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Dermatology and monkeypox: What you need to know
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Diagnosing cases “can be hard and folks should keep a very open mind and consider monkeypox virus,” said Misha Rosenbach, MD, a University of Pennsylvania dermatologist and member of the American Academy of Dermatology’s ad hoc task force to develop monkeypox content.
Although it’s named after a primate, it turns out that monkeypox is quite the copycat. As dermatologists have learned, its lesions can look like those caused by a long list of other diseases including herpes, varicella, and syphilis. In small numbers, they can even appear to be insect bites.
To make things more complicated, a patient can have one or two lesions – or dozens. They often cluster in the anogenital area, likely reflecting transmission via sexual intercourse, unlike previous outbreaks in which lesions appeared all over the body. “We have to let go of some of our conceptions about what monkeypox might look like,” said dermatologist Esther Freeman, MD, PhD, associate professor of dermatology, Harvard University, Boston, and a member of the AAD task force.
To make things even more complicated, “the spectrum of illness that we are seeing has ranged from limited, subtle lesions to dramatic, widespread, ulcerative/necrotic lesions,” said Dr. Rosenbach, associate professor of dermatology at the University of Pennsylvania, Philadelphia.
But monkeypox has unique traits that can set it apart and pave the way toward a diagnosis, dermatologists say. And important patient data can help dermatologists gauge the likelihood of a case: Almost 99% of cases with data available have been in men, and among men with available information, 94% reported male-to-male sexual or close intimate contact during the 3 weeks before developing symptoms, according to a CDC report tracking cases from May through late July. So far, cases in women and children are extremely rare, although there have been some reported in the United States.
Are dermatologists likely to see monkeypox in the clinic? It’s unclear so far. Of four dermatologists interviewed for this article, only one has seen patients with monkeypox in person. But others say they’ve been sought for consultations. “I have been asked by infectious disease colleagues for advice remotely but have not seen it,” said dermatologist Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “Most of the time, they’re catching all the symptomatic cases before any need for dermatology in-person referrals.”
Still, the rapid rate of growth of the outbreak – up from 3,487 in the United States on July 25 to 12,689 as of Aug.16 – suggests that more dermatologists will see cases, and consultations may become more common too.
Know your lesions
Lesions are the telltale signs of symptomatic monkeypox. According to a recent New England Journal of Medicine study of 528 monkeypox cases from 16 nations, diagnosed between April 27 and June 24, 2022, 95% had skin lesions (58% were vesiculopustular), most commonly in the anogenital area (73%), and on the trunk/arms/or legs (55%) and face (25%), and the palms/soles (10%).
However, “the current monkeypox outbreak often presents differently from the multiple classic vesiculopustules on the skin we see in textbooks,” Dr. Yeung said. “Sometimes people can present with throat pain or rectal pain, with isolated pharyngitis or proctitis. Sometimes there are so few lesions on the skin that it can be easily confused with a bug bite, folliculitis, herpes, dyshidrotic eczema, or other skin problems. This is where dermatologists will get consulted to clarify the diagnosis while the monkeypox PCR test is pending.”
Dr. Rosenbach, who has provided consultation services to other physicians about cases, said the lesions often appear to be vesicles or pustules, “but if you go to ‘pop’ it – e.g., for testing – it’s firm and without fluid. This is likely due to pox virus inclusion, similar to other diseases such as molluscum,” caused by another pox virus, he said. Molluscum lesions are “characteristically umbilicated, with a dimple in the center, and monkeypox lesions seem to be showing a roughly similar morphology with many bowl- or caldera-shaped lesions that are donut-like in appearance,” he added.
Over time, Dr. Rosenbach said, “lesions tend to evolve slowly from smaller flesh-colored or vaguely white firm papules to broader more umbilicated/donut-shaped lesions which may erode, ulcerate, develop a crust or scab, and then heal. The amount of scarring is not yet clear, but we anticipate it to be significant, especially in patients with more widespread or severe disease.”
Jon Peebles, MD, a dermatologist at Kaiser Permanente in Largo, Md., who has treated a few in-person monkeypox cases, said the lesions can be “exquisitely painful,” although he’s also seen patients with asymptomatic lesions. “Lesions are showing a predilection for the anogenital skin, though they can occur anywhere and not uncommonly involve the oral mucosa,” said Dr. Peebles, also a member of the AAD monkeypox task force.
Dr. Yeung said it’s important to ask patients about their sexual orientation, gender identity, and sexual behaviors. “That is the only way to know who your patients are and the only way to understand who else may be at risks and can benefit from contact tracing and additional prevention measures, such as vaccination for asymptomatic sex partners.” (The Jynneos smallpox vaccine is Food and Drug Administration–approved to prevent monkeypox, although its efficacy is not entirely clear, and there’s controversy over expanding its limited availability by administering the vaccine intradermally.)
It’s also important to keep in mind that sexually transmitted infections (STIs) are common in gay and bisexual men. “Just because the patient is diagnosed with gonorrhea or syphilis does not mean the patient cannot also have monkeypox,” Dr. Rosenbach said. Indeed, the NEJM study reported that of 377 patients screened, 29% had an STI other than HIV, mostly syphilis (9%) and gonorrhea (8%). Of all 528 patients in the study (all male or transgender/nonbinary), 41% were HIV-positive, and the median number of sex partners in the last 3 months was 5 (range, 3-15).
Testing is crucial to rule monkeypox in – or out
While monkeypox lesions can be confused for other diseases, Dr. Rosenbach said that a diagnosis can be confirmed through various tests. Varicella zoster virus (VZV) and herpes simplex virus (HSV) have distinct findings on Tzanck smears (nuclear molding, multinucleated cells), and have widely available fairly rapid tests (PCR, or in some places, DFA). “Staph and bacterial folliculitis can usually be cultured quickly,” he said. “If you have someone with no risk factors/exposure, and you test for VZV, HSV, folliculitis, and it’s negative – you should know within 24 hours in most places – then you can broaden your differential diagnosis and consider alternate explanations, including monkeypox.”
Quest Diagnostics and Labcorp, two of the largest commercial labs in the United States, are now offering monkeypox tests. Labcorp says its test has a 2- to 3-day turnaround time.
As for treatment, some physicians are prescribing off-label use of tecovirimat (also known as TPOXX or ST-246), a smallpox antiviral treatment. The CDC offers guidelines about its use. “It seems to work very fast, with patients improving in 24-72 hours,” Dr. Rosenbach said. However, “it is still very challenging to give and get. There’s a cumbersome system to prescribe it, and it needs to be shipped from the national stockpile. Dermatologists should be working with their state health department, infection control, and infectious disease doctors.”
It’s likely that dermatologists are not comfortable with the process to access the drug, he said, “but if we do not act quickly to control the current outbreak, we will all – unfortunately – need to learn to be comfortable prescribing it.”
In regard to pain control, an over-the-counter painkiller approach may be appropriate depending on comorbidities, Dr. Rosenbach said. “Some patients with very severe disease, such as perianal involvement and proctitis, have such severe pain they need to be hospitalized. This is less common.”
Recommendations pending on scarring prevention
There’s limited high-quality evidence about the prevention of scarring in diseases like monkeypox, Dr. Rosenbach noted. “Any recommendations are usually based on very small, limited, uncontrolled studies. In the case of monkeypox, truly we are off the edge of the map.”
He advises cleaning lesions with gentle soap and water – keeping in mind that contaminated towels may spread disease – and potentially using a topical ointment-based dressing such as a Vaseline/nonstick dressing or Vaseline-impregnated gauze. If there’s concern about superinfection, as can occur with staph infections, topical antibiotics such as mupirocin 2% ointment may be appropriate, he said.
“Some folks like to try silica gel sheets to prevent scarring,” Dr. Rosenbach said. “There’s not a lot of evidence to support that, but they’re unlikely to be harmful. I would personally consider them, but it really depends on the extent of disease, anatomic sites involved, and access to care.”
Emory University’s Dr. Yeung also suggested using silicone gel or sheets to optimize the scar appearance once the lesions have crusted over. “People have used lasers, microneedling, etc., to improve smallpox scar appearance,” he added, “and I’m sure dermatologists will be the ones to study what works best for treating monkeypox scars.”
As for the big picture, Dr. Yeung said that dermatologists are critical in the fight to control monkeypox: “We can help our colleagues and patients manage symptoms and wound care, advocate for vaccination and treatment, treat long-term scarring sequelae, and destigmatize LGBTQ health care.”
The dermatologists interviewed for this article report no disclosures.
.
Diagnosing cases “can be hard and folks should keep a very open mind and consider monkeypox virus,” said Misha Rosenbach, MD, a University of Pennsylvania dermatologist and member of the American Academy of Dermatology’s ad hoc task force to develop monkeypox content.
Although it’s named after a primate, it turns out that monkeypox is quite the copycat. As dermatologists have learned, its lesions can look like those caused by a long list of other diseases including herpes, varicella, and syphilis. In small numbers, they can even appear to be insect bites.
To make things more complicated, a patient can have one or two lesions – or dozens. They often cluster in the anogenital area, likely reflecting transmission via sexual intercourse, unlike previous outbreaks in which lesions appeared all over the body. “We have to let go of some of our conceptions about what monkeypox might look like,” said dermatologist Esther Freeman, MD, PhD, associate professor of dermatology, Harvard University, Boston, and a member of the AAD task force.
To make things even more complicated, “the spectrum of illness that we are seeing has ranged from limited, subtle lesions to dramatic, widespread, ulcerative/necrotic lesions,” said Dr. Rosenbach, associate professor of dermatology at the University of Pennsylvania, Philadelphia.
But monkeypox has unique traits that can set it apart and pave the way toward a diagnosis, dermatologists say. And important patient data can help dermatologists gauge the likelihood of a case: Almost 99% of cases with data available have been in men, and among men with available information, 94% reported male-to-male sexual or close intimate contact during the 3 weeks before developing symptoms, according to a CDC report tracking cases from May through late July. So far, cases in women and children are extremely rare, although there have been some reported in the United States.
Are dermatologists likely to see monkeypox in the clinic? It’s unclear so far. Of four dermatologists interviewed for this article, only one has seen patients with monkeypox in person. But others say they’ve been sought for consultations. “I have been asked by infectious disease colleagues for advice remotely but have not seen it,” said dermatologist Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “Most of the time, they’re catching all the symptomatic cases before any need for dermatology in-person referrals.”
Still, the rapid rate of growth of the outbreak – up from 3,487 in the United States on July 25 to 12,689 as of Aug.16 – suggests that more dermatologists will see cases, and consultations may become more common too.
Know your lesions
Lesions are the telltale signs of symptomatic monkeypox. According to a recent New England Journal of Medicine study of 528 monkeypox cases from 16 nations, diagnosed between April 27 and June 24, 2022, 95% had skin lesions (58% were vesiculopustular), most commonly in the anogenital area (73%), and on the trunk/arms/or legs (55%) and face (25%), and the palms/soles (10%).
However, “the current monkeypox outbreak often presents differently from the multiple classic vesiculopustules on the skin we see in textbooks,” Dr. Yeung said. “Sometimes people can present with throat pain or rectal pain, with isolated pharyngitis or proctitis. Sometimes there are so few lesions on the skin that it can be easily confused with a bug bite, folliculitis, herpes, dyshidrotic eczema, or other skin problems. This is where dermatologists will get consulted to clarify the diagnosis while the monkeypox PCR test is pending.”
Dr. Rosenbach, who has provided consultation services to other physicians about cases, said the lesions often appear to be vesicles or pustules, “but if you go to ‘pop’ it – e.g., for testing – it’s firm and without fluid. This is likely due to pox virus inclusion, similar to other diseases such as molluscum,” caused by another pox virus, he said. Molluscum lesions are “characteristically umbilicated, with a dimple in the center, and monkeypox lesions seem to be showing a roughly similar morphology with many bowl- or caldera-shaped lesions that are donut-like in appearance,” he added.
Over time, Dr. Rosenbach said, “lesions tend to evolve slowly from smaller flesh-colored or vaguely white firm papules to broader more umbilicated/donut-shaped lesions which may erode, ulcerate, develop a crust or scab, and then heal. The amount of scarring is not yet clear, but we anticipate it to be significant, especially in patients with more widespread or severe disease.”
Jon Peebles, MD, a dermatologist at Kaiser Permanente in Largo, Md., who has treated a few in-person monkeypox cases, said the lesions can be “exquisitely painful,” although he’s also seen patients with asymptomatic lesions. “Lesions are showing a predilection for the anogenital skin, though they can occur anywhere and not uncommonly involve the oral mucosa,” said Dr. Peebles, also a member of the AAD monkeypox task force.
Dr. Yeung said it’s important to ask patients about their sexual orientation, gender identity, and sexual behaviors. “That is the only way to know who your patients are and the only way to understand who else may be at risks and can benefit from contact tracing and additional prevention measures, such as vaccination for asymptomatic sex partners.” (The Jynneos smallpox vaccine is Food and Drug Administration–approved to prevent monkeypox, although its efficacy is not entirely clear, and there’s controversy over expanding its limited availability by administering the vaccine intradermally.)
It’s also important to keep in mind that sexually transmitted infections (STIs) are common in gay and bisexual men. “Just because the patient is diagnosed with gonorrhea or syphilis does not mean the patient cannot also have monkeypox,” Dr. Rosenbach said. Indeed, the NEJM study reported that of 377 patients screened, 29% had an STI other than HIV, mostly syphilis (9%) and gonorrhea (8%). Of all 528 patients in the study (all male or transgender/nonbinary), 41% were HIV-positive, and the median number of sex partners in the last 3 months was 5 (range, 3-15).
Testing is crucial to rule monkeypox in – or out
While monkeypox lesions can be confused for other diseases, Dr. Rosenbach said that a diagnosis can be confirmed through various tests. Varicella zoster virus (VZV) and herpes simplex virus (HSV) have distinct findings on Tzanck smears (nuclear molding, multinucleated cells), and have widely available fairly rapid tests (PCR, or in some places, DFA). “Staph and bacterial folliculitis can usually be cultured quickly,” he said. “If you have someone with no risk factors/exposure, and you test for VZV, HSV, folliculitis, and it’s negative – you should know within 24 hours in most places – then you can broaden your differential diagnosis and consider alternate explanations, including monkeypox.”
Quest Diagnostics and Labcorp, two of the largest commercial labs in the United States, are now offering monkeypox tests. Labcorp says its test has a 2- to 3-day turnaround time.
As for treatment, some physicians are prescribing off-label use of tecovirimat (also known as TPOXX or ST-246), a smallpox antiviral treatment. The CDC offers guidelines about its use. “It seems to work very fast, with patients improving in 24-72 hours,” Dr. Rosenbach said. However, “it is still very challenging to give and get. There’s a cumbersome system to prescribe it, and it needs to be shipped from the national stockpile. Dermatologists should be working with their state health department, infection control, and infectious disease doctors.”
It’s likely that dermatologists are not comfortable with the process to access the drug, he said, “but if we do not act quickly to control the current outbreak, we will all – unfortunately – need to learn to be comfortable prescribing it.”
In regard to pain control, an over-the-counter painkiller approach may be appropriate depending on comorbidities, Dr. Rosenbach said. “Some patients with very severe disease, such as perianal involvement and proctitis, have such severe pain they need to be hospitalized. This is less common.”
Recommendations pending on scarring prevention
There’s limited high-quality evidence about the prevention of scarring in diseases like monkeypox, Dr. Rosenbach noted. “Any recommendations are usually based on very small, limited, uncontrolled studies. In the case of monkeypox, truly we are off the edge of the map.”
He advises cleaning lesions with gentle soap and water – keeping in mind that contaminated towels may spread disease – and potentially using a topical ointment-based dressing such as a Vaseline/nonstick dressing or Vaseline-impregnated gauze. If there’s concern about superinfection, as can occur with staph infections, topical antibiotics such as mupirocin 2% ointment may be appropriate, he said.
“Some folks like to try silica gel sheets to prevent scarring,” Dr. Rosenbach said. “There’s not a lot of evidence to support that, but they’re unlikely to be harmful. I would personally consider them, but it really depends on the extent of disease, anatomic sites involved, and access to care.”
Emory University’s Dr. Yeung also suggested using silicone gel or sheets to optimize the scar appearance once the lesions have crusted over. “People have used lasers, microneedling, etc., to improve smallpox scar appearance,” he added, “and I’m sure dermatologists will be the ones to study what works best for treating monkeypox scars.”
As for the big picture, Dr. Yeung said that dermatologists are critical in the fight to control monkeypox: “We can help our colleagues and patients manage symptoms and wound care, advocate for vaccination and treatment, treat long-term scarring sequelae, and destigmatize LGBTQ health care.”
The dermatologists interviewed for this article report no disclosures.
.
Diagnosing cases “can be hard and folks should keep a very open mind and consider monkeypox virus,” said Misha Rosenbach, MD, a University of Pennsylvania dermatologist and member of the American Academy of Dermatology’s ad hoc task force to develop monkeypox content.
Although it’s named after a primate, it turns out that monkeypox is quite the copycat. As dermatologists have learned, its lesions can look like those caused by a long list of other diseases including herpes, varicella, and syphilis. In small numbers, they can even appear to be insect bites.
To make things more complicated, a patient can have one or two lesions – or dozens. They often cluster in the anogenital area, likely reflecting transmission via sexual intercourse, unlike previous outbreaks in which lesions appeared all over the body. “We have to let go of some of our conceptions about what monkeypox might look like,” said dermatologist Esther Freeman, MD, PhD, associate professor of dermatology, Harvard University, Boston, and a member of the AAD task force.
To make things even more complicated, “the spectrum of illness that we are seeing has ranged from limited, subtle lesions to dramatic, widespread, ulcerative/necrotic lesions,” said Dr. Rosenbach, associate professor of dermatology at the University of Pennsylvania, Philadelphia.
But monkeypox has unique traits that can set it apart and pave the way toward a diagnosis, dermatologists say. And important patient data can help dermatologists gauge the likelihood of a case: Almost 99% of cases with data available have been in men, and among men with available information, 94% reported male-to-male sexual or close intimate contact during the 3 weeks before developing symptoms, according to a CDC report tracking cases from May through late July. So far, cases in women and children are extremely rare, although there have been some reported in the United States.
Are dermatologists likely to see monkeypox in the clinic? It’s unclear so far. Of four dermatologists interviewed for this article, only one has seen patients with monkeypox in person. But others say they’ve been sought for consultations. “I have been asked by infectious disease colleagues for advice remotely but have not seen it,” said dermatologist Howa Yeung, MD, MSc, assistant professor of dermatology, Emory University, Atlanta. “Most of the time, they’re catching all the symptomatic cases before any need for dermatology in-person referrals.”
Still, the rapid rate of growth of the outbreak – up from 3,487 in the United States on July 25 to 12,689 as of Aug.16 – suggests that more dermatologists will see cases, and consultations may become more common too.
Know your lesions
Lesions are the telltale signs of symptomatic monkeypox. According to a recent New England Journal of Medicine study of 528 monkeypox cases from 16 nations, diagnosed between April 27 and June 24, 2022, 95% had skin lesions (58% were vesiculopustular), most commonly in the anogenital area (73%), and on the trunk/arms/or legs (55%) and face (25%), and the palms/soles (10%).
However, “the current monkeypox outbreak often presents differently from the multiple classic vesiculopustules on the skin we see in textbooks,” Dr. Yeung said. “Sometimes people can present with throat pain or rectal pain, with isolated pharyngitis or proctitis. Sometimes there are so few lesions on the skin that it can be easily confused with a bug bite, folliculitis, herpes, dyshidrotic eczema, or other skin problems. This is where dermatologists will get consulted to clarify the diagnosis while the monkeypox PCR test is pending.”
Dr. Rosenbach, who has provided consultation services to other physicians about cases, said the lesions often appear to be vesicles or pustules, “but if you go to ‘pop’ it – e.g., for testing – it’s firm and without fluid. This is likely due to pox virus inclusion, similar to other diseases such as molluscum,” caused by another pox virus, he said. Molluscum lesions are “characteristically umbilicated, with a dimple in the center, and monkeypox lesions seem to be showing a roughly similar morphology with many bowl- or caldera-shaped lesions that are donut-like in appearance,” he added.
Over time, Dr. Rosenbach said, “lesions tend to evolve slowly from smaller flesh-colored or vaguely white firm papules to broader more umbilicated/donut-shaped lesions which may erode, ulcerate, develop a crust or scab, and then heal. The amount of scarring is not yet clear, but we anticipate it to be significant, especially in patients with more widespread or severe disease.”
Jon Peebles, MD, a dermatologist at Kaiser Permanente in Largo, Md., who has treated a few in-person monkeypox cases, said the lesions can be “exquisitely painful,” although he’s also seen patients with asymptomatic lesions. “Lesions are showing a predilection for the anogenital skin, though they can occur anywhere and not uncommonly involve the oral mucosa,” said Dr. Peebles, also a member of the AAD monkeypox task force.
Dr. Yeung said it’s important to ask patients about their sexual orientation, gender identity, and sexual behaviors. “That is the only way to know who your patients are and the only way to understand who else may be at risks and can benefit from contact tracing and additional prevention measures, such as vaccination for asymptomatic sex partners.” (The Jynneos smallpox vaccine is Food and Drug Administration–approved to prevent monkeypox, although its efficacy is not entirely clear, and there’s controversy over expanding its limited availability by administering the vaccine intradermally.)
It’s also important to keep in mind that sexually transmitted infections (STIs) are common in gay and bisexual men. “Just because the patient is diagnosed with gonorrhea or syphilis does not mean the patient cannot also have monkeypox,” Dr. Rosenbach said. Indeed, the NEJM study reported that of 377 patients screened, 29% had an STI other than HIV, mostly syphilis (9%) and gonorrhea (8%). Of all 528 patients in the study (all male or transgender/nonbinary), 41% were HIV-positive, and the median number of sex partners in the last 3 months was 5 (range, 3-15).
Testing is crucial to rule monkeypox in – or out
While monkeypox lesions can be confused for other diseases, Dr. Rosenbach said that a diagnosis can be confirmed through various tests. Varicella zoster virus (VZV) and herpes simplex virus (HSV) have distinct findings on Tzanck smears (nuclear molding, multinucleated cells), and have widely available fairly rapid tests (PCR, or in some places, DFA). “Staph and bacterial folliculitis can usually be cultured quickly,” he said. “If you have someone with no risk factors/exposure, and you test for VZV, HSV, folliculitis, and it’s negative – you should know within 24 hours in most places – then you can broaden your differential diagnosis and consider alternate explanations, including monkeypox.”
Quest Diagnostics and Labcorp, two of the largest commercial labs in the United States, are now offering monkeypox tests. Labcorp says its test has a 2- to 3-day turnaround time.
As for treatment, some physicians are prescribing off-label use of tecovirimat (also known as TPOXX or ST-246), a smallpox antiviral treatment. The CDC offers guidelines about its use. “It seems to work very fast, with patients improving in 24-72 hours,” Dr. Rosenbach said. However, “it is still very challenging to give and get. There’s a cumbersome system to prescribe it, and it needs to be shipped from the national stockpile. Dermatologists should be working with their state health department, infection control, and infectious disease doctors.”
It’s likely that dermatologists are not comfortable with the process to access the drug, he said, “but if we do not act quickly to control the current outbreak, we will all – unfortunately – need to learn to be comfortable prescribing it.”
In regard to pain control, an over-the-counter painkiller approach may be appropriate depending on comorbidities, Dr. Rosenbach said. “Some patients with very severe disease, such as perianal involvement and proctitis, have such severe pain they need to be hospitalized. This is less common.”
Recommendations pending on scarring prevention
There’s limited high-quality evidence about the prevention of scarring in diseases like monkeypox, Dr. Rosenbach noted. “Any recommendations are usually based on very small, limited, uncontrolled studies. In the case of monkeypox, truly we are off the edge of the map.”
He advises cleaning lesions with gentle soap and water – keeping in mind that contaminated towels may spread disease – and potentially using a topical ointment-based dressing such as a Vaseline/nonstick dressing or Vaseline-impregnated gauze. If there’s concern about superinfection, as can occur with staph infections, topical antibiotics such as mupirocin 2% ointment may be appropriate, he said.
“Some folks like to try silica gel sheets to prevent scarring,” Dr. Rosenbach said. “There’s not a lot of evidence to support that, but they’re unlikely to be harmful. I would personally consider them, but it really depends on the extent of disease, anatomic sites involved, and access to care.”
Emory University’s Dr. Yeung also suggested using silicone gel or sheets to optimize the scar appearance once the lesions have crusted over. “People have used lasers, microneedling, etc., to improve smallpox scar appearance,” he added, “and I’m sure dermatologists will be the ones to study what works best for treating monkeypox scars.”
As for the big picture, Dr. Yeung said that dermatologists are critical in the fight to control monkeypox: “We can help our colleagues and patients manage symptoms and wound care, advocate for vaccination and treatment, treat long-term scarring sequelae, and destigmatize LGBTQ health care.”
The dermatologists interviewed for this article report no disclosures.
Children and COVID: ED visits and new admissions change course
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
Acute otitis media pneumococcal disease burden in children due to serotypes not included in vaccines
My group in Rochester, N.Y., examined the current pneumococcal serotypes causing AOM in children. From our data, we can determine the PCV13 vaccine types that escape prevention and cause AOM and understand what effect to expect from the new pneumococcal conjugate vaccines (PCVs) that will be coming soon. There are limited data from middle ear fluid (MEF) cultures on which to base such analyses. Tympanocentesis is the preferred method for securing MEF for culture and our group is unique in providing such data to the Centers for Disease Control and publishing our results on a periodic basis to inform clinicians.
Pneumococci are the second most common cause of acute otitis media (AOM) since the introduction of pneumococcal conjugate vaccines (PCVs) more than 2 decades ago.1,2 Pneumococcal AOM causes more severe acute disease and more often causes suppurative complications than Haemophilus influenzae, which is the most common cause of AOM. Prevention of pneumococcal AOM will be a highly relevant contributor to cost-effectiveness analyses for the anticipated introduction of PCV15 (Merck) and PCV20 (Pfizer). Both PCV15 and PCV20 have been licensed for adult use; PCV15 licensure for infants and children occurred in June 2022 for invasive pneumococcal disease and is anticipated in the near future for PCV20. They are improvements over PCV13 because they add serotypes that cause invasive pneumococcal diseases, although less so for prevention of AOM, on the basis of our data.
Nasopharyngeal colonization is a necessary pathogenic step in progression to pneumococcal disease. However, not all strains of pneumococci expressing different capsular serotypes are equally virulent and likely to cause disease. In PCV-vaccinated populations, vaccine pressure and antibiotic resistance drive PCV serotype replacement with nonvaccine serotypes (NVTs), gradually reducing the net effectiveness of the vaccines. Therefore, knowledge of prevalent NVTs colonizing the nasopharynx identifies future pneumococcal serotypes most likely to emerge as pathogenic.
We published an effectiveness study of PCV13.3 A relative reduction of 86% in AOM caused by strains expressing PCV13 serotypes was observed in the first few years after PCV13 introduction. The greatest reduction in MEF samples was in serotype 19A, with a relative reduction of 91%. However, over time the vaccine type efficacy of PCV13 against MEF-positive pneumococcal AOM has eroded. There was no clear efficacy against serotype 3, and we still observed cases of serotype 19A and 19F. PCV13 vaccine failures have been even more frequent in Europe (nearly 30% of pneumococcal AOM in Europe is caused by vaccine serotypes) than our data indicate, where about 10% of AOM is caused by PCV13 serotypes.
In our most recent publication covering 2015-2019, we described results from 589 children, aged 6-36 months, from whom we collected 2,042 nasopharyngeal samples.2,4 During AOM, 495 MEF samples from 319 AOM-infected children were collected (during bilateral infections, tympanocentesis was performed in both ears). Whether bacteria were isolated was based per AOM case, not per tap. The average age of children with AOM was 15 months (range 6-31 months). The three most prevalent nasopharyngeal pneumococcal serotypes were 35B, 23B, and 15B/C. Serotype 35B was the most common at AOM visits in both the nasopharynx and MEF samples followed by serotype 15B/C. Nonsusceptibility among pneumococci to penicillin, azithromycin, and multiple other antibiotics was high. Increasing resistance to ceftriaxone was also observed.
Based on our results, if PCV15 (PCV13 + 22F and 33F) effectiveness is identical to PCV13 for the included serotypes and 100% efficacy for the added serotypes is presumed, PCV15 will reduce pneumococcal AOMs by 8%, pneumococcal nasopharyngeal colonization events at onset of AOM by 6%, and pneumococcal nasopharyngeal colonization events during health by 3%. As for the projected reductions brought about by PCV20 (PCV15 + 8, 10A, 11A, 12F, and 15B), presuming serotype 15B is efficacious against serotype 15C and 100% efficacy for the added serotypes, PCV20 will reduce pneumococcal AOMs by 22%, pneumococcal nasopharyngeal colonization events at onset of AOM by 20%, and pneumococcal nasopharyngeal colonization events during health by 3% (Figure).
The CDC estimated that, in 2004, pneumococcal disease in the United States caused 4 million illness episodes, 22,000 deaths, 445,000 hospitalizations, 774,000 emergency department visits, 5 million outpatient visits, and 4.1 million outpatient antibiotic prescriptions. Direct medical costs totaled $3.5 billion. Pneumonia (866,000 cases) accounted for 22% of all cases and 72% of pneumococcal costs. AOM and sinusitis (1.5 million cases each) composed 75% of cases and 16% of direct medical costs.5 However, if indirect costs are taken into account, such as work loss by parents of young children, the cost of pneumococcal disease caused by AOM alone may exceed $6 billion annually6 and become dominant in the cost-effectiveness analysis in high-income countries.
Despite widespread use of PCV13, Pneumococcus has shown its resilience under vaccine pressure such that the organism remains a very common AOM pathogen. All-cause AOM has declined modestly and pneumococcal AOM caused by the specific serotypes in PCVs has declined dramatically since the introduction of PCVs. However, the burden of pneumococcal AOM disease is still considerable.
The notion that strains expressing serotypes that were not included in PCV7 were less virulent was proven wrong within a few years after introduction of PCV7, with the emergence of strains expressing serotype 19A, and others. The same cycle occurred after introduction of PCV13. It appears to take about 4 years after introduction of a PCV before peak effectiveness is achieved – which then begins to erode with emergence of NVTs. First, the NVTs are observed to colonize the nasopharynx as commensals and then from among those strains new disease-causing strains emerge.
At the most recent meeting of the International Society of Pneumococci and Pneumococcal Diseases in Toronto in June, many presentations focused on the fact that PCVs elicit highly effective protective serotype-specific antibodies to the capsular polysaccharides of included types. However, 100 serotypes are known. The limitations of PCVs are becoming increasingly apparent. They are costly and consume a large portion of the Vaccines for Children budget. Children in the developing world remain largely unvaccinated because of the high cost. NVTs that have emerged to cause disease vary by country, vary by adult vs. pediatric populations, and are dynamically changing year to year. Forthcoming PCVs of 15 and 20 serotypes will be even more costly than PCV13, will not include many newly emerged serotypes, and will probably likewise encounter “serotype replacement” because of high immune evasion by pneumococci.
When Merck and Pfizer made their decisions on serotype composition for PCV15 and PCV20, respectively, they were based on available data at the time regarding predominant serotypes causing invasive pneumococcal disease in countries that had the best data and would be the market for their products. However, from the time of the decision to licensure of vaccine is many years, and during that time the pneumococcal serotypes have changed, more so for AOM, and I predict more change will occur in the future.
In the past 3 years, Dr. Pichichero has received honoraria from Merck to attend 1-day consulting meetings and his institution has received investigator-initiated research grants to study aspects of PCV15. In the past 3 years, he was reimbursed for expenses to attend the ISPPD meeting in Toronto to present a poster on potential efficacy of PCV20 to prevent complicated AOM.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital.
References
1. Kaur R et al. Pediatrics. 2017;140(3).
2. Kaur R et al. Eur J Clin Microbiol Infect Dis. 2021;41:37-44..
3. Pichichero M et al. Lancet Child Adolesc Health. 2018;2(8):561-8.
4. Zhou F et al. Pediatrics. 2008;121(2):253-60.
5. Huang SS et al. Vaccine. 2011;29(18):3398-412.
6. Casey JR and Pichichero ME. Clin Pediatr (Phila). 2014;53(9):865-73. .
My group in Rochester, N.Y., examined the current pneumococcal serotypes causing AOM in children. From our data, we can determine the PCV13 vaccine types that escape prevention and cause AOM and understand what effect to expect from the new pneumococcal conjugate vaccines (PCVs) that will be coming soon. There are limited data from middle ear fluid (MEF) cultures on which to base such analyses. Tympanocentesis is the preferred method for securing MEF for culture and our group is unique in providing such data to the Centers for Disease Control and publishing our results on a periodic basis to inform clinicians.
Pneumococci are the second most common cause of acute otitis media (AOM) since the introduction of pneumococcal conjugate vaccines (PCVs) more than 2 decades ago.1,2 Pneumococcal AOM causes more severe acute disease and more often causes suppurative complications than Haemophilus influenzae, which is the most common cause of AOM. Prevention of pneumococcal AOM will be a highly relevant contributor to cost-effectiveness analyses for the anticipated introduction of PCV15 (Merck) and PCV20 (Pfizer). Both PCV15 and PCV20 have been licensed for adult use; PCV15 licensure for infants and children occurred in June 2022 for invasive pneumococcal disease and is anticipated in the near future for PCV20. They are improvements over PCV13 because they add serotypes that cause invasive pneumococcal diseases, although less so for prevention of AOM, on the basis of our data.
Nasopharyngeal colonization is a necessary pathogenic step in progression to pneumococcal disease. However, not all strains of pneumococci expressing different capsular serotypes are equally virulent and likely to cause disease. In PCV-vaccinated populations, vaccine pressure and antibiotic resistance drive PCV serotype replacement with nonvaccine serotypes (NVTs), gradually reducing the net effectiveness of the vaccines. Therefore, knowledge of prevalent NVTs colonizing the nasopharynx identifies future pneumococcal serotypes most likely to emerge as pathogenic.
We published an effectiveness study of PCV13.3 A relative reduction of 86% in AOM caused by strains expressing PCV13 serotypes was observed in the first few years after PCV13 introduction. The greatest reduction in MEF samples was in serotype 19A, with a relative reduction of 91%. However, over time the vaccine type efficacy of PCV13 against MEF-positive pneumococcal AOM has eroded. There was no clear efficacy against serotype 3, and we still observed cases of serotype 19A and 19F. PCV13 vaccine failures have been even more frequent in Europe (nearly 30% of pneumococcal AOM in Europe is caused by vaccine serotypes) than our data indicate, where about 10% of AOM is caused by PCV13 serotypes.
In our most recent publication covering 2015-2019, we described results from 589 children, aged 6-36 months, from whom we collected 2,042 nasopharyngeal samples.2,4 During AOM, 495 MEF samples from 319 AOM-infected children were collected (during bilateral infections, tympanocentesis was performed in both ears). Whether bacteria were isolated was based per AOM case, not per tap. The average age of children with AOM was 15 months (range 6-31 months). The three most prevalent nasopharyngeal pneumococcal serotypes were 35B, 23B, and 15B/C. Serotype 35B was the most common at AOM visits in both the nasopharynx and MEF samples followed by serotype 15B/C. Nonsusceptibility among pneumococci to penicillin, azithromycin, and multiple other antibiotics was high. Increasing resistance to ceftriaxone was also observed.
Based on our results, if PCV15 (PCV13 + 22F and 33F) effectiveness is identical to PCV13 for the included serotypes and 100% efficacy for the added serotypes is presumed, PCV15 will reduce pneumococcal AOMs by 8%, pneumococcal nasopharyngeal colonization events at onset of AOM by 6%, and pneumococcal nasopharyngeal colonization events during health by 3%. As for the projected reductions brought about by PCV20 (PCV15 + 8, 10A, 11A, 12F, and 15B), presuming serotype 15B is efficacious against serotype 15C and 100% efficacy for the added serotypes, PCV20 will reduce pneumococcal AOMs by 22%, pneumococcal nasopharyngeal colonization events at onset of AOM by 20%, and pneumococcal nasopharyngeal colonization events during health by 3% (Figure).
The CDC estimated that, in 2004, pneumococcal disease in the United States caused 4 million illness episodes, 22,000 deaths, 445,000 hospitalizations, 774,000 emergency department visits, 5 million outpatient visits, and 4.1 million outpatient antibiotic prescriptions. Direct medical costs totaled $3.5 billion. Pneumonia (866,000 cases) accounted for 22% of all cases and 72% of pneumococcal costs. AOM and sinusitis (1.5 million cases each) composed 75% of cases and 16% of direct medical costs.5 However, if indirect costs are taken into account, such as work loss by parents of young children, the cost of pneumococcal disease caused by AOM alone may exceed $6 billion annually6 and become dominant in the cost-effectiveness analysis in high-income countries.
Despite widespread use of PCV13, Pneumococcus has shown its resilience under vaccine pressure such that the organism remains a very common AOM pathogen. All-cause AOM has declined modestly and pneumococcal AOM caused by the specific serotypes in PCVs has declined dramatically since the introduction of PCVs. However, the burden of pneumococcal AOM disease is still considerable.
The notion that strains expressing serotypes that were not included in PCV7 were less virulent was proven wrong within a few years after introduction of PCV7, with the emergence of strains expressing serotype 19A, and others. The same cycle occurred after introduction of PCV13. It appears to take about 4 years after introduction of a PCV before peak effectiveness is achieved – which then begins to erode with emergence of NVTs. First, the NVTs are observed to colonize the nasopharynx as commensals and then from among those strains new disease-causing strains emerge.
At the most recent meeting of the International Society of Pneumococci and Pneumococcal Diseases in Toronto in June, many presentations focused on the fact that PCVs elicit highly effective protective serotype-specific antibodies to the capsular polysaccharides of included types. However, 100 serotypes are known. The limitations of PCVs are becoming increasingly apparent. They are costly and consume a large portion of the Vaccines for Children budget. Children in the developing world remain largely unvaccinated because of the high cost. NVTs that have emerged to cause disease vary by country, vary by adult vs. pediatric populations, and are dynamically changing year to year. Forthcoming PCVs of 15 and 20 serotypes will be even more costly than PCV13, will not include many newly emerged serotypes, and will probably likewise encounter “serotype replacement” because of high immune evasion by pneumococci.
When Merck and Pfizer made their decisions on serotype composition for PCV15 and PCV20, respectively, they were based on available data at the time regarding predominant serotypes causing invasive pneumococcal disease in countries that had the best data and would be the market for their products. However, from the time of the decision to licensure of vaccine is many years, and during that time the pneumococcal serotypes have changed, more so for AOM, and I predict more change will occur in the future.
In the past 3 years, Dr. Pichichero has received honoraria from Merck to attend 1-day consulting meetings and his institution has received investigator-initiated research grants to study aspects of PCV15. In the past 3 years, he was reimbursed for expenses to attend the ISPPD meeting in Toronto to present a poster on potential efficacy of PCV20 to prevent complicated AOM.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital.
References
1. Kaur R et al. Pediatrics. 2017;140(3).
2. Kaur R et al. Eur J Clin Microbiol Infect Dis. 2021;41:37-44..
3. Pichichero M et al. Lancet Child Adolesc Health. 2018;2(8):561-8.
4. Zhou F et al. Pediatrics. 2008;121(2):253-60.
5. Huang SS et al. Vaccine. 2011;29(18):3398-412.
6. Casey JR and Pichichero ME. Clin Pediatr (Phila). 2014;53(9):865-73. .
My group in Rochester, N.Y., examined the current pneumococcal serotypes causing AOM in children. From our data, we can determine the PCV13 vaccine types that escape prevention and cause AOM and understand what effect to expect from the new pneumococcal conjugate vaccines (PCVs) that will be coming soon. There are limited data from middle ear fluid (MEF) cultures on which to base such analyses. Tympanocentesis is the preferred method for securing MEF for culture and our group is unique in providing such data to the Centers for Disease Control and publishing our results on a periodic basis to inform clinicians.
Pneumococci are the second most common cause of acute otitis media (AOM) since the introduction of pneumococcal conjugate vaccines (PCVs) more than 2 decades ago.1,2 Pneumococcal AOM causes more severe acute disease and more often causes suppurative complications than Haemophilus influenzae, which is the most common cause of AOM. Prevention of pneumococcal AOM will be a highly relevant contributor to cost-effectiveness analyses for the anticipated introduction of PCV15 (Merck) and PCV20 (Pfizer). Both PCV15 and PCV20 have been licensed for adult use; PCV15 licensure for infants and children occurred in June 2022 for invasive pneumococcal disease and is anticipated in the near future for PCV20. They are improvements over PCV13 because they add serotypes that cause invasive pneumococcal diseases, although less so for prevention of AOM, on the basis of our data.
Nasopharyngeal colonization is a necessary pathogenic step in progression to pneumococcal disease. However, not all strains of pneumococci expressing different capsular serotypes are equally virulent and likely to cause disease. In PCV-vaccinated populations, vaccine pressure and antibiotic resistance drive PCV serotype replacement with nonvaccine serotypes (NVTs), gradually reducing the net effectiveness of the vaccines. Therefore, knowledge of prevalent NVTs colonizing the nasopharynx identifies future pneumococcal serotypes most likely to emerge as pathogenic.
We published an effectiveness study of PCV13.3 A relative reduction of 86% in AOM caused by strains expressing PCV13 serotypes was observed in the first few years after PCV13 introduction. The greatest reduction in MEF samples was in serotype 19A, with a relative reduction of 91%. However, over time the vaccine type efficacy of PCV13 against MEF-positive pneumococcal AOM has eroded. There was no clear efficacy against serotype 3, and we still observed cases of serotype 19A and 19F. PCV13 vaccine failures have been even more frequent in Europe (nearly 30% of pneumococcal AOM in Europe is caused by vaccine serotypes) than our data indicate, where about 10% of AOM is caused by PCV13 serotypes.
In our most recent publication covering 2015-2019, we described results from 589 children, aged 6-36 months, from whom we collected 2,042 nasopharyngeal samples.2,4 During AOM, 495 MEF samples from 319 AOM-infected children were collected (during bilateral infections, tympanocentesis was performed in both ears). Whether bacteria were isolated was based per AOM case, not per tap. The average age of children with AOM was 15 months (range 6-31 months). The three most prevalent nasopharyngeal pneumococcal serotypes were 35B, 23B, and 15B/C. Serotype 35B was the most common at AOM visits in both the nasopharynx and MEF samples followed by serotype 15B/C. Nonsusceptibility among pneumococci to penicillin, azithromycin, and multiple other antibiotics was high. Increasing resistance to ceftriaxone was also observed.
Based on our results, if PCV15 (PCV13 + 22F and 33F) effectiveness is identical to PCV13 for the included serotypes and 100% efficacy for the added serotypes is presumed, PCV15 will reduce pneumococcal AOMs by 8%, pneumococcal nasopharyngeal colonization events at onset of AOM by 6%, and pneumococcal nasopharyngeal colonization events during health by 3%. As for the projected reductions brought about by PCV20 (PCV15 + 8, 10A, 11A, 12F, and 15B), presuming serotype 15B is efficacious against serotype 15C and 100% efficacy for the added serotypes, PCV20 will reduce pneumococcal AOMs by 22%, pneumococcal nasopharyngeal colonization events at onset of AOM by 20%, and pneumococcal nasopharyngeal colonization events during health by 3% (Figure).
The CDC estimated that, in 2004, pneumococcal disease in the United States caused 4 million illness episodes, 22,000 deaths, 445,000 hospitalizations, 774,000 emergency department visits, 5 million outpatient visits, and 4.1 million outpatient antibiotic prescriptions. Direct medical costs totaled $3.5 billion. Pneumonia (866,000 cases) accounted for 22% of all cases and 72% of pneumococcal costs. AOM and sinusitis (1.5 million cases each) composed 75% of cases and 16% of direct medical costs.5 However, if indirect costs are taken into account, such as work loss by parents of young children, the cost of pneumococcal disease caused by AOM alone may exceed $6 billion annually6 and become dominant in the cost-effectiveness analysis in high-income countries.
Despite widespread use of PCV13, Pneumococcus has shown its resilience under vaccine pressure such that the organism remains a very common AOM pathogen. All-cause AOM has declined modestly and pneumococcal AOM caused by the specific serotypes in PCVs has declined dramatically since the introduction of PCVs. However, the burden of pneumococcal AOM disease is still considerable.
The notion that strains expressing serotypes that were not included in PCV7 were less virulent was proven wrong within a few years after introduction of PCV7, with the emergence of strains expressing serotype 19A, and others. The same cycle occurred after introduction of PCV13. It appears to take about 4 years after introduction of a PCV before peak effectiveness is achieved – which then begins to erode with emergence of NVTs. First, the NVTs are observed to colonize the nasopharynx as commensals and then from among those strains new disease-causing strains emerge.
At the most recent meeting of the International Society of Pneumococci and Pneumococcal Diseases in Toronto in June, many presentations focused on the fact that PCVs elicit highly effective protective serotype-specific antibodies to the capsular polysaccharides of included types. However, 100 serotypes are known. The limitations of PCVs are becoming increasingly apparent. They are costly and consume a large portion of the Vaccines for Children budget. Children in the developing world remain largely unvaccinated because of the high cost. NVTs that have emerged to cause disease vary by country, vary by adult vs. pediatric populations, and are dynamically changing year to year. Forthcoming PCVs of 15 and 20 serotypes will be even more costly than PCV13, will not include many newly emerged serotypes, and will probably likewise encounter “serotype replacement” because of high immune evasion by pneumococci.
When Merck and Pfizer made their decisions on serotype composition for PCV15 and PCV20, respectively, they were based on available data at the time regarding predominant serotypes causing invasive pneumococcal disease in countries that had the best data and would be the market for their products. However, from the time of the decision to licensure of vaccine is many years, and during that time the pneumococcal serotypes have changed, more so for AOM, and I predict more change will occur in the future.
In the past 3 years, Dr. Pichichero has received honoraria from Merck to attend 1-day consulting meetings and his institution has received investigator-initiated research grants to study aspects of PCV15. In the past 3 years, he was reimbursed for expenses to attend the ISPPD meeting in Toronto to present a poster on potential efficacy of PCV20 to prevent complicated AOM.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital.
References
1. Kaur R et al. Pediatrics. 2017;140(3).
2. Kaur R et al. Eur J Clin Microbiol Infect Dis. 2021;41:37-44..
3. Pichichero M et al. Lancet Child Adolesc Health. 2018;2(8):561-8.
4. Zhou F et al. Pediatrics. 2008;121(2):253-60.
5. Huang SS et al. Vaccine. 2011;29(18):3398-412.
6. Casey JR and Pichichero ME. Clin Pediatr (Phila). 2014;53(9):865-73. .
Few hepatitis C patients receive timely treatment: CDC
Fewer than 1 in 3 people infected with hepatitis C virus (HCV) begin receiving treatment within a year of their diagnosis, according to a new report by the Centers for Disease Control and Prevention.
Although HCV infection can be cured in more than 95% of patients with safe, oral medication, many barriers prevent people from receiving the care they need, experts say. These include insurance restrictions and the need for specialist visits.
to diagnosis and treatment,” said Carolyn Wester, MD, MPH, director of the CDC’s Division of Viral Hepatitis, during an Aug. 9 press call. “People shouldn’t have to jump over hurdles to access lifesaving treatments.”
The CDC report was published in Vital Signs.
An estimated 2.2 million Americans are living with HCV infection. The most recent data indicate that new infections increased more than threefold from 2011 to 2019. HCV transmission usually occurs through contact with the blood of an infected person. Today, most people become infected with the virus by sharing needles, syringes, and other equipment used to inject drugs, according to the CDC.
The researchers used a nationwide administrative claims database to identify more than 47,600 adults diagnosed with HCV infection from Jan. 30, 2019 through Oct. 31, 2020. Most patients (79%) were Medicaid recipients, 7% were Medicare patients, and 14% had private insurance. CDC researchers found that just 23% of Medicaid recipients, 28% of Medicare patients, and 35% of patients with private insurance began receiving direct-acting antiviral agents (DAAs) within 360 days of receiving a positive HCV test result. Of those who did receive treatment, most (from 75% to 84%) began receiving treatment within 180 days of their diagnosis.
Among people on Medicaid plans, patients who lived in states with treatment restrictions were 23% less likely to receive timely treatment (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.81), compared with those living in states with no restrictions. Medicaid patients who were Black or of another race other than White were also less likely than White patients to be treated for HCV within the same year as their diagnosis. The lowest rates of treatment were among adults younger than 40 years, regardless of insurance type. This age group had the highest rates of new infections.
Actual treatment percentages may be even smaller than the number captured in this study, because the study included patients with continuous insurance coverage, Dr. Wester said, “so in many ways, [these] are the individuals who are set up to have the best access to care and treatment.”
Dr. Wester mentioned several steps that could improve access to DAAs for patients with HCV infection:
- Provide treatment outside of specialist offices, such as primary care and community clinics, substance use treatment centers, and syringe services programs.
- Increase the number of primary care providers offering hepatitis C treatment.
- Provide treatment in as few visits as possible.
- Eliminate restrictions by insurance providers on treatment.
A ‘health injustice’
While DAA treatments are effective, they are also expensive. Generic medications cost around $24,000 for a 12-week course, and some brand-name drugs are estimated to cost more than three times that amount. Many insurance companies, therefore, have treatment restrictions in place, including the following:
- There must be evidence of liver fibrosis for a patient to be treated.
- The doctor prescribing treatment must be a liver specialist or an infectious disease specialist.
- The patient must meet sobriety requirements.
- Treatment requires preauthorization approval from insurance carriers.
These criteria prevent patients from getting the care that they need, said Jonathan Mermin, MD, MPH, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, during the press call. “Restricting access to hepatitis C treatment turns an infectious disease into a health injustice,” he added.
Oluwaseun Falade-Nwulia, MBBS, MPH, an infectious disease specialist and assistant professor of medicine at the Johns Hopkins University School of Medicine, Baltimore, emphasized the importance of removing barriers to HCV treatment and expanding HCV care out of specialist offices. She noted that treatment for HCV infection should begin immediately after a patient’s diagnosis. Previously, guidelines recommended waiting 6 months from the time a patient was diagnosed with HCV to begin treatment to see whether the patient’s body could clear the infection on its own. Now, guidelines recommend that after a diagnosis of acute HCV, “HCV treatment should be initiated without awaiting spontaneous resolution.” But some insurance companies still ask for evidence that a patient has been infected for at least 6 months before approving therapy, Dr. Falade-Nwulia noted.
“We have a system that has so many structural barriers for patients who we know already have so many social determinants of health working against them to access any health care,” she said. “I think it’s doubly devastating that patients that can actually get to a provider and get a prescription may still not have access to [the medication] because of structural barriers, such as restrictions based on a need to prove chronicity.”
A version of this article first appeared on Medscape.com.
Fewer than 1 in 3 people infected with hepatitis C virus (HCV) begin receiving treatment within a year of their diagnosis, according to a new report by the Centers for Disease Control and Prevention.
Although HCV infection can be cured in more than 95% of patients with safe, oral medication, many barriers prevent people from receiving the care they need, experts say. These include insurance restrictions and the need for specialist visits.
to diagnosis and treatment,” said Carolyn Wester, MD, MPH, director of the CDC’s Division of Viral Hepatitis, during an Aug. 9 press call. “People shouldn’t have to jump over hurdles to access lifesaving treatments.”
The CDC report was published in Vital Signs.
An estimated 2.2 million Americans are living with HCV infection. The most recent data indicate that new infections increased more than threefold from 2011 to 2019. HCV transmission usually occurs through contact with the blood of an infected person. Today, most people become infected with the virus by sharing needles, syringes, and other equipment used to inject drugs, according to the CDC.
The researchers used a nationwide administrative claims database to identify more than 47,600 adults diagnosed with HCV infection from Jan. 30, 2019 through Oct. 31, 2020. Most patients (79%) were Medicaid recipients, 7% were Medicare patients, and 14% had private insurance. CDC researchers found that just 23% of Medicaid recipients, 28% of Medicare patients, and 35% of patients with private insurance began receiving direct-acting antiviral agents (DAAs) within 360 days of receiving a positive HCV test result. Of those who did receive treatment, most (from 75% to 84%) began receiving treatment within 180 days of their diagnosis.
Among people on Medicaid plans, patients who lived in states with treatment restrictions were 23% less likely to receive timely treatment (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.81), compared with those living in states with no restrictions. Medicaid patients who were Black or of another race other than White were also less likely than White patients to be treated for HCV within the same year as their diagnosis. The lowest rates of treatment were among adults younger than 40 years, regardless of insurance type. This age group had the highest rates of new infections.
Actual treatment percentages may be even smaller than the number captured in this study, because the study included patients with continuous insurance coverage, Dr. Wester said, “so in many ways, [these] are the individuals who are set up to have the best access to care and treatment.”
Dr. Wester mentioned several steps that could improve access to DAAs for patients with HCV infection:
- Provide treatment outside of specialist offices, such as primary care and community clinics, substance use treatment centers, and syringe services programs.
- Increase the number of primary care providers offering hepatitis C treatment.
- Provide treatment in as few visits as possible.
- Eliminate restrictions by insurance providers on treatment.
A ‘health injustice’
While DAA treatments are effective, they are also expensive. Generic medications cost around $24,000 for a 12-week course, and some brand-name drugs are estimated to cost more than three times that amount. Many insurance companies, therefore, have treatment restrictions in place, including the following:
- There must be evidence of liver fibrosis for a patient to be treated.
- The doctor prescribing treatment must be a liver specialist or an infectious disease specialist.
- The patient must meet sobriety requirements.
- Treatment requires preauthorization approval from insurance carriers.
These criteria prevent patients from getting the care that they need, said Jonathan Mermin, MD, MPH, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, during the press call. “Restricting access to hepatitis C treatment turns an infectious disease into a health injustice,” he added.
Oluwaseun Falade-Nwulia, MBBS, MPH, an infectious disease specialist and assistant professor of medicine at the Johns Hopkins University School of Medicine, Baltimore, emphasized the importance of removing barriers to HCV treatment and expanding HCV care out of specialist offices. She noted that treatment for HCV infection should begin immediately after a patient’s diagnosis. Previously, guidelines recommended waiting 6 months from the time a patient was diagnosed with HCV to begin treatment to see whether the patient’s body could clear the infection on its own. Now, guidelines recommend that after a diagnosis of acute HCV, “HCV treatment should be initiated without awaiting spontaneous resolution.” But some insurance companies still ask for evidence that a patient has been infected for at least 6 months before approving therapy, Dr. Falade-Nwulia noted.
“We have a system that has so many structural barriers for patients who we know already have so many social determinants of health working against them to access any health care,” she said. “I think it’s doubly devastating that patients that can actually get to a provider and get a prescription may still not have access to [the medication] because of structural barriers, such as restrictions based on a need to prove chronicity.”
A version of this article first appeared on Medscape.com.
Fewer than 1 in 3 people infected with hepatitis C virus (HCV) begin receiving treatment within a year of their diagnosis, according to a new report by the Centers for Disease Control and Prevention.
Although HCV infection can be cured in more than 95% of patients with safe, oral medication, many barriers prevent people from receiving the care they need, experts say. These include insurance restrictions and the need for specialist visits.
to diagnosis and treatment,” said Carolyn Wester, MD, MPH, director of the CDC’s Division of Viral Hepatitis, during an Aug. 9 press call. “People shouldn’t have to jump over hurdles to access lifesaving treatments.”
The CDC report was published in Vital Signs.
An estimated 2.2 million Americans are living with HCV infection. The most recent data indicate that new infections increased more than threefold from 2011 to 2019. HCV transmission usually occurs through contact with the blood of an infected person. Today, most people become infected with the virus by sharing needles, syringes, and other equipment used to inject drugs, according to the CDC.
The researchers used a nationwide administrative claims database to identify more than 47,600 adults diagnosed with HCV infection from Jan. 30, 2019 through Oct. 31, 2020. Most patients (79%) were Medicaid recipients, 7% were Medicare patients, and 14% had private insurance. CDC researchers found that just 23% of Medicaid recipients, 28% of Medicare patients, and 35% of patients with private insurance began receiving direct-acting antiviral agents (DAAs) within 360 days of receiving a positive HCV test result. Of those who did receive treatment, most (from 75% to 84%) began receiving treatment within 180 days of their diagnosis.
Among people on Medicaid plans, patients who lived in states with treatment restrictions were 23% less likely to receive timely treatment (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.81), compared with those living in states with no restrictions. Medicaid patients who were Black or of another race other than White were also less likely than White patients to be treated for HCV within the same year as their diagnosis. The lowest rates of treatment were among adults younger than 40 years, regardless of insurance type. This age group had the highest rates of new infections.
Actual treatment percentages may be even smaller than the number captured in this study, because the study included patients with continuous insurance coverage, Dr. Wester said, “so in many ways, [these] are the individuals who are set up to have the best access to care and treatment.”
Dr. Wester mentioned several steps that could improve access to DAAs for patients with HCV infection:
- Provide treatment outside of specialist offices, such as primary care and community clinics, substance use treatment centers, and syringe services programs.
- Increase the number of primary care providers offering hepatitis C treatment.
- Provide treatment in as few visits as possible.
- Eliminate restrictions by insurance providers on treatment.
A ‘health injustice’
While DAA treatments are effective, they are also expensive. Generic medications cost around $24,000 for a 12-week course, and some brand-name drugs are estimated to cost more than three times that amount. Many insurance companies, therefore, have treatment restrictions in place, including the following:
- There must be evidence of liver fibrosis for a patient to be treated.
- The doctor prescribing treatment must be a liver specialist or an infectious disease specialist.
- The patient must meet sobriety requirements.
- Treatment requires preauthorization approval from insurance carriers.
These criteria prevent patients from getting the care that they need, said Jonathan Mermin, MD, MPH, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, during the press call. “Restricting access to hepatitis C treatment turns an infectious disease into a health injustice,” he added.
Oluwaseun Falade-Nwulia, MBBS, MPH, an infectious disease specialist and assistant professor of medicine at the Johns Hopkins University School of Medicine, Baltimore, emphasized the importance of removing barriers to HCV treatment and expanding HCV care out of specialist offices. She noted that treatment for HCV infection should begin immediately after a patient’s diagnosis. Previously, guidelines recommended waiting 6 months from the time a patient was diagnosed with HCV to begin treatment to see whether the patient’s body could clear the infection on its own. Now, guidelines recommend that after a diagnosis of acute HCV, “HCV treatment should be initiated without awaiting spontaneous resolution.” But some insurance companies still ask for evidence that a patient has been infected for at least 6 months before approving therapy, Dr. Falade-Nwulia noted.
“We have a system that has so many structural barriers for patients who we know already have so many social determinants of health working against them to access any health care,” she said. “I think it’s doubly devastating that patients that can actually get to a provider and get a prescription may still not have access to [the medication] because of structural barriers, such as restrictions based on a need to prove chronicity.”
A version of this article first appeared on Medscape.com.
Polio virus found in NYC sewer system
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
Polio virus has been discovered in New York City’s sewers, suggesting that the virus is circulating in the city, New York’s health authorities said Aug. 12.
“For every one case of paralytic polio identified, hundreds more may be undetected,” Dr. Bassett said. “The best way to keep adults and children polio-free is through safe and effective immunization.”
Polio can cause permanent paralysis of limbs and even death in some cases. Before this outbreak, the last case of polio in the United States was in 2013.
The announcement came after a man in Rockland County, New York, north of the city, was stricken with polio at the end of July and paralyzed.
Now, health officials fear that the detection of polio in NYC wastewater could bring other cases of paralytic polio.
“It is not surprising, since this is something already seen with Rockland County,” Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told this news organization. “This is solely the result of under-vaccination in the area. I think it’s likely that we will see a few paralytic cases but not a high number.”
Vaccinations declined in pandemic
Among the worries is that vaccination rates across New York City dipped during the pandemic because pediatrician visits were postponed.
In New York City, the overall rate of polio vaccination among children aged 5 years or younger is 86%. Still, in some city ZIP codes, fewer than two-thirds of children in that age group have received the full dosage, which worries health officials.
However, most adults were vaccinated against polio as children.
Across New York state, nearly 80% of people have been vaccinated, according to data from the state public health department. Those who are unvaccinated are at risk, but the polio vaccine is nearly 100% effective in people who are fully immunized.
New York health authorities are calling on those who are unvaccinated to get their shots immediately.
“The risk to New Yorkers is real, but the defense is so simple – get vaccinated against polio,” New York City Health Commissioner Ashwin Vasan, MD, PhD, said in a statement. “Polio is entirely preventable, and its reappearance should be a call for all of us.”
Though many of those who are infected have no symptoms, about 4% will get viral meningitis “and about 1 in 200 will become paralyzed,” according to a news release.
Symptoms can be flu-like
Symptoms can include those similar to the flu, such as sore throat, fever, fatigue, nausea, and stomach ache. There is no cure for the disease.
The city’s health department has given no details about where exactly polio had been found in NYC’s wastewater nor did they give dates the virus was detected.
Health authorities urged parents of children who are not yet fully vaccinated to bring them to their pediatricians.
In 1916, polio killed 6,000 people in the United States and left at least another 21,000 – most of them children – permanently disabled.
An outbreak in 1952 caused paralysis in more than 20,000 people and left many children on iron lungs. The first effective vaccine emerged just a few years later and the virus began to wane.
A version of this article first appeared on Medscape.com.
NYC switching children’s COVID vaccine sites to monkeypox
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
Seniors intend to receive variant-specific COVID booster in coming months
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
U.S. tops 10,000 confirmed monkeypox cases: CDC
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
In RA, tofacitinib shows higher infection rate than TNF inhibitors
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
FROM ANNALS OF THE RHEUMATIC DISEASES
FDA authorizes intradermal use of Jynneos vaccine for monkeypox
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.