Dermatology News

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Dr. Reichenberg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Dr. Reichenberg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Dr. Reichenberg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

TOPLINE:

Hypoplastic pitted amelogenesis imperfecta may affect patients with the rare genetic disorder Kindler epidermolysis bullosa (KEB).

METHODOLOGY:

• KEB or Kindler syndrome, a genetic skin-blistering disease associated with pathogenic variants in FERMT1, is the rarest type of EB. Early detection and preventive measures can minimize complications, such as gum disease and other oral health issues, that have been reported in patients with KEB.
• Amelogenesis imperfecta is a group of rare genetic developmental conditions characterized by tooth enamel defects and can be associated with hypersensitivity and eruption disturbances in teeth, as well as periodontal conditions.
• Researchers conducted a longitudinal study on 36 patients with KEB (age, 2 weeks to 70 years; 42% female) from two clinics in Germany and Chile from 2003 to 2023, with follow-up times of 1-24 years.
• The primary outcomes were presence of orofacial features, including amelogenesis imperfecta, intraoral wounds,  and periodontal disease, and oral squamous cell carcinoma.

TAKEAWAY:

• All 11 patients with information on enamel structure in their records had pitted enamel anomalies (pitted amelogenesis imperfecta), with variable severity.
• Of patients whose enamel could not be analyzed, three had all teeth crowned in their 20s, suggesting enamel defects, and two had all teeth extracted in their teens or 20s, indicating severe periodontal disease.
• The most common orofacial features were periodontal disease (27 of 36 patients), intraoral lesions (16 of 22 patients), angular cheilitis (24 of 33 patients), and cheilitis (22 of 34 patients), gingival overgrowth (17 of 26 patients), microstomia (14 of 25 patients), and vestibular obliteration (8 of 16 patients).
• Oral squamous cell carcinoma was diagnosed at the site of chronic lip lesions in two patients, with lethal outcomes.

IN PRACTICE:

These findings highlight the extent and severity of oral manifestations in KEB, the authors concluded, adding that “oral care is mandatory” in patients with KEB.

SOURCE:

This report, led by Susanne Krämer, DDS, MSc, of Medical Faculty and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany, was published online in JAMA Dermatology.

LIMITATIONS:

The small sample size and the retrospective nature of the study could limit its generalizability.

DISCLOSURES:

The authors did not disclose any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Hypoplastic pitted amelogenesis imperfecta may affect patients with the rare genetic disorder Kindler epidermolysis bullosa (KEB).

METHODOLOGY:

• KEB or Kindler syndrome, a genetic skin-blistering disease associated with pathogenic variants in FERMT1, is the rarest type of EB. Early detection and preventive measures can minimize complications, such as gum disease and other oral health issues, that have been reported in patients with KEB.
• Amelogenesis imperfecta is a group of rare genetic developmental conditions characterized by tooth enamel defects and can be associated with hypersensitivity and eruption disturbances in teeth, as well as periodontal conditions.
• Researchers conducted a longitudinal study on 36 patients with KEB (age, 2 weeks to 70 years; 42% female) from two clinics in Germany and Chile from 2003 to 2023, with follow-up times of 1-24 years.
• The primary outcomes were presence of orofacial features, including amelogenesis imperfecta, intraoral wounds,  and periodontal disease, and oral squamous cell carcinoma.

TAKEAWAY:

• All 11 patients with information on enamel structure in their records had pitted enamel anomalies (pitted amelogenesis imperfecta), with variable severity.
• Of patients whose enamel could not be analyzed, three had all teeth crowned in their 20s, suggesting enamel defects, and two had all teeth extracted in their teens or 20s, indicating severe periodontal disease.
• The most common orofacial features were periodontal disease (27 of 36 patients), intraoral lesions (16 of 22 patients), angular cheilitis (24 of 33 patients), and cheilitis (22 of 34 patients), gingival overgrowth (17 of 26 patients), microstomia (14 of 25 patients), and vestibular obliteration (8 of 16 patients).
• Oral squamous cell carcinoma was diagnosed at the site of chronic lip lesions in two patients, with lethal outcomes.

IN PRACTICE:

These findings highlight the extent and severity of oral manifestations in KEB, the authors concluded, adding that “oral care is mandatory” in patients with KEB.

SOURCE:

This report, led by Susanne Krämer, DDS, MSc, of Medical Faculty and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany, was published online in JAMA Dermatology.

LIMITATIONS:

The small sample size and the retrospective nature of the study could limit its generalizability.

DISCLOSURES:

The authors did not disclose any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Hypoplastic pitted amelogenesis imperfecta may affect patients with the rare genetic disorder Kindler epidermolysis bullosa (KEB).

METHODOLOGY:

• KEB or Kindler syndrome, a genetic skin-blistering disease associated with pathogenic variants in FERMT1, is the rarest type of EB. Early detection and preventive measures can minimize complications, such as gum disease and other oral health issues, that have been reported in patients with KEB.
• Amelogenesis imperfecta is a group of rare genetic developmental conditions characterized by tooth enamel defects and can be associated with hypersensitivity and eruption disturbances in teeth, as well as periodontal conditions.
• Researchers conducted a longitudinal study on 36 patients with KEB (age, 2 weeks to 70 years; 42% female) from two clinics in Germany and Chile from 2003 to 2023, with follow-up times of 1-24 years.
• The primary outcomes were presence of orofacial features, including amelogenesis imperfecta, intraoral wounds,  and periodontal disease, and oral squamous cell carcinoma.

TAKEAWAY:

• All 11 patients with information on enamel structure in their records had pitted enamel anomalies (pitted amelogenesis imperfecta), with variable severity.
• Of patients whose enamel could not be analyzed, three had all teeth crowned in their 20s, suggesting enamel defects, and two had all teeth extracted in their teens or 20s, indicating severe periodontal disease.
• The most common orofacial features were periodontal disease (27 of 36 patients), intraoral lesions (16 of 22 patients), angular cheilitis (24 of 33 patients), and cheilitis (22 of 34 patients), gingival overgrowth (17 of 26 patients), microstomia (14 of 25 patients), and vestibular obliteration (8 of 16 patients).
• Oral squamous cell carcinoma was diagnosed at the site of chronic lip lesions in two patients, with lethal outcomes.

IN PRACTICE:

These findings highlight the extent and severity of oral manifestations in KEB, the authors concluded, adding that “oral care is mandatory” in patients with KEB.

SOURCE:

This report, led by Susanne Krämer, DDS, MSc, of Medical Faculty and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany, was published online in JAMA Dermatology.

LIMITATIONS:

The small sample size and the retrospective nature of the study could limit its generalizability.

DISCLOSURES:

The authors did not disclose any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

SAN DIEGO — In two different phase 2b trial extensions, oral treatment with Janus kinase (JAK) inhibitors showed improved skin clearance in patients with vitiligo, according to presentations at a late-breaking session at the annual meeting of the American Academy of Dermatology (AAD).

In one, the addition of narrow-band ultraviolet-B (NB-UVB) light therapy to ritlecitinib appears more effective than ritlecitinib alone. In the other study, the effectiveness of upadacitinib appears to improve over time.

Based on the ritlecitinib data, “if you have phototherapy in your office, it might be good to couple it with ritlecitinib for vitiligo patients,” said Emma Guttman-Yassky, MD, PhD, chair of the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, who presented the findings.

However, because of the relatively small numbers in the extension study, Dr. Guttman-Yassky characterized the evidence as preliminary and in need of further investigation.

For vitiligo, the only approved JAK inhibitor is ruxolitinib, 1.5%, in a cream formulation. In June, ritlecitinib (Litfulo) was approved by the Food and Drug Administration (FDA) for alopecia areata. Phototherapy, which has been used for decades in the treatment of vitiligo, has an established efficacy and safety profile as a stand-alone vitiligo treatment. Upadacitinib has numerous indications for inflammatory diseases, such as rheumatoid arthritis, and was granted FDA approval for atopic dermatitis in 2022.
 

NB-UVB Arm Added in Ritlecitinib Extension

The ritlecitinib study population was drawn from patients with non-segmental vitiligo who initially participated in a 24-week dose-ranging period of a phase 2b trial published last year. In that study, 364 patients were randomized to doses of once-daily ritlecitinib ranging from 10 to 50 mg with or without a 4-week loading regimen. Higher doses were generally associated with greater efficacy on the primary endpoint of facial vitiligo area scoring index (F-VASI) but not with a greater risk for adverse events.

In the 24-week extension study, 187 patients received a 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib for the remaining 20 weeks. Another 43 patients were randomized to one of two arms: The same 4-week loading regimen of 200-mg ritlecitinib daily followed by 50 mg of daily ritlecitinib or to 50-mg daily ritlecitinib without a loading dose but combined with NB-UVB delivered twice per week.

Important to interpretation of results, there was an additional twist. Patients in the randomized arm who had < 10% improvement in the total vitiligo area severity index (T-VASI) at week 12 of the extension were discontinued from the study.

The endpoints considered when comparing ritlecitinib with or without NB-UVB at the end of the extension study were F-VASI, T-VASI, patient global impression of change, and adverse events. Responses were assessed on the basis of both observed and last observation carried forward (LOCF).

Of the 43 people, who were randomized in the extension study, nine (21%) had < 10% improvement in T-VASI and were therefore discontinued from the study.

At the end of 24 weeks, both groups had a substantial response to their assigned therapy, but the addition of NB-UVB increased rates of response, although not always at a level of statistical significance, according to Dr. Guttman-Yassky.

For the percent improvement in F-VASI, specifically, the increase did not reach significance on the basis of LOCF (57.9% vs 51.5%; P = .158) but was highly significant on the basis of observed responses (69.6% vs 55.1%; P = .009). For T-VASI, differences for adjunctive NB-UVB over monotherapy did not reach significance for either observed or LOCF responses, but it was significant for observed responses in a patient global impression of change.
 

Small Numbers Limit Strength of Ritlecitinib, NB-UVB Evidence

However, Dr. Guttman-Yassky said it is important “to pay attention to the sample sizes” when noting the lack of significance.

The combination appeared safe, and there were no side effects associated with the addition of twice-weekly NB-UVB to ritlecitinib.

She acknowledged that the design of this analysis was “complicated” and that the number of randomized patients was small. She suggested the findings support the potential for benefit from the combination of a JAK inhibitor and NB-UVB, both of which have shown efficacy as monotherapy in previous studies. She indicated that a trial of this combination is reasonable while awaiting a more definitive study.

One of the questions that might be posed in a larger study is the timing of NB-UVB, such as whether it is best reserved for those with inadequate early response to a JAK inhibitor or if optimal results are achieved when a JAK inhibitor and NB-UVB are initiated simultaneously.

Upadacitinib Monotherapy Results

One rationale for initiating therapy with the combination of a JAK inhibitor and NB-UVB is the potential for a more rapid response, but extended results from a second phase 2b study with a different oral JAK inhibitor, upadacitinib, suggested responses on JAK inhibitor monotherapy improve steadily over time.

“The overall efficacy continued to improve without reaching a plateau at 1 year,” reported Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, Nice, France. He spoke at the same AAD late-breaking session as Dr. Guttman-Yassky.

The 24-week dose-ranging data from the upadacitinib trial were previously reported at the 2023 annual meeting of the European Association of Dermatology and Venereology. In the placebo-controlled portion, which randomized 185 patients with extensive non-segmental vitiligo to 6 mg, 11 mg, or 22 mg, the two higher doses were significantly more effective than placebo.

In the extension, patients in the placebo group were randomized to 11 mg or 22 mg, while those in the higher dose groups remained on their assigned therapies.
 

F-VASI Almost Doubled in Extension Trial

From week 24 to week 52, there was nearly a doubling of the percent F-VASI reduction, climbing from 32% to 60.8% in the 11-mg group and from 38.7% to 64.9% in the 22-mg group, Dr. Passeron said. Placebo groups who were switched to active therapy at 24 weeks rapidly approached the rates of F-VASI response of those initiated on upadacitinib.

The percent reductions in T-VASI, although lower, followed the same pattern. For the 11-mg group, the reduction climbed from 16% at 24 weeks to 44.7% at 52 weeks. For the 22-mg group, the reduction climbed from 22.9% to 44.4%. Patients who were switched from placebo to 11 mg or to 22 mg also experienced improvements in T-VASI up to 52 weeks, although the level of improvement was lower than that in patients initially randomized to the higher doses of upadacitinib.

There were “no new safety signals” for upadacitinib, which is FDA-approved for multiple indications, according to Dr. Passeron. He said acne-like lesions were the most bothersome adverse event, and cases of herpes zoster were “rare.”

A version of these data was published in a British Journal of Dermatology supplement just prior to the AAD meeting.

Phase 3 vitiligo trials are planned for both ritlecitinib and upadacitinib.

Dr. Guttman-Yassky reported financial relationships with approximately 45 pharmaceutical companies, including Pfizer, which makes ritlecitinib and provided funding for the study she discussed. Dr. Passeron reported financial relationships with approximately 40 pharmaceutical companies, including AbbVie, which makes upadacitinib and provided funding for the study he discussed.

A version of this article appeared on Medscape.com.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

Immersive virtual reality (VR) distraction therapy may be more effective at controlling pain in hospitalized patients with cancer than a two-dimensional guided imagery experience, suggests a new randomized controlled trial.

While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.

MedStar Health

“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”

To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
 

Study Methods and Results

Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.

“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”

The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.

“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.

Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.

“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
 

Downsides to Using VR

Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.

Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
 

Future VR Research

“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”

This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A review of 22 articles found a higher incidence of “altered skin sensations” and alopecia in individuals receiving oral semaglutide than in those receiving placebo.

METHODOLOGY:

• The Food and Drug Administration’s  has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
• In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.

TAKEAWAY:

• Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
• Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
• Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
• On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.

IN PRACTICE:

“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.

SOURCE:

Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

DISCLOSURES:

This study did not report any funding sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Dr. Treadwell

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Dr. Treadwell

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Dr. Treadwell

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.