Heidi Splete

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.

Analysis of additional lung fluid samples confirms the presence of vitamin E acetate in patients with electronic-cigarette, or vaping, product use–associated lung injury, according to a report on 51 patients in 16 states.

The average age of the patients was 23 years; 69% were male.

The report extends previous work by the Centers for Disease Control and Prevention to test for harmful substances in bronchoalveolar-lavage (BAL) fluid obtained from patients with electronic-cigarette, or vaping, product use–associated lung injury (EVALI) as part of a strategy to understand and manage the recent outbreak of EVALI cases in the United States, wrote Benjamin C. Blount, PhD, of the Division of Laboratory Sciences at the CDC’s National Center for Environmental Health, and colleagues.

“CDC was addressing a serious outbreak of lung injury that was sometimes lethal; but after the first 10 weeks of the outbreak investigation, the cause was still unknown,” Dr. Blount said in an interview. “Possible theories could not be evaluated unless the laboratory could develop tests that could confidently connect exposure to lung injury. Detection of toxicants in bronchoalveolar-lavage fluid from patients with EVALI can provide direct information on exposure within the lung.”

In a study published in the New England Journal of Medicine, the researchers examined the BAL of 51 cases of EVALI from 16 states. They analyzed the samples for multiple toxicants, including vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes.

Overall, 77% of the patients reported using products containing THC, 67% reported using products containing nicotine, and 51% reported using both types.

Researchers found vitamin E acetate in 48 of the 51 patients (94%); no vitamin E acetate was found in the BAL of healthy controls. Coconut oil and limonene were found in one patient each, but none of the other toxicants was found in the samples from the patients or controls.

In addition, 47 of the 50 patients for whom data were available either had detectable tetrahydrocannabinol (THC) or its metabolites in their BAL fluid samples, or they reported vaping THC products within 90 days before they became ill. Nicotine or its metabolites were found in 30 of 47 patients (64%).

The study findings were limited by several factors, including the potential role of vitamin E acetate as a marker for exposure to other toxicants, the uncertainty of the role of aerosolized constituents formed when vitamin E acetate is heated, and the lack of data on the timing and burden of toxicant exposure, the investigators noted.

As for the next steps in research, “additional studies are needed to examine the respiratory effects of inhaling aerosolized vitamin E acetate and provide information on whether vitamin E acetate in isolation causes lung injury,” Dr. Blount explained. Analysis of the aerosol and gases generated by case-associated product fluids is ongoing.

“When CDC developed the BAL study for this response, we considered several possible toxicants in this investigation to find a possible cause of the outbreak,” Dr. Blount noted. “To accomplish the study, CDC’s Environmental Health Laboratory developed 12 analytical methods and validated them in less than 3 weeks because of the urgent nature of the emergency.”

Dr. Blount said he would advise clinicians to “continue to reference CDC guidance on treating suspected or EVALI patients.” In December, the CDC published updated guidance for clinicians on hospitalized EVALI patients. “Following this guidance and other recommendations could reduce EVALI-associated morbidity and mortality,” Dr. Blount said.

The study was supported in part by the National Cancer Institute, the FDA Center for Tobacco Products, and Ohio State University Pelotonia Intramural Research. The researchers had no financial conflicts to disclose.

SOURCE: Blount BC et al. N Engl J Med. 2020 Feb 20. doi: 10.1056/NEJMoa1916433.

Psoriasis patients are at increased risk for several types of cancer, notably lymphoma and keratinocyte cancer, based on data from a systematic review and meta-analysis of more than 2 million patients.

Previous studies have identified an increased overall cancer risk in psoriasis patients, compared with the general population or controls without psoriasis, and both lymphomas and keratinocyte cancers occur more often in psoriasis patients, compared with controls, but additional larger studies have been conducted since the last meta-analysis was published in 2013, wrote Sofie Vaengebjerg, MD, of the University of Copenhagen and colleagues.

To better identify the risk of cancer in psoriasis and psoriatic arthritis patients and to explore the impact of biologics, the researchers reviewed data from 112 studies totaling 2,053,932 patients in a study published in JAMA Dermatology.

Overall, the risk of any cancer was slightly higher in psoriasis patients (risk ratio, 1.21; 95% confidence interval, 1.11-1.33), compared with controls, with a prevalence of 4.78% and an incidence rate of 11.75 per 1,000 person-years. The most common cancer among psoriasis patients was keratinocyte cancer, with a risk ratio of 2.28 (95% CI, 1.73-3.01), a prevalence of 2.55%, and an incidence rate of 4.35 per 1,000 person-years.

Other cancers with significantly elevated risk among psoriasis patients were lymphomas (RR, 1.56; 95% CI, 1.37-1.78), lung cancer (RR, 1.26; 95% CI, 1.13-1.40), and bladder cancer (RR, 1.12; 95% CI, 1.04-1.19).

No increased risk of cancer was noted among psoriasis patients who were treated with biologics. “However, patients receiving biologic agents are selected and the results might be reliant on selection bias, and studies investigating long-term safety of these drugs are still limited,” the researchers wrote.

In addition, psoriatic arthritis was not associated with any overall increase in cancer risk, with the exception of three studies showing an increased risk for breast cancer, the researchers noted. The overall cancer prevalence for psoriatic arthritis patients was 5.74%, with an incidence rate of 6.44 per 1,000 person-years.

The study findings were limited by several factors, including the inconsistencies in study design and characteristics and the small amount of data on biologic agents and psoriatic arthritis, the researchers noted. However, the results were strengthened by the large number of patients, real-world study settings, inclusion of biologics, and analysis of cancer in psoriatic arthritis patients.

“Clinicians treating patients with psoriasis should be aware of this increased risk, especially for lymphomas, as immunogenic treatment might be associated with exacerbations,” and should be aware that more research is needed to assess cancer risk associated with biologics, they concluded.

The study received no outside funding. Lead author Dr. Vaengebjerg had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including AbbVie, Janssen, Novartis, Eli Lilly, LEO Pharma, UCB, Almirall, and Sanofi.

SOURCE: Vaengebjerg S et al. JAMA Dermatol. 2020 Feb 19. doi:10.1001/jamadermatol.2020.0024.

Psoriasis patients are at increased risk for several types of cancer, notably lymphoma and keratinocyte cancer, based on data from a systematic review and meta-analysis of more than 2 million patients.

Previous studies have identified an increased overall cancer risk in psoriasis patients, compared with the general population or controls without psoriasis, and both lymphomas and keratinocyte cancers occur more often in psoriasis patients, compared with controls, but additional larger studies have been conducted since the last meta-analysis was published in 2013, wrote Sofie Vaengebjerg, MD, of the University of Copenhagen and colleagues.

To better identify the risk of cancer in psoriasis and psoriatic arthritis patients and to explore the impact of biologics, the researchers reviewed data from 112 studies totaling 2,053,932 patients in a study published in JAMA Dermatology.

Overall, the risk of any cancer was slightly higher in psoriasis patients (risk ratio, 1.21; 95% confidence interval, 1.11-1.33), compared with controls, with a prevalence of 4.78% and an incidence rate of 11.75 per 1,000 person-years. The most common cancer among psoriasis patients was keratinocyte cancer, with a risk ratio of 2.28 (95% CI, 1.73-3.01), a prevalence of 2.55%, and an incidence rate of 4.35 per 1,000 person-years.

Other cancers with significantly elevated risk among psoriasis patients were lymphomas (RR, 1.56; 95% CI, 1.37-1.78), lung cancer (RR, 1.26; 95% CI, 1.13-1.40), and bladder cancer (RR, 1.12; 95% CI, 1.04-1.19).

No increased risk of cancer was noted among psoriasis patients who were treated with biologics. “However, patients receiving biologic agents are selected and the results might be reliant on selection bias, and studies investigating long-term safety of these drugs are still limited,” the researchers wrote.

In addition, psoriatic arthritis was not associated with any overall increase in cancer risk, with the exception of three studies showing an increased risk for breast cancer, the researchers noted. The overall cancer prevalence for psoriatic arthritis patients was 5.74%, with an incidence rate of 6.44 per 1,000 person-years.

The study findings were limited by several factors, including the inconsistencies in study design and characteristics and the small amount of data on biologic agents and psoriatic arthritis, the researchers noted. However, the results were strengthened by the large number of patients, real-world study settings, inclusion of biologics, and analysis of cancer in psoriatic arthritis patients.

“Clinicians treating patients with psoriasis should be aware of this increased risk, especially for lymphomas, as immunogenic treatment might be associated with exacerbations,” and should be aware that more research is needed to assess cancer risk associated with biologics, they concluded.

The study received no outside funding. Lead author Dr. Vaengebjerg had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including AbbVie, Janssen, Novartis, Eli Lilly, LEO Pharma, UCB, Almirall, and Sanofi.

SOURCE: Vaengebjerg S et al. JAMA Dermatol. 2020 Feb 19. doi:10.1001/jamadermatol.2020.0024.

Psoriasis patients are at increased risk for several types of cancer, notably lymphoma and keratinocyte cancer, based on data from a systematic review and meta-analysis of more than 2 million patients.

Previous studies have identified an increased overall cancer risk in psoriasis patients, compared with the general population or controls without psoriasis, and both lymphomas and keratinocyte cancers occur more often in psoriasis patients, compared with controls, but additional larger studies have been conducted since the last meta-analysis was published in 2013, wrote Sofie Vaengebjerg, MD, of the University of Copenhagen and colleagues.

To better identify the risk of cancer in psoriasis and psoriatic arthritis patients and to explore the impact of biologics, the researchers reviewed data from 112 studies totaling 2,053,932 patients in a study published in JAMA Dermatology.

Overall, the risk of any cancer was slightly higher in psoriasis patients (risk ratio, 1.21; 95% confidence interval, 1.11-1.33), compared with controls, with a prevalence of 4.78% and an incidence rate of 11.75 per 1,000 person-years. The most common cancer among psoriasis patients was keratinocyte cancer, with a risk ratio of 2.28 (95% CI, 1.73-3.01), a prevalence of 2.55%, and an incidence rate of 4.35 per 1,000 person-years.

Other cancers with significantly elevated risk among psoriasis patients were lymphomas (RR, 1.56; 95% CI, 1.37-1.78), lung cancer (RR, 1.26; 95% CI, 1.13-1.40), and bladder cancer (RR, 1.12; 95% CI, 1.04-1.19).

No increased risk of cancer was noted among psoriasis patients who were treated with biologics. “However, patients receiving biologic agents are selected and the results might be reliant on selection bias, and studies investigating long-term safety of these drugs are still limited,” the researchers wrote.

In addition, psoriatic arthritis was not associated with any overall increase in cancer risk, with the exception of three studies showing an increased risk for breast cancer, the researchers noted. The overall cancer prevalence for psoriatic arthritis patients was 5.74%, with an incidence rate of 6.44 per 1,000 person-years.

The study findings were limited by several factors, including the inconsistencies in study design and characteristics and the small amount of data on biologic agents and psoriatic arthritis, the researchers noted. However, the results were strengthened by the large number of patients, real-world study settings, inclusion of biologics, and analysis of cancer in psoriatic arthritis patients.

“Clinicians treating patients with psoriasis should be aware of this increased risk, especially for lymphomas, as immunogenic treatment might be associated with exacerbations,” and should be aware that more research is needed to assess cancer risk associated with biologics, they concluded.

The study received no outside funding. Lead author Dr. Vaengebjerg had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including AbbVie, Janssen, Novartis, Eli Lilly, LEO Pharma, UCB, Almirall, and Sanofi.

SOURCE: Vaengebjerg S et al. JAMA Dermatol. 2020 Feb 19. doi:10.1001/jamadermatol.2020.0024.

Nine infants younger than 1 year of age were infected with the virus that causes COVID-19 and hospitalized in China between Dec. 8, 2019, and Feb. 6, 2020, based on data from the Chinese central government and local health departments.

Courtesy NIAID-RML

“As of February 6, 2020, China reported 31,211 confirmed cases of COVID-19 and 637 fatalities,” wrote Min Wei, MD, of Wuhan University, China, and colleagues. However, “few infections in children have been reported.”

In a research letter published in JAMA, the investigators reviewed data from nine infants aged 28 days to 1 year who were hospitalized with a diagnosis of COVID-19 between Dec. 8, 2019, and Feb. 6, 2020. The ages of the infants ranged from 1 month to 11 months, and seven were female. The patients included two children from Beijing, two from Hainan, and one each from the areas of Guangdong, Anhui, Shanghai, Zhejiang, and Guizhou.

All infected infants had at least one infected family member, and the infants’ infections occurred after the family members’ infections; seven infants lived in Wuhan or had family members who had visited Wuhan.

One of the infants had no symptoms but tested positive for the 2019 novel coronavirus, and two others had a diagnosis but missing information on any symptoms. Fever occurred in four patients, and mild upper respiratory tract symptoms occurred in two patients.

None of the infants died, and none reported severe complications or the need for intensive care or mechanical ventilation, the investigators said. The fact that most of the infants were female might suggest that they are more susceptible to the virus than males, although overall COVID-19 viral infections have been more common in adult men, especially those with chronic comorbidities, Dr. Wei and associates noted.

The study findings were limited by the small sample size and lack of symptom data for some patients, the researchers said. However, the results confirm that the COVID-19 virus is transmissible to infants younger than 1 year, and adult caregivers should exercise protective measures including wearing masks, washing hands before contact with infants, and routinely sterilizing toys and tableware, they emphasized.

The study was supported by the National Natural Science Foundation of China and the Fundamental Research Funds for the Central Universities. The researchers had no financial conflicts to disclose.

SOURCE: Wei M et al. JAMA. 2020 Feb 14. doi:10.1001/jama.2020.2131.

Nine infants younger than 1 year of age were infected with the virus that causes COVID-19 and hospitalized in China between Dec. 8, 2019, and Feb. 6, 2020, based on data from the Chinese central government and local health departments.

Courtesy NIAID-RML

“As of February 6, 2020, China reported 31,211 confirmed cases of COVID-19 and 637 fatalities,” wrote Min Wei, MD, of Wuhan University, China, and colleagues. However, “few infections in children have been reported.”

In a research letter published in JAMA, the investigators reviewed data from nine infants aged 28 days to 1 year who were hospitalized with a diagnosis of COVID-19 between Dec. 8, 2019, and Feb. 6, 2020. The ages of the infants ranged from 1 month to 11 months, and seven were female. The patients included two children from Beijing, two from Hainan, and one each from the areas of Guangdong, Anhui, Shanghai, Zhejiang, and Guizhou.

All infected infants had at least one infected family member, and the infants’ infections occurred after the family members’ infections; seven infants lived in Wuhan or had family members who had visited Wuhan.

One of the infants had no symptoms but tested positive for the 2019 novel coronavirus, and two others had a diagnosis but missing information on any symptoms. Fever occurred in four patients, and mild upper respiratory tract symptoms occurred in two patients.

None of the infants died, and none reported severe complications or the need for intensive care or mechanical ventilation, the investigators said. The fact that most of the infants were female might suggest that they are more susceptible to the virus than males, although overall COVID-19 viral infections have been more common in adult men, especially those with chronic comorbidities, Dr. Wei and associates noted.

The study findings were limited by the small sample size and lack of symptom data for some patients, the researchers said. However, the results confirm that the COVID-19 virus is transmissible to infants younger than 1 year, and adult caregivers should exercise protective measures including wearing masks, washing hands before contact with infants, and routinely sterilizing toys and tableware, they emphasized.

The study was supported by the National Natural Science Foundation of China and the Fundamental Research Funds for the Central Universities. The researchers had no financial conflicts to disclose.

SOURCE: Wei M et al. JAMA. 2020 Feb 14. doi:10.1001/jama.2020.2131.

Nine infants younger than 1 year of age were infected with the virus that causes COVID-19 and hospitalized in China between Dec. 8, 2019, and Feb. 6, 2020, based on data from the Chinese central government and local health departments.

Courtesy NIAID-RML

“As of February 6, 2020, China reported 31,211 confirmed cases of COVID-19 and 637 fatalities,” wrote Min Wei, MD, of Wuhan University, China, and colleagues. However, “few infections in children have been reported.”

In a research letter published in JAMA, the investigators reviewed data from nine infants aged 28 days to 1 year who were hospitalized with a diagnosis of COVID-19 between Dec. 8, 2019, and Feb. 6, 2020. The ages of the infants ranged from 1 month to 11 months, and seven were female. The patients included two children from Beijing, two from Hainan, and one each from the areas of Guangdong, Anhui, Shanghai, Zhejiang, and Guizhou.

All infected infants had at least one infected family member, and the infants’ infections occurred after the family members’ infections; seven infants lived in Wuhan or had family members who had visited Wuhan.

One of the infants had no symptoms but tested positive for the 2019 novel coronavirus, and two others had a diagnosis but missing information on any symptoms. Fever occurred in four patients, and mild upper respiratory tract symptoms occurred in two patients.

None of the infants died, and none reported severe complications or the need for intensive care or mechanical ventilation, the investigators said. The fact that most of the infants were female might suggest that they are more susceptible to the virus than males, although overall COVID-19 viral infections have been more common in adult men, especially those with chronic comorbidities, Dr. Wei and associates noted.

The study findings were limited by the small sample size and lack of symptom data for some patients, the researchers said. However, the results confirm that the COVID-19 virus is transmissible to infants younger than 1 year, and adult caregivers should exercise protective measures including wearing masks, washing hands before contact with infants, and routinely sterilizing toys and tableware, they emphasized.

The study was supported by the National Natural Science Foundation of China and the Fundamental Research Funds for the Central Universities. The researchers had no financial conflicts to disclose.

SOURCE: Wei M et al. JAMA. 2020 Feb 14. doi:10.1001/jama.2020.2131.

Changes in gut microbiota linked to red meat intake over time were significantly associated with increased risk of coronary heart disease, regardless of baseline microbiota measures, based on data from 760 participants in the Nurses’ Health Study.

“A gut microbiota–related metabolite, trimethylamine N-oxide (TMAO), has been related to risks of major adverse cardiovascular events including myocardial infarction and coronary heart disease (CHD) in epidemiological studies,” but previous studies have not examined the impact of long-term changes in TMAO on CHD risk, wrote Yoriko Heianza, RD, PhD, of Tulane University, New Orleans, and colleagues.

Red meat has been shown to increase TMAO levels, whereas discontinuation of red meat intake reduced plasma TMAO levels (Eur Heart J 2019;40:583-94), the investigators wrote.

In their study, published in the Journal of the American College of Cardiology, the researchers evaluated blood samples from 760 women who were participants in the Nurses’ Health Study. The samples were collected at two time points: 1989-1990 and 2000-2002. The researchers identified 360 incident cases of CHD over the study period and compared them with matched controls.

Over roughly 10 years, increases in TMAO over time were significantly associated with increased CHD risk, with a relative risk of 1.58 for the top tertile and a relative risk of 1.33 per each standard deviation.

Women with elevated levels of TMAO both at baseline and at the 10-year point had the highest CHD risk (relative risk 1.79), compared with women with low TMAO levels at baseline and 10 years later.

The researchers also found an impact of diet on the TMAO-CHD relationship. Individuals with unhealthy eating patterns based on the Alternate Healthy Eating Index showed greater increases in TMAO and greater CHD risk. By contrast, greater adherence to healthy eating habits attenuated the impact of TMAO and CHD.

The study findings were limited by several factors, including the inability to assess the timing of the changes in the metabolites that contributed to CHD, the reliance on self-reports for dietary patterns and other variables, and the inclusion only of women health professionals in the study population, the researchers noted. However, the results were strengthened by the availability of long-term blood samples and a patient population free of disease at baseline.

In addition, “adherence to healthy dietary patterns may modulate the adverse relationship between TMAO changes and CHD, suggesting that TMAO as a potential intermediate endpoint of interventions focusing on dietary modifications for CHD prevention,” the researchers wrote.

“The findings of the study provide further evidence for the role of TMAO as a predictive biomarker for atherosclerotic heart disease and strengthen the case for TMAO as a potential intervention target in CV [cardiovascular] disease prevention,” wrote Paul A. Heidenreich, MD, and Petra Mamic, MD, of Stanford (Calif.) University, in an accompanying editorial.

In addition, “It is increasingly clear that GMB [gut microbiota] metabolites have biological activity, and that dietary changes alter the GMB and its metabolic output, with subsequent modulation of downstream host effects,” they wrote.

“While acknowledging the limitations of self-reported dietary pattern assessment, this is an important finding because it suggests that healthy dietary patterns may in some ways neutralize TMAO’s harmful effects on the CV system, potentially through other identified and unidentified GMB-mediated pathways,” they added.

The study was sponsored in part by the National Institutes of Health, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. Neither the researchers nor the editorialists had any financial conflicts to disclose.

SOURCES: Heianza Y et al. J Am Coll Cardiol. 2020 Feb 17. doi: 0.1016/j.jacc.2019.11.060; Heidenreich PA, Mamic P. J Am Coll Cardiol. 2020 Feb 17. doi: 10.1016/j.jacc.2019.12.023.

Changes in gut microbiota linked to red meat intake over time were significantly associated with increased risk of coronary heart disease, regardless of baseline microbiota measures, based on data from 760 participants in the Nurses’ Health Study.

“A gut microbiota–related metabolite, trimethylamine N-oxide (TMAO), has been related to risks of major adverse cardiovascular events including myocardial infarction and coronary heart disease (CHD) in epidemiological studies,” but previous studies have not examined the impact of long-term changes in TMAO on CHD risk, wrote Yoriko Heianza, RD, PhD, of Tulane University, New Orleans, and colleagues.

Red meat has been shown to increase TMAO levels, whereas discontinuation of red meat intake reduced plasma TMAO levels (Eur Heart J 2019;40:583-94), the investigators wrote.

In their study, published in the Journal of the American College of Cardiology, the researchers evaluated blood samples from 760 women who were participants in the Nurses’ Health Study. The samples were collected at two time points: 1989-1990 and 2000-2002. The researchers identified 360 incident cases of CHD over the study period and compared them with matched controls.

Over roughly 10 years, increases in TMAO over time were significantly associated with increased CHD risk, with a relative risk of 1.58 for the top tertile and a relative risk of 1.33 per each standard deviation.

Women with elevated levels of TMAO both at baseline and at the 10-year point had the highest CHD risk (relative risk 1.79), compared with women with low TMAO levels at baseline and 10 years later.

The researchers also found an impact of diet on the TMAO-CHD relationship. Individuals with unhealthy eating patterns based on the Alternate Healthy Eating Index showed greater increases in TMAO and greater CHD risk. By contrast, greater adherence to healthy eating habits attenuated the impact of TMAO and CHD.

The study findings were limited by several factors, including the inability to assess the timing of the changes in the metabolites that contributed to CHD, the reliance on self-reports for dietary patterns and other variables, and the inclusion only of women health professionals in the study population, the researchers noted. However, the results were strengthened by the availability of long-term blood samples and a patient population free of disease at baseline.

In addition, “adherence to healthy dietary patterns may modulate the adverse relationship between TMAO changes and CHD, suggesting that TMAO as a potential intermediate endpoint of interventions focusing on dietary modifications for CHD prevention,” the researchers wrote.

“The findings of the study provide further evidence for the role of TMAO as a predictive biomarker for atherosclerotic heart disease and strengthen the case for TMAO as a potential intervention target in CV [cardiovascular] disease prevention,” wrote Paul A. Heidenreich, MD, and Petra Mamic, MD, of Stanford (Calif.) University, in an accompanying editorial.

In addition, “It is increasingly clear that GMB [gut microbiota] metabolites have biological activity, and that dietary changes alter the GMB and its metabolic output, with subsequent modulation of downstream host effects,” they wrote.

“While acknowledging the limitations of self-reported dietary pattern assessment, this is an important finding because it suggests that healthy dietary patterns may in some ways neutralize TMAO’s harmful effects on the CV system, potentially through other identified and unidentified GMB-mediated pathways,” they added.

The study was sponsored in part by the National Institutes of Health, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. Neither the researchers nor the editorialists had any financial conflicts to disclose.

SOURCES: Heianza Y et al. J Am Coll Cardiol. 2020 Feb 17. doi: 0.1016/j.jacc.2019.11.060; Heidenreich PA, Mamic P. J Am Coll Cardiol. 2020 Feb 17. doi: 10.1016/j.jacc.2019.12.023.

Changes in gut microbiota linked to red meat intake over time were significantly associated with increased risk of coronary heart disease, regardless of baseline microbiota measures, based on data from 760 participants in the Nurses’ Health Study.

“A gut microbiota–related metabolite, trimethylamine N-oxide (TMAO), has been related to risks of major adverse cardiovascular events including myocardial infarction and coronary heart disease (CHD) in epidemiological studies,” but previous studies have not examined the impact of long-term changes in TMAO on CHD risk, wrote Yoriko Heianza, RD, PhD, of Tulane University, New Orleans, and colleagues.

Red meat has been shown to increase TMAO levels, whereas discontinuation of red meat intake reduced plasma TMAO levels (Eur Heart J 2019;40:583-94), the investigators wrote.

In their study, published in the Journal of the American College of Cardiology, the researchers evaluated blood samples from 760 women who were participants in the Nurses’ Health Study. The samples were collected at two time points: 1989-1990 and 2000-2002. The researchers identified 360 incident cases of CHD over the study period and compared them with matched controls.

Over roughly 10 years, increases in TMAO over time were significantly associated with increased CHD risk, with a relative risk of 1.58 for the top tertile and a relative risk of 1.33 per each standard deviation.

Women with elevated levels of TMAO both at baseline and at the 10-year point had the highest CHD risk (relative risk 1.79), compared with women with low TMAO levels at baseline and 10 years later.

The researchers also found an impact of diet on the TMAO-CHD relationship. Individuals with unhealthy eating patterns based on the Alternate Healthy Eating Index showed greater increases in TMAO and greater CHD risk. By contrast, greater adherence to healthy eating habits attenuated the impact of TMAO and CHD.

The study findings were limited by several factors, including the inability to assess the timing of the changes in the metabolites that contributed to CHD, the reliance on self-reports for dietary patterns and other variables, and the inclusion only of women health professionals in the study population, the researchers noted. However, the results were strengthened by the availability of long-term blood samples and a patient population free of disease at baseline.

In addition, “adherence to healthy dietary patterns may modulate the adverse relationship between TMAO changes and CHD, suggesting that TMAO as a potential intermediate endpoint of interventions focusing on dietary modifications for CHD prevention,” the researchers wrote.

“The findings of the study provide further evidence for the role of TMAO as a predictive biomarker for atherosclerotic heart disease and strengthen the case for TMAO as a potential intervention target in CV [cardiovascular] disease prevention,” wrote Paul A. Heidenreich, MD, and Petra Mamic, MD, of Stanford (Calif.) University, in an accompanying editorial.

In addition, “It is increasingly clear that GMB [gut microbiota] metabolites have biological activity, and that dietary changes alter the GMB and its metabolic output, with subsequent modulation of downstream host effects,” they wrote.

“While acknowledging the limitations of self-reported dietary pattern assessment, this is an important finding because it suggests that healthy dietary patterns may in some ways neutralize TMAO’s harmful effects on the CV system, potentially through other identified and unidentified GMB-mediated pathways,” they added.

The study was sponsored in part by the National Institutes of Health, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. Neither the researchers nor the editorialists had any financial conflicts to disclose.

SOURCES: Heianza Y et al. J Am Coll Cardiol. 2020 Feb 17. doi: 0.1016/j.jacc.2019.11.060; Heidenreich PA, Mamic P. J Am Coll Cardiol. 2020 Feb 17. doi: 10.1016/j.jacc.2019.12.023.

Systemic acne treatments may be underused in non-Hispanic black patients, women, and Medicaid patients, based on findings from a retrospective, cohort study of 29,928 individuals with acne.

“Our findings suggest the presence of racial/ethnic, sex, and insurance-based disparities in health care use and treatment for acne and raise particular concern for undertreatment among racial/ethnic minority and female patients,” John S. Barbieri, MD, a dermatology research fellow at the University of Pennsylvania, Philadelphia, and colleagues wrote in a study published in JAMA Dermatology.

Data from previous studies have suggested racial disparities in the management of several dermatologic conditions, including atopic dermatitis and psoriasis, but associations between social demographics and prescribing patterns have not been well studied for acne treatment, the authors noted.

For the current study, the researchers used deidentified data from the Optum electronic health record from Jan. 1, 2007 to June 30, 2017. In all, 29,928 patients aged 15-35 years and who were being treated for acne were included in the study. Of that total, 64% were women, 8% were non-Hispanic black and 68% were white, with the remaining patients grouped as non-Hispanic Asian, Hispanic, or other.

Non-Hispanic black patients were significantly more likely to be seen by a dermatologist, compared with non-Hispanic white patients, who were designated as the reference (odds ratio, 1.20). However, the black patients were less likely to receive prescriptions for any acne medication (incidence rate ratio, 0.89).

Non-Hispanic black patients were more likely than non-Hispanic white patients to be prescribed topical retinoids or topical antibiotics (OR, 1.25 and 1.35, respectively). They were also were less likely than their white counterparts to be prescribed oral antibiotics, spironolactone, and isotretinoin (OR, 0.80, 0.68, and 0.39, respectively).

Overall, men were more than twice as likely as women to receive prescriptions for isotretinoin (OR, 2.44). They were also more likely to receive prescriptions for the other treatments, but the differences were not as high as those for isotretinoin.

In addition, patients with Medicaid insurance were significantly less likely than those with commercial insurance (the reference) to see a dermatologist (OR, 0.46). Medicaid patients also were less likely to be prescribed topical retinoids, oral antibiotics, spironolactone, or isotretinoin (OR, 0.82, 0.87, 0.50, and 0.43, respectively).

The study findings were limited by several factors, among them, the use of automated pharmacy data without confirmation that patients had picked up the medications they had been prescribed, the researchers said. The study also lacked data on acne severity, clinical outcomes, and the use of over-the-counter acne treatments.

“Further study is needed to confirm our findings, provide understanding of the reasons for these potential disparities, and develop strategies to ensure equitable care for patients with acne,” the researchers concluded.

The study was supported in part by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, and by a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Barbieri had no financial conflicts to disclose. One of the study coauthors disclosed relationships with Pfizer, Eli Lilly, and Novartis.

SOURCE: Barbieri JS et al. JAMA Dermatol. 2020 Feb 5. doi: 10.1001/jamadermatol.2019.4818.

Systemic acne treatments may be underused in non-Hispanic black patients, women, and Medicaid patients, based on findings from a retrospective, cohort study of 29,928 individuals with acne.

“Our findings suggest the presence of racial/ethnic, sex, and insurance-based disparities in health care use and treatment for acne and raise particular concern for undertreatment among racial/ethnic minority and female patients,” John S. Barbieri, MD, a dermatology research fellow at the University of Pennsylvania, Philadelphia, and colleagues wrote in a study published in JAMA Dermatology.

Data from previous studies have suggested racial disparities in the management of several dermatologic conditions, including atopic dermatitis and psoriasis, but associations between social demographics and prescribing patterns have not been well studied for acne treatment, the authors noted.

For the current study, the researchers used deidentified data from the Optum electronic health record from Jan. 1, 2007 to June 30, 2017. In all, 29,928 patients aged 15-35 years and who were being treated for acne were included in the study. Of that total, 64% were women, 8% were non-Hispanic black and 68% were white, with the remaining patients grouped as non-Hispanic Asian, Hispanic, or other.

Non-Hispanic black patients were significantly more likely to be seen by a dermatologist, compared with non-Hispanic white patients, who were designated as the reference (odds ratio, 1.20). However, the black patients were less likely to receive prescriptions for any acne medication (incidence rate ratio, 0.89).

Non-Hispanic black patients were more likely than non-Hispanic white patients to be prescribed topical retinoids or topical antibiotics (OR, 1.25 and 1.35, respectively). They were also were less likely than their white counterparts to be prescribed oral antibiotics, spironolactone, and isotretinoin (OR, 0.80, 0.68, and 0.39, respectively).

Overall, men were more than twice as likely as women to receive prescriptions for isotretinoin (OR, 2.44). They were also more likely to receive prescriptions for the other treatments, but the differences were not as high as those for isotretinoin.

In addition, patients with Medicaid insurance were significantly less likely than those with commercial insurance (the reference) to see a dermatologist (OR, 0.46). Medicaid patients also were less likely to be prescribed topical retinoids, oral antibiotics, spironolactone, or isotretinoin (OR, 0.82, 0.87, 0.50, and 0.43, respectively).

The study findings were limited by several factors, among them, the use of automated pharmacy data without confirmation that patients had picked up the medications they had been prescribed, the researchers said. The study also lacked data on acne severity, clinical outcomes, and the use of over-the-counter acne treatments.

“Further study is needed to confirm our findings, provide understanding of the reasons for these potential disparities, and develop strategies to ensure equitable care for patients with acne,” the researchers concluded.

The study was supported in part by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, and by a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Barbieri had no financial conflicts to disclose. One of the study coauthors disclosed relationships with Pfizer, Eli Lilly, and Novartis.

SOURCE: Barbieri JS et al. JAMA Dermatol. 2020 Feb 5. doi: 10.1001/jamadermatol.2019.4818.

Systemic acne treatments may be underused in non-Hispanic black patients, women, and Medicaid patients, based on findings from a retrospective, cohort study of 29,928 individuals with acne.

“Our findings suggest the presence of racial/ethnic, sex, and insurance-based disparities in health care use and treatment for acne and raise particular concern for undertreatment among racial/ethnic minority and female patients,” John S. Barbieri, MD, a dermatology research fellow at the University of Pennsylvania, Philadelphia, and colleagues wrote in a study published in JAMA Dermatology.

Data from previous studies have suggested racial disparities in the management of several dermatologic conditions, including atopic dermatitis and psoriasis, but associations between social demographics and prescribing patterns have not been well studied for acne treatment, the authors noted.

For the current study, the researchers used deidentified data from the Optum electronic health record from Jan. 1, 2007 to June 30, 2017. In all, 29,928 patients aged 15-35 years and who were being treated for acne were included in the study. Of that total, 64% were women, 8% were non-Hispanic black and 68% were white, with the remaining patients grouped as non-Hispanic Asian, Hispanic, or other.

Non-Hispanic black patients were significantly more likely to be seen by a dermatologist, compared with non-Hispanic white patients, who were designated as the reference (odds ratio, 1.20). However, the black patients were less likely to receive prescriptions for any acne medication (incidence rate ratio, 0.89).

Non-Hispanic black patients were more likely than non-Hispanic white patients to be prescribed topical retinoids or topical antibiotics (OR, 1.25 and 1.35, respectively). They were also were less likely than their white counterparts to be prescribed oral antibiotics, spironolactone, and isotretinoin (OR, 0.80, 0.68, and 0.39, respectively).

Overall, men were more than twice as likely as women to receive prescriptions for isotretinoin (OR, 2.44). They were also more likely to receive prescriptions for the other treatments, but the differences were not as high as those for isotretinoin.

In addition, patients with Medicaid insurance were significantly less likely than those with commercial insurance (the reference) to see a dermatologist (OR, 0.46). Medicaid patients also were less likely to be prescribed topical retinoids, oral antibiotics, spironolactone, or isotretinoin (OR, 0.82, 0.87, 0.50, and 0.43, respectively).

The study findings were limited by several factors, among them, the use of automated pharmacy data without confirmation that patients had picked up the medications they had been prescribed, the researchers said. The study also lacked data on acne severity, clinical outcomes, and the use of over-the-counter acne treatments.

“Further study is needed to confirm our findings, provide understanding of the reasons for these potential disparities, and develop strategies to ensure equitable care for patients with acne,” the researchers concluded.

The study was supported in part by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, and by a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Barbieri had no financial conflicts to disclose. One of the study coauthors disclosed relationships with Pfizer, Eli Lilly, and Novartis.

SOURCE: Barbieri JS et al. JAMA Dermatol. 2020 Feb 5. doi: 10.1001/jamadermatol.2019.4818.

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

A single dose of the human papillomavirus vaccine is as effective as two or three doses for preventing cervical cancer in girls and women vaccinated at 15-19 years of age, based on data from a retrospective study of more than 100,000 girls and women.

The Centers for Disease Control and Prevention’s current recommendations include a two-dose vaccine schedule for the HPV vaccine for girls and boys younger than 15 years, and a three-dose schedule for girls and young women aged 16-26 years who had their first dose before turning 15.

However, rates of HPV vaccination in the United States fall short of those in other developed nations, and evidence supporting the protective value of a specific number of vaccine doses are mixed, wrote Ana M. Rodriguez, MD, MPH, of the University of Texas Medical Branch at Galveston, and colleagues. Fewer than three doses could have benefits, including easier logistics, lower costs, higher acceptance rates, and fewer side effects, they said. The study was published in Cancer.

The researchers reviewed data from 66,541 girls and women aged 9-26 years who had received at least one dose of HPV vaccine (4vHPV) between Jan. 1, 2006, and June 30, 2015, and 66,541 matched unvaccinated controls. The primary outcomes were histologically confirmed preinvasive cervical disease and high-grade cytology.

Overall, the adjusted hazard ratios for histologically confirmed preinvasive cervical disease among patients vaccinated at the ages of 15-19 years with one, two, and three doses were similar, at 0.64, 0.72, and 0.66, respectively, compared with unvaccinated individuals.

The risk of high-grade cytology was significantly lower for girls and women who received three doses at age 15-19 years, compared with unvaccinated individuals, but no difference was seen in high-grade cytology between unvaccinated individuals and those who received one or two doses. In addition, the unadjusted rate of preinvasive cervical disease at 5 years was 2.65% for unvaccinated teens aged 15-19 years, compared with 1.62%, 1.99%, and 1.86% in the one-, two- and three-dose groups, respectively.The findings were limited by several factors, including the use of billing codes to determine outcomes and the inability to determine potential vaccination through multiple insurance carriers, and the inclusion only of privately insured patients from the claims database, the researchers noted.

However, the results support findings from previous studies and show a similar level of association between varying vaccine doses and preinvasive cervical lesions in the 15- to 19-year-old population, they said.

“Efforts should focus on not only the need to initiate the HPV vaccine but also the need for beginning and continuing cervical cancer screening among young women who are vaccinated at older ages (18 years and older),” they said.

In an editorial accompanying the study, Julia M.L. Brotherton, PhD, MPH, and Karin Sundström, MD, PhD, of the University of Melbourne, Australia, and the Karolinska Institutet, Stockholm, respectively, wrote that the study’s strengths included the large numbers of girls and women who received a single dose of the HPV vaccine, compared with previous studies, as well as the adjustments for histories of sexually transmitted infections and pregnancy (Cancer. 2020 Feb 10. doi: 10.1002/cncr.32696). “Initial observational data from vaccination programs did not support equivalent one-dose protection against genital warts or cervical disease, but such data may have been confounded by potentially higher risk characteristics of women who only ever received one or two doses of an intended three-dose course i.e., women noncompliant with the vaccine program [amplified by the monitoring of outcomes among the initial catch-up populations of already infected women]) and by the inherent bias that prevalent infection/disease is more likely to become apparent coincidently with the earlier doses in a vaccine course,” they said. The study findings have implications for global goals to eliminate cervical cancer, the editorial authors noted.

“If one dose of an HPV vaccine were sufficient for effective protection, HPV vaccine implementation and scale-up would require less logistics (while being amenable to a periodic campaign approach), available doses could be extended further, and the overall cost would be lower,” they said.

The study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health, and by the Cancer Prevention Research Institute of Texas. The researchers had no financial conflicts to disclose.

Dr. Brotherton disclosed serving as an investigator for Seqirus and Merck; Dr. Sundström disclosed research funding for her institution from Merck and MSD Sweden.

SOURCE: Rodriguez AM et al. Cancer. 2020 Feb 10. doi: 10.1002/cncr.32700.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

White Hispanic adults report a lower quality of life and less knowledge of skin cancer and sun protection behaviors than white non-Hispanic adults, survey results of 175 adults with nonmelanoma skin cancer show.

“The incidence of nonmelanoma skin cancer (NMSC) is lower in Hispanics when compared to Caucasians, but a high index of suspicion is needed given ethnic differences in presentation,” wrote Ali Rajabi-Estarabadi, MD, of the University of Miami, and colleagues.

Hispanic patients with NMSC tend to be younger than non-Hispanic white patients, and their basal cell carcinomas are more likely to be pigmented, the investigators noted. Although previous research suggests ethnic disparities in NMSC, factors including sun safety knowledge and quality of life after diagnosis have not been well studied, they said.

With this in mind, the investigators conducted a survey of white Hispanics and non-Hispanics treated for NMSC. The results were published as a research letter in the Journal of the American Academy of Dermatology.

The investigators recruited 175 consecutive patients being treated for NMSC with Mohs surgery at a single center. The average age of the patients was 67 years; 58 identified as white Hispanic, 116 identified as white non-Hispanic.

Skin cancer quality of life scores were significantly higher (worse) among white Hispanic patients, compared with white non-Hispanic patients (9.7 vs. 6.0).

White Hispanic patients had significantly lower skin cancer knowledge scores, compared with white non-Hispanics (P = .003). White Hispanics were significantly more likely than white non-Hispanics to report never wearing hats (39% vs. 12%) and never wearing sunglasses (26% vs. 9%) for sun protection.

The findings were limited by the study population that included only residents of South Florida. However, the results highlight the need for “targeted patient education initiatives to bridge ethnic disparities regarding cancer knowledge and ultimately improve [quality of life] among Hispanic skin cancer suffers,” the investigators concluded.

The study received no outside funding. The investigators declared no conflicts of interest.

SOURCE: Rajabi-Estarabadi A et al. J Am Acad Dermatol. 2020 Feb 4. doi: 10.1016/j.jaad.2020.01.063.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

[email protected]

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.