphagia, bloating, and esophageal acid exposure, and 70% had normal pH levels at the end of the study.

No serious perioperative adverse events occurred in either group during the study period; 19 original MSA patients and 10 MSA crossover patients reported dysphagia, but they reported less at 6 months and 12 months, compared with baseline.

The study findings were limited by several factors, including the relatively short follow-up period and the different methods of pH testing at 6 months (transnasal impedance) and at 12 months (telemetry capsule), the researchers noted. However, the results support MSA as an effective option for patients with medically refractory regurgitative GERD that was superior to PPI for controlling regurgitation.

“Regurgitation and associated heartburn symptoms responded to MSA even when completely nonresponsive to PPI therapy, in line with the mechanical, volume origin of regurgitative symptoms,” they concluded.

Dr. Bell and several coauthors disclosed honoraria from Ethicon for teaching services. The study was supported in part by Ethicon.

SOURCE: Bell R et al. Clin Gastroenterol Hepatol. 2019. doi: 10.1016/j.cgh.2019.08.056.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

tborden@mdedge.com

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

tborden@mdedge.com

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Elevated serum levels of circulating sex hormones were found to be associated with lower odds of asthma in women, possibly explaining in part the different prevalence of asthma in men and women, according to the findings of a large cross-sectional population based study.

Yueh-Ying Han, PhD, of the Children’s Hospital of Pittsburgh and colleagues investigated the role of free testosterone and estradiol levels and current asthma among adults. The impact of obesity on that association was also examined. The investigators analyzed data from 7,615 adults (3,953 men and 3,662 women) who participated in the 2013-2014 and 2015-2016 U.S. National Health and Nutrition Examination Survey. The data included health interviews, examination components, and laboratory tests on each patient. Serum samples were analyzed by the division of laboratory sciences of the Centers for Disease Control and Prevention. Logistic regression was used for the multivariable analysis of sex hormone levels (as quartiles) and current asthma, and the analysis was done separately on men and women. Pregnant women were excluded, in addition to individuals with incomplete data. The exclusions tended to be Hispanic, former smokers, lower income, and lacking private insurance. The overall prevalence of current asthma in the sample was 9% (6% in men and 13% in women).

Three models were generated based on serum levels in women and in men.

For model 1 (unadjusted for estradiol), women whose serum testosterone levels were in the second and fourth quartiles had 30%-45% significantly lower odds of having current asthma than those whose serum testosterone level was in the lowest quartile. Among men, those whose serum testosterone levels were in the second and fourth quartiles had 12%-13% lower odds for current asthma.

For model 2 (unadjusted for free testosterone), women whose serum estradiol levels were in the third quartile had 34% significantly lower odds of having current asthma than those whose estradiol levels were in the lowest quartile. The findings were similar for men, that is, those whose serum estradiol levels were in the third quartile had 30% lower odds for having asthma, compared with those with in the lowest quartile.

For model 3 (a multivariable model including serum levels of both estradiol and free testosterone), women whose serum testosterone levels were in the second and fourth quartiles had 30% and 44% lower odds of current asthma than those whose serum testosterone levels were in the lowest quartile. But in this multivariable model, the association between serum estradiol and current asthma was not significant. Among men (models 1-3), the magnitude of the estimated effect of serum testosterone and serum estradiol on current asthma was similar to that observed in female participants, but neither serum testosterone nor serum estradiol was significantly associated with current asthma.

The investigators then analyzed the impact of obesity on the relationship between serum hormone levels and obesity. Obesity was defined as body mass index equal to or greater than 30 kg/m². A total of 1,370 men and 1,653 women were included in this analysis. In multivariable analyses of the obese participants, adjustment without (model 1) and with (model 3) serum estradiol, serum free-testosterone levels in the highest (fourth) quartile were significantly associated with reduced odds of asthma in obese women. In multivariable analyses without (model 2) and with (model 3), serum estradiol levels above the first quartile were significantly associated with reduced odds of current asthma in obese women.

In contrast to the results in obese women, neither serum free testosterone nor serum estradiol was significantly associated with current asthma in obese men or nonobese women.

Dr. Han and coauthors suggested a possible mechanism of the role of sex hormones in asthma. “Androgens such as testosterone may reduce innate and adaptive immune responses, while estrogen and progesterone may enhance T-helper cell type 2 allergic airway inflammation.”

They concluded: “We found that elevated serum levels of both free testosterone and estradiol were significantly associated with reduced odds of asthma in obese women, and that elevated levels of serum estradiol were significantly associated with reduced odds of asthma in nonobese men. Our findings further suggest that sex steroid hormones play a role in known sex differences in asthma among adults.”

One coauthor has received research materials from Merck and GlaxoSmithKline (inhaled steroids), as well as Pharmavite (vitamin D and placebo capsules), to provide medications free of cost to participants in National Institutes for Health–funded studies, unrelated to the current work. The other authors reported no conflicts of interest.

tborden@mdedge.com

SOURCE: Han Y-Y et al. J Respir Crit Care Med. 2019 Sep 16. doi: 10.1164/rccm.201905-0996OC.

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

Iron deficiency anemia (IDA) is a serious health problem that affects millions of women globally. Heavy menstrual bleeding (HMB) is one of the most common causes of IDA in women in North America.

In this supplement to OBG Management, the authors describe the signs, symptoms, and laboratory evaluation for HMB and IDA, including a comprehensive diagnostic and treatment algorithm for the practicing physician. The authors also discuss the characteristics of iron-repletion therapies currently available in the United States to help you make the best choice for your patient.

Click here to read the supplement

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

mlesney@mdedge.com

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

mlesney@mdedge.com

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

The use of a grass-based allergy immunotherapy (AIT) lowered the risk of progression from milder to more severe asthma, according to the results of a large, real-world, industry-sponsored, observational study.

Photo courtesy Oak Ridge National Laboratory

The researchers analyzed a cohort of 1,739,440 patients aged 12 years and older using 2005-2014 data from a statutory health insurance database in Germany. From this population, 39,167 individuals aged 14 years or older were classified as having incident asthma during the observation period and were included in the study.

The severity of asthma was classified according to the treatment steps recommended by the Global Initiative for Asthma (GINA).

Among these, 4,111 patients (10.5%) received AIT. AIT use was associated with a significantly decreased likelihood of asthma progression from GINA step 1 to step 3 (hazard ratio, 0.87; 95% confidence interval, 0.80‐0.95) and GINA step 3 to step 4 (HR, 0.66; 95% CI, 0.60‐0.74).

Medications for GINA step 2 (3.5%) and GINA step 5 (0.03%) were rarely prescribed, so the researchers could not analyze the transition between GINA steps 1 and 2, step 2 and 3, and step 4 and 5.

A total of 8,726 patients had at least one transition between GINA steps 1, 3, or 4, and 1,085 had two transitions, though not all 39,167 patients were under risk of severity progression into all GINA steps, according to the authors.

The findings are consistent with earlier studies that indicate grass-based immunotherapy can effectively treat asthma symptoms and potentially asthma progression (J Allergy Clin Immuno. 2012;129[3];717-25; J Allergy Clin Immunol. 2018;141[2]:529‐38).

“This study indicates that AIT may modify the course of asthma. Our study supports the assumption that treatment with AIT may prevent the progression from mild to more severe asthma,” the authors concluded.

The study was financially supported by ALK‐Abelló; several of the authors were also employees of or received funding from the company.

mlesney@mdedge.com

SOURCE: Schmitt J et al. Allergy. 2019. doi: 10.1111/all.14020.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

A new study has found that a group of four collagen metabolites are promising biomarkers for axial spondyloarthritis (axSpA) that could potentially distinguish patients without radiographic signs of disease and those with ankylosing spondylitis.

“This current study illustrates the potential of serological metabolites of tissue destruction as novel disease activity biomarkers in axSpA,” wrote Markéta Hušáková, PhD, of the Institute of Rheumatology and Department of Rheumatology at First Faculty of Medicine Charles University in Prague and coauthors. The study was published in Scientific Reports.

To determine if certain collagen metabolites could indicate axSpA disease activity and distinguish nonradiographic axial spondyloarthritis (nr-axSpA) from ankylosing spondylitis (AS), the researchers examined 193 recently diagnosed axSpA patients and 100 asymptomatic controls. Of the 193 patients, 121 had nr-axSpA and 72 had AS.

The researchers found that four collagen metabolites occurred at significantly higher serum levels in both subtypes of axSpA patients, compared with controls: for C1M, a mean of 43.4 ng/mL for AS and 34.6 ng/mL for nr-axSpA versus 24.5 ng/mL for controls; for C2M, 0.35 and 0.36 versus 0.26; for C3M, 15.4 and 12.8 versus 7.8; and for C4M2, 27.8 and 22.4 versus 15.2. Mean serum levels of C1M, C3M, and C4M2 were significantly higher in AS patients when compared with nr-axSpA patients. Of the four collagen metabolites, C3M was the best for differentiating between axSpA patients and asymptomatic controls (area under receiver operator characteristics curve, 0.95; specificity, 92.0; sensitivity, 83.4) and between nr-axSpA patients and controls (AUC, 0.93; specificity, 80.0; sensitivity, 92.6) and AS patients (AUC, 0.98; specificity, 92.0; sensitivity, 91.7).

The authors acknowledged their study’s limitations, including the inability to investigate changes in biomarker levels and disease activity over time. In addition, there was a lack of clinical information about cardiovascular or other systemic complications, as well as no clinical or radiographic examination of the asymptomatic individuals, which could have revealed factors influencing their metabolite levels.

Two of the authors acknowledged being employees of fibrosis biomarker developer Nordic Bioscience; another researcher acknowledged being a stockholder. No additional conflicts of interest were reported.

SOURCE: Hušáková M et al. Sci Rep. 2019 Aug 2. doi: 10.1038/s41598-019-47502-z.

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

sworcester@mdedge.com

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

sworcester@mdedge.com

EDINBURGH – Consolidation therapy with obinutuzumab after chemoimmunotherapy for B-cell chronic lymphocytic leukemia (B-CLL) was highly effective for eradicating minimal residual disease (MRD) within 6 months following randomization in the seamless phase 2/3 GALACTIC trial.

Of 14 patients who were MRD positive after chemoimmunotherapy and randomized to consolidation with the type II monoclonal antibody targeting the CD20 antigen, 10 achieved MRD negativity in the bone marrow by 6 months, and 13 achieved MRD negativity in the peripheral blood by 6 months, Talha Munir, MD, reported at the International Workshop on Chronic Lymphocytic Leukemia.

“And that translated into [progression-free survival] improvement in the consolidation arm,” said Dr. Munir of St. James’s University, Leeds, England.

The median progression-free survival in that arm was not reached, whereas progression-free survival in 15 MRD-positive patients randomized to the nonconsolidation arm was 16.6 months, he said.

Further, no difference was seen in median progression-free survival, overall survival, or MRD duration between the consolidation arm and 19 patients who were not randomized because of MRD negativity after chemoimmunotherapy, he noted.

Achieving MRD negativity in CLL confers a survival advantage, and obinutuzumab has shown greater efficacy with respect to MRD in CLL when compared with previous anti-CD20 antibodies, and it is less immune suppressive than the anti-CD52 antibody alemtuzumab, he explained.

The GALACTIC trial was designed to assess the safety and efficacy of obinutuzumab consolidation for eradicating MRD and whether its effects would prolong progression-free survival in patients with B-CLL who recently responded to chemoimmunotherapy. Those achieving complete response or partial response at 3-24 months after chemoimmunotherapy, and who remained MRD-positive, were eligible for randomization.

The planned sample size was 188 patients, but the trial was closed early in February 2017 because of poor recruitment; a total of 48 patients were enrolled, including the 19 nonrandomized, MRD-negative patients.

Patients randomized to consolidation received 1,000 mg of obinutuzumab weekly for the first four doses, and then every other week for four additional doses.

Obinutuzumab was well tolerated with minimal infusion-related reactions and toxicity, Dr. Munir said.

Despite the low recruitment, both the phase 2 and 3 endpoints were assessed as positive, because the consolidation strategy was so efficacious, Dr. Munir noted, concluding that the findings provide further evidence of the value of MRD negativity for improving outcomes in CLL.

The GALACTIC trial was developed by the GALACTIC Trial Management Group with the support of the UKCLL/NCRI CLL Clinical Trials Subgroup. The trial is funded by Cancer Research UK and Roche and sponsored by the University of Leeds. Dr. Munir reported having no disclosures.

sworcester@mdedge.com

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

MINNEAPOLIS -- When William “Bill” Wachsman, MD, PhD, joined the executive board of the Association of VA Hematology/Oncology earlier this decade, the organization revolved around its annual meeting. Now, AVAHO is expanding its horizons, and Dr. Wachsman plans to push for a wider focus and greater impact as its new president.

“We’re a group of like-minded individuals who came together about 15 years ago and said we want to take better care of our patients, coordinate our services, and better educate ourselves,” said Dr. Wachsman, a hematologist/oncologist with US Department of Veterans Affairs (VA) San Diego Health Care System, University of California San Diego School of Medicine, and Moores Cancer Center. “We’re still dedicated to this mission. Moving forward, I want to improve educational opportunities, encourage our interest groups to develop initiatives, and utilize our foundation to support medical professionals and improve patient care within the VA.”

Dr. Wachsman took over as AVAHO’s president on the last day of the organization’s annual meeting in Minneapolis. He replaces immediate past president Mark Klein, MD, and will serve for 1 year.

According to Dr. Wachsman, AVAHO is unique among cancer/hematology associations because it’s not limited to physicians. “Everyone who’s involved with the care of patients with hematologic or oncologic disease can be involved. You don’t need to be an employee of the VA.”

Indeed, AVAHO’s approximately 800 members include medical oncologists and hematologists, surgical oncologists, radiation oncologists, pharmacists, nurses, nurse practitioners, advanced practice registered nurses, physician assistants, social workers, cancer registrars, and other allied health professionals.

AVAHO is also unique because it’s not a VA organization. “It’s an association of people are interested in better care for patients at the VA,” Dr. Wachsman said.

Over the next year, Dr. Wachsman hopes to form a community advisory board “that can not only give us advice, but reach out to other associations in the VA and in oncology to spread the word about what we’re doing.” Other forms of outreach can help AVAHO gain influence among policymakers, he said.

As for AVAHO’s foundation, he hopes to bring in funding through grants to support fellowship awards and to help VA sites around the nation develop infrastructure to support clinical trials.

On another national level, he said, AVAHO can improve its relationship with the VA with a goal of promoting honest and productive communication that goes both ways. “You have to get to know each other,” he said, “before you jump into the same pool and begin to swim.”

Here are 5 articles from the October issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Bronchiolitis is a feared complication of connective tissue disease

To take the posttest, go to: https://bit.ly/2klWpRb
Expires April 8, 2020

2. Stress incontinence surgery improves sexual dysfunction

To take the posttest, go to: https://bit.ly/2m0wb71
Expires April 10, 2020

3. Survey finds psoriasis patients seek relief with alternative therapies

To take the posttest, go to: https://bit.ly/2lZZDtO
Expires April 10, 2020

4. New data further suggest that stress does a number on the CV system

To take the posttest, go to: https://bit.ly/2lR31ax
Expires April 11, 2020

5. Rate of objects ingested by young children increased over last two decades

To take the posttest, go to: https://bit.ly/2mmYptb
Expires April 12, 2020

Here are 5 articles from the October issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Bronchiolitis is a feared complication of connective tissue disease

To take the posttest, go to: https://bit.ly/2klWpRb
Expires April 8, 2020

2. Stress incontinence surgery improves sexual dysfunction

To take the posttest, go to: https://bit.ly/2m0wb71
Expires April 10, 2020

3. Survey finds psoriasis patients seek relief with alternative therapies

To take the posttest, go to: https://bit.ly/2lZZDtO
Expires April 10, 2020

4. New data further suggest that stress does a number on the CV system

To take the posttest, go to: https://bit.ly/2lR31ax
Expires April 11, 2020

5. Rate of objects ingested by young children increased over last two decades

To take the posttest, go to: https://bit.ly/2mmYptb
Expires April 12, 2020

Here are 5 articles from the October issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Bronchiolitis is a feared complication of connective tissue disease

To take the posttest, go to: https://bit.ly/2klWpRb
Expires April 8, 2020

2. Stress incontinence surgery improves sexual dysfunction

To take the posttest, go to: https://bit.ly/2m0wb71
Expires April 10, 2020

3. Survey finds psoriasis patients seek relief with alternative therapies

To take the posttest, go to: https://bit.ly/2lZZDtO
Expires April 10, 2020

4. New data further suggest that stress does a number on the CV system

To take the posttest, go to: https://bit.ly/2lR31ax
Expires April 11, 2020

5. Rate of objects ingested by young children increased over last two decades

To take the posttest, go to: https://bit.ly/2mmYptb
Expires April 12, 2020