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Topical Tapinarof and Roflumilast for Psoriasis: Where Do they Fit In?
HUNTINGTON BEACH, CALIF. — The Food and Drug Administration and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.
At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”
Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”
Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)
The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.
Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — The Food and Drug Administration and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.
At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”
Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”
Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)
The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.
Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — The Food and Drug Administration and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.
At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”
Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”
Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)
The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.
Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.
A version of this article first appeared on Medscape.com.
FROM PDA 2024
Topical Treatment Provides a Noninvasive Option for Pyogenic Granuloma in Children
HUNTINGTON BEACH, CALIF. — Mounting according to Julie Dhossche, MD.
A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”
Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.
In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.
At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
Surgery May Still Be Needed
For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.
If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”
Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”
As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”
When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”
Dr. Dhossche reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — Mounting according to Julie Dhossche, MD.
A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”
Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.
In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.
At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
Surgery May Still Be Needed
For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.
If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”
Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”
As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”
When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”
Dr. Dhossche reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIF. — Mounting according to Julie Dhossche, MD.
A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”
Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.
In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.
At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
Surgery May Still Be Needed
For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.
If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”
Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”
As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”
When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”
Dr. Dhossche reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
FROM PDA 2024
Managing Vitiligo: Combination Therapies, New Treatments
HUNTINGTON BEACH, CALIFORNIA — When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.
“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”
As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.
“Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.
“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”
The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.
“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinib, upadacitinib, povorcitinib, and baricitinib on vitiligo are underway.
Combining Phototherapy With Topical Treatment
A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”
Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”
While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”
For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”
Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
Tissue, Cellular Grafts
Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.
The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.
In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”
Dr. Shiu disclosed that she received research support from AbbVie.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIFORNIA — When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.
“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”
As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.
“Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.
“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”
The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.
“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinib, upadacitinib, povorcitinib, and baricitinib on vitiligo are underway.
Combining Phototherapy With Topical Treatment
A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”
Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”
While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”
For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”
Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
Tissue, Cellular Grafts
Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.
The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.
In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”
Dr. Shiu disclosed that she received research support from AbbVie.
A version of this article first appeared on Medscape.com.
HUNTINGTON BEACH, CALIFORNIA — When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.
“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”
As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.
“Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.
“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”
The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.
“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinib, upadacitinib, povorcitinib, and baricitinib on vitiligo are underway.
Combining Phototherapy With Topical Treatment
A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”
Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”
While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”
For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”
Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
Tissue, Cellular Grafts
Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.
The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.
In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”
Dr. Shiu disclosed that she received research support from AbbVie.
A version of this article first appeared on Medscape.com.
FROM PDA 2024
Ivonescimab: Possible New First-Line Standard in PD-L1–Positive Advanced NSCLC?
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
according to recent findings from the HARMONi-2 trial.
“This is the first randomized, phase 3 study to demonstrate a clinically significant improvement in efficacy with a novel drug compared to pembrolizumab in advanced NSCLC,” said study investigator Caicun Zhou, MD, PhD, with Shanghai Pulmonary Hospital in China,
The results highlight ivonescimab’s potential to become a “new standard of care” in advanced PD-L1–positive advanced NSCLC, said Dr. Zhou, who presented the analysis at the annual International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in San Diego. Dr. Zhou is president-elect of the IASLC.
Ivonescimab (AK112) is a novel, potentially first-in-class investigational bispecific antibody that targets PD-1 and vascular endothelial growth factor (VEGF) developed by Akeso Biopharma, which funded the HARMONi-2 trial.
Conducted at 55 centers in China, HARMONi-2 enrolled 398 patients with untreated locally advanced or metastatic NSCLC, Eastern Cooperative Oncology Group Performance Status of 0 or 1, PD-L1 positive (with at least 1% of tumor cells expressing PD-L1), and no EGFR mutations or ALK rearrangements.
Patients were randomly allocated (1:1) to receive ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every 3 weeks. The two groups were well balanced, and randomization was stratified by histology (squamous vs nonsquamous), clinical stage (IIIB/IIIC vs IV) and PD-L1 expression (PD-L1 of 1%-49% vs 50% or greater).
Dr. Zhou reported that patients who received ivonescimab were progression free for nearly twice as long as those on pembrolizumab — a median of 11.1 vs 5.8 months, indicating a 49% lower risk for progression or death (stratified hazard ratio [HR], 0.51; P < .0001).
The meaningful improvement in PFS with ivonescimab, compared with pembrolizumab, was “broadly consistent” in all prespecified subgroups, Dr. Zhou noted. That included patients with squamous NSCLC (HR, 0.48) and nonsquamous NSCLC (HR, 0.54), those with PD-L1 expression of 1%-49% (HR, 0.54) and 50% or higher (HR, 0.46), as well as those with liver metastases (HR, 0.47) and brain metastases (HR, 0.55).
The PFS benefit seen with ivonescimab in HARMONi-2 is “striking,” and the results “highlight the potential benefits of combined VEGF and PD-1 blockade together,” said John Heymach, MD, with the University of Texas MD Anderson Cancer Center in Houston, who served as discussant for the study.
Ivonescimab also led to a higher objective response rate (50% vs 38.5%) and disease control rate (89.9% vs 70.5%).
Grade 3 or higher treatment-related adverse events occurred in more patients receiving ivonescimab — 29.4% vs 15.6% on pembrolizumab. The difference largely stemmed from higher rates of proteinuria, hypertension, and lab abnormalities.
The rates of serious treatment-related adverse events were similar between the groups —20.8% in the ivonescimab group and 16.1% in the pembrolizumab group. Rates of grade 3 or higher immune-related adverse events were also similar, occurring in 7% of patients treated with ivonescimab and 8% of those receiving pembrolizumab.
In patients with squamous cell carcinoma, in particular, ivonescimab demonstrated a “very manageable” safety profile, Dr. Zhou noted. In this group, grade 3 or higher treatment-related adverse events occurred in 22.2% of patients (vs 18.7% receiving pembrolizumab).
Ivonescimab was associated with comparable but “numerically better” time to deterioration of global health status, based on the EORTC Core Quality of Life questionnaire, Dr. Zhou said.
Although the “really impressive and clinically meaningful” PFS benefits extended across different subgroups, “we await the overall survival results and additional studies done outside of China to confirm the benefit seen,” Dr. Heymach noted.
He also cautioned that, for patients with low to intermediate PD-L1 expression (1%-49%), pembrolizumab monotherapy “would not be the relevant comparator in the US and the rest of the world, and different study designs are going to be required for those populations.”
Based on the results of HARMONi-2, Akeso’s partner, Summit Therapeutics, plans to initiate HARMONi-7 in early 2025.
HARMONi-7 is currently planned as a multiregional, phase 3 clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression (50% or more).
Dr. Zhou has received consulting fees from Qilu Pharmaceutical, Hengrui, and TopAlliance Biosciences and honoraria from Eli Lilly China, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Alice, C-Stone, Luye Pharma, TopAlliance Biosciences, Amoy Diagnostics, and AnHeart Therapeutics. Dr. Heymach is a consultant for AbbVie, AnHeart Therapeutics, ArriVent Biopharma, AstraZeneca, BioCurity Pharmaceuticals, BioNTech, Blueprint Medicines, Boehringer Ingelheim, BMS, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Mirati Therapeutics, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, and Takeda.
A version of this article first appeared on Medscape.com.
FROM WCLC 2024
Could Aspirin Avert Bad Outcomes in Leukemia?
A new analysis hints that there may be a benefit from aspirin for hospitalized patients with leukemia. In a preliminary study, researchers found that aspirin users had much lower odds of intracranial bleeding, deep vein thrombosis, in-hospital mortality, and septic stroke.
Aspirin users also spent less time in the hospital and had less costly care.
No one is suggesting that clinicians give aspirin to hospitalized patients with leukemia when the drug is not otherwise indicated. However, the findings, released at the Society of Hematologic Oncology (SOHO 2024) meeting in Houston, do indicate that more research is warranted, study lead author Jayalekshmi Jayakumar, MD, of the Brooklyn Hospital Center in New York City, said in a presentation.
“We hope our study can act as background for further prospective and experimental studies to explore this association,” she said. “If we can establish causation, then aspirin has a potential to be a thromboprophylactic agent to enhance outcomes and reduce resource utilization among leukemia hospitalizations.”
Dr. Jayakumar noted that previous research has suggested aspirin may help prevent deep vein thrombosis in patients with breast and pancreatic cancer. And in blood cancer, animal research has suggested that aspirin may “promote apoptosis in leukemia cells and decrease the spread of leukemia cells through platelet inhibition,” she said.
However, “we do not have any prospective or retrospective studies to establish causation or to see if this actually has some value within the clinical practice,” she noted.
Dr. Jayakumar stated that new study aims to detect whether aspirin may be beneficial in leukemia. She and her colleagues retrospectively tracked 1,663,149 US hospitalizations of patients with leukemia from 2016 to 2020 via the National Inpatient Sample. Of those patients, 11.2% used aspirin, although the data didn’t say whether they started it during hospitalization, and dosages were not reported. Aspirin users were older (mean age, 74.53 years vs 64.83 years in nonusers).
After adjustment for confounders, aspirin users had lower odds of several conditions than nonusers:
- Epistaxis (odds ratio [OR], 0.63; 95% CI, 0.55-0.72; P < .001)
- Hemoptysis (OR, 0.71; 95% CI, 0.61-0.82; P < .001)
- Intracranial bleed (OR, 0.74; 95% CI, 0.64-0.85; P < .001)
- Deep vein thrombosis (OR, 0.72; 95% CI, 0.66-0.78; P < .001)
- In-hospital mortality (OR, 0.54; 95% CI, 0.50-0.58; P < .001)
- Sepsis (OR, 0.71; 95% CI, 0.68-0.75; P < .001)
- Septic shock (OR, 0.55; 95% CI, 0.50-0.60; P < .001)
There was no association reported for gastrointestinal bleeding, a possible side effect of aspirin use, or tumor lysis syndrome. Aspirin users also had a shorter typical stay (−2.8 days) and lower typical hospital charges ($40,719).
“We also found that aspirin users had a slightly reduced risk of minor bleeding and infection compared to non–aspirin users,” Dr. Jayakumar said.
In an interview, Dr. Jayakumar noted that the study is retrospective and declined to speculate on why aspirin may have benefits or why it may have the seemingly contradictory effect of reducing both blood clots and bleeding.
Aspirin is one of the least expensive drugs in existence.
In an interview, Richard M. Stone, MD, oncologist at Dana-Farber Cancer Institute in Boston, who’s familiar with the study findings but didn’t take part in the research, said the findings are “totally counterintuitive.”
“It doesn’t mean they should be rejected, but they should be highly scrutinized,” he said.
Dr. Stone added that bleeding is a major risk in leukemia due to low platelet counts, although platelet transplants can be helpful, and patients rarely die of bleeding. Thrombosis is also a problem in leukemia, he said, and it’s being increasingly recognized as a risk in acute myeloid leukemia.
No funding was reported. Dr. Jayakumar and Dr. Stone had no disclosures.
A version of this article appeared on Medscape.com.
A new analysis hints that there may be a benefit from aspirin for hospitalized patients with leukemia. In a preliminary study, researchers found that aspirin users had much lower odds of intracranial bleeding, deep vein thrombosis, in-hospital mortality, and septic stroke.
Aspirin users also spent less time in the hospital and had less costly care.
No one is suggesting that clinicians give aspirin to hospitalized patients with leukemia when the drug is not otherwise indicated. However, the findings, released at the Society of Hematologic Oncology (SOHO 2024) meeting in Houston, do indicate that more research is warranted, study lead author Jayalekshmi Jayakumar, MD, of the Brooklyn Hospital Center in New York City, said in a presentation.
“We hope our study can act as background for further prospective and experimental studies to explore this association,” she said. “If we can establish causation, then aspirin has a potential to be a thromboprophylactic agent to enhance outcomes and reduce resource utilization among leukemia hospitalizations.”
Dr. Jayakumar noted that previous research has suggested aspirin may help prevent deep vein thrombosis in patients with breast and pancreatic cancer. And in blood cancer, animal research has suggested that aspirin may “promote apoptosis in leukemia cells and decrease the spread of leukemia cells through platelet inhibition,” she said.
However, “we do not have any prospective or retrospective studies to establish causation or to see if this actually has some value within the clinical practice,” she noted.
Dr. Jayakumar stated that new study aims to detect whether aspirin may be beneficial in leukemia. She and her colleagues retrospectively tracked 1,663,149 US hospitalizations of patients with leukemia from 2016 to 2020 via the National Inpatient Sample. Of those patients, 11.2% used aspirin, although the data didn’t say whether they started it during hospitalization, and dosages were not reported. Aspirin users were older (mean age, 74.53 years vs 64.83 years in nonusers).
After adjustment for confounders, aspirin users had lower odds of several conditions than nonusers:
- Epistaxis (odds ratio [OR], 0.63; 95% CI, 0.55-0.72; P < .001)
- Hemoptysis (OR, 0.71; 95% CI, 0.61-0.82; P < .001)
- Intracranial bleed (OR, 0.74; 95% CI, 0.64-0.85; P < .001)
- Deep vein thrombosis (OR, 0.72; 95% CI, 0.66-0.78; P < .001)
- In-hospital mortality (OR, 0.54; 95% CI, 0.50-0.58; P < .001)
- Sepsis (OR, 0.71; 95% CI, 0.68-0.75; P < .001)
- Septic shock (OR, 0.55; 95% CI, 0.50-0.60; P < .001)
There was no association reported for gastrointestinal bleeding, a possible side effect of aspirin use, or tumor lysis syndrome. Aspirin users also had a shorter typical stay (−2.8 days) and lower typical hospital charges ($40,719).
“We also found that aspirin users had a slightly reduced risk of minor bleeding and infection compared to non–aspirin users,” Dr. Jayakumar said.
In an interview, Dr. Jayakumar noted that the study is retrospective and declined to speculate on why aspirin may have benefits or why it may have the seemingly contradictory effect of reducing both blood clots and bleeding.
Aspirin is one of the least expensive drugs in existence.
In an interview, Richard M. Stone, MD, oncologist at Dana-Farber Cancer Institute in Boston, who’s familiar with the study findings but didn’t take part in the research, said the findings are “totally counterintuitive.”
“It doesn’t mean they should be rejected, but they should be highly scrutinized,” he said.
Dr. Stone added that bleeding is a major risk in leukemia due to low platelet counts, although platelet transplants can be helpful, and patients rarely die of bleeding. Thrombosis is also a problem in leukemia, he said, and it’s being increasingly recognized as a risk in acute myeloid leukemia.
No funding was reported. Dr. Jayakumar and Dr. Stone had no disclosures.
A version of this article appeared on Medscape.com.
A new analysis hints that there may be a benefit from aspirin for hospitalized patients with leukemia. In a preliminary study, researchers found that aspirin users had much lower odds of intracranial bleeding, deep vein thrombosis, in-hospital mortality, and septic stroke.
Aspirin users also spent less time in the hospital and had less costly care.
No one is suggesting that clinicians give aspirin to hospitalized patients with leukemia when the drug is not otherwise indicated. However, the findings, released at the Society of Hematologic Oncology (SOHO 2024) meeting in Houston, do indicate that more research is warranted, study lead author Jayalekshmi Jayakumar, MD, of the Brooklyn Hospital Center in New York City, said in a presentation.
“We hope our study can act as background for further prospective and experimental studies to explore this association,” she said. “If we can establish causation, then aspirin has a potential to be a thromboprophylactic agent to enhance outcomes and reduce resource utilization among leukemia hospitalizations.”
Dr. Jayakumar noted that previous research has suggested aspirin may help prevent deep vein thrombosis in patients with breast and pancreatic cancer. And in blood cancer, animal research has suggested that aspirin may “promote apoptosis in leukemia cells and decrease the spread of leukemia cells through platelet inhibition,” she said.
However, “we do not have any prospective or retrospective studies to establish causation or to see if this actually has some value within the clinical practice,” she noted.
Dr. Jayakumar stated that new study aims to detect whether aspirin may be beneficial in leukemia. She and her colleagues retrospectively tracked 1,663,149 US hospitalizations of patients with leukemia from 2016 to 2020 via the National Inpatient Sample. Of those patients, 11.2% used aspirin, although the data didn’t say whether they started it during hospitalization, and dosages were not reported. Aspirin users were older (mean age, 74.53 years vs 64.83 years in nonusers).
After adjustment for confounders, aspirin users had lower odds of several conditions than nonusers:
- Epistaxis (odds ratio [OR], 0.63; 95% CI, 0.55-0.72; P < .001)
- Hemoptysis (OR, 0.71; 95% CI, 0.61-0.82; P < .001)
- Intracranial bleed (OR, 0.74; 95% CI, 0.64-0.85; P < .001)
- Deep vein thrombosis (OR, 0.72; 95% CI, 0.66-0.78; P < .001)
- In-hospital mortality (OR, 0.54; 95% CI, 0.50-0.58; P < .001)
- Sepsis (OR, 0.71; 95% CI, 0.68-0.75; P < .001)
- Septic shock (OR, 0.55; 95% CI, 0.50-0.60; P < .001)
There was no association reported for gastrointestinal bleeding, a possible side effect of aspirin use, or tumor lysis syndrome. Aspirin users also had a shorter typical stay (−2.8 days) and lower typical hospital charges ($40,719).
“We also found that aspirin users had a slightly reduced risk of minor bleeding and infection compared to non–aspirin users,” Dr. Jayakumar said.
In an interview, Dr. Jayakumar noted that the study is retrospective and declined to speculate on why aspirin may have benefits or why it may have the seemingly contradictory effect of reducing both blood clots and bleeding.
Aspirin is one of the least expensive drugs in existence.
In an interview, Richard M. Stone, MD, oncologist at Dana-Farber Cancer Institute in Boston, who’s familiar with the study findings but didn’t take part in the research, said the findings are “totally counterintuitive.”
“It doesn’t mean they should be rejected, but they should be highly scrutinized,” he said.
Dr. Stone added that bleeding is a major risk in leukemia due to low platelet counts, although platelet transplants can be helpful, and patients rarely die of bleeding. Thrombosis is also a problem in leukemia, he said, and it’s being increasingly recognized as a risk in acute myeloid leukemia.
No funding was reported. Dr. Jayakumar and Dr. Stone had no disclosures.
A version of this article appeared on Medscape.com.
FROM SOHO 2024
Focusing on Value in Social Media Posts
CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD,
“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”
According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.
Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”
Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”
Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.
Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”
Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”
She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”
Dr. Labadie reported having no financial disclosures.
A version of this article appeared on Medscape.com.
CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD,
“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”
According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.
Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”
Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”
Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.
Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”
Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”
She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”
Dr. Labadie reported having no financial disclosures.
A version of this article appeared on Medscape.com.
CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD,
“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”
According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.
Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”
Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”
Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.
Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”
Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”
She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”
Dr. Labadie reported having no financial disclosures.
A version of this article appeared on Medscape.com.
Skip Potassium After Cardiac Surgery
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2024
Changes in Age-Related Mortality in Malignant Melanoma From 1999- 2022: A CDC Wonder Study
Background
Melanoma is one of the leading causes of solid tumor cancers. This study’s objective is to analyze temporal trends in melanoma-related mortality among age groups in the US before and during COVID-19. To date, no previous studies have analyzed year-to-year trends in melanoma mortality by age group using the CDC Wonder database. A 2011 analysis previously showed increasing death rates only among those over age 65 between 1992-2006.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Crude mortality rates per 100,000 and annual percentage change using Joinpoint regression were used to analyze yearly trends among age groups.
Results
From 1999 to 2022, overall mortality rate fell from 2.91 to 2.07, and mortality rates among all age groups decreased with the exception of those over age 85. Age 35-44 crude mortality rate decreased from 1.42 to .7. Age 45-54 crude mortality rate decreased from 3.2 to 1.51. Age 55-64 decreased from 5.6 to 3.61. Age 65-74 decreased from 9.91 to 7.79. Age 75-84 decreased from 15.44 to 15.43. Ages 85+ increased from 21.5 to 33.1. Notably, mortality among those age 75-85 decreased by only .01, and were increased across the timespan of 2000-2020.
Conclusions
These results show that there may be differences between age groups in how mortality due to melanoma of age groups has changed from 1992-2022. While overall mortality attributed to melanoma fell during this period, mortality in those over age 85 increased. Future studies should confirm these results with different data sets and further investigate the reasons for these disparities.
Background
Melanoma is one of the leading causes of solid tumor cancers. This study’s objective is to analyze temporal trends in melanoma-related mortality among age groups in the US before and during COVID-19. To date, no previous studies have analyzed year-to-year trends in melanoma mortality by age group using the CDC Wonder database. A 2011 analysis previously showed increasing death rates only among those over age 65 between 1992-2006.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Crude mortality rates per 100,000 and annual percentage change using Joinpoint regression were used to analyze yearly trends among age groups.
Results
From 1999 to 2022, overall mortality rate fell from 2.91 to 2.07, and mortality rates among all age groups decreased with the exception of those over age 85. Age 35-44 crude mortality rate decreased from 1.42 to .7. Age 45-54 crude mortality rate decreased from 3.2 to 1.51. Age 55-64 decreased from 5.6 to 3.61. Age 65-74 decreased from 9.91 to 7.79. Age 75-84 decreased from 15.44 to 15.43. Ages 85+ increased from 21.5 to 33.1. Notably, mortality among those age 75-85 decreased by only .01, and were increased across the timespan of 2000-2020.
Conclusions
These results show that there may be differences between age groups in how mortality due to melanoma of age groups has changed from 1992-2022. While overall mortality attributed to melanoma fell during this period, mortality in those over age 85 increased. Future studies should confirm these results with different data sets and further investigate the reasons for these disparities.
Background
Melanoma is one of the leading causes of solid tumor cancers. This study’s objective is to analyze temporal trends in melanoma-related mortality among age groups in the US before and during COVID-19. To date, no previous studies have analyzed year-to-year trends in melanoma mortality by age group using the CDC Wonder database. A 2011 analysis previously showed increasing death rates only among those over age 65 between 1992-2006.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Crude mortality rates per 100,000 and annual percentage change using Joinpoint regression were used to analyze yearly trends among age groups.
Results
From 1999 to 2022, overall mortality rate fell from 2.91 to 2.07, and mortality rates among all age groups decreased with the exception of those over age 85. Age 35-44 crude mortality rate decreased from 1.42 to .7. Age 45-54 crude mortality rate decreased from 3.2 to 1.51. Age 55-64 decreased from 5.6 to 3.61. Age 65-74 decreased from 9.91 to 7.79. Age 75-84 decreased from 15.44 to 15.43. Ages 85+ increased from 21.5 to 33.1. Notably, mortality among those age 75-85 decreased by only .01, and were increased across the timespan of 2000-2020.
Conclusions
These results show that there may be differences between age groups in how mortality due to melanoma of age groups has changed from 1992-2022. While overall mortality attributed to melanoma fell during this period, mortality in those over age 85 increased. Future studies should confirm these results with different data sets and further investigate the reasons for these disparities.
Geographical Trends in Malignant Melanoma from 1999-2022: A CDC Wonder Study
Background
Melanoma is the fifth leading cause of cancer in the United States. This study’s objective is to analyze geographical trends in melanoma-related mortality in the US before and during COVID-19. To date, no previous studies have analyzed geographical trends in melanoma mortality using the CDC Wonder data base. Previous literature reports Utah, Vermont, Delaware, Minnesota and New Hampshire as having the highest UV-attributable incidence rates of melanoma.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Age-adjusted mortality rates (AAMR) per 100,000 and annual percentage change (APC) using Joinpoint regression were used to analyze state and regional trends.
Results
From 1999 to 2019, the states with the largest increase in AAMR were Idaho (0.91) and Colorado (0.63) while Oklahoma (-1.07), Nevada (-0.94), and Texas (-0.92) saw the largest decreases. During COVID-19 (2019 to 2021), the states with the largest increase in AAMR were South Dakota (1.42), Oregon (1.09), and Montana (1.08) while Vermont (-1.02), Minnesota (-0.45), and Connecticut (-0.38) had the largest declines. From 2006-2022, except 2020, the Northeast consistently had the lowest AAMR. From 2008-2012 the West consistently had the highest AAMR. From 2013-2022, except 2015, the Midwest had the highest AAMR. From 2009 onwards, all 4 regions have seen an overall decline in AAMR with their lowest values being in 2022.
Conclusions
Idaho had the highest AAMR before COVID-19 while Oklahoma had the lowest. During COVID-19, South Dakota saw the highest AAMR while Vermont had the lowest. AAMRs have been trending downwards across all 4 regions since 2009 and the Northeast has fared the best over that period. These results should be used to increase implementation and enforcement of preventative measures to reduce UV exposure, especially in states with higher AAMRs. Further research should examine statewide sun protection programs to search for any relationship with their AAMRs.
Background
Melanoma is the fifth leading cause of cancer in the United States. This study’s objective is to analyze geographical trends in melanoma-related mortality in the US before and during COVID-19. To date, no previous studies have analyzed geographical trends in melanoma mortality using the CDC Wonder data base. Previous literature reports Utah, Vermont, Delaware, Minnesota and New Hampshire as having the highest UV-attributable incidence rates of melanoma.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Age-adjusted mortality rates (AAMR) per 100,000 and annual percentage change (APC) using Joinpoint regression were used to analyze state and regional trends.
Results
From 1999 to 2019, the states with the largest increase in AAMR were Idaho (0.91) and Colorado (0.63) while Oklahoma (-1.07), Nevada (-0.94), and Texas (-0.92) saw the largest decreases. During COVID-19 (2019 to 2021), the states with the largest increase in AAMR were South Dakota (1.42), Oregon (1.09), and Montana (1.08) while Vermont (-1.02), Minnesota (-0.45), and Connecticut (-0.38) had the largest declines. From 2006-2022, except 2020, the Northeast consistently had the lowest AAMR. From 2008-2012 the West consistently had the highest AAMR. From 2013-2022, except 2015, the Midwest had the highest AAMR. From 2009 onwards, all 4 regions have seen an overall decline in AAMR with their lowest values being in 2022.
Conclusions
Idaho had the highest AAMR before COVID-19 while Oklahoma had the lowest. During COVID-19, South Dakota saw the highest AAMR while Vermont had the lowest. AAMRs have been trending downwards across all 4 regions since 2009 and the Northeast has fared the best over that period. These results should be used to increase implementation and enforcement of preventative measures to reduce UV exposure, especially in states with higher AAMRs. Further research should examine statewide sun protection programs to search for any relationship with their AAMRs.
Background
Melanoma is the fifth leading cause of cancer in the United States. This study’s objective is to analyze geographical trends in melanoma-related mortality in the US before and during COVID-19. To date, no previous studies have analyzed geographical trends in melanoma mortality using the CDC Wonder data base. Previous literature reports Utah, Vermont, Delaware, Minnesota and New Hampshire as having the highest UV-attributable incidence rates of melanoma.
Methods
The CDC Wonder database was used to collect data on melanoma-related mortality rates in the US from 1999-2022. Age-adjusted mortality rates (AAMR) per 100,000 and annual percentage change (APC) using Joinpoint regression were used to analyze state and regional trends.
Results
From 1999 to 2019, the states with the largest increase in AAMR were Idaho (0.91) and Colorado (0.63) while Oklahoma (-1.07), Nevada (-0.94), and Texas (-0.92) saw the largest decreases. During COVID-19 (2019 to 2021), the states with the largest increase in AAMR were South Dakota (1.42), Oregon (1.09), and Montana (1.08) while Vermont (-1.02), Minnesota (-0.45), and Connecticut (-0.38) had the largest declines. From 2006-2022, except 2020, the Northeast consistently had the lowest AAMR. From 2008-2012 the West consistently had the highest AAMR. From 2013-2022, except 2015, the Midwest had the highest AAMR. From 2009 onwards, all 4 regions have seen an overall decline in AAMR with their lowest values being in 2022.
Conclusions
Idaho had the highest AAMR before COVID-19 while Oklahoma had the lowest. During COVID-19, South Dakota saw the highest AAMR while Vermont had the lowest. AAMRs have been trending downwards across all 4 regions since 2009 and the Northeast has fared the best over that period. These results should be used to increase implementation and enforcement of preventative measures to reduce UV exposure, especially in states with higher AAMRs. Further research should examine statewide sun protection programs to search for any relationship with their AAMRs.
To Choose the Best First-line Drug for CML, Consider Efficacy and Cost
When it comes to selecting a cost-effective, first-line tyrosine kinase inhibitor (TKI) for the treatment of chronic myeloid leukemia (CML), consider the treatment goal.
For survival, generic imatinib remains the gold standard, Elias Jabbour, MD, said during a session at the annual meeting of the Society of Hematologic Oncology in Houston.
For treatment-free remission, generic dasatinib or another generic second-generation TKI is needed, but not yet available in the United States, so generic imatinib is the best current choice, said Dr. Jabbour, a professor of medicine in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Prior to the availability of generic imatinib, that wasn’t the case, he noted, explaining that second-generation TKIs met the cost-efficacy criteria, but now — at about $35 per month or about $400 per year — imatinib is far less expensive than the approximately $250,000 per year that brand-name second- and third-generation TKIs can currently cost.
To have treatment value, any new TKI should cost $40,000-$50,000 per quality-adjusted life-year, which is defined as the quality and duration of life after a novel TKI vs with the existing standard of care, Dr. Jabbour said.
And to qualify as a frontline therapy for CML, any new TKI should show efficacy superior to second-generation TKIs, in addition to meeting the cost-effectiveness criteria.
“It is hard to show survival benefit anymore, but we need to improve on the rate of durable deep molecular remission,” he said.
An equivalent or better long-term safety profile over at least 7-8 years is also needed.
Based on the current literature, none of the TKIs currently being evaluated has met that standard, although some trials are ongoing.
In a recent editorial, Dr. Jabbour and colleagues outlined treatment recommendations based on the currently available data. They suggested using lower-than-approved doses of TKIs in both frontline and later therapies to reduce toxicity, improve treatment compliance, and reduce costs.
They also suggested that the absence of an early molecular response might not warrant changing the TKI, especially when a second-generation TKI was used first line.
When treatment-free remission is not a therapeutic goal or is unlikely, changing the TKI to improve the depth of molecular response, which has been shown to improve the likelihood of treatment-free remission, could do more harm than good, they argued.
Instead, consider reducing the dose to manage reversible side effects, they suggested, noting that generic imatinib, and eventually generic dasatinib and possibly other generic second-generation TKIs, will likely offer 90% of patients with CML an effective, safe, and affordable treatment that normalizes life expectancy and leads to treatment-free remission in 30%-50% of patients over time.
Dr. Jabbour disclosed ties with AbbVie, Almoosa Specialist Hospital, Amgen, Ascentage Pharma, Biologix FZ, Hikma Pharmaceuticals, Kite, Takeda, and Terns.
A version of this article first appeared on Medscape.com.
When it comes to selecting a cost-effective, first-line tyrosine kinase inhibitor (TKI) for the treatment of chronic myeloid leukemia (CML), consider the treatment goal.
For survival, generic imatinib remains the gold standard, Elias Jabbour, MD, said during a session at the annual meeting of the Society of Hematologic Oncology in Houston.
For treatment-free remission, generic dasatinib or another generic second-generation TKI is needed, but not yet available in the United States, so generic imatinib is the best current choice, said Dr. Jabbour, a professor of medicine in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Prior to the availability of generic imatinib, that wasn’t the case, he noted, explaining that second-generation TKIs met the cost-efficacy criteria, but now — at about $35 per month or about $400 per year — imatinib is far less expensive than the approximately $250,000 per year that brand-name second- and third-generation TKIs can currently cost.
To have treatment value, any new TKI should cost $40,000-$50,000 per quality-adjusted life-year, which is defined as the quality and duration of life after a novel TKI vs with the existing standard of care, Dr. Jabbour said.
And to qualify as a frontline therapy for CML, any new TKI should show efficacy superior to second-generation TKIs, in addition to meeting the cost-effectiveness criteria.
“It is hard to show survival benefit anymore, but we need to improve on the rate of durable deep molecular remission,” he said.
An equivalent or better long-term safety profile over at least 7-8 years is also needed.
Based on the current literature, none of the TKIs currently being evaluated has met that standard, although some trials are ongoing.
In a recent editorial, Dr. Jabbour and colleagues outlined treatment recommendations based on the currently available data. They suggested using lower-than-approved doses of TKIs in both frontline and later therapies to reduce toxicity, improve treatment compliance, and reduce costs.
They also suggested that the absence of an early molecular response might not warrant changing the TKI, especially when a second-generation TKI was used first line.
When treatment-free remission is not a therapeutic goal or is unlikely, changing the TKI to improve the depth of molecular response, which has been shown to improve the likelihood of treatment-free remission, could do more harm than good, they argued.
Instead, consider reducing the dose to manage reversible side effects, they suggested, noting that generic imatinib, and eventually generic dasatinib and possibly other generic second-generation TKIs, will likely offer 90% of patients with CML an effective, safe, and affordable treatment that normalizes life expectancy and leads to treatment-free remission in 30%-50% of patients over time.
Dr. Jabbour disclosed ties with AbbVie, Almoosa Specialist Hospital, Amgen, Ascentage Pharma, Biologix FZ, Hikma Pharmaceuticals, Kite, Takeda, and Terns.
A version of this article first appeared on Medscape.com.
When it comes to selecting a cost-effective, first-line tyrosine kinase inhibitor (TKI) for the treatment of chronic myeloid leukemia (CML), consider the treatment goal.
For survival, generic imatinib remains the gold standard, Elias Jabbour, MD, said during a session at the annual meeting of the Society of Hematologic Oncology in Houston.
For treatment-free remission, generic dasatinib or another generic second-generation TKI is needed, but not yet available in the United States, so generic imatinib is the best current choice, said Dr. Jabbour, a professor of medicine in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Prior to the availability of generic imatinib, that wasn’t the case, he noted, explaining that second-generation TKIs met the cost-efficacy criteria, but now — at about $35 per month or about $400 per year — imatinib is far less expensive than the approximately $250,000 per year that brand-name second- and third-generation TKIs can currently cost.
To have treatment value, any new TKI should cost $40,000-$50,000 per quality-adjusted life-year, which is defined as the quality and duration of life after a novel TKI vs with the existing standard of care, Dr. Jabbour said.
And to qualify as a frontline therapy for CML, any new TKI should show efficacy superior to second-generation TKIs, in addition to meeting the cost-effectiveness criteria.
“It is hard to show survival benefit anymore, but we need to improve on the rate of durable deep molecular remission,” he said.
An equivalent or better long-term safety profile over at least 7-8 years is also needed.
Based on the current literature, none of the TKIs currently being evaluated has met that standard, although some trials are ongoing.
In a recent editorial, Dr. Jabbour and colleagues outlined treatment recommendations based on the currently available data. They suggested using lower-than-approved doses of TKIs in both frontline and later therapies to reduce toxicity, improve treatment compliance, and reduce costs.
They also suggested that the absence of an early molecular response might not warrant changing the TKI, especially when a second-generation TKI was used first line.
When treatment-free remission is not a therapeutic goal or is unlikely, changing the TKI to improve the depth of molecular response, which has been shown to improve the likelihood of treatment-free remission, could do more harm than good, they argued.
Instead, consider reducing the dose to manage reversible side effects, they suggested, noting that generic imatinib, and eventually generic dasatinib and possibly other generic second-generation TKIs, will likely offer 90% of patients with CML an effective, safe, and affordable treatment that normalizes life expectancy and leads to treatment-free remission in 30%-50% of patients over time.
Dr. Jabbour disclosed ties with AbbVie, Almoosa Specialist Hospital, Amgen, Ascentage Pharma, Biologix FZ, Hikma Pharmaceuticals, Kite, Takeda, and Terns.
A version of this article first appeared on Medscape.com.
FROM SOHO 2024