AUSTIN – The incidence of pediatric invasive melanoma has decreased since 2002, but males are more likely to die from the disease, compared with females. The risk of death is also significantly increased in black patients, other nonwhite patients, and in cases where surgery was not performed.

Doug Brunk/MDedge News

Those are key findings from a study that set out to investigate the incidence of pediatric melanoma over the last 2 decades and factors influencing survival. At the annual meeting of the Society for Pediatric Dermatology, one of the study authors, Spandana Maddukuri, said that pediatric melanoma is the most common skin cancer in the pediatric population, accounting for 1-3% of all pediatric malignancies and 1%-4% of all cases of melanoma (Pediatr Surg. 2013;48[11]:2207-13).

“Nonmodifiable risk factors are similar to those in adult melanoma and include fair skin, light hair and eye color, increased number of congenital nevi, and family history of melanoma,” said Ms. Maddukuri, a third-year student at New Jersey Medical School, Newark. “Environmental risk factors are similar to those in adult melanoma and include exposure to UV radiation. About 60% of children do not meet standard ABCDE [asymmetrical, border, color, diameter, evolving] diagnosis criteria, which often leads to delayed diagnosis.”

Some of the characteristics that are more commonly found in pediatric lesions include amelanosis, bleeding, uniform color, and variable diameter (J Am Acad Dermatol. 2013; 68[6]:913-25).

Ms. Maddukuri and colleagues queried the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database for cases of malignant melanoma that were diagnosed in individuals aged younger than 20 years between 2002 and 2015. After excluding all cases of adult melanoma and all cases of in situ melanoma, they included 1,620 patients in the final analysis and divided them into five age groups: less than 1 year, 1-4 years, 5-9 years, 10-14 years, and 15-19 years. They calculated the overall incidence rate per 100,000 population of pediatric melanoma based on data from the 2000 U.S. Census. Age-, sex-, and race-specific incidence rates were also calculated. Kaplan-Meier and Cox regression analyses to investigate disease-specific survival and risk factors.

With each successive age group, the investigators observed that incidence rate was significantly higher than that of the previous age group (P less than .005). “However, the most striking increase in incidence occurs between the age group of 10-14 and 15-19,” she said. “Sex also influenced incidence rates. Males had an incidence rate of 0.396 per 100,000 population while females had an incidence rate of 0.579 per 100,000 population.”


Race also influenced incidence rates. White patients had the highest incidence rate of 0.605 per 100,000 population, while blacks had the lowest incident rate at 0.042 per 100,000 population. American Indian and Alaska Native patients had incidence rates of 0.046 per 100,000 population, while Asians and Pacific Islanders had an incidence rate of 0.127 per 100,000 population.

The researchers found that increased survival was associated with white race, female sex, treatment with surgical intervention, and age older than 5 years. No differences in survival were observed regarding the primary anatomic location or extent of disease. The hazard ratio of death from invasive melanoma was significantly increased in males (HR, 2.34), black patients (HR, 3.96), other nonwhite patients (HR, 3.64), and in cases where surgery was not performed (HR, 6.04).

“It is surprising that, although incidence is significantly higher in white patients and females, compared to black patients and males, respectively, the risk of dying from melanoma is much higher in black patients and males,” Ms. Maddukuri said in an interview at the meeting. “Overall, the dermatologic community is on the right track in screening and diagnosing pediatric melanoma, as seen by the decreased incidence over the last 2 decades. However, increased awareness regarding pediatric melanoma is still encouraged. I believe we were able to identify certain populations that need more attention in terms of screening, diagnosis, and treatment, which are patients less than 5 years old, black and other nonwhite patients, and males.”

She acknowledged certain shortcomings of the study, including a limited clinical history of the patient population because of the nature of the database. She also said that further studies are required to investigate the contributing factors to decreasing incidence and to evaluate the relationship of the favorable prognostic factors to increased survival. The researchers are currently working on correlating incidence rates with UV exposure and geographical location.

They reported having no financial disclosures.

[email protected]

AUSTIN – The incidence of pediatric invasive melanoma has decreased since 2002, but males are more likely to die from the disease, compared with females. The risk of death is also significantly increased in black patients, other nonwhite patients, and in cases where surgery was not performed.

Doug Brunk/MDedge News

Those are key findings from a study that set out to investigate the incidence of pediatric melanoma over the last 2 decades and factors influencing survival. At the annual meeting of the Society for Pediatric Dermatology, one of the study authors, Spandana Maddukuri, said that pediatric melanoma is the most common skin cancer in the pediatric population, accounting for 1-3% of all pediatric malignancies and 1%-4% of all cases of melanoma (Pediatr Surg. 2013;48[11]:2207-13).

“Nonmodifiable risk factors are similar to those in adult melanoma and include fair skin, light hair and eye color, increased number of congenital nevi, and family history of melanoma,” said Ms. Maddukuri, a third-year student at New Jersey Medical School, Newark. “Environmental risk factors are similar to those in adult melanoma and include exposure to UV radiation. About 60% of children do not meet standard ABCDE [asymmetrical, border, color, diameter, evolving] diagnosis criteria, which often leads to delayed diagnosis.”

Some of the characteristics that are more commonly found in pediatric lesions include amelanosis, bleeding, uniform color, and variable diameter (J Am Acad Dermatol. 2013; 68[6]:913-25).

Ms. Maddukuri and colleagues queried the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database for cases of malignant melanoma that were diagnosed in individuals aged younger than 20 years between 2002 and 2015. After excluding all cases of adult melanoma and all cases of in situ melanoma, they included 1,620 patients in the final analysis and divided them into five age groups: less than 1 year, 1-4 years, 5-9 years, 10-14 years, and 15-19 years. They calculated the overall incidence rate per 100,000 population of pediatric melanoma based on data from the 2000 U.S. Census. Age-, sex-, and race-specific incidence rates were also calculated. Kaplan-Meier and Cox regression analyses to investigate disease-specific survival and risk factors.

With each successive age group, the investigators observed that incidence rate was significantly higher than that of the previous age group (P less than .005). “However, the most striking increase in incidence occurs between the age group of 10-14 and 15-19,” she said. “Sex also influenced incidence rates. Males had an incidence rate of 0.396 per 100,000 population while females had an incidence rate of 0.579 per 100,000 population.”


Race also influenced incidence rates. White patients had the highest incidence rate of 0.605 per 100,000 population, while blacks had the lowest incident rate at 0.042 per 100,000 population. American Indian and Alaska Native patients had incidence rates of 0.046 per 100,000 population, while Asians and Pacific Islanders had an incidence rate of 0.127 per 100,000 population.

The researchers found that increased survival was associated with white race, female sex, treatment with surgical intervention, and age older than 5 years. No differences in survival were observed regarding the primary anatomic location or extent of disease. The hazard ratio of death from invasive melanoma was significantly increased in males (HR, 2.34), black patients (HR, 3.96), other nonwhite patients (HR, 3.64), and in cases where surgery was not performed (HR, 6.04).

“It is surprising that, although incidence is significantly higher in white patients and females, compared to black patients and males, respectively, the risk of dying from melanoma is much higher in black patients and males,” Ms. Maddukuri said in an interview at the meeting. “Overall, the dermatologic community is on the right track in screening and diagnosing pediatric melanoma, as seen by the decreased incidence over the last 2 decades. However, increased awareness regarding pediatric melanoma is still encouraged. I believe we were able to identify certain populations that need more attention in terms of screening, diagnosis, and treatment, which are patients less than 5 years old, black and other nonwhite patients, and males.”

She acknowledged certain shortcomings of the study, including a limited clinical history of the patient population because of the nature of the database. She also said that further studies are required to investigate the contributing factors to decreasing incidence and to evaluate the relationship of the favorable prognostic factors to increased survival. The researchers are currently working on correlating incidence rates with UV exposure and geographical location.

They reported having no financial disclosures.

[email protected]

AUSTIN – The incidence of pediatric invasive melanoma has decreased since 2002, but males are more likely to die from the disease, compared with females. The risk of death is also significantly increased in black patients, other nonwhite patients, and in cases where surgery was not performed.

Doug Brunk/MDedge News

Those are key findings from a study that set out to investigate the incidence of pediatric melanoma over the last 2 decades and factors influencing survival. At the annual meeting of the Society for Pediatric Dermatology, one of the study authors, Spandana Maddukuri, said that pediatric melanoma is the most common skin cancer in the pediatric population, accounting for 1-3% of all pediatric malignancies and 1%-4% of all cases of melanoma (Pediatr Surg. 2013;48[11]:2207-13).

“Nonmodifiable risk factors are similar to those in adult melanoma and include fair skin, light hair and eye color, increased number of congenital nevi, and family history of melanoma,” said Ms. Maddukuri, a third-year student at New Jersey Medical School, Newark. “Environmental risk factors are similar to those in adult melanoma and include exposure to UV radiation. About 60% of children do not meet standard ABCDE [asymmetrical, border, color, diameter, evolving] diagnosis criteria, which often leads to delayed diagnosis.”

Some of the characteristics that are more commonly found in pediatric lesions include amelanosis, bleeding, uniform color, and variable diameter (J Am Acad Dermatol. 2013; 68[6]:913-25).

Ms. Maddukuri and colleagues queried the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database for cases of malignant melanoma that were diagnosed in individuals aged younger than 20 years between 2002 and 2015. After excluding all cases of adult melanoma and all cases of in situ melanoma, they included 1,620 patients in the final analysis and divided them into five age groups: less than 1 year, 1-4 years, 5-9 years, 10-14 years, and 15-19 years. They calculated the overall incidence rate per 100,000 population of pediatric melanoma based on data from the 2000 U.S. Census. Age-, sex-, and race-specific incidence rates were also calculated. Kaplan-Meier and Cox regression analyses to investigate disease-specific survival and risk factors.

With each successive age group, the investigators observed that incidence rate was significantly higher than that of the previous age group (P less than .005). “However, the most striking increase in incidence occurs between the age group of 10-14 and 15-19,” she said. “Sex also influenced incidence rates. Males had an incidence rate of 0.396 per 100,000 population while females had an incidence rate of 0.579 per 100,000 population.”


Race also influenced incidence rates. White patients had the highest incidence rate of 0.605 per 100,000 population, while blacks had the lowest incident rate at 0.042 per 100,000 population. American Indian and Alaska Native patients had incidence rates of 0.046 per 100,000 population, while Asians and Pacific Islanders had an incidence rate of 0.127 per 100,000 population.

The researchers found that increased survival was associated with white race, female sex, treatment with surgical intervention, and age older than 5 years. No differences in survival were observed regarding the primary anatomic location or extent of disease. The hazard ratio of death from invasive melanoma was significantly increased in males (HR, 2.34), black patients (HR, 3.96), other nonwhite patients (HR, 3.64), and in cases where surgery was not performed (HR, 6.04).

“It is surprising that, although incidence is significantly higher in white patients and females, compared to black patients and males, respectively, the risk of dying from melanoma is much higher in black patients and males,” Ms. Maddukuri said in an interview at the meeting. “Overall, the dermatologic community is on the right track in screening and diagnosing pediatric melanoma, as seen by the decreased incidence over the last 2 decades. However, increased awareness regarding pediatric melanoma is still encouraged. I believe we were able to identify certain populations that need more attention in terms of screening, diagnosis, and treatment, which are patients less than 5 years old, black and other nonwhite patients, and males.”

She acknowledged certain shortcomings of the study, including a limited clinical history of the patient population because of the nature of the database. She also said that further studies are required to investigate the contributing factors to decreasing incidence and to evaluate the relationship of the favorable prognostic factors to increased survival. The researchers are currently working on correlating incidence rates with UV exposure and geographical location.

They reported having no financial disclosures.

[email protected]

Colorectal cancer (CRC) incidence continues to rise in younger adults, with no signs of plateauing, according to investigators who recently conducted an analysis of a large US cancer registry.

Adults aged 50 years and younger accounted for about 12% of colorectal cancer diagnoses in 2015, up from 10% in 2004, and significantly more of those younger patients had advanced disease at diagnosis as compared to older adults, according to the analysis of the National Cancer Database (NCDB) by Boone Goodgame, MD, of the University of Texas at Austin, and colleagues.

“These results may provide support for adjusting CRC screening guidelines to identify patients before the age of 50 years,” said Dr. Goodgame and study coauthors in Cancer.

Only 5.8% of colorectal cancer cases were diagnosed in individuals younger than 45 years, suggesting that age may be an “appropriate target” for the screening age, the authors said in their report, alluding to the 2018 qualified recommendation from the American Cancer Society to begin screening at age 45.

However, a member of the U.S. Preventive Services Task Force – which continues to recommend screening of asymptomatic adults starting at 50 years – said in an editorial that it remains “unknown” whether the harms of screening for sporadic cases of colorectal cancer in younger individuals would outweigh the benefits.

The study by Dr. Goodgame and colleagues included a total of 1,185,763 colorectal cancer cases in the NCDB during 2004-2015, of which 89% were diagnosed at the age of 50 or older, and 11% were diagnosed in younger individuals.

The proportion of colorectal cancer cases diagnosed in people aged 50 years and younger increased from 10.0% to 12.2% during the study period (P less than .0001), with comparable increases for both rectal and colon primary tumors, according to the the journal article.

Younger patients were more likely to have stage III and stage IV disease than older patients were, according to the investigators. Stage III disease was reported for 28.1% and 23.1% of younger individuals and those over 50 years, respectively, while stage IV disease was reported for 23.5% and 16.9% (P less than .0001 for both comparisons).

Race and sex differences were seen in proportions of patients younger than 50 years with colorectal cancer, further analysis of the NCDB data showed.

Among men, only non-Hispanic whites had a significant increase in colorectal cancer diagnoses under the age of 50 years over the study period, while in women, significant increases were seen in Hispanic and non-Hispanic whites, according to the report.

It’s unclear exactly what’s behind the increase in colorectal cancer diagnosis, the authors acknowledged in their report, citing a host of potentially explanatory factors, such as access to health care, lifestyle factors such as obesity, or increased antibiotic use.

Some say the increase could simply be from the more liberal use of colonoscopy, resulting in a lead time bias, the authors noted.

“However, a change in the lead-time bias should also increase the proportion of earlier stage disease in younger adults, and we did not see this in our study,” they said in the report. “Therefore, increasing colonoscopy use does not appear to be a sufficient explanation for this association.”

In any case, more studies are needed to better determine the risks, benefits, and costs of screening individuals younger than 50 years for colorectal cancer, they concluded, saying that their data should be included in an “ongoing discussion” of screening guidelines.

Dr. Goodgame and coauthors made no conflict of interest disclosures related to the study, which was supported by the National Cancer Institute and the Cancer Prevention and Research Institute of Texas.

SOURCE: Virostko J et al. Cancer. 2019 Jul 22. doi: 10.1002/cncr.32347.

Colorectal cancer (CRC) incidence continues to rise in younger adults, with no signs of plateauing, according to investigators who recently conducted an analysis of a large US cancer registry.

Adults aged 50 years and younger accounted for about 12% of colorectal cancer diagnoses in 2015, up from 10% in 2004, and significantly more of those younger patients had advanced disease at diagnosis as compared to older adults, according to the analysis of the National Cancer Database (NCDB) by Boone Goodgame, MD, of the University of Texas at Austin, and colleagues.

“These results may provide support for adjusting CRC screening guidelines to identify patients before the age of 50 years,” said Dr. Goodgame and study coauthors in Cancer.

Only 5.8% of colorectal cancer cases were diagnosed in individuals younger than 45 years, suggesting that age may be an “appropriate target” for the screening age, the authors said in their report, alluding to the 2018 qualified recommendation from the American Cancer Society to begin screening at age 45.

However, a member of the U.S. Preventive Services Task Force – which continues to recommend screening of asymptomatic adults starting at 50 years – said in an editorial that it remains “unknown” whether the harms of screening for sporadic cases of colorectal cancer in younger individuals would outweigh the benefits.

The study by Dr. Goodgame and colleagues included a total of 1,185,763 colorectal cancer cases in the NCDB during 2004-2015, of which 89% were diagnosed at the age of 50 or older, and 11% were diagnosed in younger individuals.

The proportion of colorectal cancer cases diagnosed in people aged 50 years and younger increased from 10.0% to 12.2% during the study period (P less than .0001), with comparable increases for both rectal and colon primary tumors, according to the the journal article.

Younger patients were more likely to have stage III and stage IV disease than older patients were, according to the investigators. Stage III disease was reported for 28.1% and 23.1% of younger individuals and those over 50 years, respectively, while stage IV disease was reported for 23.5% and 16.9% (P less than .0001 for both comparisons).

Race and sex differences were seen in proportions of patients younger than 50 years with colorectal cancer, further analysis of the NCDB data showed.

Among men, only non-Hispanic whites had a significant increase in colorectal cancer diagnoses under the age of 50 years over the study period, while in women, significant increases were seen in Hispanic and non-Hispanic whites, according to the report.

It’s unclear exactly what’s behind the increase in colorectal cancer diagnosis, the authors acknowledged in their report, citing a host of potentially explanatory factors, such as access to health care, lifestyle factors such as obesity, or increased antibiotic use.

Some say the increase could simply be from the more liberal use of colonoscopy, resulting in a lead time bias, the authors noted.

“However, a change in the lead-time bias should also increase the proportion of earlier stage disease in younger adults, and we did not see this in our study,” they said in the report. “Therefore, increasing colonoscopy use does not appear to be a sufficient explanation for this association.”

In any case, more studies are needed to better determine the risks, benefits, and costs of screening individuals younger than 50 years for colorectal cancer, they concluded, saying that their data should be included in an “ongoing discussion” of screening guidelines.

Dr. Goodgame and coauthors made no conflict of interest disclosures related to the study, which was supported by the National Cancer Institute and the Cancer Prevention and Research Institute of Texas.

SOURCE: Virostko J et al. Cancer. 2019 Jul 22. doi: 10.1002/cncr.32347.

Colorectal cancer (CRC) incidence continues to rise in younger adults, with no signs of plateauing, according to investigators who recently conducted an analysis of a large US cancer registry.

Adults aged 50 years and younger accounted for about 12% of colorectal cancer diagnoses in 2015, up from 10% in 2004, and significantly more of those younger patients had advanced disease at diagnosis as compared to older adults, according to the analysis of the National Cancer Database (NCDB) by Boone Goodgame, MD, of the University of Texas at Austin, and colleagues.

“These results may provide support for adjusting CRC screening guidelines to identify patients before the age of 50 years,” said Dr. Goodgame and study coauthors in Cancer.

Only 5.8% of colorectal cancer cases were diagnosed in individuals younger than 45 years, suggesting that age may be an “appropriate target” for the screening age, the authors said in their report, alluding to the 2018 qualified recommendation from the American Cancer Society to begin screening at age 45.

However, a member of the U.S. Preventive Services Task Force – which continues to recommend screening of asymptomatic adults starting at 50 years – said in an editorial that it remains “unknown” whether the harms of screening for sporadic cases of colorectal cancer in younger individuals would outweigh the benefits.

The study by Dr. Goodgame and colleagues included a total of 1,185,763 colorectal cancer cases in the NCDB during 2004-2015, of which 89% were diagnosed at the age of 50 or older, and 11% were diagnosed in younger individuals.

The proportion of colorectal cancer cases diagnosed in people aged 50 years and younger increased from 10.0% to 12.2% during the study period (P less than .0001), with comparable increases for both rectal and colon primary tumors, according to the the journal article.

Younger patients were more likely to have stage III and stage IV disease than older patients were, according to the investigators. Stage III disease was reported for 28.1% and 23.1% of younger individuals and those over 50 years, respectively, while stage IV disease was reported for 23.5% and 16.9% (P less than .0001 for both comparisons).

Race and sex differences were seen in proportions of patients younger than 50 years with colorectal cancer, further analysis of the NCDB data showed.

Among men, only non-Hispanic whites had a significant increase in colorectal cancer diagnoses under the age of 50 years over the study period, while in women, significant increases were seen in Hispanic and non-Hispanic whites, according to the report.

It’s unclear exactly what’s behind the increase in colorectal cancer diagnosis, the authors acknowledged in their report, citing a host of potentially explanatory factors, such as access to health care, lifestyle factors such as obesity, or increased antibiotic use.

Some say the increase could simply be from the more liberal use of colonoscopy, resulting in a lead time bias, the authors noted.

“However, a change in the lead-time bias should also increase the proportion of earlier stage disease in younger adults, and we did not see this in our study,” they said in the report. “Therefore, increasing colonoscopy use does not appear to be a sufficient explanation for this association.”

In any case, more studies are needed to better determine the risks, benefits, and costs of screening individuals younger than 50 years for colorectal cancer, they concluded, saying that their data should be included in an “ongoing discussion” of screening guidelines.

Dr. Goodgame and coauthors made no conflict of interest disclosures related to the study, which was supported by the National Cancer Institute and the Cancer Prevention and Research Institute of Texas.

SOURCE: Virostko J et al. Cancer. 2019 Jul 22. doi: 10.1002/cncr.32347.

Fluad (aIIV3), an adjuvanted flu vaccine that’s recommended for people aged 65 and older, does a better job than do conventional flu vaccines in young children, according to an industry-funded synthesis of six studies.

KatarzynaBialasiewicz/Thinkstock

The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”

Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).

Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.

Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.

In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.

Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”

As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”

For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.

In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.

They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”

Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”

According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.

The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.

SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.

Fluad (aIIV3), an adjuvanted flu vaccine that’s recommended for people aged 65 and older, does a better job than do conventional flu vaccines in young children, according to an industry-funded synthesis of six studies.

KatarzynaBialasiewicz/Thinkstock

The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”

Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).

Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.

Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.

In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.

Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”

As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”

For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.

In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.

They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”

Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”

According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.

The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.

SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.

Fluad (aIIV3), an adjuvanted flu vaccine that’s recommended for people aged 65 and older, does a better job than do conventional flu vaccines in young children, according to an industry-funded synthesis of six studies.

KatarzynaBialasiewicz/Thinkstock

The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”

Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).

Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.

Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.

In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.

Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”

As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”

For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.

In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.

They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”

Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”

According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.

The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.

SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.

A diet rich in plant-based foods, especially healthier ones, may ward off type 2 diabetes in adults, according to a new systematic review and meta-analysis of nine observational studies.

The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”

According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.

For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.

The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).

The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.

Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.

The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.

SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.

A diet rich in plant-based foods, especially healthier ones, may ward off type 2 diabetes in adults, according to a new systematic review and meta-analysis of nine observational studies.

The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”

According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.

For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.

The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).

The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.

Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.

The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.

SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.

A diet rich in plant-based foods, especially healthier ones, may ward off type 2 diabetes in adults, according to a new systematic review and meta-analysis of nine observational studies.

The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”

According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.

For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.

The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).

The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.

Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.

The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.

SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.

Adjuvanted trivalent inactivated influenza vaccine (aIIV3) appears as safe as nonadjuvanted flu vaccines for children at risk for serious flu complications, according to a study in the International Journal of Infectious Diseases.

©Micah Young/istockphoto.com

Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.

The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).

One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.

The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”

Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.

[email protected]

Adjuvanted trivalent inactivated influenza vaccine (aIIV3) appears as safe as nonadjuvanted flu vaccines for children at risk for serious flu complications, according to a study in the International Journal of Infectious Diseases.

©Micah Young/istockphoto.com

Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.

The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).

One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.

The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”

Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.

[email protected]

Adjuvanted trivalent inactivated influenza vaccine (aIIV3) appears as safe as nonadjuvanted flu vaccines for children at risk for serious flu complications, according to a study in the International Journal of Infectious Diseases.

©Micah Young/istockphoto.com

Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.

The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).

One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.

The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”

Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.

[email protected]

MADRID – Filgotinib, an investigational oral Janus kinase (JAK) 1 inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) when added to methotrexate in patients who were inadequately responding to treatment with the conventional disease-modifying antirheumatic drug (cDMARD) in a phase 3 study.

The primary outcome results of the FINCH 1 study, which were presented at the European Congress of Rheumatology, showed that significantly more patients treated with filgotinib than placebo were able to achieve 20% improvement in American College of Rheumatology response criteria (ACR20).

At week 12, an ACR20 response was achieved by 69.8% of 480 patients treated with filgotinib 100 mg/day, 76.6% of 475 treated with filgotinib 200 mg/day, and 49.9% of 475 given a matching daily placebo (P less than .0001 for both comparisons). Adalimumab (Humira; 40 mg every 2 weeks) was used as an active comparator in the trial, and 70.8% of 325 patients treated with this biologic drug achieved an ACR20.

Similar patterns were seen for the ACR50 and ACR70 responses: more than 50% of patients treated with filgotinib or adalimumab achieved an ACR50 versus 33.3% of patients treated with placebo. The ACR70 response rate was more than 30% in patients treated with either biologic, compared against 14.9% with placebo.

The percentages of patients in the filgotinib 100-mg, filgotinib 200-mg, adalimumab, and placebo arms who achieved a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) of 3.2 or less at 12 weeks were 38.8%, 49.9%, 43.4%, and 23.4%. At 24 weeks, the rates were 53.1%, 60.6%, 50.5%, and 33.7%.

At 12 weeks, analysis showed that filgotinib 200 mg was noninferior to adalimumab in achieving a DAS28-CRP of 3.2 or less.

These study data, together with the results of two other phase 3 studies – FINCH 2 and FINCH 3 – will be used to submit a new drug application to the Food and Drug Administration for the use of filgotinib in the treatment of RA later this year, the drug’s developer, Gilead Sciences, announced on July 1. Each of the trials has addressed a different population of RA patients; while FINCH 1 looked at inadequate responders to methotrexate, FINCH 2 looked at those with an inadequate response to biologic DMARDs, and FINCH 3 recruited RA patients who were naive to methotrexate therapy.

FINCH 1 was a 1-year study, said presenting study investigator Bernard Combe, MD, PhD, professor of rheumatology at Montpellier (France) University and head of the bone and joint diseases department at the university. A total of 1,759 patients were randomized and 1,755 received study treatment with filgotinib, adalimumab, or placebo in addition to methotrexate. Data for the first 24 weeks were presented.

Dr. Combe and coauthors used hierarchical statistical testing to first compare the 200-mg dose versus placebo for the primary endpoint, and then, if positive, the percentage of patients at 12 weeks achieving a DAS28-CRP score of 3.2 or less and the score at 12 weeks on the Health Assessment Questionnaire – Disability Index (HAQ-DI), and then the DAS28-CRP again at 24 weeks. This was repeated with the 100-mg dose until finally noninferiority of the 200-mg dose versus adalimumab in DAS28-CRP at 12 weeks was tested.

Other findings included a significant reduction in radiographic progression at week 24 with both doses of filgotinib versus placebo; improvements in HAQ-DI and Functional Assessment of Chronic Illness Therapy-Fatigue scores also were seen at 12 and 24 weeks.

“The selective JAK1 inhibitor filgotinib, at doses of 200 and 100 mg per day, led to significant improvement in symptoms of RA patients with inadequate response to methotrexate,” Dr. Combe concluded. It “prevented radiographic progression, and improved physical function compared to placebo.”

Importantly, the drug was “well tolerated” and “a low frequency of venous thrombotic events, serious infections, and other adverse events of interest was observed.”

Commenting on the study during the Q&A session that followed Dr. Combe’s presentation, Roy M. Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center in Dallas, noted that the choice of DAS28-CRP was “very unusual” as an endpoint after the ACR20 as it’s “almost always an ACR50 or 70.” There was also a “very high placebo response.”

Dr. Combe responded that he “wasn’t so surprised by the high placebo response. You know that this has been shown previously in some other trials.” As to why, he noted that there was an ongoing analysis but also proposed two reasons: First, the geographic region – with more than 1,700 patients from all over the world included in the trial, there could be variation in the placebo responses. Second, methotrexate might still be having a minor effect when the trial started.

The study was sponsored by Gilead Sciences in collaboration with Galapagos NV. Dr. Combe has received honoraria from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Sun Pharma Advanced Research, Boehringer Ingelheim, and Flexion. Dr. Combe is a shareholder in Novartis.

SOURCE: Combe B et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-8. Abstract LB0001, doi: 10.1136/annrheumdis-2019-eular.8676

MADRID – Filgotinib, an investigational oral Janus kinase (JAK) 1 inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) when added to methotrexate in patients who were inadequately responding to treatment with the conventional disease-modifying antirheumatic drug (cDMARD) in a phase 3 study.

The primary outcome results of the FINCH 1 study, which were presented at the European Congress of Rheumatology, showed that significantly more patients treated with filgotinib than placebo were able to achieve 20% improvement in American College of Rheumatology response criteria (ACR20).

At week 12, an ACR20 response was achieved by 69.8% of 480 patients treated with filgotinib 100 mg/day, 76.6% of 475 treated with filgotinib 200 mg/day, and 49.9% of 475 given a matching daily placebo (P less than .0001 for both comparisons). Adalimumab (Humira; 40 mg every 2 weeks) was used as an active comparator in the trial, and 70.8% of 325 patients treated with this biologic drug achieved an ACR20.

Similar patterns were seen for the ACR50 and ACR70 responses: more than 50% of patients treated with filgotinib or adalimumab achieved an ACR50 versus 33.3% of patients treated with placebo. The ACR70 response rate was more than 30% in patients treated with either biologic, compared against 14.9% with placebo.

The percentages of patients in the filgotinib 100-mg, filgotinib 200-mg, adalimumab, and placebo arms who achieved a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) of 3.2 or less at 12 weeks were 38.8%, 49.9%, 43.4%, and 23.4%. At 24 weeks, the rates were 53.1%, 60.6%, 50.5%, and 33.7%.

At 12 weeks, analysis showed that filgotinib 200 mg was noninferior to adalimumab in achieving a DAS28-CRP of 3.2 or less.

These study data, together with the results of two other phase 3 studies – FINCH 2 and FINCH 3 – will be used to submit a new drug application to the Food and Drug Administration for the use of filgotinib in the treatment of RA later this year, the drug’s developer, Gilead Sciences, announced on July 1. Each of the trials has addressed a different population of RA patients; while FINCH 1 looked at inadequate responders to methotrexate, FINCH 2 looked at those with an inadequate response to biologic DMARDs, and FINCH 3 recruited RA patients who were naive to methotrexate therapy.

FINCH 1 was a 1-year study, said presenting study investigator Bernard Combe, MD, PhD, professor of rheumatology at Montpellier (France) University and head of the bone and joint diseases department at the university. A total of 1,759 patients were randomized and 1,755 received study treatment with filgotinib, adalimumab, or placebo in addition to methotrexate. Data for the first 24 weeks were presented.

Dr. Combe and coauthors used hierarchical statistical testing to first compare the 200-mg dose versus placebo for the primary endpoint, and then, if positive, the percentage of patients at 12 weeks achieving a DAS28-CRP score of 3.2 or less and the score at 12 weeks on the Health Assessment Questionnaire – Disability Index (HAQ-DI), and then the DAS28-CRP again at 24 weeks. This was repeated with the 100-mg dose until finally noninferiority of the 200-mg dose versus adalimumab in DAS28-CRP at 12 weeks was tested.

Other findings included a significant reduction in radiographic progression at week 24 with both doses of filgotinib versus placebo; improvements in HAQ-DI and Functional Assessment of Chronic Illness Therapy-Fatigue scores also were seen at 12 and 24 weeks.

“The selective JAK1 inhibitor filgotinib, at doses of 200 and 100 mg per day, led to significant improvement in symptoms of RA patients with inadequate response to methotrexate,” Dr. Combe concluded. It “prevented radiographic progression, and improved physical function compared to placebo.”

Importantly, the drug was “well tolerated” and “a low frequency of venous thrombotic events, serious infections, and other adverse events of interest was observed.”

Commenting on the study during the Q&A session that followed Dr. Combe’s presentation, Roy M. Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center in Dallas, noted that the choice of DAS28-CRP was “very unusual” as an endpoint after the ACR20 as it’s “almost always an ACR50 or 70.” There was also a “very high placebo response.”

Dr. Combe responded that he “wasn’t so surprised by the high placebo response. You know that this has been shown previously in some other trials.” As to why, he noted that there was an ongoing analysis but also proposed two reasons: First, the geographic region – with more than 1,700 patients from all over the world included in the trial, there could be variation in the placebo responses. Second, methotrexate might still be having a minor effect when the trial started.

The study was sponsored by Gilead Sciences in collaboration with Galapagos NV. Dr. Combe has received honoraria from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Sun Pharma Advanced Research, Boehringer Ingelheim, and Flexion. Dr. Combe is a shareholder in Novartis.

SOURCE: Combe B et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-8. Abstract LB0001, doi: 10.1136/annrheumdis-2019-eular.8676

MADRID – Filgotinib, an investigational oral Janus kinase (JAK) 1 inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) when added to methotrexate in patients who were inadequately responding to treatment with the conventional disease-modifying antirheumatic drug (cDMARD) in a phase 3 study.

The primary outcome results of the FINCH 1 study, which were presented at the European Congress of Rheumatology, showed that significantly more patients treated with filgotinib than placebo were able to achieve 20% improvement in American College of Rheumatology response criteria (ACR20).

At week 12, an ACR20 response was achieved by 69.8% of 480 patients treated with filgotinib 100 mg/day, 76.6% of 475 treated with filgotinib 200 mg/day, and 49.9% of 475 given a matching daily placebo (P less than .0001 for both comparisons). Adalimumab (Humira; 40 mg every 2 weeks) was used as an active comparator in the trial, and 70.8% of 325 patients treated with this biologic drug achieved an ACR20.

Similar patterns were seen for the ACR50 and ACR70 responses: more than 50% of patients treated with filgotinib or adalimumab achieved an ACR50 versus 33.3% of patients treated with placebo. The ACR70 response rate was more than 30% in patients treated with either biologic, compared against 14.9% with placebo.

The percentages of patients in the filgotinib 100-mg, filgotinib 200-mg, adalimumab, and placebo arms who achieved a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) of 3.2 or less at 12 weeks were 38.8%, 49.9%, 43.4%, and 23.4%. At 24 weeks, the rates were 53.1%, 60.6%, 50.5%, and 33.7%.

At 12 weeks, analysis showed that filgotinib 200 mg was noninferior to adalimumab in achieving a DAS28-CRP of 3.2 or less.

These study data, together with the results of two other phase 3 studies – FINCH 2 and FINCH 3 – will be used to submit a new drug application to the Food and Drug Administration for the use of filgotinib in the treatment of RA later this year, the drug’s developer, Gilead Sciences, announced on July 1. Each of the trials has addressed a different population of RA patients; while FINCH 1 looked at inadequate responders to methotrexate, FINCH 2 looked at those with an inadequate response to biologic DMARDs, and FINCH 3 recruited RA patients who were naive to methotrexate therapy.

FINCH 1 was a 1-year study, said presenting study investigator Bernard Combe, MD, PhD, professor of rheumatology at Montpellier (France) University and head of the bone and joint diseases department at the university. A total of 1,759 patients were randomized and 1,755 received study treatment with filgotinib, adalimumab, or placebo in addition to methotrexate. Data for the first 24 weeks were presented.

Dr. Combe and coauthors used hierarchical statistical testing to first compare the 200-mg dose versus placebo for the primary endpoint, and then, if positive, the percentage of patients at 12 weeks achieving a DAS28-CRP score of 3.2 or less and the score at 12 weeks on the Health Assessment Questionnaire – Disability Index (HAQ-DI), and then the DAS28-CRP again at 24 weeks. This was repeated with the 100-mg dose until finally noninferiority of the 200-mg dose versus adalimumab in DAS28-CRP at 12 weeks was tested.

Other findings included a significant reduction in radiographic progression at week 24 with both doses of filgotinib versus placebo; improvements in HAQ-DI and Functional Assessment of Chronic Illness Therapy-Fatigue scores also were seen at 12 and 24 weeks.

“The selective JAK1 inhibitor filgotinib, at doses of 200 and 100 mg per day, led to significant improvement in symptoms of RA patients with inadequate response to methotrexate,” Dr. Combe concluded. It “prevented radiographic progression, and improved physical function compared to placebo.”

Importantly, the drug was “well tolerated” and “a low frequency of venous thrombotic events, serious infections, and other adverse events of interest was observed.”

Commenting on the study during the Q&A session that followed Dr. Combe’s presentation, Roy M. Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center in Dallas, noted that the choice of DAS28-CRP was “very unusual” as an endpoint after the ACR20 as it’s “almost always an ACR50 or 70.” There was also a “very high placebo response.”

Dr. Combe responded that he “wasn’t so surprised by the high placebo response. You know that this has been shown previously in some other trials.” As to why, he noted that there was an ongoing analysis but also proposed two reasons: First, the geographic region – with more than 1,700 patients from all over the world included in the trial, there could be variation in the placebo responses. Second, methotrexate might still be having a minor effect when the trial started.

The study was sponsored by Gilead Sciences in collaboration with Galapagos NV. Dr. Combe has received honoraria from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Sun Pharma Advanced Research, Boehringer Ingelheim, and Flexion. Dr. Combe is a shareholder in Novartis.

SOURCE: Combe B et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):77-8. Abstract LB0001, doi: 10.1136/annrheumdis-2019-eular.8676

The SVS Political Action Committee has set an aggressive fundraising goal for this current 2020 election cycle, and your contribution is critical to helping the PAC to meet this goal. The SVS PAC is one of the most effective tools for communicating with policymakers on Capitol Hill to make the greatest impact on legislative issues that affect your patients and your practices. Contributions allow the PAC Committee to establish strong relationships with members of Congress and cultivate congressional champions for our legislative and regulatory priorities. Make your donation or enhance your previously made donation to the SVS PAC here. Want to learn more? Click here.

The SVS Political Action Committee has set an aggressive fundraising goal for this current 2020 election cycle, and your contribution is critical to helping the PAC to meet this goal. The SVS PAC is one of the most effective tools for communicating with policymakers on Capitol Hill to make the greatest impact on legislative issues that affect your patients and your practices. Contributions allow the PAC Committee to establish strong relationships with members of Congress and cultivate congressional champions for our legislative and regulatory priorities. Make your donation or enhance your previously made donation to the SVS PAC here. Want to learn more? Click here.

The SVS Political Action Committee has set an aggressive fundraising goal for this current 2020 election cycle, and your contribution is critical to helping the PAC to meet this goal. The SVS PAC is one of the most effective tools for communicating with policymakers on Capitol Hill to make the greatest impact on legislative issues that affect your patients and your practices. Contributions allow the PAC Committee to establish strong relationships with members of Congress and cultivate congressional champions for our legislative and regulatory priorities. Make your donation or enhance your previously made donation to the SVS PAC here. Want to learn more? Click here.

White people and older people are more likely than are nonwhites and young people to follow skin safety guidelines, according to a survey of passersby and skin-cancer screening attendees in Washington, D.C.

“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”

For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).

The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).

The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.


Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).

“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”

The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.

No study funding was reported. The study authors reported no relevant disclosures.

White people and older people are more likely than are nonwhites and young people to follow skin safety guidelines, according to a survey of passersby and skin-cancer screening attendees in Washington, D.C.

“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”

For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).

The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).

The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.


Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).

“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”

The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.

No study funding was reported. The study authors reported no relevant disclosures.

White people and older people are more likely than are nonwhites and young people to follow skin safety guidelines, according to a survey of passersby and skin-cancer screening attendees in Washington, D.C.

“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”

For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).

The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).

The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.


Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).

“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”

The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.

No study funding was reported. The study authors reported no relevant disclosures.

Clinical question: Is 6 months of dual antiplatelet therapy (DAPT) therapy noninferior to 12 months, following ST-elevation myocardial infarction (STEMI) with placement of second-generation drug-eluting stents?

Background: DAPT has been the standard of care to prevent abrupt thrombotic closure of vessels following percutaneous coronary intervention (PCI) and placement of stents. The recommended duration of DAPT was lengthened from at least 30 days in bare metal stents to at least 12 months in earlier-generation drug-eluting stents after observation of high rates of in-stent thrombosis of drug-eluting stents.

Trials have shown that there is no difference in outcomes comparing 6 month vs. 12 months in DAPT for PCI in the cases of non-ST-elevation MI and unstable angina. However, there are no randomized controlled studies comparing 6 vs. 12 months of DAPT with newer drug-eluting stents following STEMI. Newer drug-eluting stents are made of biocompatible polymers with thinner struts and are thought to be fully absorbed by 3 months. International guidelines still recommend 12 months of DAPT following drug-eluting stent placement following STEMI.

Study design: Prospective, unblinded, randomized, multicenter noninferiority trial.

Setting: The study was performed at 17 sites in the Netherlands, Norway, Poland, and Switzerland.

Synopsis: This study enrolled 1100 patients with STEMI started on DAPT during December 2011-June 2015. Overall, 870 patients were randomized to continue DAPT or to change to single antiplatelet therapy (SAPT) at 6 months. Exclusions included embolic events, cardiogenic shock, revascularization, bleeding, or being on anticoagulation. Patients were followed for 24 months.

The primary endpoint was a composite of all-cause mortality, any MI, any revascularization, stroke, or thrombolysis. Incidence of the composite endpoint was 4.8% of SAPT cases, and 6.6% of DAPT cases. Noninferiority was met (P = .004) because the upper 95% confidence interval of 1.27 was smaller than the prespecified noninferiority margin of 1.66. The secondary endpoint of safety and bleeding at 18 months was 3.2% for SAPT, and 4.3% for DAPT with HR of 0.75.

Medtronic’s new stent was used in 92% of the cases of this industry-sponsored study. Despite usage of a composite endpoint, there was no difference in the individual elements of the composite in subgroup analyses. There was a low event rate in both arms likely because of the exclusions that led to a lower-risk population. The individual operators were able to choose the P2Y12 inhibitor.

Bottom line: This industry-sponsored randomized, control trial showed noninferiority of 6 months of DAPT to 12 months of therapy following STEMI to prevent in-stent thrombosis with newer second- generation drug-eluting stents. However, the study’s results may be limited to lower-risk patients, without need for revascularization, oral anticoagulation, or with stroke or cardiogenic shock.

Citation: Kedhi E et al. Six months versus 12 months of dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): Randomised, multicenter, noninferiority trial. BMJ. 2018;363:k3793.

Dr. Lennon is an instructor of medicine at Northwestern University Feinberg School of Medicine and a hospitalist at Northwestern Memorial Hospital, both in Chicago.

Clinical question: Is 6 months of dual antiplatelet therapy (DAPT) therapy noninferior to 12 months, following ST-elevation myocardial infarction (STEMI) with placement of second-generation drug-eluting stents?

Background: DAPT has been the standard of care to prevent abrupt thrombotic closure of vessels following percutaneous coronary intervention (PCI) and placement of stents. The recommended duration of DAPT was lengthened from at least 30 days in bare metal stents to at least 12 months in earlier-generation drug-eluting stents after observation of high rates of in-stent thrombosis of drug-eluting stents.

Trials have shown that there is no difference in outcomes comparing 6 month vs. 12 months in DAPT for PCI in the cases of non-ST-elevation MI and unstable angina. However, there are no randomized controlled studies comparing 6 vs. 12 months of DAPT with newer drug-eluting stents following STEMI. Newer drug-eluting stents are made of biocompatible polymers with thinner struts and are thought to be fully absorbed by 3 months. International guidelines still recommend 12 months of DAPT following drug-eluting stent placement following STEMI.

Study design: Prospective, unblinded, randomized, multicenter noninferiority trial.

Setting: The study was performed at 17 sites in the Netherlands, Norway, Poland, and Switzerland.

Synopsis: This study enrolled 1100 patients with STEMI started on DAPT during December 2011-June 2015. Overall, 870 patients were randomized to continue DAPT or to change to single antiplatelet therapy (SAPT) at 6 months. Exclusions included embolic events, cardiogenic shock, revascularization, bleeding, or being on anticoagulation. Patients were followed for 24 months.

The primary endpoint was a composite of all-cause mortality, any MI, any revascularization, stroke, or thrombolysis. Incidence of the composite endpoint was 4.8% of SAPT cases, and 6.6% of DAPT cases. Noninferiority was met (P = .004) because the upper 95% confidence interval of 1.27 was smaller than the prespecified noninferiority margin of 1.66. The secondary endpoint of safety and bleeding at 18 months was 3.2% for SAPT, and 4.3% for DAPT with HR of 0.75.

Medtronic’s new stent was used in 92% of the cases of this industry-sponsored study. Despite usage of a composite endpoint, there was no difference in the individual elements of the composite in subgroup analyses. There was a low event rate in both arms likely because of the exclusions that led to a lower-risk population. The individual operators were able to choose the P2Y12 inhibitor.

Bottom line: This industry-sponsored randomized, control trial showed noninferiority of 6 months of DAPT to 12 months of therapy following STEMI to prevent in-stent thrombosis with newer second- generation drug-eluting stents. However, the study’s results may be limited to lower-risk patients, without need for revascularization, oral anticoagulation, or with stroke or cardiogenic shock.

Citation: Kedhi E et al. Six months versus 12 months of dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): Randomised, multicenter, noninferiority trial. BMJ. 2018;363:k3793.

Dr. Lennon is an instructor of medicine at Northwestern University Feinberg School of Medicine and a hospitalist at Northwestern Memorial Hospital, both in Chicago.

Clinical question: Is 6 months of dual antiplatelet therapy (DAPT) therapy noninferior to 12 months, following ST-elevation myocardial infarction (STEMI) with placement of second-generation drug-eluting stents?

Background: DAPT has been the standard of care to prevent abrupt thrombotic closure of vessels following percutaneous coronary intervention (PCI) and placement of stents. The recommended duration of DAPT was lengthened from at least 30 days in bare metal stents to at least 12 months in earlier-generation drug-eluting stents after observation of high rates of in-stent thrombosis of drug-eluting stents.

Trials have shown that there is no difference in outcomes comparing 6 month vs. 12 months in DAPT for PCI in the cases of non-ST-elevation MI and unstable angina. However, there are no randomized controlled studies comparing 6 vs. 12 months of DAPT with newer drug-eluting stents following STEMI. Newer drug-eluting stents are made of biocompatible polymers with thinner struts and are thought to be fully absorbed by 3 months. International guidelines still recommend 12 months of DAPT following drug-eluting stent placement following STEMI.

Study design: Prospective, unblinded, randomized, multicenter noninferiority trial.

Setting: The study was performed at 17 sites in the Netherlands, Norway, Poland, and Switzerland.

Synopsis: This study enrolled 1100 patients with STEMI started on DAPT during December 2011-June 2015. Overall, 870 patients were randomized to continue DAPT or to change to single antiplatelet therapy (SAPT) at 6 months. Exclusions included embolic events, cardiogenic shock, revascularization, bleeding, or being on anticoagulation. Patients were followed for 24 months.

The primary endpoint was a composite of all-cause mortality, any MI, any revascularization, stroke, or thrombolysis. Incidence of the composite endpoint was 4.8% of SAPT cases, and 6.6% of DAPT cases. Noninferiority was met (P = .004) because the upper 95% confidence interval of 1.27 was smaller than the prespecified noninferiority margin of 1.66. The secondary endpoint of safety and bleeding at 18 months was 3.2% for SAPT, and 4.3% for DAPT with HR of 0.75.

Medtronic’s new stent was used in 92% of the cases of this industry-sponsored study. Despite usage of a composite endpoint, there was no difference in the individual elements of the composite in subgroup analyses. There was a low event rate in both arms likely because of the exclusions that led to a lower-risk population. The individual operators were able to choose the P2Y12 inhibitor.

Bottom line: This industry-sponsored randomized, control trial showed noninferiority of 6 months of DAPT to 12 months of therapy following STEMI to prevent in-stent thrombosis with newer second- generation drug-eluting stents. However, the study’s results may be limited to lower-risk patients, without need for revascularization, oral anticoagulation, or with stroke or cardiogenic shock.

Citation: Kedhi E et al. Six months versus 12 months of dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): Randomised, multicenter, noninferiority trial. BMJ. 2018;363:k3793.

Dr. Lennon is an instructor of medicine at Northwestern University Feinberg School of Medicine and a hospitalist at Northwestern Memorial Hospital, both in Chicago.

The US Department of Veterans Affairs (VA) has a well-established National HIV Program, says Dr. Richard Stone, executive in charge of the VHA. In fact, he notes, the VA is the single largest provider of HIV care in America and has treated 31,000 veterans for HIV.

Thus, the VA plays a critical role in the effort to establish tools and resources to eradicate HIV in the US, Stone says, “one veteran at a time.” To realize this “ambitious but achievable target,” the VA is:

• Offering HIV testing at least once to every veteran and more often to those at risk;
• Rapidly linking those who are diagnosed to effective treatment;
• Deploying an HIV health force to hard-hit areas of the country, expanding timely access to high-quality HIV care and prevention across the VA’s integrated network, with both face-to-face encounters and telehealth; and
• Offering pre-exposure prophylaxis (PrEP) when clinically appropriate.

The primary goal, Stone says, is for veterans with HIV or at risk for HIV to be able to access the best care “safely and free from stigma and discrimination.”

Resources and educational tools are available at www.hiv.va.gov, including recently updated fact sheets and videos for patients about PrEP

The US Department of Veterans Affairs (VA) has a well-established National HIV Program, says Dr. Richard Stone, executive in charge of the VHA. In fact, he notes, the VA is the single largest provider of HIV care in America and has treated 31,000 veterans for HIV.

Thus, the VA plays a critical role in the effort to establish tools and resources to eradicate HIV in the US, Stone says, “one veteran at a time.” To realize this “ambitious but achievable target,” the VA is:

• Offering HIV testing at least once to every veteran and more often to those at risk;
• Rapidly linking those who are diagnosed to effective treatment;
• Deploying an HIV health force to hard-hit areas of the country, expanding timely access to high-quality HIV care and prevention across the VA’s integrated network, with both face-to-face encounters and telehealth; and
• Offering pre-exposure prophylaxis (PrEP) when clinically appropriate.

The primary goal, Stone says, is for veterans with HIV or at risk for HIV to be able to access the best care “safely and free from stigma and discrimination.”

Resources and educational tools are available at www.hiv.va.gov, including recently updated fact sheets and videos for patients about PrEP

The US Department of Veterans Affairs (VA) has a well-established National HIV Program, says Dr. Richard Stone, executive in charge of the VHA. In fact, he notes, the VA is the single largest provider of HIV care in America and has treated 31,000 veterans for HIV.

Thus, the VA plays a critical role in the effort to establish tools and resources to eradicate HIV in the US, Stone says, “one veteran at a time.” To realize this “ambitious but achievable target,” the VA is:

• Offering HIV testing at least once to every veteran and more often to those at risk;
• Rapidly linking those who are diagnosed to effective treatment;
• Deploying an HIV health force to hard-hit areas of the country, expanding timely access to high-quality HIV care and prevention across the VA’s integrated network, with both face-to-face encounters and telehealth; and
• Offering pre-exposure prophylaxis (PrEP) when clinically appropriate.

The primary goal, Stone says, is for veterans with HIV or at risk for HIV to be able to access the best care “safely and free from stigma and discrimination.”

Resources and educational tools are available at www.hiv.va.gov, including recently updated fact sheets and videos for patients about PrEP