The case for anti–IL-17 agents as first-line biologics in psoriatic arthritis

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Tue, 02/07/2023 - 16:47

Current major guidelines for treatment of psoriatic arthritis (PsA) shortchange the value of the anti–interleukin-17 biologics for this disease, Kenneth B. Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Kenneth B. Gordon, Medical College of Wisconsin
Dr. Kenneth B. Gordon

The 2018 joint American College of Rheumatology/National Psoriasis Association guidelines recommend the anti–tumor necrosis factor agents as first-line biologic therapy for PsA, with the anti–IL-17 biologics held in reserve as second-tier therapy for when the anti-TNFs don’t work. That’s largely because the guidance was developed before the compelling evidence for the anti–IL-17 agents as the biologics of choice was appreciated, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

“Many people go by these guidelines,” the dermatologist noted. “I think it’s really critical to look at the data and not just the guidelines because the guidelines don’t give full credit to the anti–IL-17 agents,” he added.

“Emerging psoriatic arthritis data may likely put this class of medications into the forefront of treatment for patients who have both psoriasis and psoriatic arthritis because you generally get higher responses for the skin disease than with anti-TNF therapy, and with similar responses in psoriatic arthritis.”

Two IL-17 inhibitors are approved for both PsA and psoriasis: secukinumab (Cosentyx) and ixekizumab (Taltz). In addition, brodalumab (Siliq), approved for psoriasis, is expected to receive an expanded indication for PsA based upon its strong showing in the AMVISION-1 and -2 trials. Data from those trials, as well as the FUTURE 2 trial for secukinumab and SPIRIT-P1 for ixekizumab, consistently document at least 20% improvement in the ACR criteria for PsA severity – that is, an ACR 20 response – in 50%-60% of patients on one of the three IL-17 inhibitors, as well as ACR 50 response rates of around 30%. Those outcomes are quite consistent with the impact of the anti-TNF biologics on joint disease. But the TNF inhibitors can’t touch the anti–IL-17 biologics when it comes to improvement in Psoriasis Area and Severity Index (PASI) scores: The anti–IL-17 agents have week-52 PASI 75 response rates in the range of 80%, PASI 90 response rates of 70%-75%, and PASI 100 response rates of 40%-55%, with the highest-end results being seen with brodalumab, he continued.

A point worth remembering when prescribing secukinumab is that the approved dose for PsA is 150 mg every 4 weeks, which is just half of the typical dose in psoriasis.

“I spend a lot of time convincing my rheumatology colleagues that if you’re treating both psoriasis and psoriatic arthritis, use the psoriasis dose. There’s some evidence that the higher dose provides some benefit in terms of prevention of permanent joint damage by x-ray,” Dr. Gordon said.

Evidence that TNF inhibitors inhibit permanent joint damage in patients with PsA has been considered a major advantage, establishing this medication class as first-line biologic therapy. But anti–IL-17 therapies appear to have a similar beneficial effect. That was demonstrated in the SPIRIT-P1 trial, where Sharp scores – a radiographic measure of progression of joint damage – were similar at 24 weeks in PsA patients randomized to ixekizumab as compared to adalimumab, with both biologics being superior to placebo. An Assessment of SpondyloArthritis International Society 20% improvement (ASAS 20) response or an ACR 50 response doesn’t capture what’s going on with regard to axial disease. That’s assessed through ASAS 20 and ASAS 40 responses – that is, at least 20% or 40% improvement, compared with baseline, in Assessment in Ankylosing Spondylitis scores. And in the MEASURE 1 and 2 trials, secukinumab achieved robust improvement in axial disease as reflected in favorable ASAS 20 and ASAS 40 responses through 52 weeks in patients with active ankylosing spondylitis.

“The anti–IL-17 agents do actually work in ankylosing spondylitis, which might be a surrogate for the treatment effect in axial psoriatic arthritis,” Dr. Gordon commented.

The phase 3b MAXIMISE trial presented at the 2019 EULAR meeting looked specifically at the impact of secukinumab in patients with psoriatic arthritis with axial involvement. An ASAS 20 response at week 12 was seen in 67% and 65% of patients randomized to secukinumab at 150 or 300 mg, respectively, if they were on concomitant methotrexate, and 64% and 61% if they were not, compared with ASAS 20 rates of 34% and 31% in placebo-treated controls.

“This is the only study of an anti–IL-17 agent that’s been done for axial disease to date in psoriatic arthritis. It’s very, very encouraging,” the dermatologist commented.

 

Durability of response and safety

“In terms of safety, the anti–IL-17s have been a truly remarkable success story. There are very low rates of things to be concerned about,” Dr. Gordon said.

Oral candidiasis occurs in 2%-4% of treated patients, but he noted, “It’s almost always very mild disease” that’s easily treatable with nystatin or, in the worst case, with some fluconazole.

Inflammatory bowel disease (IBD) as a side effect of anti–IL-17 therapy has been a controversial issue. Dr. Gordon’s interpretation of the evidence is that there probably is a very slight increase in the risk of developing ulcerative colitis, but not Crohn’s disease.

“This rate is extraordinarily low, so while it’s something that I consider, and if a patient has a personal history of IBD I will sometimes hesitate to use an anti–IL-17 agent, in patients who don’t have a personal history I’ll go ahead,” he explained.

There is a signal of a slight increase in risk of depression in patients on brodalumab, which isn’t the case for secukinumab or ixekizumab.

Importantly, large long-term extension studies with years of follow-up show that the initially low adverse event rates associated with the IL-17 inhibitors don’t increase over time; rather, they remain steady over years of use.

Long-term maintenance of response with these biologics is impressive. “It’s not perfect, but it’s still a tremendous advantage for patients, especially if you can get them through that initial period,” Dr. Gordon said.

For example, in the long-term extension of the UNCOVER-1 trial, psoriasis patients who had clear or almost clear skin at week 12 on ixekizumab and continued to take the medication open label for 5 years had PASI 75, 90, and 100 response rates of 94%, 82%, and 47%, respectively, at week 264.
 

What about IL-12/23 and IL-23 inhibitors in PsA?

In a separate presentation at the MedscapeLive seminar, Bruce E. Strober, MD, PhD, said that, although ustekinumab (Stelara) is approved for both psoriasis and PsA, the IL-12/-23 inhibitor’s efficacy in PsA is inconsistent and lower than other approved biologics. In contrast, the IL-23 inhibitor guselkumab (Tremfya), which also has the dual indications, is a strong performer in both. In the DISCOVER-2 trial, conducted in treatment-naive patients with PsA, guselkumab at the approved dose of 100 mg every 8 weeks achieved ACR 20, 50, and 70 rates of 64%, 31%, and 19%, respectively. It was also significantly better than placebo for resolution of enthesitis.

Dr. Bruce E. Strober
Dr. Bruce E. Strober

An important caveat: While radiographic inhibition of progression of joint disease occurred with guselkumab dosed at 100 mg every 4 weeks in DISCOVER-2, that’s not the approved dose. At 100 mg every 8 weeks – the FDA-approved dosing for both psoriatic arthritis and psoriasis – radiographic inhibition wasn’t better than with placebo, noted Dr. Strober, a dermatologist at Yale University, New Haven, Conn.

Dr. Gordon and Dr. Strober are clinical trialists who reported receiving research support and/or honoraria from more than a dozen pharmaceutical companies, including virtually all of those with biologics for dermatology.

MedscapeLive and this news organization are owned by the same parent company.

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Current major guidelines for treatment of psoriatic arthritis (PsA) shortchange the value of the anti–interleukin-17 biologics for this disease, Kenneth B. Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Kenneth B. Gordon, Medical College of Wisconsin
Dr. Kenneth B. Gordon

The 2018 joint American College of Rheumatology/National Psoriasis Association guidelines recommend the anti–tumor necrosis factor agents as first-line biologic therapy for PsA, with the anti–IL-17 biologics held in reserve as second-tier therapy for when the anti-TNFs don’t work. That’s largely because the guidance was developed before the compelling evidence for the anti–IL-17 agents as the biologics of choice was appreciated, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

“Many people go by these guidelines,” the dermatologist noted. “I think it’s really critical to look at the data and not just the guidelines because the guidelines don’t give full credit to the anti–IL-17 agents,” he added.

“Emerging psoriatic arthritis data may likely put this class of medications into the forefront of treatment for patients who have both psoriasis and psoriatic arthritis because you generally get higher responses for the skin disease than with anti-TNF therapy, and with similar responses in psoriatic arthritis.”

Two IL-17 inhibitors are approved for both PsA and psoriasis: secukinumab (Cosentyx) and ixekizumab (Taltz). In addition, brodalumab (Siliq), approved for psoriasis, is expected to receive an expanded indication for PsA based upon its strong showing in the AMVISION-1 and -2 trials. Data from those trials, as well as the FUTURE 2 trial for secukinumab and SPIRIT-P1 for ixekizumab, consistently document at least 20% improvement in the ACR criteria for PsA severity – that is, an ACR 20 response – in 50%-60% of patients on one of the three IL-17 inhibitors, as well as ACR 50 response rates of around 30%. Those outcomes are quite consistent with the impact of the anti-TNF biologics on joint disease. But the TNF inhibitors can’t touch the anti–IL-17 biologics when it comes to improvement in Psoriasis Area and Severity Index (PASI) scores: The anti–IL-17 agents have week-52 PASI 75 response rates in the range of 80%, PASI 90 response rates of 70%-75%, and PASI 100 response rates of 40%-55%, with the highest-end results being seen with brodalumab, he continued.

A point worth remembering when prescribing secukinumab is that the approved dose for PsA is 150 mg every 4 weeks, which is just half of the typical dose in psoriasis.

“I spend a lot of time convincing my rheumatology colleagues that if you’re treating both psoriasis and psoriatic arthritis, use the psoriasis dose. There’s some evidence that the higher dose provides some benefit in terms of prevention of permanent joint damage by x-ray,” Dr. Gordon said.

Evidence that TNF inhibitors inhibit permanent joint damage in patients with PsA has been considered a major advantage, establishing this medication class as first-line biologic therapy. But anti–IL-17 therapies appear to have a similar beneficial effect. That was demonstrated in the SPIRIT-P1 trial, where Sharp scores – a radiographic measure of progression of joint damage – were similar at 24 weeks in PsA patients randomized to ixekizumab as compared to adalimumab, with both biologics being superior to placebo. An Assessment of SpondyloArthritis International Society 20% improvement (ASAS 20) response or an ACR 50 response doesn’t capture what’s going on with regard to axial disease. That’s assessed through ASAS 20 and ASAS 40 responses – that is, at least 20% or 40% improvement, compared with baseline, in Assessment in Ankylosing Spondylitis scores. And in the MEASURE 1 and 2 trials, secukinumab achieved robust improvement in axial disease as reflected in favorable ASAS 20 and ASAS 40 responses through 52 weeks in patients with active ankylosing spondylitis.

“The anti–IL-17 agents do actually work in ankylosing spondylitis, which might be a surrogate for the treatment effect in axial psoriatic arthritis,” Dr. Gordon commented.

The phase 3b MAXIMISE trial presented at the 2019 EULAR meeting looked specifically at the impact of secukinumab in patients with psoriatic arthritis with axial involvement. An ASAS 20 response at week 12 was seen in 67% and 65% of patients randomized to secukinumab at 150 or 300 mg, respectively, if they were on concomitant methotrexate, and 64% and 61% if they were not, compared with ASAS 20 rates of 34% and 31% in placebo-treated controls.

“This is the only study of an anti–IL-17 agent that’s been done for axial disease to date in psoriatic arthritis. It’s very, very encouraging,” the dermatologist commented.

 

Durability of response and safety

“In terms of safety, the anti–IL-17s have been a truly remarkable success story. There are very low rates of things to be concerned about,” Dr. Gordon said.

Oral candidiasis occurs in 2%-4% of treated patients, but he noted, “It’s almost always very mild disease” that’s easily treatable with nystatin or, in the worst case, with some fluconazole.

Inflammatory bowel disease (IBD) as a side effect of anti–IL-17 therapy has been a controversial issue. Dr. Gordon’s interpretation of the evidence is that there probably is a very slight increase in the risk of developing ulcerative colitis, but not Crohn’s disease.

“This rate is extraordinarily low, so while it’s something that I consider, and if a patient has a personal history of IBD I will sometimes hesitate to use an anti–IL-17 agent, in patients who don’t have a personal history I’ll go ahead,” he explained.

There is a signal of a slight increase in risk of depression in patients on brodalumab, which isn’t the case for secukinumab or ixekizumab.

Importantly, large long-term extension studies with years of follow-up show that the initially low adverse event rates associated with the IL-17 inhibitors don’t increase over time; rather, they remain steady over years of use.

Long-term maintenance of response with these biologics is impressive. “It’s not perfect, but it’s still a tremendous advantage for patients, especially if you can get them through that initial period,” Dr. Gordon said.

For example, in the long-term extension of the UNCOVER-1 trial, psoriasis patients who had clear or almost clear skin at week 12 on ixekizumab and continued to take the medication open label for 5 years had PASI 75, 90, and 100 response rates of 94%, 82%, and 47%, respectively, at week 264.
 

What about IL-12/23 and IL-23 inhibitors in PsA?

In a separate presentation at the MedscapeLive seminar, Bruce E. Strober, MD, PhD, said that, although ustekinumab (Stelara) is approved for both psoriasis and PsA, the IL-12/-23 inhibitor’s efficacy in PsA is inconsistent and lower than other approved biologics. In contrast, the IL-23 inhibitor guselkumab (Tremfya), which also has the dual indications, is a strong performer in both. In the DISCOVER-2 trial, conducted in treatment-naive patients with PsA, guselkumab at the approved dose of 100 mg every 8 weeks achieved ACR 20, 50, and 70 rates of 64%, 31%, and 19%, respectively. It was also significantly better than placebo for resolution of enthesitis.

Dr. Bruce E. Strober
Dr. Bruce E. Strober

An important caveat: While radiographic inhibition of progression of joint disease occurred with guselkumab dosed at 100 mg every 4 weeks in DISCOVER-2, that’s not the approved dose. At 100 mg every 8 weeks – the FDA-approved dosing for both psoriatic arthritis and psoriasis – radiographic inhibition wasn’t better than with placebo, noted Dr. Strober, a dermatologist at Yale University, New Haven, Conn.

Dr. Gordon and Dr. Strober are clinical trialists who reported receiving research support and/or honoraria from more than a dozen pharmaceutical companies, including virtually all of those with biologics for dermatology.

MedscapeLive and this news organization are owned by the same parent company.

Current major guidelines for treatment of psoriatic arthritis (PsA) shortchange the value of the anti–interleukin-17 biologics for this disease, Kenneth B. Gordon, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Kenneth B. Gordon, Medical College of Wisconsin
Dr. Kenneth B. Gordon

The 2018 joint American College of Rheumatology/National Psoriasis Association guidelines recommend the anti–tumor necrosis factor agents as first-line biologic therapy for PsA, with the anti–IL-17 biologics held in reserve as second-tier therapy for when the anti-TNFs don’t work. That’s largely because the guidance was developed before the compelling evidence for the anti–IL-17 agents as the biologics of choice was appreciated, according to Dr. Gordon, professor and chair of the department of dermatology at the Medical College of Wisconsin, Milwaukee.

“Many people go by these guidelines,” the dermatologist noted. “I think it’s really critical to look at the data and not just the guidelines because the guidelines don’t give full credit to the anti–IL-17 agents,” he added.

“Emerging psoriatic arthritis data may likely put this class of medications into the forefront of treatment for patients who have both psoriasis and psoriatic arthritis because you generally get higher responses for the skin disease than with anti-TNF therapy, and with similar responses in psoriatic arthritis.”

Two IL-17 inhibitors are approved for both PsA and psoriasis: secukinumab (Cosentyx) and ixekizumab (Taltz). In addition, brodalumab (Siliq), approved for psoriasis, is expected to receive an expanded indication for PsA based upon its strong showing in the AMVISION-1 and -2 trials. Data from those trials, as well as the FUTURE 2 trial for secukinumab and SPIRIT-P1 for ixekizumab, consistently document at least 20% improvement in the ACR criteria for PsA severity – that is, an ACR 20 response – in 50%-60% of patients on one of the three IL-17 inhibitors, as well as ACR 50 response rates of around 30%. Those outcomes are quite consistent with the impact of the anti-TNF biologics on joint disease. But the TNF inhibitors can’t touch the anti–IL-17 biologics when it comes to improvement in Psoriasis Area and Severity Index (PASI) scores: The anti–IL-17 agents have week-52 PASI 75 response rates in the range of 80%, PASI 90 response rates of 70%-75%, and PASI 100 response rates of 40%-55%, with the highest-end results being seen with brodalumab, he continued.

A point worth remembering when prescribing secukinumab is that the approved dose for PsA is 150 mg every 4 weeks, which is just half of the typical dose in psoriasis.

“I spend a lot of time convincing my rheumatology colleagues that if you’re treating both psoriasis and psoriatic arthritis, use the psoriasis dose. There’s some evidence that the higher dose provides some benefit in terms of prevention of permanent joint damage by x-ray,” Dr. Gordon said.

Evidence that TNF inhibitors inhibit permanent joint damage in patients with PsA has been considered a major advantage, establishing this medication class as first-line biologic therapy. But anti–IL-17 therapies appear to have a similar beneficial effect. That was demonstrated in the SPIRIT-P1 trial, where Sharp scores – a radiographic measure of progression of joint damage – were similar at 24 weeks in PsA patients randomized to ixekizumab as compared to adalimumab, with both biologics being superior to placebo. An Assessment of SpondyloArthritis International Society 20% improvement (ASAS 20) response or an ACR 50 response doesn’t capture what’s going on with regard to axial disease. That’s assessed through ASAS 20 and ASAS 40 responses – that is, at least 20% or 40% improvement, compared with baseline, in Assessment in Ankylosing Spondylitis scores. And in the MEASURE 1 and 2 trials, secukinumab achieved robust improvement in axial disease as reflected in favorable ASAS 20 and ASAS 40 responses through 52 weeks in patients with active ankylosing spondylitis.

“The anti–IL-17 agents do actually work in ankylosing spondylitis, which might be a surrogate for the treatment effect in axial psoriatic arthritis,” Dr. Gordon commented.

The phase 3b MAXIMISE trial presented at the 2019 EULAR meeting looked specifically at the impact of secukinumab in patients with psoriatic arthritis with axial involvement. An ASAS 20 response at week 12 was seen in 67% and 65% of patients randomized to secukinumab at 150 or 300 mg, respectively, if they were on concomitant methotrexate, and 64% and 61% if they were not, compared with ASAS 20 rates of 34% and 31% in placebo-treated controls.

“This is the only study of an anti–IL-17 agent that’s been done for axial disease to date in psoriatic arthritis. It’s very, very encouraging,” the dermatologist commented.

 

Durability of response and safety

“In terms of safety, the anti–IL-17s have been a truly remarkable success story. There are very low rates of things to be concerned about,” Dr. Gordon said.

Oral candidiasis occurs in 2%-4% of treated patients, but he noted, “It’s almost always very mild disease” that’s easily treatable with nystatin or, in the worst case, with some fluconazole.

Inflammatory bowel disease (IBD) as a side effect of anti–IL-17 therapy has been a controversial issue. Dr. Gordon’s interpretation of the evidence is that there probably is a very slight increase in the risk of developing ulcerative colitis, but not Crohn’s disease.

“This rate is extraordinarily low, so while it’s something that I consider, and if a patient has a personal history of IBD I will sometimes hesitate to use an anti–IL-17 agent, in patients who don’t have a personal history I’ll go ahead,” he explained.

There is a signal of a slight increase in risk of depression in patients on brodalumab, which isn’t the case for secukinumab or ixekizumab.

Importantly, large long-term extension studies with years of follow-up show that the initially low adverse event rates associated with the IL-17 inhibitors don’t increase over time; rather, they remain steady over years of use.

Long-term maintenance of response with these biologics is impressive. “It’s not perfect, but it’s still a tremendous advantage for patients, especially if you can get them through that initial period,” Dr. Gordon said.

For example, in the long-term extension of the UNCOVER-1 trial, psoriasis patients who had clear or almost clear skin at week 12 on ixekizumab and continued to take the medication open label for 5 years had PASI 75, 90, and 100 response rates of 94%, 82%, and 47%, respectively, at week 264.
 

What about IL-12/23 and IL-23 inhibitors in PsA?

In a separate presentation at the MedscapeLive seminar, Bruce E. Strober, MD, PhD, said that, although ustekinumab (Stelara) is approved for both psoriasis and PsA, the IL-12/-23 inhibitor’s efficacy in PsA is inconsistent and lower than other approved biologics. In contrast, the IL-23 inhibitor guselkumab (Tremfya), which also has the dual indications, is a strong performer in both. In the DISCOVER-2 trial, conducted in treatment-naive patients with PsA, guselkumab at the approved dose of 100 mg every 8 weeks achieved ACR 20, 50, and 70 rates of 64%, 31%, and 19%, respectively. It was also significantly better than placebo for resolution of enthesitis.

Dr. Bruce E. Strober
Dr. Bruce E. Strober

An important caveat: While radiographic inhibition of progression of joint disease occurred with guselkumab dosed at 100 mg every 4 weeks in DISCOVER-2, that’s not the approved dose. At 100 mg every 8 weeks – the FDA-approved dosing for both psoriatic arthritis and psoriasis – radiographic inhibition wasn’t better than with placebo, noted Dr. Strober, a dermatologist at Yale University, New Haven, Conn.

Dr. Gordon and Dr. Strober are clinical trialists who reported receiving research support and/or honoraria from more than a dozen pharmaceutical companies, including virtually all of those with biologics for dermatology.

MedscapeLive and this news organization are owned by the same parent company.

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Medscape Article

Several approaches recommended to reduce filler, neuromodulator complications

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Changed
Mon, 11/30/2020 - 15:28

Most potential complications associated with filler and neuromodulator injections can be managed or prevented, and the right protocols can help in the rare cases of serious complications, Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Katie Beleznay

The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.

In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.

To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.

To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.

Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
 

Complications associated with fillers

When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.

The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.

Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.

Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.

If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.

Tips for prevention

Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.

When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.

Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.

Always ask and use caution if patients have had other recent surgical procedures, she added.

Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.

Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.

MedscapeLive and this news organization are owned by the same parent company.

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Most potential complications associated with filler and neuromodulator injections can be managed or prevented, and the right protocols can help in the rare cases of serious complications, Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Katie Beleznay

The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.

In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.

To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.

To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.

Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
 

Complications associated with fillers

When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.

The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.

Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.

Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.

If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.

Tips for prevention

Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.

When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.

Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.

Always ask and use caution if patients have had other recent surgical procedures, she added.

Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.

Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.

MedscapeLive and this news organization are owned by the same parent company.

Most potential complications associated with filler and neuromodulator injections can be managed or prevented, and the right protocols can help in the rare cases of serious complications, Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

Dr. Katie Beleznay

The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.

In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.

To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.

To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.

Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
 

Complications associated with fillers

When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.

The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.

Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.

Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.

If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.

Tips for prevention

Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.

When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.

Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.

Always ask and use caution if patients have had other recent surgical procedures, she added.

Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.

Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.

MedscapeLive and this news organization are owned by the same parent company.

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Expanded indications likely for apremilast

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Big changes are coming in the use of oral apremilast, currently approved for moderate to severe psoriasis and plaque psoriasis in adults, Bruce E. Strober, MD, PhD, predicted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“We’ll have a pediatric indication for apremilast in psoriasis down the line, and probably a mild to moderate indication for psoriasis, meaning we can use this drug in patients in whom we typically think about using only topical therapies. Keep on the lookout: I think the mild to moderate indication may be coming next year, and that’s going to really shake up the whole landscape of psoriasis therapy,” said Dr. Strober, a dermatologist at Yale University in New Haven, Conn., and Central Connecticut Dermatology in Cromwell, Conn.
 

Mild or moderate psoriasis

Apremilast manufacturer Amgen has announced positive topline results from the phase 3 ADVANCE trial, a multicenter, placebo-controlled, double-blind, study of 595 patients with mild or moderate psoriasis as defined by an involved body surface area of 2%-15% and a Psoriasis Area and Severity Index score of 2-15. Participants were randomized to the approved dose of apremilast (Otezla) – 30 mg twice daily – or placebo for 16 weeks, followed by 16 weeks of open-label apremilast for all. The full study findings haven’t yet been published or presented at a medical conference, but Amgen announced that the results were positive for all primary and secondary endpoints, and the company plans to file a request with the Food and Drug Administration for an expanded indication for the oral agent.

Pediatric studies

A recently published phase 2, open-label, 1-year study of apremilast in 42 children and adolescents with moderate to severe plaque psoriasis demonstrated that weight-based dosing is the best approach in the pediatric population. The study, which serves as the template for coming phase 3 trials, showed that dosing apremilast at 20 mg twice daily in youths weighing not more than 35 kg and 30 mg twice daily in those who weighed more provided pharmacokinetic exposure similar to that achieved with apremilast at the standard adult dose of 30 mg twice daily. Most participants liked the taste of the tablet.

“My prediction is apremilast will have efficacy in children and teenagers comparable to what it has in adults, with a similar safety and adverse event profile,” Dr. Strober said.

Apremilast works by blocking phosphodiesterase type 4, thereby reducing cyclic AMP metabolism, with a resultant increase in cyclic AMP levels. Cyclic AMP is a regulator of inflammation. Boosting its level has the effect of decreasing tumor necrosis factor and other proinflammatory cytokines while increasing anti-inflammatory mediators, such as interleukin-10.

Dr. Strober characterized apremilast’s efficacy as “modest” by contemporary standards in adults with moderate to severe psoriasis, with week 16 PASI 75 rates of about 30% in randomized trials, compared with 5% in placebo-treated controls. He considers it a good option in patients with moderate disease who are needle phobic and in those averse to the inconvenience of laboratory monitoring. The drug is useful in treating psoriasis in especially challenging locations. Apremilast is specifically approved for scalp psoriasis, and Dr. Strober has anecdotally found it helpful in patients with palmoplantar psoriasis or genital psoriasis.

“Apremilast has tolerability issues: first and foremost diarrhea, nausea, and headache. Probably 15%-20% of patients have nausea or diarrhea ranging from mild to severe, and 1 in 20 have headache. You have to warn patients,” he said.

Roughly 1% of patients experience depressed mood. “I’ve seen it in a few patients. I definitely believe it’s real, so query patients about mood changes while taking apremilast,” the dermatologist advised.

One in 5 patients loses 5% of body weight during the first 6 months on apremilast, but there’s no additional weight loss thereafter. It’s wrong to characterize the oral agent as a weight-loss drug, though, since 80% of patients don’t lose weight, Dr. Strober noted.
 

 

 

Topical PDE-4 inhibitor shows promise

Separately at the Las Vegas meeting, Linda Stein Gold, MD, provided highlights of a phase 2b randomized trial of a topical cream formulation of an extremely potent PDE-4 inhibitor, roflumilast, in patients with chronic plaque psoriasis. This molecule is a couple hundred times more effective at inhibiting the PDE-4 receptor than either oral apremilast or topical crisaborole (Eucrisa). And as a once-daily topical agent with very little systemic absorption, roflumilast cream sidesteps the tolerability issues that accompany apremilast.

“Roflumilast is currently available as an oral formulation for treatment of [chronic obstructive pulmonary disease], so it has a fairly well-established safety profile,” noted Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

The 12-week, multicenter, phase 2b study sponsored by Arcutis Biotherapeutics included 331 patients with chronic plaque psoriasis who were randomized to once-daily 0.3% roflumilast cream, 0.15% roflumilast cream, or vehicle. Three-quarters of participants had baseline moderate disease.

A week-8 Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear skin or almost clear, plus at least a 2-grade improvement from baseline occurred in 32% of the high-dose roflumilast group, 25% of those on the 0.15% formulation, and 10% of controls. On the secondary endpoint of improvement in tough-to-treat intertriginous psoriasis, at week 12 an intertriginous IGA score of 0 or 1 plus at least a 2-point improvement from baseline was seen in 86% of the 0.3% roflumilast cream group, 50% on low-dose therapy, and 29% of controls. Moreover, the clinical improvements in IGA and itch kicked in quickly, with significant separation from placebo by week 2, Dr. Stein Gold noted.

The phase 3 program is now recruiting participants.

Dr. Strober and Dr. Stein Gold reported receiving research funding from and serving as consultants to Amgen and numerous other pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

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Big changes are coming in the use of oral apremilast, currently approved for moderate to severe psoriasis and plaque psoriasis in adults, Bruce E. Strober, MD, PhD, predicted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“We’ll have a pediatric indication for apremilast in psoriasis down the line, and probably a mild to moderate indication for psoriasis, meaning we can use this drug in patients in whom we typically think about using only topical therapies. Keep on the lookout: I think the mild to moderate indication may be coming next year, and that’s going to really shake up the whole landscape of psoriasis therapy,” said Dr. Strober, a dermatologist at Yale University in New Haven, Conn., and Central Connecticut Dermatology in Cromwell, Conn.
 

Mild or moderate psoriasis

Apremilast manufacturer Amgen has announced positive topline results from the phase 3 ADVANCE trial, a multicenter, placebo-controlled, double-blind, study of 595 patients with mild or moderate psoriasis as defined by an involved body surface area of 2%-15% and a Psoriasis Area and Severity Index score of 2-15. Participants were randomized to the approved dose of apremilast (Otezla) – 30 mg twice daily – or placebo for 16 weeks, followed by 16 weeks of open-label apremilast for all. The full study findings haven’t yet been published or presented at a medical conference, but Amgen announced that the results were positive for all primary and secondary endpoints, and the company plans to file a request with the Food and Drug Administration for an expanded indication for the oral agent.

Pediatric studies

A recently published phase 2, open-label, 1-year study of apremilast in 42 children and adolescents with moderate to severe plaque psoriasis demonstrated that weight-based dosing is the best approach in the pediatric population. The study, which serves as the template for coming phase 3 trials, showed that dosing apremilast at 20 mg twice daily in youths weighing not more than 35 kg and 30 mg twice daily in those who weighed more provided pharmacokinetic exposure similar to that achieved with apremilast at the standard adult dose of 30 mg twice daily. Most participants liked the taste of the tablet.

“My prediction is apremilast will have efficacy in children and teenagers comparable to what it has in adults, with a similar safety and adverse event profile,” Dr. Strober said.

Apremilast works by blocking phosphodiesterase type 4, thereby reducing cyclic AMP metabolism, with a resultant increase in cyclic AMP levels. Cyclic AMP is a regulator of inflammation. Boosting its level has the effect of decreasing tumor necrosis factor and other proinflammatory cytokines while increasing anti-inflammatory mediators, such as interleukin-10.

Dr. Strober characterized apremilast’s efficacy as “modest” by contemporary standards in adults with moderate to severe psoriasis, with week 16 PASI 75 rates of about 30% in randomized trials, compared with 5% in placebo-treated controls. He considers it a good option in patients with moderate disease who are needle phobic and in those averse to the inconvenience of laboratory monitoring. The drug is useful in treating psoriasis in especially challenging locations. Apremilast is specifically approved for scalp psoriasis, and Dr. Strober has anecdotally found it helpful in patients with palmoplantar psoriasis or genital psoriasis.

“Apremilast has tolerability issues: first and foremost diarrhea, nausea, and headache. Probably 15%-20% of patients have nausea or diarrhea ranging from mild to severe, and 1 in 20 have headache. You have to warn patients,” he said.

Roughly 1% of patients experience depressed mood. “I’ve seen it in a few patients. I definitely believe it’s real, so query patients about mood changes while taking apremilast,” the dermatologist advised.

One in 5 patients loses 5% of body weight during the first 6 months on apremilast, but there’s no additional weight loss thereafter. It’s wrong to characterize the oral agent as a weight-loss drug, though, since 80% of patients don’t lose weight, Dr. Strober noted.
 

 

 

Topical PDE-4 inhibitor shows promise

Separately at the Las Vegas meeting, Linda Stein Gold, MD, provided highlights of a phase 2b randomized trial of a topical cream formulation of an extremely potent PDE-4 inhibitor, roflumilast, in patients with chronic plaque psoriasis. This molecule is a couple hundred times more effective at inhibiting the PDE-4 receptor than either oral apremilast or topical crisaborole (Eucrisa). And as a once-daily topical agent with very little systemic absorption, roflumilast cream sidesteps the tolerability issues that accompany apremilast.

“Roflumilast is currently available as an oral formulation for treatment of [chronic obstructive pulmonary disease], so it has a fairly well-established safety profile,” noted Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

The 12-week, multicenter, phase 2b study sponsored by Arcutis Biotherapeutics included 331 patients with chronic plaque psoriasis who were randomized to once-daily 0.3% roflumilast cream, 0.15% roflumilast cream, or vehicle. Three-quarters of participants had baseline moderate disease.

A week-8 Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear skin or almost clear, plus at least a 2-grade improvement from baseline occurred in 32% of the high-dose roflumilast group, 25% of those on the 0.15% formulation, and 10% of controls. On the secondary endpoint of improvement in tough-to-treat intertriginous psoriasis, at week 12 an intertriginous IGA score of 0 or 1 plus at least a 2-point improvement from baseline was seen in 86% of the 0.3% roflumilast cream group, 50% on low-dose therapy, and 29% of controls. Moreover, the clinical improvements in IGA and itch kicked in quickly, with significant separation from placebo by week 2, Dr. Stein Gold noted.

The phase 3 program is now recruiting participants.

Dr. Strober and Dr. Stein Gold reported receiving research funding from and serving as consultants to Amgen and numerous other pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

Big changes are coming in the use of oral apremilast, currently approved for moderate to severe psoriasis and plaque psoriasis in adults, Bruce E. Strober, MD, PhD, predicted at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“We’ll have a pediatric indication for apremilast in psoriasis down the line, and probably a mild to moderate indication for psoriasis, meaning we can use this drug in patients in whom we typically think about using only topical therapies. Keep on the lookout: I think the mild to moderate indication may be coming next year, and that’s going to really shake up the whole landscape of psoriasis therapy,” said Dr. Strober, a dermatologist at Yale University in New Haven, Conn., and Central Connecticut Dermatology in Cromwell, Conn.
 

Mild or moderate psoriasis

Apremilast manufacturer Amgen has announced positive topline results from the phase 3 ADVANCE trial, a multicenter, placebo-controlled, double-blind, study of 595 patients with mild or moderate psoriasis as defined by an involved body surface area of 2%-15% and a Psoriasis Area and Severity Index score of 2-15. Participants were randomized to the approved dose of apremilast (Otezla) – 30 mg twice daily – or placebo for 16 weeks, followed by 16 weeks of open-label apremilast for all. The full study findings haven’t yet been published or presented at a medical conference, but Amgen announced that the results were positive for all primary and secondary endpoints, and the company plans to file a request with the Food and Drug Administration for an expanded indication for the oral agent.

Pediatric studies

A recently published phase 2, open-label, 1-year study of apremilast in 42 children and adolescents with moderate to severe plaque psoriasis demonstrated that weight-based dosing is the best approach in the pediatric population. The study, which serves as the template for coming phase 3 trials, showed that dosing apremilast at 20 mg twice daily in youths weighing not more than 35 kg and 30 mg twice daily in those who weighed more provided pharmacokinetic exposure similar to that achieved with apremilast at the standard adult dose of 30 mg twice daily. Most participants liked the taste of the tablet.

“My prediction is apremilast will have efficacy in children and teenagers comparable to what it has in adults, with a similar safety and adverse event profile,” Dr. Strober said.

Apremilast works by blocking phosphodiesterase type 4, thereby reducing cyclic AMP metabolism, with a resultant increase in cyclic AMP levels. Cyclic AMP is a regulator of inflammation. Boosting its level has the effect of decreasing tumor necrosis factor and other proinflammatory cytokines while increasing anti-inflammatory mediators, such as interleukin-10.

Dr. Strober characterized apremilast’s efficacy as “modest” by contemporary standards in adults with moderate to severe psoriasis, with week 16 PASI 75 rates of about 30% in randomized trials, compared with 5% in placebo-treated controls. He considers it a good option in patients with moderate disease who are needle phobic and in those averse to the inconvenience of laboratory monitoring. The drug is useful in treating psoriasis in especially challenging locations. Apremilast is specifically approved for scalp psoriasis, and Dr. Strober has anecdotally found it helpful in patients with palmoplantar psoriasis or genital psoriasis.

“Apremilast has tolerability issues: first and foremost diarrhea, nausea, and headache. Probably 15%-20% of patients have nausea or diarrhea ranging from mild to severe, and 1 in 20 have headache. You have to warn patients,” he said.

Roughly 1% of patients experience depressed mood. “I’ve seen it in a few patients. I definitely believe it’s real, so query patients about mood changes while taking apremilast,” the dermatologist advised.

One in 5 patients loses 5% of body weight during the first 6 months on apremilast, but there’s no additional weight loss thereafter. It’s wrong to characterize the oral agent as a weight-loss drug, though, since 80% of patients don’t lose weight, Dr. Strober noted.
 

 

 

Topical PDE-4 inhibitor shows promise

Separately at the Las Vegas meeting, Linda Stein Gold, MD, provided highlights of a phase 2b randomized trial of a topical cream formulation of an extremely potent PDE-4 inhibitor, roflumilast, in patients with chronic plaque psoriasis. This molecule is a couple hundred times more effective at inhibiting the PDE-4 receptor than either oral apremilast or topical crisaborole (Eucrisa). And as a once-daily topical agent with very little systemic absorption, roflumilast cream sidesteps the tolerability issues that accompany apremilast.

“Roflumilast is currently available as an oral formulation for treatment of [chronic obstructive pulmonary disease], so it has a fairly well-established safety profile,” noted Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

The 12-week, multicenter, phase 2b study sponsored by Arcutis Biotherapeutics included 331 patients with chronic plaque psoriasis who were randomized to once-daily 0.3% roflumilast cream, 0.15% roflumilast cream, or vehicle. Three-quarters of participants had baseline moderate disease.

A week-8 Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear skin or almost clear, plus at least a 2-grade improvement from baseline occurred in 32% of the high-dose roflumilast group, 25% of those on the 0.15% formulation, and 10% of controls. On the secondary endpoint of improvement in tough-to-treat intertriginous psoriasis, at week 12 an intertriginous IGA score of 0 or 1 plus at least a 2-point improvement from baseline was seen in 86% of the 0.3% roflumilast cream group, 50% on low-dose therapy, and 29% of controls. Moreover, the clinical improvements in IGA and itch kicked in quickly, with significant separation from placebo by week 2, Dr. Stein Gold noted.

The phase 3 program is now recruiting participants.

Dr. Strober and Dr. Stein Gold reported receiving research funding from and serving as consultants to Amgen and numerous other pharmaceutical companies.

MedscapeLive and this news organization are owned by the same parent company.

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Treatment pipeline holds promise for rosacea

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Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

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Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

Treatments in the pipeline may offer more options for rosacea sufferers, according to Linda Stein Gold, MD, director of clinical research, in the department of dermatology, Henry Ford Hospital in Detroit.

sruilk/shutterstock

In addition, topical minocycline has recently been approved by the Food and Drug Administration for the treatment of rosacea in a 1.5% foam formulation. “The reason it has taken so long to have a minocycline product is that it is challenging to deliver it topically,” she said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually. Studies of higher concentrations were not significantly better for rosacea, so development of the 1.5% foam was pursued, although a 4% foam is approved for the treatment of acne.

Dr. Stein Gold shared results from a pair of 12-week randomized trials in which significantly more patients treated with topical minocycline foam showed treatment success, compared with those on vehicle, based on Investigator’s Global Assessment (IGA) scores of clear or almost clear and a decrease of at least two grades from baseline: 52.1% versus 43.0% in one study and 49.1% versus 39.0% in the second, statistically significant differences. The product also was well tolerated, with most patients reporting no side effects or mild side effects.

Research on how to maximize effectiveness of available treatments such as ivermectin is ongoing, but several new treatments in the pipeline continue to show promising results, she noted.

An up-and-coming rosacea treatment is an old product used in a new way: Benzoyl peroxide in a microencapsulated form. “Benzoyl peroxide is encased in silica molecules that allow very slow release of the benzoyl peroxide into the skin and that leads to decreased irritation,” Dr. Stein Gold explained. The deposit of active ingredient on the skin appears to stay below the level of irritation.

Dr. Stein Gold and colleagues conducted two randomized, vehicle-controlled trials in which 733 adults with moderate to severe rosacea were treated with either the encapsulated benzoyl peroxide cream formulation or a vehicle applied once daily for 12 weeks.

At 12 weeks, IGA success increased over the course of the studies, and reached 43.5% in one and 50.1% in the other, compared with 16.1% and 25.9%, respectively, for the vehicle groups in those studies (P < .001 for both). Overall, she described this as “a nice improvement for a drug that we had not considered to be part of our treatment armamentarium for our rosacea patients.”

Dr. Stein Gold also shared data from a phase 2 study of low-dose oral minocycline in adults with papulopustular rosacea. A group of 200 patients used the drug or a placebo once daily for 16 weeks. The study examined 20-mg and 40-mg extended-release formulations, and found a significant improvement with the 40-mg dose over the 20-mg dose and over placebo, in terms of those who reached an IGA of 0 or 1, with a 2 grade improvement. While this is a phase 2 study, it may lead to oral minocycline as another treatment option, she said.

“It is an exciting time for the treatment of rosacea, with a variety of options and an active pipeline, so we can aim for clear skin for our patients,” she commented.

Dr. Stein Gold disclosed serving as an investigator and consultant for Galderma, Vyne, Sun, Sol Gel, and Almirall; she is a consultant and speaker for Ortho.

MedscapeLive and this news organization are owned by the same parent company.
 

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Merino wool clothing improves atopic dermatitis, studies find

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Mon, 11/23/2020 - 10:39

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

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Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

Conventional wisdom holds that patients with atopic dermatitis (AD) should shun wool clothing in favor of cotton or silk, because wool is said to be irritating and promote itching. But not so when the garments are made of fine-diameter fibers of merino wool, Joseph F. Fowler, Jr., MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually.

“We’ve always though that wool is bad in atopics, right? Indeed, rough wool might be. But fine wool garments can actually improve atopic dermatitis, probably because wool is the most breathable fabric and has the best temperature regulation qualities of any fabric we can wear,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky).

He was first author of a randomized, 12-week, crossover, assessor-blinded clinical trial which showed precisely that. And a second, similarly designed study, this one conducted in Australia, also concluded that fine merino wool assists in the management of AD.

The study by Dr. Fowler and coinvestigators included 50 children and adults with mild or moderate AD who either wore top-and-bottom base layer merino wool ensembles for 6 weeks and then switched to their regular nonwoolen clothing, or vice versa. The mean Eczema Area and Severity Index (EASI) score in those initially randomized to merino wool improved from a mean baseline of 4.5 to 1.7 at week 6, a significantly greater improvement than in the group wearing their regular clothing. Similarly, those who switched to merino wool after 6 weeks experienced a significant decrease in EASI scores from that point on to week 12, while those who switched from merino wool to their regular clothing did not.

Mean Dermatology Life Quality Index (DLQI) scores in patients who wore merino wool first improved from 6.9 at baseline to 3.4 at week 6. Those who wore their regular clothing first went from a mean baseline DLQI of 6.7 to 6.2 at week 6 – a nonsignificant change – but then improved to a week 12 mean DLQI of 3.7 while wearing wool. There was no improvement in DLQI scores while participants were wearing their regular clothing.

Static Investigator’s Global Assessment scores showed significantly greater improvement while patients wore merino wool garments than their regular clothing.

The Australian study included 39 patients with mild to moderate AD aged between 4 weeks and 3 years. This, too, was a 12-week, randomized, crossover, assessor-blinded clinical trial. Participating children wore merino wool for 6 weeks and cotton ensembles chosen by their parents for an equal time. The primary endpoint was change in the SCORing Atopic Dermatitis (SCORAD) index after each 6-week period. The mean 7.6-point greater SCORAD reduction at 6 weeks while wearing merino wool, compared with cotton, was “a pretty impressive reduction,” Dr. Fowler observed.

Reductions in the secondary endpoints of Atopic Dermatitis Severity Index and Infants’ Dermatitis Quality of Life Index while wearing merino wool followed suit. In contrast, switching from wool to cotton resulted in an increase in both scores. Also, use of topical corticosteroids was significantly reduced while patients wore merino wool.

Wool harvested from merino sheep is characterized by fine-diameter fibers. In Dr. Fowler’s study the mean fiber diameter was 17.5 mcm. This makes for a soft fabric with outstanding moisture absorbance capacity, a quality that’s beneficial in patients with AD, since their lesional skin loses the ability to regulate moisture, the dermatologist explained.

Both randomized trials were funded by Australian Wool Innovation and the Australian government.

MedscapeLive and this news organization are owned by the same parent company.
 

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Photosensitivity diagnosis made simple

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Fri, 11/20/2020 - 16:17

 

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

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Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

 

Some patients with photosensitivity disorders present with a rash, while others report a history of reactivity, said Vincent DeLeo, MD, of the University of Southern California, Los Angeles.

“When a patient comes in who makes you suspect a photosensitivity, there will be two different presentations,” he said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In some cases, the patient presents with a reaction they believe is sun related, although they don’t have a rash currently, he said. In other cases, “you as a good clinician suspect photosensitivity because the eruption is in a photo distribution,” although the patient may or may not relate it to sun exposure, he added.

Dr. DeLeo noted a few key points to include when taking the history in patients with likely photosensitivity, whether or not they present with a rash.

“I always ask patients when did the episode occur? Is it chronic?” Also ask about timing: Does the reaction occur in the sun, or later? Does it occur quickly and go away within hours, or occur within days or weeks of exposure?

“Always take a good drug history, as photosensitivity can often be related to drugs,” Dr. DeLeo noted. For example, approximately 50% of individuals on amiodarone will have some type of photosensitivity, he said.

Other drug-induced photosensitive conditions include drug-induced subacute cutaneous lupus and pseudoporphyria from NSAIDs, as well as hyperpigmentation from diltiazem, which most often occurs in Black women, he said.

“Photodrug reactions are usually related to UVA radiation, and that is important because you can develop it through the window while driving in your car”: The car windows do not protect against UVA, Dr. DeLeo said. If you have a patient who tells you about a photosensitivity or has a rash and they are on a photosensitizing drug, first rule out connective tissue disease, then discontinue the drug in collaboration with the patient’s internist and wait for the reaction to disappear, and it should, he said.

Some photosensitivity rashes have characteristic patterns, notably connective tissue disease patterns in lupus and dermatomyositis patients, bullous eruptions in cases of porphyria or phototoxic contact dermatitis, and eczematous eruptions, Dr. DeLeo noted.

Patients who present without a rash, but report a history of a reaction that they believe is related to sun exposure, fall into two categories: some had a rash that occurred while in the sun and disappeared quickly, and some had one that occurred hours or days after exposure and lasted a few days to weeks, said Dr. DeLeo.

The differential diagnosis in the patient with immediate photosensitivity is fairly clear: These patients usually have solar urticaria, he said. However, some lupus patients may report this reaction so it is important to rule out connective tissue disease. The diagnosis can be made with phototesting or do a simple test by having the patient sit out in the sunshine, he said.

For the patient who has a delayed reactivity after sun exposure, and doesn’t have the reaction when they come to the office, the differential diagnosis in a simply applied way is that, if the reaction spared the face, it is likely polymorphous light eruption (PMLE); but if the face is involved, the patient likely has photoallergic contact dermatitis, Dr. DeLeo explained. However, always consider the alternatives of connective tissue disease, drug reactions, and contact dermatitis that is not photoallergic, he noted.

PMLE “is the most common photosensitivity reaction that we see in the United States,” and it almost always occurs when people are away from home, usually on vacation, said Dr. DeLeo. The differential diagnosis for patients with recurrent or delayed rash involving the face could be photoallergic contact dermatitis, but rule out airborne contact dermatitis, personal care product contact dermatitis, and chronic actinic dermatitis, he said. A work-up for these patients could include a photo test, photopatch test, or patch test.

Dr. DeLeo disclosed serving as a consultant for Estee Lauder.

MedscapeLive and this news organization are owned by the same parent company.

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Sunscreen myths, controversies continue

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Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

A woman has sunscreen applied to her back.
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Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.



Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

 

 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

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Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

A woman has sunscreen applied to her back.
Aja Koska/Getty Images

Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.



Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

 

 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

Many myths persist about sunscreen use and safety, and further sunscreen regulations may be impacted by legislation in the wake of the ongoing COVID-19 pandemic, according to Steven Q. Wang, MD, director of dermatologic surgery and dermatology, Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J.

A woman has sunscreen applied to her back.
Aja Koska/Getty Images

Although sunscreens are regulated as an OTC drug under the Food and Drug Administration, concerns persist about the safety of sunscreen active ingredients, including avobenzone, oxybenzone, and octocrylene, Dr. Wang said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

In 2019, the FDA proposed a rule that requested additional information on sunscreen ingredients. In response, researchers examined six active ingredients used in sunscreen products. The preliminary results were published in JAMA Dermatology in 2019, with a follow-up study published in 2020 . The studies examined the effect of sunscreen application on plasma concentration as a sign of absorption of sunscreen active ingredients.
 

High absorption

Overall, the maximum level of blood concentration went above the 0.5 ng/mL threshold for waiving nonclinical toxicology studies for all six ingredients. However, the studies had several key limitations, Dr. Wang pointed out. “The maximum usage condition applied in these studies was unrealistic,” he said. “Most people when they use a sunscreen don’t reapply and don’t use enough,” he said.

Also, just because an ingredient is absorbed into the bloodstream does not mean it is toxic or harmful to humans, he said. Sunscreens have been used for 5 or 6 decades with almost zero reports of systemic toxicity, he observed.

The conclusions from the studies were that the FDA wanted additional research, but “they do not indicate that individuals should refrain from using sunscreen as a way to protect themselves from skin cancer,” Dr. Wang emphasized.



Congress passed the CARES Act in March 2020 to provide financial relief for individuals affected by the novel coronavirus, COVID-19. “Within that act, there is a provision to reform modernized U.S. regulatory framework on OTC drug reviews,” which will add confusion to the development of a comprehensive monograph about sunscreen because the regulatory process will change, he said.

In the meantime, confusion will likely increase among patients, who may, among other strategies, attempt to make their own sunscreen products at home, as evidenced by videos of individuals making their own products that have had thousands of views, said Dr. Wang. However, these products have no UV protection, he said.

For current sunscreen products, manufacturers are likely to focus on titanium dioxide and zinc oxide products, which fall into the GRASE I category for active ingredients recognized as safe and effective. More research is needed on homosalate, avobenzone, octisalate, and octocrylene, which are currently in the GRASE III category, meaning the data are insufficient to make statements about safety, he said.

Vitamin D concerns

Another sunscreen concern is that use will block healthy vitamin D production, Dr. Wang said. Vitamin D enters the body in two ways, either through food or through the skin, and the latter requires UVB exposure, he explained. “If you started using a sunscreen with SPF 15 that blocks 93% of UVB, you can essentially shut down vitamin D production in the skin,” but that is in the laboratory setting, he said. What happens in reality is different, as people use much less than in a lab setting, and many people put on a small amount of sunscreen and then spend more time in the sun, thereby increasing exposure, Dr. Wang noted.

For example, a study published in 1988 showed that long-term sunscreen users had levels of vitamin D that were less than 50% of those seen in non–sunscreen users. However, another study published in 1995 showed that serum vitamin D levels were not significantly different between users of an SPF 17 sunscreen and a placebo over a 7-month period.
 

 

 

Is a higher SPF better?

Many patients believe that the difference between a sunscreen with an SPF of 30 and 60 is negligible. “People generally say that SPF 30 blocks 96.7% of UVB and SPF 60 blocks 98.3%, but that’s the wrong way of looking at it,” said Dr. Wang. Instead, consider “how much of the UV ray is able to pass through the sunscreen and reach your skin and do damage,” he said. If a product with SPF 30 allows a transmission of 3.3% and a product with SPF 60 allows a transmission of 1.7%, “the SPF 60 product has 194% better protection in preventing the UV reaching the skin,” he said.

Over a lifetime, individuals will build up more UV damage with consistent use of SPF 30, compared with SPF 60 products, so this myth is important to dispel, Dr. Wang emphasized. “It is the transmission we should focus on, not the blockage,” he said.

Also, consider that the inactive ingredients matter in sunscreens, such as water resistance and film-forming technology that helps promote full coverage, Dr. Wang said, but don’t discount features such as texture, aesthetics, smell, and color, all of which impact compliance.

“Sunscreen is very personal, and people do not want to use a product just because of the SPF value, they want to use a product based on how it makes them feel,” he said.

At the end of the day, “the best sunscreen is the one a patient will use regularly and actually enjoy using,” Dr. Wang concluded.

Dr. Wang had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

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Expert shares key facts about keloid therapy

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Fri, 11/20/2020 - 14:26

Most patients who present to a dermatologist with a keloid say they want it gone “by whatever means possible, and yesterday,” although few understand what this process entails, according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

Hilary Baldwin, MD, Acne Treatment &amp; Research Center, Morristown, NJ and Brooklyn, NY
Dr. Hilary E. Baldwin

A key point to keep in mind about keloids is that, while they result from trauma, however slight, trauma alone does not cause them, Dr. Baldwin said in a presentation at the virtual MedscapeLive’s annual Las Vegas Dermatology Seminar.

In general, people with darker skin form keloids more easily and consistently than those with lighter skin, but keloids in people with darker skin are often easier to treat, Dr. Baldwin added. Also worth noting is the fact that earlobe keloids recur less frequently, she said.

Most patients with keloids are not surgical candidates, and they need convincing to pursue alternative options, Dr. Baldwin said.

However, successful management of keloids starts with sorting out what the patient wants. Some want “eradication with normal skin,” which is not realistic, versus simply flattening, lightening, or eradication of the keloid and leaving a scar, she noted. “That skin is never going to look normal,” she said. “Very often, they don’t need the whole thing gone, they just want to be better, and not itch or cause them to think about it all the time.”

Quality clinical research on the management of keloids is limited, Dr. Baldwin continued. “If you are holding out for a good randomized, placebo-controlled, double-blind study with a healthy ‘N,’ adequate follow-up rational conclusions, don’t hold your breath,” she said. The few literature reviews on keloids in recent decades concluded that modalities used to treat keloids are based on anecdotal evidence rather than rigorous research, she noted.
 

Size (and shape) matters

The decision to cut a keloid depends on several factors, including lesion size, shape, age, and location, but especially patient commitment to follow up and postsurgery care, said Dr. Baldwin.

She noted that larger keloids are no more difficult to remove than smaller ones, and patients tend to be more satisfied with the outcome with larger keloids. In terms of shape, pedunculated lesions are most amenable to surgery because of their small footprint. “Often the base does not contain keloidal tissue, and the patient gets the maximum benefit for the least risk,” she said. In addition, the residue from the removal of large keloids is often more acceptable.

Options for adjunctive therapy when excising keloids include corticosteroids, radiation, interferon, pressure dressings, dextran hydrogel scaffolding, and possibly botulinum toxin A, Dr. Baldwin said.
 

Adjunctive treatment alternatives

Intralesional corticosteroids can prevent the recurrence of keloids, and Dr. Baldwin recommends a 40 mg/cc injection into the base and walls of the excision site immediately postop, with repeat injections every 2 weeks for 2 months regardless of the patient’s clinical appearance. However, appearance determines the dose and concentration during 6 months of monthly follow-up, she said.

Radiation therapy, while not an effective monotherapy for keloids, can be used as an adjunct. A short radiation treatment plan may improve compliance, and no local malignancies linked to radiation therapy for keloids have been reported, she said. Dr. Baldwin also shared details of using an in-office superficial radiation therapy with the SRT-100 device, which she said has shown some ability to reduce recurrence of keloids.

Interferon, which can reduce production of collagen and increase collagenase can be used in an amount of 1.5 million units per linear cm around the base and walls of a keloid excision (maximum is 5 million units a day). Be aware that patients can develop flulike symptoms within a day or so, and warn patients to take it easy and monitor for symptoms, she said.

Studies of imiquimod for keloid recurrence have yielded mixed results, and a 2020 literature review concluded that it is not recommended as a treatment option for keloids, said Dr. Baldwin. Pressure dressings also have not shown effectiveness on existing lesions.

Botulinum toxin A has been studied as a way to prevent hypertrophic scars and keloids and potentially for preventing recurrence by injecting at the wound edges, she said. A meta-analysis showed that botulinum toxin was superior to corticosteroids for treating keloids, but “there were a lot of problems with the studies,” she said.

One other option for postexcision keloid treatment is dextran hydrogel scaffolding, which involves a triple-stranded collagen denatured by heat, with the addition of dextran to form a scaffold for fibroblasts, Dr. Baldwin said. This product, when injected prior to the final closure of surgical excision of keloids, may improve outcomes in certain areas, such as the earlobe, she said.

Dr. Baldwin concluded with comments about preventing other keloids from getting out of hand, which is extraordinarily challenging. However, treatment with dupilumab might provide an answer, although data are limited and more research is needed. She cited a case study of a male patient who had severe atopic dermatitis, with two keloids that improved after 7 months on dupilumab. The Th2 cytokines interleukin (IL)–4 and IL-13 have been implicated as key mediators in the pathogenesis of fibroproliferative disorders, which may respond to dupilumab, which targets Th2, she noted.

Dr. Baldwin had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

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Most patients who present to a dermatologist with a keloid say they want it gone “by whatever means possible, and yesterday,” although few understand what this process entails, according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

Hilary Baldwin, MD, Acne Treatment &amp; Research Center, Morristown, NJ and Brooklyn, NY
Dr. Hilary E. Baldwin

A key point to keep in mind about keloids is that, while they result from trauma, however slight, trauma alone does not cause them, Dr. Baldwin said in a presentation at the virtual MedscapeLive’s annual Las Vegas Dermatology Seminar.

In general, people with darker skin form keloids more easily and consistently than those with lighter skin, but keloids in people with darker skin are often easier to treat, Dr. Baldwin added. Also worth noting is the fact that earlobe keloids recur less frequently, she said.

Most patients with keloids are not surgical candidates, and they need convincing to pursue alternative options, Dr. Baldwin said.

However, successful management of keloids starts with sorting out what the patient wants. Some want “eradication with normal skin,” which is not realistic, versus simply flattening, lightening, or eradication of the keloid and leaving a scar, she noted. “That skin is never going to look normal,” she said. “Very often, they don’t need the whole thing gone, they just want to be better, and not itch or cause them to think about it all the time.”

Quality clinical research on the management of keloids is limited, Dr. Baldwin continued. “If you are holding out for a good randomized, placebo-controlled, double-blind study with a healthy ‘N,’ adequate follow-up rational conclusions, don’t hold your breath,” she said. The few literature reviews on keloids in recent decades concluded that modalities used to treat keloids are based on anecdotal evidence rather than rigorous research, she noted.
 

Size (and shape) matters

The decision to cut a keloid depends on several factors, including lesion size, shape, age, and location, but especially patient commitment to follow up and postsurgery care, said Dr. Baldwin.

She noted that larger keloids are no more difficult to remove than smaller ones, and patients tend to be more satisfied with the outcome with larger keloids. In terms of shape, pedunculated lesions are most amenable to surgery because of their small footprint. “Often the base does not contain keloidal tissue, and the patient gets the maximum benefit for the least risk,” she said. In addition, the residue from the removal of large keloids is often more acceptable.

Options for adjunctive therapy when excising keloids include corticosteroids, radiation, interferon, pressure dressings, dextran hydrogel scaffolding, and possibly botulinum toxin A, Dr. Baldwin said.
 

Adjunctive treatment alternatives

Intralesional corticosteroids can prevent the recurrence of keloids, and Dr. Baldwin recommends a 40 mg/cc injection into the base and walls of the excision site immediately postop, with repeat injections every 2 weeks for 2 months regardless of the patient’s clinical appearance. However, appearance determines the dose and concentration during 6 months of monthly follow-up, she said.

Radiation therapy, while not an effective monotherapy for keloids, can be used as an adjunct. A short radiation treatment plan may improve compliance, and no local malignancies linked to radiation therapy for keloids have been reported, she said. Dr. Baldwin also shared details of using an in-office superficial radiation therapy with the SRT-100 device, which she said has shown some ability to reduce recurrence of keloids.

Interferon, which can reduce production of collagen and increase collagenase can be used in an amount of 1.5 million units per linear cm around the base and walls of a keloid excision (maximum is 5 million units a day). Be aware that patients can develop flulike symptoms within a day or so, and warn patients to take it easy and monitor for symptoms, she said.

Studies of imiquimod for keloid recurrence have yielded mixed results, and a 2020 literature review concluded that it is not recommended as a treatment option for keloids, said Dr. Baldwin. Pressure dressings also have not shown effectiveness on existing lesions.

Botulinum toxin A has been studied as a way to prevent hypertrophic scars and keloids and potentially for preventing recurrence by injecting at the wound edges, she said. A meta-analysis showed that botulinum toxin was superior to corticosteroids for treating keloids, but “there were a lot of problems with the studies,” she said.

One other option for postexcision keloid treatment is dextran hydrogel scaffolding, which involves a triple-stranded collagen denatured by heat, with the addition of dextran to form a scaffold for fibroblasts, Dr. Baldwin said. This product, when injected prior to the final closure of surgical excision of keloids, may improve outcomes in certain areas, such as the earlobe, she said.

Dr. Baldwin concluded with comments about preventing other keloids from getting out of hand, which is extraordinarily challenging. However, treatment with dupilumab might provide an answer, although data are limited and more research is needed. She cited a case study of a male patient who had severe atopic dermatitis, with two keloids that improved after 7 months on dupilumab. The Th2 cytokines interleukin (IL)–4 and IL-13 have been implicated as key mediators in the pathogenesis of fibroproliferative disorders, which may respond to dupilumab, which targets Th2, she noted.

Dr. Baldwin had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

Most patients who present to a dermatologist with a keloid say they want it gone “by whatever means possible, and yesterday,” although few understand what this process entails, according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

Hilary Baldwin, MD, Acne Treatment &amp; Research Center, Morristown, NJ and Brooklyn, NY
Dr. Hilary E. Baldwin

A key point to keep in mind about keloids is that, while they result from trauma, however slight, trauma alone does not cause them, Dr. Baldwin said in a presentation at the virtual MedscapeLive’s annual Las Vegas Dermatology Seminar.

In general, people with darker skin form keloids more easily and consistently than those with lighter skin, but keloids in people with darker skin are often easier to treat, Dr. Baldwin added. Also worth noting is the fact that earlobe keloids recur less frequently, she said.

Most patients with keloids are not surgical candidates, and they need convincing to pursue alternative options, Dr. Baldwin said.

However, successful management of keloids starts with sorting out what the patient wants. Some want “eradication with normal skin,” which is not realistic, versus simply flattening, lightening, or eradication of the keloid and leaving a scar, she noted. “That skin is never going to look normal,” she said. “Very often, they don’t need the whole thing gone, they just want to be better, and not itch or cause them to think about it all the time.”

Quality clinical research on the management of keloids is limited, Dr. Baldwin continued. “If you are holding out for a good randomized, placebo-controlled, double-blind study with a healthy ‘N,’ adequate follow-up rational conclusions, don’t hold your breath,” she said. The few literature reviews on keloids in recent decades concluded that modalities used to treat keloids are based on anecdotal evidence rather than rigorous research, she noted.
 

Size (and shape) matters

The decision to cut a keloid depends on several factors, including lesion size, shape, age, and location, but especially patient commitment to follow up and postsurgery care, said Dr. Baldwin.

She noted that larger keloids are no more difficult to remove than smaller ones, and patients tend to be more satisfied with the outcome with larger keloids. In terms of shape, pedunculated lesions are most amenable to surgery because of their small footprint. “Often the base does not contain keloidal tissue, and the patient gets the maximum benefit for the least risk,” she said. In addition, the residue from the removal of large keloids is often more acceptable.

Options for adjunctive therapy when excising keloids include corticosteroids, radiation, interferon, pressure dressings, dextran hydrogel scaffolding, and possibly botulinum toxin A, Dr. Baldwin said.
 

Adjunctive treatment alternatives

Intralesional corticosteroids can prevent the recurrence of keloids, and Dr. Baldwin recommends a 40 mg/cc injection into the base and walls of the excision site immediately postop, with repeat injections every 2 weeks for 2 months regardless of the patient’s clinical appearance. However, appearance determines the dose and concentration during 6 months of monthly follow-up, she said.

Radiation therapy, while not an effective monotherapy for keloids, can be used as an adjunct. A short radiation treatment plan may improve compliance, and no local malignancies linked to radiation therapy for keloids have been reported, she said. Dr. Baldwin also shared details of using an in-office superficial radiation therapy with the SRT-100 device, which she said has shown some ability to reduce recurrence of keloids.

Interferon, which can reduce production of collagen and increase collagenase can be used in an amount of 1.5 million units per linear cm around the base and walls of a keloid excision (maximum is 5 million units a day). Be aware that patients can develop flulike symptoms within a day or so, and warn patients to take it easy and monitor for symptoms, she said.

Studies of imiquimod for keloid recurrence have yielded mixed results, and a 2020 literature review concluded that it is not recommended as a treatment option for keloids, said Dr. Baldwin. Pressure dressings also have not shown effectiveness on existing lesions.

Botulinum toxin A has been studied as a way to prevent hypertrophic scars and keloids and potentially for preventing recurrence by injecting at the wound edges, she said. A meta-analysis showed that botulinum toxin was superior to corticosteroids for treating keloids, but “there were a lot of problems with the studies,” she said.

One other option for postexcision keloid treatment is dextran hydrogel scaffolding, which involves a triple-stranded collagen denatured by heat, with the addition of dextran to form a scaffold for fibroblasts, Dr. Baldwin said. This product, when injected prior to the final closure of surgical excision of keloids, may improve outcomes in certain areas, such as the earlobe, she said.

Dr. Baldwin concluded with comments about preventing other keloids from getting out of hand, which is extraordinarily challenging. However, treatment with dupilumab might provide an answer, although data are limited and more research is needed. She cited a case study of a male patient who had severe atopic dermatitis, with two keloids that improved after 7 months on dupilumab. The Th2 cytokines interleukin (IL)–4 and IL-13 have been implicated as key mediators in the pathogenesis of fibroproliferative disorders, which may respond to dupilumab, which targets Th2, she noted.

Dr. Baldwin had no relevant financial conflicts to disclose.

MedscapeLive and this news organization are owned by the same parent company.

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